Download Lidil Oxymetazoline

Lidil
Oxymetazoline
Nasal drops
Formulae
Lidil Nasal drops: Each 100 ml contains Oxymetazoline hydrochloride 50 mg
Excipients: Benzalkonium chloride; Monobasic sodium phosphate anhydrous;
Dibasic sodium phosphate dodecahydrate; 0.10 N Sodium hydroxide; Distilled
water qs.
Lidil Infantil Nasal drops: Each 100 ml contains Oxymetazoline hydrochloride
25 mg. Excipients: Benzalkonium chloride; Monobasic sodium phosphate
anhydrous; Dibasic sodium phosphate dodecahydrate; 0.10 N Sodium hydroxide;
Distilled water qs.
Therapeutic Use
Nasal decongestant.
Indications
Lidil is indicated for the symptomatic treatment of acute congestive conditions
in rhinitis and sinusitis.
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Pharmacological Ac tion
Oxymetazoline is an imidazole derivative with sympathomimetic properties and
strong vasoconstrictor effect which immediately produces a decongestant and
detumescent effect at the site of application. The application of either Lidil or
Lidil Infantil, as spray or drops, rapidly restores normal breathing conditions,
without reducing the basal mucosal secretion. The effect lasts 6-12 hours,
ensuring a good night’s rest.
Dosage and Administration
Lidil (adults) is indicated for the treatment of adults and children over 12 years
of age.
Adults:
Spray: 1 spray in each nostril, 2 to 3 times a day.
Drops: Instill 1 or 2 drops in each nostril, 2 to 3 times a day.
Children over 12 years of age:
Spray: 1 spray in each nostril, once or twice a day.
Drops: Instill 1 or 2 drops in each nostril, once or twice a day.
Lidil Infantil is indicated for the treatment of children between 6 and 12 years
of age.
Children between 6 and 12 years of age:
Spray: 1 spray in each nostril, once or twice a day.
Drops: Instill 1 or 2 drops in each nostril, once or twice a day.
Administration:
Lidil can be used indistinctively as spray or drops.
Spray: Insert the tip of the bottle into each nostril and, squeeze it firmly, while
breathing in deeply through the nose.
Drops: Lean your head back, and instill the drops in each nostril by gently
squeezing the inverted container.
Administration to children must be made under adult supervision.
C ontraindications
Known hypersensitivity to any of the ingredients of the product. Closed-angle
glaucoma. Patients at risk of urinary retention due to prostate disorders. Patients
treated with MAO inhibitors. Children under 6 years of age.
Precautions and Warnings
Avoid prolonged treatments because of the risk of rebound congestion and rhinitis
medicamentosa.
Due to its sympathomimetic activity, it should be administered with caution to
elderly patients, to patients with hypertension, heart diseases, diabetes or
hyperthyroidism.
After the first administration of a nasal preparation, microbial contamination of the
preparation may occur.
Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Fetal toxicity is attributable to the pharmacological effects of Oxymetazoline:
Tachycardia and fetal hyperactivity. Therefore, Lidil drops should only be used
during pregnancy after a close risk benefit evaluation.
Nursing: It should not be administered during nursing due to possible cardiovascular
effects on the infant.
Pediatric use: In infants and children under 6 years of age it may produce
somnolence, drowsiness, vomiting and tachycardia, therefore its use is
contraindicated.
Geriatric use: Administer with caution.
Drug Interac tions
Bromocriptine: Risk of vasoconstriction or hypertension. Non-selective MAO
inhibitors (iproniazid): Risk of hypertensive crisis which due to the prolonged
action of MAO inhibitors may occur even 15 days after discontinuation of these
drugs. Selective MAO inhibitors (moclobemide, toloxatone): Although no
interactions between these MAO inhibitors and alpha-adrenergic vasoconstrictor
agents have been described, they should be administered with extreme caution.
Adverse Reac tions
Nasal dryness. Very rarely and temporarily: Nasal burning or stinging, sneezing or
increased nasal discharge. In case of prolonged use or high doses systemic effects
may occur: Headache, insomnia, palpitations.
O verdosage
If taken by mouth, disorders of consciousness or somnolence may occur, which may
lead to coma, hypertension, bradycardia, and hypothermia. After a thorough
evaluation of the patient, considering the time lapsed from administration, the
amount of drug taken, and once having discarded any contraindication regarding
certain procedures, the physician will decide upon carrying out the general rescue
treatment: Gastric evacuation (gastric lavage or vomiting) and activated charcoal
administration, clinical and blood pressure control, supportive treatment.
In the event of overdosage go to the nearest hospital or contact the Toxicology
Centers: Children’s Hospital Ricardo Gutiérrez: (011) 4962-6666 / 2247, Hospital
A. Posadas: (011) 4654-6648 / 4658-7777.
How Supplied
Lidil: Double-use Plastic bottle (double use - spray and drops) containing 15 ml
of 0.05% solution.
Lidil Infantil: Double-use Plastic bottle (double use - spray and drops)
containing 15 ml of 0.025% solution.
The plastic bottle is filled up to half of its volume to allow spray formation when
squeezing.
Before using this product verify the integrity of the safety seal by checking if the
bridges connecting the ring to the cap are intact.
Sold under prescription
Made in Argentina
Product authorized by the Ministry of Health
Certificates Nº 27,970 and 27,971
Technical Director: Mirta Beatriz Fariña, Pharmacist
Manufactured at Álvaro Barros 1113,
B1838CMC Luis Guillón,
Pcia.de Buenos Aires
Last revised: December 2000
Medicinal Product
Keep out of the reach of children
Keep in a dry place at temperature below 30° C
Information to Health Care Professionals and Patients:
0-800-333-5658
Roemmers S.A.I.C.F.
Fray Justo Sarmiento 2350,
B1636AKJ Olivos,
Pcia. de Buenos Aires
(16)
B 1117501872
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www.roemmers.com.ar