PHARMACOLOGICAL CLASSIFICATION A 7.1 Vasodilators Hypotensives
PHARMACOLOGICAL ACTION: NIFEDIPINE a calcium antagonist improves oxygen supply to the myocardium and decreases of oxygen requirements. NIFEDIPINE has a vasodilatory effect on the peripheral arterial beds causing a fall in peripheral vascular resistance and an increase in peripheral blood flow.
INDICATIONS: Treatment and prophylaxis of angina pectoris, including prinzmetal's angina. Intermittent arterial vasospasm (Raynaud's) in the absence of any underlying collagen, arteriosclerotic or other vascular disease. Initial management of hypertensive emergency
CONTRA-INDICATIONS: The safety of BSP NIFEDIPINE 10 mg in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE: The usual dose in 10 mg to 20 mg three times daily. For the treatment of prinzmetal's angina doses of 20 mg four times daily may be required. The Capsules should be swallowed whole with some fluid before meals.
THREAT OF ANGINA PECTORIS ATTACK: as a more rapid onset of action is required for impending attacks of angina pectoris. The Capsule should be bitten and the contents allowed to remain in the mouth for a short while. The active substance can then be rapidly absorbed through the buccal mucosa. The recommended dosage regimen for the treatment of intermittent arteriolar vasospasm (Raynaud's) is 10 mg to 20 mg three times daily, according to the response. Treatment of hypertensive emergency: 10 - 20 mg orally, sublingually or bucally.
SIDE EFFECTS: Headache, facial flushing, dizziness and nausea, a feeling of warmth, tiredness and gastro-intestinal disturbances may occur. Ischaemic or anginal pain may occur about 15 to 30 minutes after taking BSP NIFEDIPINE 10 mg possibly due to a fall in perfusion pressure and increase in heart rate, in such a case a reduction in dosage or discontinuation of the preparation is recommended.
Some patients may have hypotension and some patients have had excessive and poorly tolerated hypotension. Syncope has been reported but a recurrence can be prevented by a reduction in the dosage of BSP NIFEDIPINE 10 mg. Tachycardia peripheral oedema - unrelated to congestive cardiac failure, perspiration and nervousness have been reported. An increased frequently of angina may occur. Myocardial infarction has been reported.
There have been reports of abnormalities in liver function due to hypersensitivity reactions. Gingival hyperplasia have been reported.
SPECIAL PRECAUTIONS NIFEDIPINE can enhance the action of blood pressure-lowering preparations and beta-receptor blockers.
BSP NIFEDIPINE does not replace the nitro-glycerines in an acute attack of angina pectoris.
Blood pressure should be monitored carefully during initiation and upward titration of BSP NIFEDIPINE 10 mg especially if patients are on antihypertensive therapy.
Care should be exercised in dialysis patients with malignant hypertension and irreversible kidney failure with hypovolaemia as a marked fall in blood pressure may occur. The antihypertensive effect of NIFEDIPINE may be potentiated by concomitant administration of cimetidine. An increase in blood glucose has been noted, therefore care must be taken in patients with diabetes mellitus.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Flushing headaches, lowering of blood pressure and increase in heart rate.
No specific antidote is available. Treatment is symptomatic and supportive.
IDENTIFICATION: Orange-coloured soft gelatine capsules filled with a yellow viscous liquid.
PRESENTATION: Blister pack of 10's/12's in boxes of 84.
Bottles of 100 capsules of 10 mg NIFEDIPINE.
Bottles of 250 capsules of 10 mg NIFEDIPINE.
STORAGE INSTRUCTIONS: Store below 25°C, as the gelatin capsules may stick together.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NOTE: BSP NIFEDIPINE 10 mg capsules should only be removed from the glass bottle or blister pack by the patient immediately before use, and the cap should be replaced on the glass bottle.
REGISTRATION NUMBER Y/7.1/330.
NAME AND BUSINESS ADDRESS OF THE APPLICANT: BROVAR S & P (Pty) Ltd
24 Dogar Street
Delville Ext 1