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Salbutamol
Guaifenesin
Ventolin® Expectorant
PRODUCT DESCRIPTION
Salbutamol + Guaifenesin (Ventolin® Expectorant) Capsule: Grey and blue, hard gelatin capsules marked with ‘VENTOLIN
EXPECTORANT’ and ‘GlaxoSmithKline’. Each capsule contains 100mg Guaifenesin and 2mg Salbutamol (as sulfate).
Salbutamol + Guaifenesin (Ventolin® Expectorant) Syrup Sugar Free: Each 5mL of orange flavored syrup contains 50mg
Guaifenesin and 1.0mg Salbutamol (as sulfate).
PHARMACOLOGICAL PROPERTIES
Mechanism of action
Salbutamol is a selective beta- 2 adrenoceptor agonist. At therapeutic doses it acts on the beta- 2 adrenoceptors of bronchial
muscle.
Guaifenesin can make the viscous mucus of the respiratory pathway more fluid and therefore expectoration and reduces cough.
Pharmacodynamic Effects
Salbutamol is a selective beta2-adrenoceptor agonist. At therapeutic doses it acts on the beta2-adrenoceptors of bronchial muscle
providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction.
Pharmacokinetics
Absorption
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism
to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine.
Guaiphenesin is well-absorbed after oral administration. After the administration of 600 mg guaiphenesin in healthy adult
volunteers the Cmax was approx 1.4 micrograms/ml with Tmax about 15 minutes after drug administration.
Distribution
The bioavailability of orally adminisstered salbutamol is about 50%. Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the
inactive 4’-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine.
Guaiphenesin has a plasma half-life of approx 1 hour and was not detectable in the blood after 8 hours. Guaiphenesin appears to
undergo both oxidation and demethylation.
Elimination
The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. The faeces are a
minor route of excretion.
Guaiphenesin is excreted in urine.
Non-clinical Information
In common with other potent selective beta- 2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given
subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5mg/kg, 4 times the maximum
human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no
significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of
lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50mg/kg/day, 78 times
the maximum human oral dose.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of salbutamol up to 50 mg/kg.
Animal studies on guaiphenesin to assess carcinogenicity, genotoxicity, or effects on fertility or embryo-fetal development have not
been performed.
INDICATIONS
Salbutamol is a selective beta- 2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short
acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma
unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to
respond to treatment with salbutamol may signal a need for urgent medical advice or treatment.
The combination of salbutamol with guaifenesin is designed to relieve respiratory obstruction and improve pulmonary ventilation.
Respiratory disorders where bronchospasm and excessive secretion of tenacious mucus are complicating factors, e.g. bronchial
asthma, chronic bronchitis and emphysema.
DOSAGE AND ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta- 2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient’s
therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be
increased on medical advice.
Populations
The volumes of syrup quoted are based on a formulation strength of 2 mg salbutamol per 10 ml of syrup.
•
Adults
10 to 20 ml of expectorant syrup (2 to 4 mg salbutamol) 2 or 3 times a day.
•
Children
2 to 6 years:
5 to 10 ml of expectorant syrup (1 to 2 mg salbutamol) 2 or 3 times daily.
6 to 12 years:
10 ml of expectorant syrup (2 mg salbutamol) 2 or 3 times daily.
Over 12 years:
10 to 20 ml of expectorant syrup (2 to 4 mg salbutamol) 2 or 3 times daily.
Special patient groups
In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to
initiate treatment with 10 ml of syrup (2 mg salbutamol) 3 or 4 times per day.
Salbutamol + Guaifenesin (Ventolin® Expectorant) Capsule
The capsule may be swallowed whole or the contents may be dispersed in a little water to produce a pleasantly flavoured
suspension, if preferred.
Adults & Children over 12 years: 1-2 capsules two 2 or three 3 times a day.
Children 6-12 years: 1 capsule two or three times a day.
Below 6 years: Not recommended.
CONTRAINDICATIONS
Salbutamol + Guaifenesin (Ventolin® Expectorant) is contraindicated in patients with a history of hypersensitivity to any ingredient
of the preparation.
Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.
WARNINGS & PRECAUTIONS
General
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically
and by lung function tests. Increasing use of short-acting inhaled beta- 2 agonists to control symptoms indicates deterioration of
asthma control. Under these conditions, the patient’s therapy plan should be reassessed. Sudden and progressive deterioration
in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy.
In patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not
increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta- 2 agonist therapy mainly from parenteral and nebulised administration.
Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine
derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin®) can induce reversible metabolic changes, for example
increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has
been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Long term treatment with salbutamol and guaiphenesin expectorant syrup (sugar-containing formulation) increases the risk of
dental caries. It is important that adequate dental hygiene is maintained.
Effects on Ability to Drive and Use Machines
None reported.
DRUG INTERACTIONS
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see
Non-clinical Information). There is no information on the effects of guaiphenesin on human fertility.
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any
possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have
been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications
during their pregnancies. Because no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies
is 2-3%, a relationship with salbutamol use cannot be established.
The safety of guaiphenesin during pregnancy has not been established.
Lactation
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits
outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
ADVERSE EFFECTS
As the combination product contains salbutamol and guaifenesin, the type and severity of adverse reactions associated with each
of the components may be expected. The adverse reaction profile is derived from the individual components since there are
limited clinical and post marketing reports available for the combination product.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10),
common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including
isolated reports. Very common and common reactions were generally determined from clinical trial data. Rare and very rare
reactions were generally determined from spontaneous data.
Salbutamol
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension
and collapse.
Metabolism and nutrition disorders
Rare:
Hypokalaemia.
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Nervous system disorders
Very common:
Tremor.
Common:
Headache.
Very rare:
Hyperactivity.
Cardiac disorders
Common:
Tachycardia, palpitations.
Rare:
Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and
extrasystoles.
Vascular disorders:
Rare:
Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common:
Muscle cramps.
Very rare:
Feeling of muscle tension.
Guaiphenesin
Immune system disorders
Unknown:
Hypersensitivity and allergic reactions including anaphylactic reactions, angioedema, rash,
urticaria and dyspnoea.
Gastrointestinal disorders
Unknown:
nausea, vomiting, abdominal discomfort.
OVERDOSAGE AND TREATMENT
Overdosage
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events
(see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist
therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or
worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of
overdose.
Very large doses of guaiphenesin cause nausea and vomiting.
Treatment
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
INCOMPATIBILITY
Salbutamol + Guaifenesin (Ventolin® Expectorant) syrup: Dilution with Syrup BP or Sobitol solution is not recommended as this
may result in precipitation of the cellulose thickening agent. Admixture of Salbutamol + Guaifenesin (Ventolin® Expectorant) Syrup
with other liquid preparations is not recommended.
Excipients
Hydroxypropyl methylcellulose
Sodium benzoate
Saccharin sodium
Lactic acid
Orange flavour (IFF 17.40.0095)
Mint Essence
Silica
Maize starch
Purified water
STORAGE CONDITION
Salbutamol + Guaifenesin (Ventolin® Expectorant) Capsule: Store at temperatures not exceeding 30oC.
Salbutamol + Guaifenesin (Ventolin® Expectorant) Syrup: Stored at a temperatures not exceeding 30oC. Protect from light.
INSTRUCTION FOR USE/HANDLING
Dilution:
Sugar-free formulation:
Salbutamol and guaiphenesin expectorant syrup may be diluted with Purified Water BP. The resulting mixture should be protected
from light and used within 28 days.
A 50% v/v dilution of salbutamol and guaiphenesin expectorant syrup has been shown to be adequately preserved against
microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water BP
used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.
AVAILABILITY
Ventolin® Expectorant Capsule: Strip foil by 10’s (Box of 50’s)
Ventolin® Expectorant Syrup Sugar Free: Bottles of 60 and 120mL.
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN is a registered trademark of the GlaxoSmithKline group of companies.
© 2014, GlaxoSmithKline group of companies. All rights reserved.
Version number: GDS16
Revision date: 05 February 2014
Manufactured by: SmithKline Beecham
Don Celso Tuason Avenue, Cainta, Rizal, Philippines
For:
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
Salbutamol sulphate
Ventolin®
2mg Tablet
PRODUCT DESCRIPTION
Each white, circular, flat faced tablet with bevelled edges, engraved on one face with “GX/CN3” contains 2mg salbutamol,
as sulphate.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of
bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction.
Pharmacokinetics
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism
to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route
of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours.
Salbutamol is bound to plasma proteins to the extent of 10%.
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass
metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine. The
bioavailability of orally administered salbutamol is about 50%.
Pre-clinical Safety Data
In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice
when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5mg/kg, 4
times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally
throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal
mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial
malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of Salbutamol (Ventolin®) up to
50 mg/kg.
INDICATIONS
Salbutamol (Ventolin®) is a selective beta-2 adrenoceptor agonist indicated for the treatment or prevention of
bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis
and emphysema.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent
asthma unresponsive to Salbutamol (Ventolin®), treatment with inhaled corticosteroids is recommended to achieve and
maintain control. Failing to respond to treatment with Salbutamol (Ventolin®) may signal a need for urgent medical advice
or treatment.
Salbutamol (Ventolin®) tablets are indicated for the relief of bronchospasm in bronchial asthma of all types, chronic
bronchitis and emphysema.
DOSAGE AND ADMINISTRATION
Salbutamol (Ventolin®) has a duration of action of 4 to 6 hours in most patients.
Increasing use of β2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's
therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only
be increased on medical advice.

Adults
The usual effective dose is 4 mg (2 tablets) 3 or 4 times per day.
If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8 mg (4 tablets).
Some patients obtain adequate relief with 2 mg (1 tablet) 3 or 4 times daily.

Children
2 - 12 years
2 mg (1 tablet) 3 or 4 times daily.
Over 12 year
2 to 4 mg (1 to 2 tablets) 3 or 4 times daily.

Special patient groups
In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate
treatment with 2 mg (1 tablet) salbutamol 3 or 4 times per day.
CONTRAINDICATIONS
Salbutamol (Ventolin®) Tablets are contra-indicated in patients with a history of hypersensitivity to any of their
components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
WARNINGS AND PRECAUTIONS
The management of asthma should normally follow a stepwise programme, and patient response should be monitored
clinically and by lung function tests.
Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control.
Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma
control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In
patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should
not increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol (Ventolin®) should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised
administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant
treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are
monitored in such situations.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin®) can induce reversible metabolic changes, for
example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of
ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Effects on Ability to Drive and Use Machines
None reported
DRUG INTERACTIONS
Salbutamol (Ventolin®) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed
together.
Salbutamol (Ventolin®) is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in
animals (see Pre-clinical Safety Data).
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than
any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb
defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking
multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for
congenital anomalies is 2 to 3%, a relationship with salbutamol use cannot be established.
Lactation
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected
benefits outweigh any potential risk.
It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
ADVERSE EFFECTS
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common
(1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to 1/1000) and very rare
(1/10,000) including isolated reports. Very common and common reactions were generally determined from clinical trial
data. Rare and very rare reactions were generally determined from spontaneous data.
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders
Rare:
Hypokalaemia.
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Nervous system disorders
Very common:
Tremor.
Common:
Headache.
Very rare:
Hyperactivity.
Cardiac disorders
Common:
Tachycardia, palpitations.
Rare:
Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular disorders
Rare:
Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common:
Muscle cramps.
Very rare:
Feeling of muscle tension.
OVERDOSAGE AND TREATMENT
The most common signs and symptoms of overdose with Salbutamol (Ventolin®) are transient beta agonist
pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdose with Salbutamol (Ventolin®). Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting betaagonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is
persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be
indicated in the setting of overdose.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has
been taken via the oral route.
Treatment
Further management should be as clinically indicated or as recommended by the national poisons centre, where
available.
STORAGE CONDITIONS
Store at temperatures not exceeding 30oC.
AVAILABILITY
Salbutamol (Ventolin®) 2mg Tablet: 10 tablets per foil strip (box of 100s).
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN is a registered trademark of the GlaxoSmithKline group of companies
©2014, GlaxoSmithKline. All rights reserved.
Version number: GDS21/IPI06
Imported by:
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
Mfd by:
Aspen Bad Oldesloe GmbH
Bad Oldesloe, Germany
Revision date: 05 Feb 2014
Salbutamol sulphate
Ventolin®
2mg/5mL Syrup
Anti-asthma
PRODUCT DESCRIPTION
Salbutamol (Ventolin®) 2mg/5mL Syrup, orange flavour: Each 5mL of orange flavoured, orange-coloured, sugar-free
syrup contains 2mg Salbutamol (as sulfate).
PHARMACOLOGIC PROPERTIES
Pharmacodynamics
Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of
bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction.
Pharmacokinetics
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by
metabolism to the inactive 4'-0- sulphate (phenolic sulphate) which is also excreted primarily in the urine.
The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by
inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass
metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine. The
bioavailability of orally administered salbutamol is about 50%.
Pre-clinical Safety Data
In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice
when given subcutaneously. In a reproductive study, 9.3% of foetuses are found to have cleft palate, at 2.5mg/kg, 4
times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally
throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal
mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed
cranial malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of Salbutamol (Ventolin®) up
to 50 mg/kg.
INDICATIONS
Salbutamol (Ventolin®) is a selective beta-2 adrenoceptor agonist indicated for the treatment or prevention of
bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic
bronchitis and emphysema.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with
persistent asthma unresponsive to Salbutamol (Ventolin®), treatment with inhaled corticosteroids is recommended to
achieve and maintain control. Failing to respond to treatment with Salbutamol (Ventolin®) may signal a need for
urgent medical advice or treatment.
Salbutamol (Ventolin®) syrup is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic
bronchitis and emphysema.
Salbutamol (Ventolin®) Syrup is suitable oral therapy for children or those adults who prefer liquid medicines.
DOSAGE AND ADMINISTRATION
Salbutamol (Ventolin®) has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-2 agonists may be a sign of worsening asthma.
Under these conditions a reassessment of the patient's therapy plan may be required and concomitant
glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should
only be increased on medical advice.

Adults
The usual effective dose is 10ml salbutamol (4 mg of salbutamol) 3 or 4 times per day. If adequate bronchodilation is
not obtained each single dose may be gradually increased to as much as 20ml of syrup (8 mg salbutamol).
Some patients obtain adequate relief with 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily).

Children
2-6 years 2.5 to 5ml of syrup (1 to 2 mg salbutamol) 3 or 4 times daily.
6-12 years 5ml of syrup (2 mg salbutamol) 3 or 4 times daily.
Over 12 years 5 to 10ml of syrup (2 to 4 mg salbutamol) 3 or 4 times daily.

Special patient groups
In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to
initiate treatment with 5ml of syrup (2 mg salbutamol) 3 or 4 times per day.
CONTRAINDICATIONS
Salbutamol (Ventolin®) Syrup is contraindicated in patients with a history of hypersensitivity to any of its components.
Non-i.v. formulations of Salbutamol (Ventolin®) must not be used to arrest uncomplicated premature labour or
threatened abortion.
WARNINGS AND PRECAUTIONS
The management of asthma should normally follow a stepwise programme, and patient response should be
monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 agonists to control
symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be
reassessed. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration
should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow
monitoring may be instituted.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they
should not increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol (Ventolin®) should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised
administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant
treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium
levels are monitored in such situations.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin®) can induce reversible metabolic changes,
for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the
development of ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this
effect.
Long term treatment with Salbutamol (Ventolin®) Syrup (Sugar-containing formulation) increases the risk of dental
caries. It is important that adequate dental hygiene is maintained.
Effects on Ability to Drive and Use Machines
None Reported.
DRUG INTERACTIONS
Salbutamol (Ventolin®) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed
together.
Salbutamol (Ventolin®) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in
animals (see Pre-clinical Safety Data).
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater
than any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb
defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were
taking multiple medications during their pregnancies.
As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a
relationship with salbutamol use cannot be established.
Lactation
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected
benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the
neonate.
ADVERSE EFFECTS
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common
(1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to 1/1000) and very rare
(1/10,000) including isolated reports. Very common and common reactions were generally determined from clinical
trial data. Rare and very rare reactions were generally determined from spontaneous data.
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm,
hypotension and collapse.
Metabolism and nutrition disorders
Rare:
Hypokalaemia.
Potentially serious hypokalaemia may result from beta2 agonist therapy.
Nervous system disorders
Very common:
Tremor.
Common:
Headache.
Very rare:
Hyperactivity.
Cardiac disorders
Common:
Tachycardia, palpitations.
Rare:
Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and
extrasystoles.
Vascular disorders
Rare:
Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common:
Muscle cramps.
Very rare:
Feeling of muscle tension.
OVERDOSAGE AND TREATMENT
The most common signs and symptoms of overdose with Salbutamol (Ventolin®) are transient beta agonist
pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdose with Salbutamol (Ventolin®). Serum potassium levels should be
monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting
beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly
if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as
wheezing) may be indicated in the setting of overdose.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when Salbutamol
(Ventolin®) overdose has been taken via the oral route.
Treatment
Further management should be as clinically indicated or as recommended by the national poisons centre, where
available.
Incompatibilities
Salbutamol (Ventolin®) Syrup, orange flavour (Sugar-free formulation):
Dilution of Salbutamol (Ventolin®) Syrup with Syrup BP or Sorbitol solution is not recommended as this may result in
precipitation of the cellulose thickening agent.
STORAGE CONDITION
Salbutamol (Ventolin®) Syrup, orange flavour: Store below 30ºC. Protect from light.
INSTRUCTIONS FOR USE/HANDLING
Dilution:
Salbutamol (Ventolin®) Syrup, orange flavour (Sugar-free formulation):
May be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within
28 days.
A 50% v/v dilution of Salbutamol (Ventolin®) Syrup has been shown to be adequately preserved against microbial
contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water
used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.
Admixture of Salbutamol (Ventolin®) Syrup with other liquid preparation is not recommended.
AVAILABILITY
Salbutamol (Ventolin®) 2mg/5mL syrup, orange flavour: Bottles of 60mL
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN is a registered trademark of the GlaxoSmithKline group of companies
©2014, GlaxoSmithKline. All rights reserved.
Version number: GDS21/IPI05
Revision date: 05 February 2014
Mfd by:
SmithKline Beecham
Don Celso Tuason Avenue, Cainta, Rizal, Philippines
for
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
2
LEAGSK012
LEAGSK012
GSK-ContractMfg-Eur-UK-
UnitedKingdom-Sovrin-Slough
*Multi-MarketCentral-GEXP;Angola-AGO;Burundi-BDI;Cambodia-KHM;
Egypt-EGY;Indonesia-IDN;Kenya-KEN;Myanmar-MMR;Pakistan-PAK;
Philippines-PHL;Rwanda-RWA;Uganda-UGA;Vietnam-VNM
VENTOLIN ROTAHALER
Ventolin
VENTOLIN ROTAHALER
1
K
0003201
Page1of2
TEXT SIZE CONTAINED IN THIS ARTWORK
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Leading: 8.0pt
Horizontal Scale: 85%
Smallest text size: 8.0pt
Microtext: No
English
Instructions for use
How to use your VENTOLIN ROTAHALER
1 Check that your ROTAHALER mouthpiece is clean, dry and free from
objects.
Hold the white end in one hand and turn the blue end as far as it
will go.
2 Push the ROTACAPS capsule into the raised hole at the blue end
of your ROTAHALER. The capsule should be pushed clear end first until
the top is level with the top of the hole.
3 Hold your ROTAHALER horizontally with the moulded line at the
top. Turn the blue end back the other way as far as it will go. This
opens the capsule.
Keep your ROTAHALER horizontal.
4 Hold your ROTAHALER away from your mouth. Breathe out fully.
Place the white end of your ROTAHALER in your mouth between
your teeth and lips. Take one quick, deep breath through the
mouthpiece. Hold this breath for as long as is comfortable or at least a
few seconds.
Remove the ROTAHALER from your mouth and exhale.
5 Pull the 2 halves of the ROTAHALER apart and throw away the capsule.
Make sure you have removed both parts of the capsule before taking
your next dose.
If your doctor has told you to take 2 capsules, wait about 30 seconds
before you take another capsule by repeating steps 2-4 above.
Keep your ROTAHALER clean and dry at all times and away from excessive heat.
How to clean your VENTOLIN ROTAHALER
Clean your ROTAHALER every 2 weeks.
• Pull the 2 halves apart and throw away the empty ROTACAPS capsule.
• Wash the 2 halves in warm water and dry thoroughly before
reassembling it.
Replace your ROTAHALER after 6 months.
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS and ROTAHALER are trade marks of the GSK group
of companies.
© 2014 GSK group of companies. All rights reserved.
Français
Mode d’emploi
Comment utiliser votre VENTOLIN ROTAHALER
1 Assurez-vous que l’embout buccal de votre ROTAHALER est propre et sec
et libre de tout objet.
Tenez l’extrémité blanche d’une main et faites pivoter l’extrémité
bleue jusqu’à ce qu’elle s’arrête.
2 Enfoncez une capsule ROTACAPS dans l’extrémité bleue de votre
ROTAHALER Vous devez enfoncer en premier le bout transparent de la
capsule jusqu´à ce qu’elle soit au niveau du haut du trou.
3 Maintenez votre ROTAHALER à l’horizontale, baguette au-dessus.
Faites pivoter l’extrémité bleue jusqu’à ce qu’elle s’arrête. Ceci
ouvrera la capsule.
Gardez votre ROTAHALER à l’horizontale
4 Tenez votre ROTAHALER loin de votre bouche. Expirez complètement.
Placez l’extrémité blanche de votre ROTAHALER dans votre bouche
entre vos dents et vos lèvres. Inspirez rapidement et profondément.
Retenez votre souffle aussi longtemps que vous le pourrez ou pendant
quelques secondes.
Retirez le ROTAHALER de votre bouche et expirez.
5 Séparez les deux moitiés du ROTAHALER et jeter la capsule. Assurez-vous
que les deux parties de la capsule soient retirées avant de prendre la dose
suivante.
Si votre médecin vous a dit de prendre deux capsules, attendez environ
30 secondes avant de prendre une autre capsule en répétant les étapes
2 jusqu’à 4 ci-dessus.
Conservez votre ROTAHALER aussi propre et sec que possible et à l'écart
d'une température trop élevée.
Comment nettoyer votre VENTOLIN ROTAHALER
Nettoyez votre ROTAHALER toutes les deux semaines.
• Séparez les deux moitiés et jetez la capsule ROTACAPS vide.
• Lavez les deux moitiés à l’eau tiède et séchez-les complétement avant
de les réassembler.
Remplacez votre ROTAHALER après 6 mois d’utilisation.
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS et ROTAHALER sont des marques déposées des
sociétés du groupe GSK.
© 2014 GSK. Tous droits réservés.
Español
Instrucciones de uso
Cómo utilizar VENTOLIN ROTAHALER
1 Verifique que la boquilla del ROTAHALER esté limpia, seca y libre de objetos.
Sostenga el extremo blanco con una mano y gire el extremo azul tanto
como sea posible.
2 Introduzca la cápsula ROTACAPS por la abertura que sobresale en el
extremo azul del ROTAHALER. Debe empujarse la cápsula introduciendo el
extremo transparente primero hasta que la parte superior de la cápsula quede
al mismo nivel que el borde superior de la abertura.
3 Sostenga el ROTAHALER en posición horizontal con la línea moldeada
hacia arriba. Vuelva a girar el extremo azul en el sentido contrario
tanto como sea posible. Este movimiento abrirá la cápsula.
Mantenga el ROTAHALER en posición horizontal.
4 Sostenga el ROTAHALER lejos de la boca. Exhale profundamente.
Colóquese el extremo blanco del ROTAHALER en la boca, entre los
dientes y los labios. Realice una inhalación profunda y rápida a través de
la boquilla. Contenga la respiración todo el tiempo que pueda hacerlo con
comodidad, o al menos durante algunos segundos.
Remueva el ROTAHALER de la boca y exhale.
5 Hale de las 2 mitades del ROTAHALER para separarlas y deseche la
cápsula. Asegúrese de retirar ambas partes de la cápsula antes de tomar
su siguiente dosis.
Si su médico le ha indicado que tome dos cápsulas, espere 30 segundos antes
de administrar otra cápsula, repitiendo los pasos 2 a 4 indicados anteriormente.
Mantenga el ROTAHALER limpio y seco en todo momento, alejado del calor
excesivo.
Cómo limpiar VENTOLIN ROTAHALER
Limpie el ROTAHALER cada 2 semanas.
• Hale de las dos mitades para separarlas y deseche la cápsula vacía
ROTACAPS.
• Lave las dos mitades con agua tibia y séquelas bien antes de volver a
ensamblar las piezas.
Reemplace el ROTAHALER después de 6 meses.
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Alemania
VENTOLIN, ROTACAPS y ROTAHALER son marcas comerciales del grupo de
compañías GSK.
© 2014 Grupo de compañías GSK. Todos los derechos reservados.
Kinyarwanda
Uburyo bwo gukoresha VENTOLIN™ ROTAHALER™ yawe
1 Reba neza ko igice cyo kumunwa cya ROTAHALER™ yawe
gisuk:uye,cyumutse kandi kidakorwaho n’ibintu.
Fata mu kuboko kumwe uhindukize umusozo w’ubururu kugeza aho
ishobora kugera.
2 Sunikira ikinini cya ROTACAPS™ mu ntoboro iri ku musozo w’ubururu wa
ROTAHALER™ yawe. Bisabwa ko ikinini gisunikwa neza kugeza aho igice
cyo hejuru kiringanira n’igice cyo hejuru cy’intoboro.
3 Fata ROTAHALER™ yawe itambitse hejuru ku murongo w’utudomo.
Hindukiza umusozo w’ubururu isubire abo yari iri kandi igere abo abo
ishobora kugera basboboka. Ibyo bizatuma ikinini gifunguka
Komeza ufate ROTAHALER yawe itambitse
4 Fata ROTAHALER™ yawe uyivanye ku munwa: Sobora umwuka bibagije.
Sbyira igice cy’umweru cya ROTAHALER™ ku munwa wawe hagati
y’amenyo n’iminwa. Humeka rimwe wihuse, umwuka muremure unyujije
ku kanwa. Komeza uwo mwuka utuze mu gihe gishoboka byibura
amasegoda make.
Vana ROTAHALER™ yawe ku munwa maze uhumeke.
5 Tandukanya ibice 2 bya ROTAHALER™ kandi ute igipfundikizo. Genzura
neza niba wavanyemo ibice 2 byose by’ikinini mbere yo kunywa doze
yawe ikurikira.
Nibawarabwiwe na muganga wawe gufata ibinini 2,rindira hashire
amasegonda hafi 30 mbere yo kunywa ikindi kinini mu buryo bwo
gusubiramo ibwirizwa rya 2-4
Uburyo bwo gusukura VENTOLIN™ ROTAHALER™ yawe
Bika ROTAHALER™ yawe ifite isuku , yumutse ibihe byose kandi kure
y’ubushyuhe
Korera isuku ROTAHALER™ yawe buri byumweru 2
• Tandukanya ibice bibiri bingana ubundi ute igipfundikizo cya
ROTACAPS™ kirimo ubusa
• Oza ivyo bice bibiri bingana mu mazi ashyushye kandi ubyumutse
neza mbere yo kongera kubifatanya.
Simbuza ROTAHALER™ nyuma ya buri mezi 6
Glaxo Wellcome GmbH & Co. KG
Industriestraβe 32- 36
23843 Bad Oldesloe
Germany
GSK yiemeje gukusanya no kugenzura niu buryo butunganye amakuru
yerekeye ibicuruzwa kandi dukangurira impuguke mu by’ubuzima
gutanga raporo z’ingaruka kuri izi nomero: + 254 20 6933 200 cyangwa
kuri [email protected]
VENTOLIN, ROTACAPS na ROTAHALER ni marike y’ibicuruzwa
by’ishyirahamwe ry’amakompanyi ya GSK
© 2014 Ishirahamwe ry’amakompanyi ya GSK, rifite uburenganzira
bwose.
Português
Instruções de Uso
Como usar o seu VENTOLIN ROTAHALER
1 Verifique se o bocal do seu ROTAHALER está limpo, seco e livre de
objetos.
Segure a extremidade de cor branca com uma das mãos e gire
totalmente a extremidade azul.
2 Insira a cápsula ROTACAPS no orifício em relevo na
extremidade do seu ROTAHALER.
A cápsula deve ser inserida com a extremidade transparente para
baixo, até que a sua extremidade superior fique ao nível da borda
superior do orifício.
3 Segure o seu ROTAHALER horizontalmente, com a linha
marcada virada para cima. Gire totalmente a extremidade azul
no sentido oposto. Este movimento abrirá a cápsula.
Mantenha o seu ROTAHALER na posição horizontal.
4 Segure o seu ROTAHALER distante da boca. Expire totalmente.
Posicione a extremidade branca do seu ROTAHALER na boca
entre os dentes e os lábios. Inspire de uma só vez, de forma
rápida e profunda, através do bocal. Segure a respiração
enquanto se sentir confortável, ou pelo menos por alguns segundos.
Retire o ROTAHALER da boca e expire.
5 Puxe as 2 metades do seu ROTAHALER em direções opostas e deite fora a
cápsula. Assegure-se de que as duas partes da cápsula foram removidas
antes de tomar a sua próxima dose.
Se o seu médico prescreveu duas cápsulas, aguarde cerca de
30 segundos antes de tomar a outra cápsula repetindo os passos
2-4 descritos anteriormente
Mantenha sempre o seu ROTAHALER limpo, seco e protegido do calor
excessivo.
Como limpar o seu VENTOLIN ROTAHALER
Limpe o seu ROTAHALER a cada 2 semanas.
• Puxe as duas metades em direções opostas e jogue fora a cápsula
ROTACAPS vazia.
• Lave as duas metades em água morna e seque completamente antes
de juntá-las novamente.
Substitua o seu ROTAHALER após 6 meses.
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS e ROTAHALER são marcas registradas do grupo de
empresas GSK.
© 2014 Grupo de empresas GSK. Todos os direitos reservados.
Tagalog
Mga tagubilin sa paggamit
Paano gagamitin ang inyong VENTOLIN ROTAHALER
1 Tiyakin na ang bahaging isinusubo o mouthpiece ng inyong ROTAHALER
ay malinis at tuyo at walang nakadikit na mga bagay.
Hawakan ang puting bahagi sa isang kamay at ikutin nang todo ang
asul na bahagi.
2 Itulak ang kapsula ng ROTACAPS papasok sa butas sa may asul
na bahagi ng inyong ROTAHALER Ang kapsula ay dapat itulak nang
una ang malinaw na dulo hanggang ang ibabaw nito ay kapantay na ng
ibabaw ng butas.
3 Hawakan ang inyong ROTAHALER nang pahaba na ang
nakaumbok na guhit o moulded line ay nasa todong itaas. Pihitin
nang pabalik ang asul na bahagi. Ito ang magbubukas sa kapsula.
Panatilihing pahaba ang inyong ROTAHALER
4 Hawakan ang inyong ROTAHALER nang malayo sa bibig. Ibugang
palabas nang husto ang hanging nasa baga ninyo.
Ilagay pagkatapos ang puting dulo ng inyong ROTAHALER sa
pagitan ng ngipin at mga labi. Itikom ang mga labi palibot ng
mouthpiece at humigop ng mabilis at malalim. Pigilan ang hangin
sa loob ng baga hangga’t komportable kayo o sa loob ng ilang segundo
man lamang.
Alisin ang ROTAHALER sa bibig ninyo at huminga.
5 Hilahin hanggang mapaghiwalay ang 2 bahagi ng ROTAHALER at itapon
ang kapsula. Tiyaking naalis ninyo ang dalawang bahagi ng kapsula bago
higupin ang inyong susunod na paggamit.
Kung sinabi sa inyo ng inyong doktor na humigop ng dalawang kapsula,
maghintay ng 30 segundo. Muli, ulitin lamang ang hakbang 2-4 sa itaas.
Paano lilinisin ang inyong VENTOLIN ROTAHALER
Panatilihing malinis at tuyo ang inyong ROTAHALER sa lahat ng oras at
malayo sa sobrang init.
Linisin ang inyong ROTAHALER tuwing 2 linggo.
• Hilahin hanggang mapaghiwalay ang dalawang bahagi at itapon ang
wala nang lamang kapsula ng ROTACAPS.
• Hugasan ang dalawang bahagi sa maligamgam na tubig at tuyuing
mabuti bago muling buuin o pagsudlungin.
Palitan ang inyong ROTAHALER pagkaraan ng 6 na buwan.
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Germany
GlaxoSmithKline Philippines Inc.
2266 Chino Roces Avenue, City of Makati 1231
Philippines
Ang VENTOLIN, ROTACAPS at ROTAHALER ay mga nakarehistrong produkto
o trade marks ng grupo ng mga kumpanya ng GSK
© 2014 GSK group of companies. All rights reserved.
Bahasa Indonesia
CARA PAKAI VENTOLIN ROTAHALER
1 Pastikan bagian mulut ROTAHALER bersih, kering dan bebas dari benda
apapun.
Pegang bagian putih dan putar bagian biru sejauh mungkin.
2 Masukan dan tekan kapsul ROTACAPS ke dalam lubang yang menonjol
pada bagian belakang ROTAHALER yang berwarna biru. Bagian kapsul
yang transparan harus masuk terlebih dahulu lalu tekan kapsul kedalam
sampai sejajar dengan bagian atas lubang.
3 Pegang ROTAHALER horisontal atau mendatar dengan garis cetakan
menghadap ke atas. Putar bagian biru sejauh mungkin. Gerakan ini akan
membuka kapsul didalam ROTAHALER.
Pastikan posisi ROTAHALER tetap horizontal.
4 Pegang ROTAHALER menjauh dari mulut. Buang napas.
Letakkan bagian ujung PUTIH ROTAHALER di mulut antara gigi dan bibir.
Lakukan 1 tarikan napas dengan cepat dan dalam melalui bagian mulut
alat. Tahan napas sebisa mungkin sekurang-kurangnya beberapa detik.
Keluarkan ROTAHALER dari mulut dan buang napas
5 Tarik kedua bagian ROTAHALER sehingga terbuka dan buang kapsul
keluar. Pastikan kedua bagian kapsul telah dikeluarkan sebelum
menggunakan ROTAHALER kembali.
Bila dokter menyarankan untuk memakai 2 kapsul, tunggu sekitar
30 detik sebelum memakai kapsul selanjutnya dengan mengulang
langkah 2-4 diatas.
Cara membersihkan VENTOLIN ROTAHALER.
Pastikan ROTAHALER selalu bersih dan kering dan jauhkan dari panas berlebih.
Bersihkan ROTAHALER setiap 2 minggu.
• Tarik dua bagian sehingga terbuka dan buang keluar kapsul
ROTACAPS yang telah kosong.
• Bersihkan kedua bagian di air hangat dan keringkan sebelum
memasangkannya kembali.
Ganti ROTAHALER setelah 6 bulan pemakaian.
Dibuat oleh:
Glaxo Wellcome GmbH & Co. KG
Industriestraße 32 – 36
23843 Bad Oldesloe
Germany
Diimpor oleh:
PT Glaxo Wellcome Indonesia
Jakarta, Indonesia
VENTOLIN, ROTACAPS and ROTAHALER are trade marks of the GSK group
of companies.
© 2014 GSK group of companies. All rights reserved.
Kiswahili
Maagizo ya namna ya kutumia
Namna ya kutumia VENTOLIN™ ROTAHALER™ yako.
1 Hakikisha kuwa eneo la kuvutia pumzi la ROTAHALER™ yako liko safi
na kavu na halina kitu chochote.
Shika sehemu nyeupe kwenye mkono mmoja kisha zungusha sehemu
ya buluu hadi ifike mwisho.
2 Sukuma kapsuli ya ROTACAPS™ iingie kwenye tundu lililoinuliwa
katika sehemu ya buluu ya ROTAHALER™ yako. Inabidi kapsuli
isukumwe huku sehemu yake nyeupe imetangulia hadi mwisho wake
ulingane na sehemu yajuu ya tundu.
3 Shika ROTAHALER™ yako ukiwa umeilaza huku mstari uliochorwa
ukiwa upande wa juu. Zungusha sehemu ya buluu upande huo
mwingine hadi ifike mwisho. Hali hii itafungua kapsuli.
Weka ROTAHALER™ yako katika hali yamlalo.
4 Ishike ROTAHALER™ yako mbali na mdomo wako. Toa pumzi kikamilifu.
Weka sehemu nyeupe ya ROTAHALER™ yako katika kinywa chako
kati ya meno Na midomo yako. Vuta pumzi ya kina kwa haraka mara
moja kupitia kwa eneo la kuvutia umzi.
Shikilia pumzi hiyo kwa muda unaoweza au angalau kwa sekunde chache.
Ondoa ROTAHALER™ kutoka kinywani mwako kisha utoe pumzi au
upumue nje.
5 Vuta na utenganishe sehemu mbili za ROTAHALER™ kisha utupe kapsuli.
Hakikisha kuwa umeondoa sehemu zote mbili za kapsuli kabla ya
kuchukua kipimo kingine cha dawa.
Ikiwa daktari wako amekwambia utumie kapsuli mbili, subiri sekunde
thelathini hivi kabla ya kutumia kapsuli nyingine huku ukirudia hatua
2-4 zilizo hapo juu.
Namna ya kusafisha VENTOLIN™ ROTAHALER™ yako.
Iweke ROTAHALER™ yako katika hali safi nakavu kila wakati na mbali
najoto jingi.
Isafishe ROTAHALER™ yako baadaya kila wiki mbili.
• Vuta na utenge sehemu zake mbili kisha utupe kapsuli tupu ya
ROTACAPS™.
• Osha sehemu hizo mbili katika maji ya vuguvugu kisha uzikaushe
vyema kabla ya kuiunganisha tena.
Pata ROTAHALER™ mpya baada ya miezi sita.
Glaxo Wellcome GmbH & Co. KG
Industriestraβe 32- 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS na ROTAHALER ni majina ya kibiashara ya kundi la
kampuni za GSK.
© 2014 GSK group of companies. Haki zote zimehifadhiwa.
Kirundi
Amabwiriza yo gukoresha
Ingene VENTOLIN™ ROTAHALER™ yawe ikoreshwa
1 Raba neza niba igice co kumunwa ca ROTAHALER™ yawe gisukuye,
cumutse kandi nta bintu bigikorako.
Fata ku mpera z’igice c’umweru mu kuboko kumwe maze uhindukize
impera y’ubururu kugeza abo ishobora kugera.
2 Sunikira ikinini ca ROTACAPS™ mu ntoboro iri hejuru ku mpera y’ubururu
ya ROTAHALER™ yawe. Ikinini kigomba gusunikwa neza kugeza igice co
hejuru kiringaniye n’igice co hejuru c’intoboro.
3 Fata ROTAHALER™ yawe itambitse hamwe umurongo w’utudomo uja
hejuru. Hindukiza impera y’ubururu igaruke inyuma igere abo ishobora
kugera hashoboka. Ivyo bizafungura ikinini.
Komeza ufate ROTAHALER™ yawe itambitse.
4 Kura ROTAHALER™ yawe ku munwa: Sohora impwemu bihagije.
Shira igice c’umweru ca ROTAHALER™ ku munwa wawe hagati y’amenyo
n’iminwa. Humeka rimwe vyihuse, impwemu ndende unyujije ku kanwa.
Gumya izo mpemu mu gihe gishoboka wumva utuje canke n’imiburiburi
amasegoda make.
Vana ROTAHALER™ yawe ku munwa maze usohore impwemu.
5 Tandukanya ibice 2 vya ROTAHALER™ kandi ute ikinini. Raba neza niba
wavanyemo ibice 2 byose vy’ikinini mbere yo kunywa undi muntu wawe
ukurikira.
Niba muganga wawe yarakubwiye gufata ibinini 2, rindira hafi
y’amasegonda 30 mbere yo kunywa ikindi kinini hanyuma usubiramo
amabwirizwa kuva kurya 2 kushika kurya4.
lngene VENTOLIN ROTAHALER ikorerwa isuku
Bika ROTAHALER™ yawe ifise isuku, yumutse ibihe vyose kandi kure
y’ubushuhe bwinshi.
Sukura ROTAHALER™ yawe buri mayinga 2.
• Tandukanya ibice bibiri hanyuma ute igifunikoca ROTACAPS™ kirimo
ubusa
• Oza ivyo bice bibiri mu mazi ashushe maze uvyumutse neza mbere yo
kongera kubisubiranya.
Simbuza ROTAHALER™ nyuma ya buri mezi 6.
Glaxo Wellcome GmbH & Co. KG
Industriestraβe 32 - 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS na ROTAHALER ni marike y’ibicuruzwa
vy’ishirahamwe y’amakampuni ya GSK
© 2014 Ishirahamwe y’amakampuni ya GSK, rifise uburenganzira bwose
1
3
2
4
5
2
LEAGSK012
Khmer
GSK-ContractMfg-Eur-UK-
UnitedKingdom-Sovrin-Slough
*Multi-MarketCentral-GEXP;Angola-AGO;Burundi-BDI;Cambodia-KHM;
Egypt-EGY;Indonesia-IDN;Kenya-KEN;Myanmar-MMR;Pakistan-PAK;
Philippines-PHL;Rwanda-RWA;Uganda-UGA;Vietnam-VNM
Ventolin
1
K
0003201
Leading: 8.0pt
Smallest text size: 8.0pt
Microtext: No
1
3
2
4
TEXT SIZE CONTAINED IN THIS ARTWORK
Horizontal Scale: 85%
5 Sika ebitundu by’akacupa ebibiri osuule kapiso.Kakasa nti ojeemu
ebitundu by’akapiso ebibiri nga tonaddamu kufuna ddagala ddala.
Omusawo wo bwaba akugambye okukozesa bu kapiso obubiri yisaawo
obutikitiki 30 nga tonaddamu kozesa kasanduuko kalala ngoyita
mitendera 2-4 waggulu.
Olongoosa otya akacupa ke ddagala ly’asima?
Kuuma akacupa nga kayonjo era nga kakalu obudde bwonna era kajje ewali
ebugumu ennng1
Longoosa akacupa ko buli luvanyuma lwa sabiiti biri
• Sika ebitundu by’akacupa ebibiri era okasuuke kapiso eweddemu.
• Yozza ebitundu ebyo ebibiri mu mazzi agabuguma era obikazze
bulungi nga tonabizaawo
Funna akacupa akalala oluvanyuma lw’e myezi 6.
Glaxo Wellcome GmbH & Co. KG
lndustriestraβe 32- 36
23843 Bad Oldesloe
Germany
VENTOLIN, ROTACAPS and ROTAHALER are trade marks of the GSK group
of companies.
© 2014 GSK group of companies. All rights reserved.
Page2of2
Body text size: 8.0pt
Luganda
Ebiragiro by’enk:ozesa
Okozesa otya akacupa k’eddagala ly’asima?
1 Kakasa nti omumwa gw’akacupa gutukula, mukalu era teguliiko
kantu konna.
Kwata oludda olweru mukono gumu era wetolooze oludda olwa
bulu okutuusa nga lukomye
2 Sindiika kapiso mu kituli ku ludda lw’akacupa olwa bulu.Kapiso erina
okusindikibwa oludda olutangaala okusooka ,okutuusa omutwe
gwako bwe gwenk:ana n’omutwe gw’e kituli.
3 Kwata akacupa bukiika era teeka entandikwa y’omusitale waggulu.
wetolooze oludda olwa bulu ngoluzza emabega okutuuka
gyerukoma.
Kino kisumulula kapiso.
Akacupa kakumire mubukiika
4 Akacupa kakwatire wala n’omumwa.Fulumiza ddala omukka.
Teeka oludda lw’akacupa olweru mu kamwa, wakkati w’amannyo
n’emimwa.sika omukka omulundi gumu ate mu bwangu nga guyita
mu mumwa gw’akacupa.siba omuka ngabwosobola oba wakiri
okumala obutikitiki obutono.
Jja akacupa mu kamwa era ote omukka.
5
Salbutamol
Ventolin®
200mcg Rotacap®
Anti-asthma
PRODUCT DESCRIPTION
Salbutamol (as sulfate) (Ventolin®) Rotacap®: Each Rotacap® contains a mixture of 200mcg microfine salbutamol sulfate
and large particle lactose (which contains milk protein) in hard gelatin cartridges.
PHARMACOLOGIC PROPERTIES
Pharmacodynamics
Salbutamol is a selective beta 2 -adrenoceptor agonist. At therapeutic doses it acts on the beta 2 -adrenoceptors of bronchial
muscle providing short acting (4 to 6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways
obstruction.
Pharmacokinetics
Absorption
After administration by the inhaled route between 10 and 20% of the dose reaches the lower airways. The remainder is
retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the
airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Distribution
Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism
On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in
the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable firstpass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
Elimination
Salbutamol administered intravenously has a half-life of four to six hours and is cleared partly renally and partly by
metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are
a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted
within 72 hours.
Pre-clinical Safety Data
In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice
when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, four
times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally
throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal
mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial
malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception
of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on
fertility, embryofetal development, litter size, birth weight or growth rate.
INDICATIONS
Salbutamol is a selective beta 2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It
provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and
emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them
prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent
asthma unresponsive to Salbutamol (Ventolin®), treatment with inhaled corticosteroids is recommended to achieve and
maintain control. Failing to respond to treatment with Salbutamol (Ventolin®) may signal a need for urgent medical advice
or treatment.
DOSAGE AND ADMINISTRATION
Salbutamol (Ventolin®) has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta 2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the
patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only
be increased on medical advice.
Salbutamol (Ventolin®) Rotacaps® capsules are for inhalation use only, using a VENTOLIN® ROTAHALER® inhaler.
RELIEF OF ACUTE BRONCHOSPASM
•
Adults
200 or 400 micrograms.
•
Children
200 micrograms.
PREVENTION OF ALLERGEN OR EXERCISE-INDUCED BRONCHOSPASM
•
Adults
400 micrograms before challenge or exertion.
•
Children
200 micrograms before challenge or exertion.
CHRONIC THERAPY
•
Adults
400 micrograms 3 or 4 times daily
•
Children
200 micrograms 3 or 4 times daily.
On demand use of Salbutamol (Ventolin®) should not exceed four times daily. Reliance on such supplementary use or a
sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions)
CONTRAINDICATIONS
Salbutamol (Ventolin®) is contraindicated in patients with a history of hypersensitivity to any of its components (see
Excipients). Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or
threatened abortion.
Salbutamol (Ventolin®) dry powder inhaler formulations are contraindicated in patients with severe milk-protein allergy or
who have a history of hypersensitivity to salbutamol or any of its formulation components (see Excipients).
WARNINGS AND PRECAUTIONS
The management of asthma should normally follow a stepwise programme, and patient response should be monitored
clinically and by lung function tests.
Increasing use of short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates deterioration of
asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to
starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised
administration.
Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with
xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in
such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing
after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled
bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a
different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient
should be advised to seek medical advice in order that any necessary additional steps may be taken.
Effects on Ability to Drive and Use Machines
None reported
DRUG INTERACTIONS
Salbutamol (Ventolin®) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed
together.
Salbutamol is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in
animals (see Pre-clinical Safety Data).
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than
any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb
defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking
multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for
congenital anomalies is 2 to 3%, a relationship with salbutamol use cannot be established.
Lactation
As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected
benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
ADVERSE EFFECTS
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare
(<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial
data. Rare and very rare events were generally determined from spontaneous data.
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and
collapse
Metabolism and nutrition disorders
Rare:
Hypokalaemia
Potentially serious hypokalaemia may result from beta2 agonist therapy
Nervous system disorders
Common:
Tremor, headache
Very rare:
Hyperactivity
Cardiac disorders
Common:
Tachycardia
Uncommon:
Palpitations
Very rare:
Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles
Vascular disorders
Rare:
Peripheral vasodilatation
Respiratory, thoracic and mediastinal disorders
Very rare:
Paradoxical bronchospasm
Gastrointestinal disorders
Uncommon:
Mouth and throat irritation
Musculoskeletal and connective tissue disorders
Uncommon:
Muscle cramps
OVERDOSAGE AND TREATMENT
The most common signs and symptoms of overdose with Salbutamol (Ventolin®) are transient beta agonist
pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin®). Serum potassium levels should be
monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting betaagonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is
persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be
indicated in the setting of overdose.
STORAGE CONDITION
To keep the Rotacap® in good condition it is important that they are stored in a dry place and where they will not be
exposed to extremes of temperature and should be stored below 30°C.
INSTRUCTIONS FOR USE/HANDLING
The Rotacap® must only be inserted in to the Rotahaler® immediately prior to use. Failure to observe this instruction will
affect the delivery of the drug.
AVAILABILITY
Salbutamol (Ventolin®) Rotacap® 200mcg: Box of 10’s and 128’s
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN, ROTACAP and ROTAHALER are registered trademarks of the GlaxoSmithKline group of companies.
©2013, GlaxoSmithKline. All rights reserved.
Version number: GDS25/IPI07
Revision date: 14 April 2014
Imported by:
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
Mfd. By:
GlaxoSmithKline Australia Pty Ltd
Boronia, Australia
Salbutamol
Ventolin®
200mcg Rotacap®
Salbutamol 200mcg and lactose in a gelatine capsule
Salbutamol (Ventolin®) Rotacap® helps to open up the airways in your lungs, making it easier for you to breathe. It helps
to relieve chest tightness, wheezing and cough associated with asthma and is used to treat breathing problems in people
with asthma.
Do not use Salbutamol (Ventolin®) Rotacap® if you are allergic (hypersensitive) to salbutamol sulfate, any of the other
ingredients or have a severe allergy to milk proteins.
If you are pregnant, planning to become pregnant or breast feeding, talk to your doctor before taking Salbutamol
(Ventolin®) Rotacap®.
BEFORE USE: Tell your doctor if you have an overactive thyroid gland, low blood potassium or if you are taking other
medicines including beta-blockers for high blood pressure or a heart condition.
USE: Salbutamol (Ventolin®) Rotacap® capsules must only be used by inhalation from a VENTOLIN® ROTAHALER® – Do
not swallow.
Adults: The starting dose is one to two inhalations (200-400mcg) once a day. The maximum dose is two inhalations
(400mcg) four times a day.
Children: The starting dose is one inhalation (200mcg) once a day. The maximum dose is one inhalation (200mcg) four
times a day.
Contact your doctor if you take too much Salbutamol (Ventolin®).
Tell your doctor if your Salbutamol (Ventolin®) does not seem to be working as well as usual or if the effects last for less
than 3 hours, as your chest problem may be getting worse and you may need a different medicine.
If your breathing or wheezing gets worse straight after using Salbutamol (Ventolin®) Rotacap®, stop using it, and contact
your doctor immediately.
SIDE EFFECTS: The most common side effects are feeling shaky, headache and heart beating faster. Uncommon side
effects are irregular heart beat (palpitations), mouth & throat irritation and muscle cramps. Rare side effects are low blood
potassium level and increased blood flow to the extremities (widening of the blood vessels). Very rare side effects are
feeling unusually restless or excitable and allergic reactions (skin rash, swelling of face/mouth, increased breathlessness
or collapse). If you have an allergic reaction or other severe side effects contact your doctor immediately.
STORAGE: Do not store above 30°C. Store in a dry place. Keep out of reach of children.
Revision date: 14 April 2014
Salbutamol
Ventolin®
200mcg Rotacap®
Salbutamol 200mcg at lactose sa isang kapsulang gelatine.
Ang Salbutamol (Ventolin®) Rotacap® ay tumutulong para buksan ang mga daanan ng hangin sa baga, para maging mas
maginhawa ang paghinga. Tumutulong itong paginhawahin ang paninikip ng dibdib, huni sa paghinga at ubong kaugnay
ng hika at ginagamit ito para gamutin ang mga problema sa paghinga ng mga taong may hika.
Huwag gagamitin ang Salbutamol (Ventolin®) Rotacap® kung kayo ay allergic (sobrang sensitibo) sa salbutamol sulfate o
alinman sa ibang mga sangkap o kung kayo ay may matinding allergy sa mga protina ng gatas.
Kung kayo ay buntis, nagbabalak magbuntis o magpasuso, kausapin muna ang doktor ninyo bago gumamit ng
Salbutamol (Ventolin®) Rotacap®.
BAGO GAMITIN: Sabihin sa doktor ninyo kung kayo ay may sobrang aktibong thyroid gland, mababang potassium sa
dugo o kung gumagamit kayo ng ibang mga gamot kabilang na ang beta-blockers para sa alta presyon o problema sa
puso.
PAGGAMIT: Ang mga kapsula ng Salbutamol (Ventolin®) Rotacap® ay ginagamit lamang sa pamamagitan ng paghigop o
inhalation mula sa isang VENTOLIN® ROTAHALER® – Huwag lulunukin ang kapsula.
Mga taong nasa hustong gulang: Ang panimulang dosis ay isa hanggang dalawang paghigop (200-400mcg) minsan sa
isang araw. Ang pinakamataas na dosis ay dalawang paghigop (400mcg) apat na beses sa isang araw.
Mga bata: Ang panimulang dosis ay isang paghigop (200mcg) minsan sa isang araw. Ang pinakamataas na dosis ay
isang paghigop (200mcg) apat na beses sa isang araw.
Kontakin ang doktor ninyo kung nakagamit kayo ng sobrang daming Salbutamol (Ventolin®).
Sabihin sa doktor ninyo kung ang Salbutamol (Ventolin®) ninyo ay parang hindi gumagana nang kasinghusay ng
karaniwan o kung ang mga epekto ay tumatagal nang kulang sa 3 oras, dahil maaaring ang problema ninyo sa dibdib ay
lumulubha at maaaring kailangan ninyo ng ibang gamot.
Kung ang paninikip o paghuni ng dibdib ay lumala pagkagamit ng Salbutamol (Ventolin®) Rotacap®, itigil kaagad ang
paggamit nito at kontakin ang duktor ninyo sa madaling panahon.
MGA DI-KANAIS-NAIS NA EPEKTO O SIDE EFFECTS: Ang pinakakaraniwang side effects ay pakiramdam na
mabubuway, pananakit ng ulo at mas mabilis na pagtibok ng puso. Ang hindi karaniwang side effects ay hindi regular na
pagtibok ng puso (palpitations), iritasyon sa bibig at lalamunan at pamumulikat ng mga kalamnan. Ang bihirang side
effects ay mababang antas ng potassium sa dugo at mas malakas na pagdaloy ng dugo sa mga kamay at paa o
extremities (pagluwang ng mga ugat). Ang napakabihirang side effects ay hindi karaniwang pakiramdam na hindi
mapalagay o magugulatin at mga allergic na reaksiyon (singaw sa balat, pamamaga ng mukha/bibig, mas malalang
pangangapos ng hininga o pagkatumba [collapse]). Kung kayo ay may allergic na reaksiyon o ibang matitinding side
effects, kontakin agad ang inyong doktor.
PAGTATAGO: Itago sa temperaturang hindi lalagpas sa 30°C sa isang tuyong lugar. Itago sa hindi maaabot ng mga
bata.
Petsa ng version: 14 Abril 2014
Salbutamol
Ventolin® Nebules®
1mg/mL Solution for Inhalation
Anti-asthma
PRODUCT DESCRIPTION
Salbutamol (Ventolin® Nebules®) Solution for Inhalation 1mg/mL is in a plastic ampoule containing a concentration of
salbutamol of 0.1% (1mg salbutamil, as the sulphate, in 1mL). Each Salbutamol (Ventolin® Nebules®) Solution for
Inhalation contains 2.5mL of solution equivalent to 2.5mg salbutamol.
PHARMACOLOGIC PROPERTIES
Pharmacodynamics
Salbutamol is a selective beta 2 -adrenoceptor agonist. At therapeutic doses it acts on the beta2-adrenoceptors of
bronchial muscle providing short acting (4 to 6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible
airways obstruction.
Pharmacokinetics
Absorption
After administration by the inhaled route, between 10 and 20% of the dose reaches the lower airways. The remainder is
retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the
airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Distribution
Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism
On reaching the systemic circulation it becomes accessible to hepatic metabolism and is excreted, primarily in the urine,
as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable firstpass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
Elimination
Salbutamol administered intravenously has a half-life of four to six hours and is cleared partly renally and partly by
metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are
a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted
within 72 hours.
Pre-clinical Safety Data
In common with other potent selective beta 2 receptor agonists, salbutamol has been shown to be teratogenic in mice
when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, 4
times the maximum human oral. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout
pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the
highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in
37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception
of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on
fertility, embryofetal development, litter size, birth weight or growth rate.
INDICATIONS
Salbutamol is a selective beta 2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It
provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and
emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them
prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent
asthma unresponsive to Salbutamol (Ventolin®), treatment with inhaled corticosteroids is recommended to achieve and
maintain control. Failing to respond to treatment with Salbutamol (Ventolin®) may signal a need for urgent medical advice
or treatment.
Salbutamol (Ventolin® Nebules®) are indicated for the routine management of chronic bronchospasm (unresponsive to
conventional therapy) and treatment of acute severe asthma (status asthmaticus).
DOSAGE AND ADMINISTRATION
Salbutamol (Ventolin®) has a duration of action of 4 to 6 hours in most patients.
Salbutamol (Ventolin® Nebules®) are intended to be used undiluted. However, if prolonged delivery time is desirable (more
than 10 minutes) dilution using sterile normal saline as a diluent may be required.
Salbutamol (Ventolin® Nebules®) are to be used with a nebuliser, under the direction of a physician.
The solution must not be injected, or swallowed.
Increasing use of beta 2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the
patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure
ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be
added to the inspired air.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only
be increased on medical advice.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local
environment. Salbutamol (Ventolin® Nebules®) should therefore be administered in a well ventilated room, particularly in
hospitals when several patients may be using nebulisers in the same space at the same time.
•
Adults and Children
A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40
milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways
obstruction.
Clinical efficacy of nebulised Salbutamol (Ventolin®) in infants under 18 months is uncertain. As transient hypoxaemia
may occur, supplemental oxygen therapy should be considered.
CONTRAINDICATIONS
Salbutamol (Ventolin® Nebules®)are contraindicated in patients with a history of hypersensitivity to any of their
components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
WARNINGS AND PRECAUTIONS
The management of asthma should normally follow a stepwise programme, and patient response should be monitored
clinically and by lung function tests.
Increasing use of short-acting inhaled beta 2 agonists to control symptoms indicates deterioration of asthma control. Under
these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma
control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In
patients considered at risk, daily peak flow monitoring may be instituted.
Salbutamol (Ventolin® Nebules®) must only be used by inhalation, to be breathed in through the mouth, and must not be
injected or swallowed.
Patients receiving treatment at home with Salbutamol (Ventolin® Nebules®) must be warned that if either the usual relief is
diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration,
but should seek medical advice.
Salbutamol (Ventolin® Nebules®) should be used with caution in patients known to have received large doses of other
sympathomimetic drugs.
Salbutamol (Ventolin®) should be administered cautiously to patients with thyrotoxicosis.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of
nebulised Salbutamol (Ventolin®) and ipratropium bromide. A combination of nebulised Salbutamol (Ventolin®) with
nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct
administration and be warned not to let the solution or mist enter the eye.
Potentially serious hypokalaemia may result from beta 2 agonist therapy mainly from parenteral and nebulised
administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant
treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are
monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing
after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled
bronchodilator, if immediately available. Salbutamol (Ventolin® Nebules®) should be discontinued, and if necessary a
different fast-acting bronchodilator instituted for ongoing use.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin®) can induce reversible metabolic changes, for
example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketacidosis has been reported.
Concurrent administration of corticosteroids can exaggerate this effect.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised
short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse
Reaction section). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be
misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist
treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and
consequent metabolic acidosis in this setting.
Effects on Ability to Drive and Use Machines
None reported.
DRUG INTERACTIONS
Salbutamol (Ventolin®) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed
together.
Salbutamol (Ventolin®) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of Salbutamol (Ventolin®) on human fertility. There were no adverse effects on
fertility in animals (see Pre-clinical Safety Data).
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than
any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb
defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking
multiple medications during their pregnancies.
As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship
with salbutamol use cannot be established.
Lactation
As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected
benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
ADVERSE EFFECTS
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare
(<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial
data. Rare and very rare events were generally determined from spontaneous data.
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and
collapse.
Metabolism and nutrition disorders
Rare:
Hypokalaemia.
Potentially serious hypokalaemia may result from beta 2 agonist therapy.
Very rare:
Lactic acidosis
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the
treatment of acute asthma exacerbation.
Nervous system disorders
Common:
Tremor, headache
Very rare:
Hyperactivity
Cardiac disorders
Common:
Tachycardia
Uncommon:
Palpitations
Very rare:
Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and
extrasystoles
Vascular disorders
Rare:
Peripheral vasodilatation
Respiratory, thoracic and mediastinal disorders
Very rare:
Paradoxical bronchospasm
Gastrointestinal disorders
Uncommon:
Mouth and throat irritation
Musculoskeletal and connective tissue disorders
Uncommon:
Muscle cramps
OVERDOSAGE AND TREATMENT
The most common signs and symptoms of overdose with Salbutamol (Ventolin®) are transient beta agonist
pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin®). Serum potassium levels should be
monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting betaagonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is
persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be
indicated in the setting of overdose.
STORAGE CONDITION
Store below 30°C and protected from light.
INSTRUCTIONS FOR USE AND HANDLING
Dilution:
Salbutamol (Ventolin® Nebules®) may be diluted with sterile normal saline.
Any unused solution in the chamber of the nebuliser must be discarded.
AVAILABILITY
Salbutamol (Ventolin® Nebules®) 1mg/mL Solution for Inhalation: 2.5mL Nebules in foil Blisters of 5 (Box of 30’s)
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN and NEBULES are registered trademarks of the GlaxoSmithKline group of companies.
©2014, GlaxoSmithKline. All rights reserved.
Version number: GDS25/IPI09
Revision date: 14 April 2014
Imported by:
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
Mfd. By:
GlaxoSmithKline Australia Pty Ltd
Boronia, Australia
2
1903301-01
GSK-ContractMfg-Eur-UKUnited Kingdom-Clement Clarke-Harlow
2.How the Ventolin Mini Spacer works
The Ventolin Mini Spacer fits on to your Ventolin Inhaler, the dose from the
Ventolin Inhaler is sprayed into the Ventolin Mini Spacer from where it can be
breathed easily into the lungs.
The Ventolin Mini Spacer has 3 main parts:
Philippines-PHL
Ventolin Inhaler
N/A
The Mouthpiece Section with valve
The Main Section
342x130
The Extension
Detachable facemasks are available in small and medium sizes for young
patients or those who are unable to inhale directly from the mouthpiece section.
N/A
3.How to Prepare the Ventolin Mini Spacer for use
with the Ventolin Inhaler
N/A
1
K
0
0
-Ventolin Mini Spacer should be cleaned before it is used for the first time.
See Section 6 (How to look after the Ventolin Mini Spacer) for full cleaning
instructions.
-Shake the Ventolin Inhaler well to ensure that the contents
of the Ventolin Inhaler are well mixed.
- Then take a slow, deep breath in through the mouthpiece.
-Hold your breath in for several seconds or as long as is
comfortable, while removing the Ventolin Mini Spacer
mouthpiece from your mouth.
- Breathe out slowly, and then continue to breathe normally.
-Remember to test that your Ventolin Inhaler is working by following the
instructions provided with your Ventolin inhaler. Point the Ventolin Inhaler
canister away from you and press down on the top of the Ventolin Inhaler
canister to release 2 puffs into the air.
-If your doctor has told you to take two puffs, wait about 30 seconds
before you take another puff by repeating the steps above.
-Push the Ventolin Inhaler mouthpiece firmly into the
Ventolin Mini Spacer extension. The Ventolin Inhaler
mouthpiece should fit snugly into the Ventolin Mini Spacer.
If you have difficulty with slow deep breaths, an alternative way to use the
Ventolin Mini Spacer is to keep your mouth tight on the mouthpiece of the
Ventolin Mini Spacer and breathe slowly in and out 4 times after pressing down
on the Ventolin Inhaler canister to release one puff. If your doctor has told you
to take two puffs, wait about 30 seconds before you take another puff using
this method.
Tell your doctor or nurse or pharmacist if you are having difficulty using the
Ventolin Mini Spacer.
The Ventolin Mini Spacer and the Ventolin Inhaler are now ready to
use. If a facemask is being used, please follow the steps in Section 5
(How to use the Ventolin Mini Spacer with a facemask).
4.How to use the Ventolin Mini Spacer with the
Ventolin Inhaler
-After use, remove the Ventolin Inhaler from the Ventolin Mini Spacer
and replace the cap on the Ventolin Inhaler.
5.How to use the Ventolin Mini Spacer and the
Ventolin Inhaler with a facemask
-Make sure that the mouthpiece is firmly attached to the main section of the
Ventolin Mini Spacer, as they may have come apart.
-Breathe out slowly as far as is comfortable to empty the lungs
of air.
Prepare the Ventolin Mini Spacer and Ventolin Inhaler as shown in Section 3
(How to prepare the Ventolin Mini Spacer and Ventolin Inhaler).
-Hold the main section of the Ventolin Mini Spacer and
slide out the extension as far as it will go.
-Place the Ventolin Mini Spacer mouthpiece between your
teeth and seal your lips around it.
Push the facemask onto the Ventolin Mini Spacer
-
mouthpiece.
-Press down on the top of the Ventolin Inhaler canister to
release one puff into the Ventolin Mini Spacer.
-Place the facemask over your mouth and nose, making sure there are no gaps.
For children and infants or patients who need help using the
Ventolin Mini Spacer, hold the mask firmly to the patients face.
-Remove the cap from the Ventolin Inhaler and check inside
it for any loose objects.
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2
1903301-01
GSK-ContractMfg-Eur-UKUnited Kingdom-Clement Clarke-Harlow
-Press down on the top of the Ventolin Inhaler canister
to release one puff into the Ventolin Mini Spacer.
Philippines-PHL
-When the parts are completely dry, push the mouthpiece back onto the main
section of the Ventolin Mini Spacer and close up the extension.
-Store the Ventolin Mini Spacer in a clean and dry place.
-Breathe in and out slowly through the mouthpiece
at least 4 times.
Ventolin Inhaler
N/A
- Take the facemask away from your face and continue to breathe normally.
-If your doctor has told you to take two puffs, wait about 30 seconds before
you take another puff by repeating the steps above.
342x130
6.How to look after the Ventolin Mini Spacer
N/A
N/A
1
K
With normal daily use, the Ventolin Mini Spacer should be replaced after
12 months.
The Ventolin Mini Spacer (and the facemask if this is being used) should be
cleaned at least once a week as follows:
-Pull the mouthpiece section off the Ventolin Mini Spacer and
slide out the extension as far as it will go.
- Wash the parts by hand in warm soapy water.
0
-Rinse all of the parts in clean water and shake off any excess water.
0
-Allow the parts to dry naturally in the air at room temperature. Don’t rub
the inside of your Ventolin Mini Spacer with a cloth or polish as this may
cause static electricity which can affect how the Ventolin Mini Spacer works.
Don’t put the Ventolin Mini Spacer in a heated place to dry more quickly.
Clement Clark International Ltd.
Edinburgh Way, Harlow, Essex CM20 2TT, UK
Imported by:
Hong Kong: GlaxoSmithKline Limited
23/F Tower 6 The Gateway
9 Canton Road, TsimShaTsui
Hong-Kong
Philippines: GlaxoSmithKline Philippines Inc.
2266 Chino Roces Avenue
Makati City 1231
VENTOLIN is a trade mark of the GSK group of companies.
© 2014 GSK group of companies. All rights reserved
Version number: GDS03
Date of issue: 31 October 2013
Ventolin Mini Spacer
Read all of these instructions and the instructions supplied with your
Ventolin pressurised metered-dose Inhaler carefully before you start
using the Ventolin Mini Spacer.
The Ventolin Mini Spacer is intended for use with Ventolin pressurised
metered-dose Inhalers only.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
Keep this product out of the sight and reach of children.
What is in this leaflet
1.What is the Ventolin Mini Spacer and what is it used for?
2.How the Ventolin Mini Spacer works
3.How to prepare the Ventolin Mini Spacer for use with the
Ventolin Inhaler
4.How to use the Ventolin Mini Spacer with the Ventolin Inhaler
5.How to use the Ventolin Mini Spacer and the Ventolin Inhaler with a
face mask
6.How to look after the Ventolin Mini Spacer
1.What is the Ventolin Mini Spacer and what is it
used for?
It is a device which is intended to make it easier for you to use your
Ventolin Inhaler effectively. It helps the medicine reach your lungs where
it is needed instead of being deposited at the back of the throat where it
may be less effective or may cause irritation. It makes it easier to use your
Ventolin Inhaler because you don’t have to press down on the Ventolin Inhaler
and breathe in at the same time.
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Salbutamol
Ventolin®
100mcg/ actuation Inhaler
Anti-asthma
PRODUCT DESCRIPTION
Each Salbutamol (Ventolin®) Inhaler is a pressurised metered-dose inhaler which delivers100 micrograms salbutamol (as
sulphate) per actuation, into the mouthpiece of a specially designed actuator. The inhaler also contains the CFC-free
propellant HFA 134a. Each canister contains at least 200 actuations.
PHARMACOLOGIC PROPERTIES
Pharmacodynamics
Salbutamol is a selective beta 2 -adrenoceptor agonist. At therapeutic doses it acts on the beta 2 -adrenoceptors of bronchial
muscle providing short acting (4 to 6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways
obstruction.
Pharmacokinetics
Absorption
After administration by the inhaled route, between 10 and 20% of the dose reaches the lower airways. The remainder is
retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the
airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Distribution
Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism
On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in
the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable firstpass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
Elimination
Salbutamol administered intravenously has a half-life of four to six hours and is cleared partly renally and partly by
metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are
a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted
within 72 hours.
Clinical Studies
Special Patient Populations
Children < 4 years of age
Paediatric clinical studies conducted at the recommended dose (SB020001, SB030001, SB030002), in patients < 4 years
with bronchospasm associated with reversible obstructive airways disease, show that the Inhaler has a safety profile
comparable to that in children ≥ 4 years, adolescents and adults.
Pre-clinical Safety Data
In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice
when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, four
times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally
throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal
mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial
malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception
of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on
fertility, embryofetal development, litter size, birth weight or growth rate.
HFA 134a has been shown to be non-toxic at very high vapour concentrations, far in excess of those likely to be
experienced by patients, in a wide range of animal species exposed daily for periods of two years.
INDICATIONS
Salbutamol is a selective beta 2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It
provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and
emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them
prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent
asthma unresponsive to Salbutamol (Ventolin®), treatment with inhaled corticosteroids is recommended to achieve and
maintain control. Failing to respond to treatment with Salbutamol (Ventolin®) may signal a need for urgent medical advice
or treatment.
DOSAGE AND ADMINISTRATION
Salbutamol (Ventolin®) has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta 2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the
patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only
be increased on medical advice.
Salbutamol (Ventolin®) Inhaler is administered by the inhaled route only.
In patients who find co-ordination of a pressurised metered-dose inhaler difficult a spacer may be used with Salbutamol
(Ventolin®) Inhaler.
Babies and young children using the Salbutamol (Ventolin®) Inhaler may benefit from the use of a paediatric spacer
device with a face mask (for example the BABYHALER®). (Recommended statement “for example the BABYHALER®” is
for use only in those markets where the Babyhaler spacer device is available). (See Clinical Studies).
RELIEF OF ACUTE BRONCHOSPASM
•
Adults
100 or 200 micrograms.
•
Children
100 micrograms. The dose may be increased to 200 micrograms if required.
PREVENTION OF ALLERGEN OR EXERCISE-INDUCED BRONCHOSPASM
•
Adults
200 micrograms before challenge or exertion.
•
Children
100 micrograms before challenge or exertion. The dose may be increased to 200 micrograms if required.
CHRONIC THERAPY
•
Adults
Up to 200 micrograms 4 times daily.
•
Children
Up to 200 micrograms 4 times daily.
On demand use of Salbutamol (Ventolin®) should not exceed four times daily. Reliance on such supplementary use or a
sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions).
CONTRAINDICATIONS
Salbutamol (Ventolin®) is contraindicated in patients with a history of hypersensitivity to any of its components (see
Excipients). Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or
threatened abortion.
WARNINGS AND PRECAUTIONS
The management of asthma should normally follow a stepwise programme, and patient response should be monitored
clinically and by lung function tests.
Increasing use of short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates deterioration of
asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to
starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Salbutamol (Ventolin®) should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised
administration.
Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with
xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in
such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing
after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled
bronchodilator, if immediately available. Salbutamol (Ventolin®) Inhaler should be discontinued, and if necessary a
different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled Salbutamol (Ventolin®) failing to give relief for at least three hours,
the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of
breath for optimum delivery of the drug to the lungs.
Effects on Ability to Drive and Use Machines
None reported.
DRUG INTERACTIONS
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol (Ventolin®) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
PREGNANCY AND LACTATION
Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in
animals (see Pre-clinical Safety Data).
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than
any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb
defects have been reported in the offspring of patients being treated with Salbutamol (Ventolin®). Some of the mothers
were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and
baseline rate for congenital anomalies is 2 to 3%, a relationship with Salbutamol (Ventolin®) use cannot be established.
Lactation
As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected
benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
ADVERSE EFFECTS
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare
(<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial
data. Rare and very rare events were generally determined from spontaneous data.
Immune system disorders
Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and
collapse
Metabolism and nutrition disorders
Rare:
Hypokalaemia
Potentially serious hypokalaemia may result from beta2 agonist therapy
Nervous system disorders
Common:
Very rare:
Cardiac disorders
Common:
Uncommon:
Very rare:
Tremor, headache
Hyperactivity
Tachycardia
Palpitations
Cardiac arrhythmias
extrasystoles
including
atrial
fibrillation,
supraventricular
tachycardia
and
Vascular disorders
Rare:
Peripheral vasodilatation
Respiratory, thoracic and mediastinal disorders
Very rare:
Paradoxical bronchospasm
Gastrointestinal disorders
Uncommon:
Mouth and throat irritation
Musculoskeletal and connective tissue disorders
Uncommon:
Muscle cramps
OVERDOSAGE AND TREATMENT
The most common signs and symptoms of overdose with Salbutamol (Ventolin®) are transient beta agonist
pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin®). Serum potassium levels should be
monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting betaagonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is
persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be
indicated in the setting of overdose.
SPECIAL PRECAUTIONS FOR STORAGE
Replace the mouthpiece cover firmly and snap it into position
Store below 30°C. Protect from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the
canister is cold.
The canister should not be broken, punctured or burnt, even when apparently empty.
INSTRUCTIONS FOR USE AND HANDLING
Testing your inhaler
Before using for the first time, remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler
well, and release two puffs into the air to make sure that it works. If it has not been used for 5 days or more, shake it well
and release 2 puffs into the air to make sure that it works.
Using your inhaler
1.
Remove the mouthpiece cover by gently squeezing the sides of the cover.
2.
Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
3.
Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are
evenly mixed.
4.
Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
5.
Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close
your lips around it but do not bite it.
6.
Just after starting to breathe in through your mouth press down on the top of the inhaler to release Salbutamol
(Ventolin®) while still breathing in steadily and deeply.
7.
While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler.
Continue holding your breath for as long as is comfortable.
8.
If you are to take further puffs keep the inhaler upright and wait about half a minute before repeating steps three
to seven.
9.
Replace the mouthpiece cover by firmly pushing and snapping the cap into position.
IMPORTANT
Do not rush Stages 5, 6 and 7. It is important that you start to breathe in as slowly as possible just before operating your
Inhaler.
Practise in front of a mirror for the first few times. If you see 'mist' coming from the top of the inhaler or the sides of your
mouth you should start again from stage two.
If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if
you have any difficulties.
CLEANING
Your inhaler should be cleaned at least once a week.
1.
Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
2.
Rinse the actuator thoroughly under warm running water.
3.
Dry the actuator THOROUGHLY inside and out.
4.
Replace the metal canister and mouthpiece cover.
DO NOT PUT THE METAL CANISTER INTO WATER.
AVAILABILITY
Salbutamol (Ventolin®) 100mcg/actuation Inhaler: 200 actuations per Metered Dose Inhaler
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Keep all medicines out of reach of children.
VENTOLIN and BABYHALER are registered trademarks of the GlaxoSmithKline group of companies.
©2009, GlaxoSmithKline. All rights reserved.
Version number: GDS25/IPI09
Imported by:
GlaxoSmithKline Philippines Inc
2266 Chino Roces Avenue, City of Makati
Tel. 892-0761
Manufactured by:
Glaxo Wellcome S.A.
Aranda de Duero, Spain
Repacked by:
GlaxoSmithKline Australia Pty. Ltd.
Boronia, Australia
Revision date: 14 April 2014