INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ANGITRATE 20 mg (tablets)
ANGITRATE 40 mg (tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ANGITRATE 20 mg (tablets)
ANGITRATE 40 mg (tablets)

COMPOSITION:
ANGITRATE 20 mg tablets contain 20 mg
isosorbide-5-mononitrate.
ANGITRATE 40 mg tablets contain 40 mg isosorbide-5-mononitrate.

PHARMACOLOGICAL CLASSIFICATION:
Category. A, 7.1.4 Vasodilators - coronary and other medicines used in angina pectoris.

PHARMACOLOGICAL ACTION:
Isosorbide-5-mononitrate exerts the typical actions of all organic nitrates on the cardiovascular system. Isosorbide-5-mononitrate decreases both preload and afterload as a result of dilatation of both venous capacitance and arteriolar resistance vessels. Since the primary determinants of myocardial oxygen demand are reduced by the nitrates, their net effect usually is to decrease myocardial consumption of oxygen. This ability to reduce the demand for oxygen appears to be most important for patient with typical angina.

Isosorbide-5-mononitrate is completely absorbed after oral administration, and is not subject to initial degradation on initial passage through the liver.

Isosorbide-5-mononitrate has an intrinsic prolonged action of up to 8 hours.

INDICATIONS:
Long-term prophylaxis of angina pectoris.

CONTRA-INDICATIONS:
Sensitivity to isosorbide-5-mononitrate.
ANGITRATE tablets should not be used in cases of shock and hypotonic collapse. In cases of myocardial infarction and in cases of very low blood pressure ANGITRATE should be administered under strict medical supervision.

ANGITRATE tablets should not be used in patients with marked anaemia, with head trauma, cerebral haemorrhage or increased intracranial pressure and should be used with caution in patients who are predisposed to closed angle glaucoma.

The safety of ANGITRATE in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
One ANGITRATE 20 mg or 40 mg tablet, 2 to 3 times daily, to be swallowed whole with some liquid after meals. For stabilisation, a dosage scheme using gradual increments is recommended so as to minimise the possible occurrence of headaches.

Not intended for relief of acute symptoms of angina pectoris.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient throbbing headache, nausea, facial flushing and dizziness can occur. Particularly at the start of treatment a fall in blood pressure and increased heart rate can occur. The action of antihypertensive agents can be intensified when used together with ANGITRATE.

If methaemoglobinaemia occurs withdrew treatment.

The simultaneous intake of alcohol can impair reactions eg. when driving or operating machinery and can increase the hypotensive effect.

There is a theoretical hazard of rapid withdrawal following chronic exposure which might be expected to produce non-exertional ischaemic cardiac pain or peripheral ischaemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage and intoxication cause vomiting, restlessness, hypotension, syncope and cyanosis. Methaemoglobinaemia could occur. Coldness, of the skin, impairment of respiration and bradycardia can ensue.

Treatment is symptomatic and supportive.

IDENTIFICATION:
ANGITRATE 20 mg and 40 mg tablets: Round, white, slightly biconvex, scored on the one side, with 20 and 40 respectively imprinted on the other side.
PRESENTATION:
ANGITRATE 20 mg tablets are available in securitainers of 60 tablets.
ANGITRATE 60 mg tablets are available in securitainers of 60 tablets.

STORAGE INSTRUCTIONS:
Store below 25 °C. Protect tablets from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
ANGITRATE 20 mg - V/7.1.4/21
ANGITRATE 40 mg - V/7.1.4/22

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
AKROMED PRODUCTS
Electron Avenue ISANDO 1600
Imported packed and distributed under licence from
Heinrich Mack Nachf, GERMANY.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1988

        578-9046

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