Download Nitrin® SR - Healthcare Pharmaceuticals

Nitrin SR
®
Nitroglycerin USP
Active Ingredient: Each sustained
release tablet contains 2.6 mg
Nitroglycerin USP. Each sustained release
capsule contains 2.6 mg Nitroglycerin
USP as sustained release pellets.
Properties & Effects: Nitrin® SR is a
potent coronary vasodilator. It also
reduces venous return and thus left
ventricular work. Nitrin® SR possesses
sustained effects because its absorption
from the gastrointestinal tract is long
lasting and continuous due to the
sustained release of active substance
from the formulation.
Indications: Prevention and treatment of
effort
and
vasospastic
angina.
Supplementary treatment of heart failure
refractory to digitalis and diuretic
treament.
Dosage and Administration: Adults and
elderly patients: Dosage should be tailored
to the requirements of the individual
patient depending on the severity of
illness and the occurrence of side-effects
but will usually be 1 or 2 tablets/capsules
taken 2-3 times daily before meals.
Children: Not recommended. Nitrin® SR is
for oral administration. Tablet/capsule
must be swallowed whole and not
chewed.
Contraindications: Nitroglycerin USP
should not be used in patients with
marked anaemia, head trauma, cerebral
haemorrhage or incipient glaucoma.
Sildenafil has been shown to potentiate
the hypotensive effects of nitrates, and its
co-administration with nitrates or nitric
oxide donors is therefore contraindicated.
Special Warnings and Precautions: As
with other drugs for the treatment of
angina pectoris, abrupt discontinuation of
therapy may lead to exacerbation of
symptoms. When discontinuing long term
treatment, the dosage should be reduced
gradually over several days.
Interactions: Nitrin® SR may potentiate
the effects of peripheral vasodilators. The
hypotensive effects of nitrates are
potentiated by concurrent administration
of sildenafil.
Pregnancy and Lactation: There is no
evidence relating to the safety of nitrates
in pregnancy and lactation. Nitrin® SR
should be administered to pregnant
women and nursing mothers unless
considered essential by the physician.
Side Effects: Headache, dizziness, mild
gastrointestinal symptoms may occur.
They disappear on dosage reduction and
usually do not necessitate the
discontinuation of the treatment.
Overdose: In the event of accidental or
deliberate overdosage toxic effects of
Nitroglycerin include vomiting, restlessness,
cyanosis, methaemoglobinaemia, syncope
and tachycardia. Patients should receive
gastric aspiration and lavage and be given
respiratory and circulatory support.
Pharmacokinetic Properties: Following
oral administration Nitroglycerin is rapidly
metabolised to glyceryl 1,2 dinitrate and
glyceryl 1,3 dinitrate. Although less potent
the metabolites probably provide the
predominant pharmacological effect.
Studies with Nitoglycerin 2.6 mg
demonstrate a tmax for both metabolites of
approximately 1 hour and an apparent t1/2
of approximately 2 hours. There is evidence
of activity extending over 6 hours or more.
Packs: Nitrin® SR tablet: Each box
contains 3x10 tablets in blister pack.
Nitrin® SR capsule: Each box contains
10x6 capsules in blister pack.
Storage: Store at a temperature not
above 250C and keep away from light.
Medicine: Keep out of reach of children
Manufactured by:
Healthcare Pharmaceuticals Limited
Rajendrapur, Bangladesh
HP 5241