Apo-ISDN

Apo-ISDN

isosorbide dinitrate

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Isosorbide dinitrate.
Description
Each sublingual tablet contains isosorbide dinitrate 5 mg.
Energy: 1 KJ (0.3 kcal). Sodium: <1 mmol (0.014 mg)
Each tablet contains isosorbide dinitrate contains 10 mg.
Energy: 2 KJ. Sodium: <1 mmol (0.023 mg)
Gluten-and tartrazine-free.
Action
Pharmacotherapeutic group: Anti-anginal Agent.
Pharmacology: Isosorbide, a nitrate, relaxes vascular smooth muscle. The efficacy of nitrates in alleviating the pain of angina pectoris is probably due to a reduction in myocardial oxygen demand rather than to an increase in myocardial oxygen supply. Although venous effects predominate, nitrates dilate both arterial and venous beds. Dilating the post-capillary vessels, including large veins, promotes a peripheral pooling of blood and decreases venous return to the heart. This reduces left ventricular end-diastolic pressure (pre-load). The arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load), and decrease in ventricular volume reduces intramyocardial tension and lessens myocardial oxygen demand.
After a single oral dose of 30 mg isosorbide, mean plasma peak concentrations of 24 ng/ml were observed within 30 minutes.
Indications/Uses
For the prophylaxis of ischemic heart pain associated with chronic angina of effort. It may reduce the number, duration, and severity of anginal attacks, increase exercise tolerance, and curtail nitroglycerin requirements.
Dosage/Direction for Use
Individualize dosage as there are wide inter-patient differences in sensitivity to isosorbide dinitrate. Usual dosage range is 5 mg to 30 mg 4 times daily, titrated according to therapeutic and patient response.
Overdosage
Symptoms: Related to vasodilation: cutaneous flushing, headache, nausea, dizziness, and hypotension.
Treatment: Gastric lavage with symptomatic and supportive therapy, including ventilation with oxygen and vasopressor amines if indicated.
Contraindications
Hypersensitivity to isosorbide or known idiosyncratic reaction to organic nitrates. Increased intracranial pressure (e.g., head trauma or cerebral hemorrhage). Withhold treatment in the presence of cardiogenic shock, or if there is a risk of shock developing.
Warnings
The data supporting the use of nitrates during the early days of the acute phase of myocardial infarction (the period during which clinical and laboratory findings are unstable) are not sufficient to establish safety.
Nitrate dependence may occur with chronic use. To avoid possible withdrawal effects, gradually reduce administration. Do not discontinue abruptly. Chest pain, acute myocardial infarction, and even sudden death have occurred during a temporary withdrawal of nitrate exposure in industry workers continuously exposed to nitrates.
Special Precautions
Tolerance to isosorbide, and cross-tolerance to other nitrates and nitrites may occur.
Administer isosorbide with caution to patients with glaucoma.
Isosorbide, like nitroyglycerin, is a potent vasodilator and causes a slight decrease in mean blood pressure (approximately 10 to 15 mm/Hg) in some patients when used in therapeutic dosages. Exercise caution using the drug for patients who are prone to or might be affected by hypotension.
Use In Pregnancy & Lactation
Pregnancy: Adequate studies in humans have not been done.
Adverse Reactions
Headache is the most frequent adverse effect, and it may be severe and persistant. This occurs most frequently at the beginning of therapy. Usually a temporary reduction in dosage will control headache along with a concomitant administration of commonly used analgesics, or by administering the drug during meals. These headaches disappear within a week of continuous, uninterrupted therapy. Advise the patient they may occur and that isosorbide is important with regard to preventing of angina. Occasionally, drug and/or exfoliative dermatitis occur. Signs of cerebral ischemia associated with postural hypotension, such as weakness and transient episodes of dizziness, may occasionally develop. Cutaneous vasodilation with flushing may occur. Rarely, a marked sensitivity to the hypotensive effects of the drug can occur with a severe response (nausea, vomiting, restlessness, perspiration, and collapse); alcohol may enhance this effect. Isosorbide can antagonize the effects of histamine, acetylcholine, and similar agents.
Drug Interactions
Isosorbide dinitrate can antagonise the effects of histamine or epinephrine, acetylcholine and similar agents.
Caution For Usage
Incompatibilities: None known.
Storage
Store in a cool, dry place. Protect from light and humidity.
MIMS Class
ATC Classification
C01DA08 - isosorbide dinitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
Presentation/Packing
SL tab 5 mg (pink) x 100's. Tab 10 mg (white, scored, identified APO 10) x 1,000's.
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