Description: Pactorin® is a preparation of Nitroglycerin. It is a potent coronary vasodilator,
which relaxes the muscles of blood vessels, causing an increase in the oxygen supply to the
heart. It also reduces venous return, lowers end-diastolic pressure in the right and left
ventricles and improves myocardial function. Retard tablets of Nitroglycerin possess
sustained effect because its absorption from the gastrointestinal tract is long lasting and
continuous, due to the sustained release of active substance from the matrix. Nitroglycerin
is suitable for the prevention as well as for reducing the severity of anginal attacks when
given in long term treatment. Pactorin® increases the tolerance of anginal patients to
exercise and decreases the sublingual Nitroglycerin demand.
Indications: Pactorin® is indicated for the prophylaxis and long term treatment of angina
pectoris, adjuvant therapy of congestive heart failure (in combination with digitalis, diuretic,
ACE-inhibitor or arterial vasodilator preparation) and myocardial infarction.
Dosage and administration: Pactorin® should be taken before meal. The dosage should
be determined individually depending on the severity of the illness and on the patients
condition. Adult and elderly patients: The usual starting dose is one tablet 2 times a day
in the morning and early afternoon (e.g. at 8 am and 2 pm, with a daily nitrate free interval
of 10 to 12 hours), which can be incremented gradually to 2 or 3 tablets 2 times a day. If
the attack is primarily nocturnal, then the daily dose should be taken in the morning and
bedtime. Children: Nitroglycerin is not recommended for use in children. Use in
pregnancy and lactation: There is no evidence relating to the safety of Nitroglycerin in
pregnancy and lactation. Nitroglycerin should not be administered to pregnant women and
nursing mothers unless considered essential by the physician.
Precautions: Nitroglycerin should be used cautiously in patients with volume depletion or
low systolic blood pressure. Regular use of Nitroglycerin (three times daily) should be
avoided because of the developing of tolerance.
Side effects: The common side effect of nitroglycerin is headache (nitrate headache),
which is frequent at the beginning of therapy. It is dose dependent and ceases within
several days. Rarely, at the time of the first administration, or when the dose is increased
blood pressure drops, or orthostatic hypotension may appear with the symptoms of
increased heart rate, daze, dizziness and the feeling of weakness. Occasionally, nausea and
vomiting may occur.
Contraindications: Nitroglycerin should not be used in patients with history of known
hypersensitivity to Nitroglycerin or any of components of this ingredient. It is also
contraindicated in patients with increased intracranial pressure, glaucoma.
Drug Interactions: Concomitant use of Nitroglycerin with alcohol may cause hypotension.
Patients receiving antihypertensive drugs should be observed for possible additive
Only for the use of medical professional
Overdose: Accidental or deliberate over dosage 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
Pharmaceutical precautions: store in a cool and dry place. Protect from light.
Presentation: Pactorin® 2.6 mg tablet: each retard tablet contains nitroglycerin USP 2.6
Package quantities: Pactorin® 2.6 mg tablet: Carton of 50 tablets in blister.
® Registered Trade Mark
Brand: ACI Limited.