Isdin

Isdin

isosorbide dinitrate

Manufacturer:

Maple Pharma

Distributor:

Averroes Pharma
Full Prescribing Info
Contents
Isosorbide dinitrate.
Description
Each Tablet contains Isosorbide Dinitrate 10mg.
Action
Pharmacology: Pharmacodynamics: Mode of action: Isosorbide dinitrate is a vasodilator.
Pharmacokinetics: Isosorbide dinitrate is readily absorbed from the oral mucosa and also following oral administration. It undergoes extensive first pass metabolism, mainly in the liver.
The major metabolites are isosorbide 2-mononitrate and isosorbide 5-mononitrate which both possess vasodilatory activity and may contribute to the activity of the parent compound.
Indications/Uses
Isosorbide dinitrate taken orally is used in the prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure.
Dosage/Direction for Use
ISDIN is administered by oral.
Isosorbide Dinitrate is used in angina pectoris in oral doses of 30mg to 120mg daily in divided doses according to the patients need. Increases in dosage should be gradual to avoid side effects.
Up to 240mg daily in divided doses may be required.
Similar doses are used as adjunctive therapy in congestive heart failure.
In order to obtain maximal therapeutic effect, it is important that the dosages of oral ISDIN be individualized in accordance with patient needs, response and tolerance. The smallest effective dose should be used initially.
Paediatric: Not recommended for use in children as efficacy and safety have not been demonstrated for this age group.
The recommended dosage regimens should be one that is able to provide a low-nitrate period or a nitrate-free period of 8-12 hours every 24 hours to prevent the development of tolerance and thus maintain the anti-anginal effects.
Overdosage
The main manifestation is hypotension and reflex tachycardia. In such events the drug should be withheld and the patient carefully monitored. Passive exercise and elevation of legs of the recumbent patient will promote venous return. In life threatening situations, administration of vasopressors should be considered.
Contraindications
Known hypersensitivity to isosorbide dinitrate or a known idiosyncratic reaction to organic nitrate drugs.
Hypotension or uncorrected hypovolaemia as the use of isosorbide dinitrate in such states could produce severe hypotension or shock.
Constrictive pericarditis and pericardial tamponade.
Severe anemia or arterial hypoxaemia.
Intracranial hypertension.
Special Precautions
Development of tolerance may occur with all forms of nitrate therapy particularly with the long acting preparations that maintain continuously high plasma nitrate concentration.
Use with caution in patients with severe renal or hepatic disease, hypothyroidism, malnutrition, or hypothermia, those with low or normal pulmonary capillary wedge pressure and in those receiving drugs that lower blood pressure.
It should be used with caution in patients who are predisposed to closed-angle glaucoma.
Increase in dosage should be gradual to avoid side effects.
Alcohol may potentiate side effects of the medication.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. ISDIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: It is not known whether isosorbide dinitrate or its metabolites are excreted in milk, or whether it has a harmful effect on the newborn. Therefore, it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
Adverse Reactions
As with nitroglycerin and other nitrates, vascular headache occurs and it may be severe and persistent. This adverse effect occurs most frequently at the beginning of therapy. Headache usually can be controlled by temporary dosage reduction, concomitant administration of commonly used analgesics or by administering the drug during meals. These headaches usually disappear within one week of continous, uninterrupted therapy. It is usually best to advise the patient of their possible occurrence and of their importance in regard to the prevention of angina. Drug and/or exfoliative dermatitis occasionally occur. Signs of cerebral ischemia associated with postural hypotension such as weakness or transient episodes of dizziness may occasionally develop. Cutaneous vasodilatation with flushing may occur. Rarely, a marked sensitivity to the hypotensive effects of the drug and severe response (nausea, vomiting, restlessness, perspiration and collapse) can occur and alcohol may enhance this effect. Isosorbide dinitrate can antagonize the effects of histamine or epinephrine, acetylcholine and similar agents.
Drug Interactions
Isosorbide dinitrate can act as a physiological antagonist to noradrenaline (norepinephrine), acetylcholine, histamine and other agents. The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiesterase inhibitors (eg sildenafil, tadalafil and vardenafil).
Orthostatic hypotension may occur with the combined use of calcium channel blockers, antihypertensive agents, phenothiazines and tricyclic anti-depressants. Use of alcohol may produce severe hypotension and collapse.
Storage
Store below 30°C.
Shelf-Life: The tablets can be used within 36 months from the date of manufacturer if kept as recommended.
MIMS Class
ATC Classification
C01DA08 - isosorbide dinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
Presentation/Packing
Tab 10 mg (white round mark maple leaf on one side and ISDIN and bisected line on the other side) x 10 x 10's.
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