ISSORBIDE DINITRATE TABLETS BP 10 mg

Suitabaly formulated for oral & sublingual use

For the use only of a Medical practitioner or a hospital or laboratory.

 DESCRIPTION OF PRODUCT:

White circular uncoated tablets having breaking marking on one side of the tablet.

COMPOTION:

Each uncoated tablet contains isosorbide dinitrate 10 mg as diuted isosorbide dinitrate Bp

THERAPEUTIC:

Antianginal

ACTION:

Compatible with beta blockers and calcium ion antagonist

INDICATIONS:

Isosorbide dinitrate is indicated for the treatment and prevention of angina pectoris, isosorbide dinitrate mat be used prophylactically to decrese frequeny severity of anginal attacks.

CONTRAINDICATIONS:

Isosorbide dinitrate is contraindicate in patient who have shown purported hypersensitivity or idiosyncrasy to it or other nitra or nitrites.

ADVERSE REACTIONS:

Adverse reaction, particulary headache and hypotension, are dose related headache is the most common adverse reaction and may be severe and persistent, cutaneous vasodiliation with flushing may occur. Transient episodes of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension, may occasionally develop. An occasional individual will exhibit marked sensitivity to the hypotensive efffect of nitrate. Drug rash and or extoliative dermatitis may occassionally occur. Nausea and vomiting appear to be uncommon.

DRUG INTEGRATION:

Alcohol may enhance any marked sensitivity to the hypertensive effect of nitrates. Isosorbide dinitrate acts on vascular smooth muscles. Therefore, any other agents that depends on vascular smooth muscle as the final common path can be and expected to have decreased effect depending on the agent.

DOSAGE:

½  to 1 tablet 4 times a day to be taken orally. Sublingual use. For immedaate action ½ to tablet to be taken sublingually.

OVERDOSAGE:

Sign any symptoms:

These include the fallowing a prompt fall in blood pressure,persistent and throbbing headach, vertigo, visual, distubances, flushed and perspiring skin (later becoming cold and cyanotic) nausea and vomiting (possibly with colic and even bloady diarrhoea), syncope, ( especially in upright position), methemolobinemia with cyanosis and anoxia, initial hyperpnea, dyspea and slow breathing, slow pulse ( discrotic and intermittent), heart block increased intracranial pressure with cerebral sympotoms of confusion and moderate fever, paralysis and coma follwed by clonic convulsions and possibly death due to circulatory collapse.

TREATMENT OF OVERDOSAGE:

Prompt removal of the ingested material by gastric lavage is reasonable. Keep the patient recumbent in a shock position and comfortably warm. Passive movements of the extermiies may aid venos retun. Administer oxygen and artificial respiration if necessary. If methemologbinemia is present administer methylene blue (1% solution), 1 to 2 mg. intravenously.

WARNING:

Epinephrine is ineffective in reversing the severe hypoteensive events associated with overdose. It and related compounds are contraindicated in this situation.

PRESENTATION : Pack of 1000 tablets.

SHELFLIFE : 36months.

STRAGE : store tightly closed in cool, dry place. (temperature not exceeding 25^oc)