Plot 8, Block ‘M’, Abimbola Street, Isolo, P.O.Box, 3344, Mushin, Lagos State.
Pharma & Chem. Co. Verovskova 57 Ljubljana, Slovenia
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-0766): Nifedipine BP 20 mg.
How to identify the Product: Nifecard Retard Extended release tablet.
Pack size: 50's.
Tablet (NRN: 04-2179): Nifedipine BP 30 mg.
How to identify the Product: Nifecard XL Extended release tablet.
Pack: Boxes of 30's.
Nifedipine is a calcium antagonist. It inhibits the transmembrane influx of extracellular calcium ions across the membranes of myocardial cells or vascular smooth muscle cells, without changing blood calcium concentrations. As a result of systemic arterial and arteriolar dilatation, nifedipine causes a reduction in peripheral vascular resistance and therefore, decreases arterial blood pressure.
Nifedipine dilates the main coronary arteries and arterioles, both in normal and ischemic myocardial regions, and is a potent inhibitor of coronary artery spasm. Nifedipine increases myocardial oxygen delivery, which accounts for its effectiveness in the treatment of angina pectoris.
Nifedipine is rapidly and nearly completely absorbed. It is high in % bound to plasma proteins. The elimination half-life is approximately 2 hours. Most of nifedipine is excreted in the urine.
Nifecard XL, by extended release of the active ingredient, provides a rise of plasma nifedipine concentrations at a gradual, controlled rate which reach a plateau at approximately 6 hours after the first dose. For subsequent dose, constant plasma concentrations at this plateau are maintained with minimal fluctuations over the 24 hour dosing period.
Arterial hypertension; coronary disease: stable angina pectoris, vasospastic angina pectoris
Severe aortic valve stenosis;
Hypersensitivity to Nifedipine.
Nifedipine should not be used in cardiogenic shock and angina pectoris at rest (because it may precipitate myocardial infarction). It should be used with caution in patients with congestive heart failure, liver insufficiency and diabetes.
Patients who have severe obstructive coronary disease may develop (though rarely) increased frequency, severity and duration of angina pectoris attack after ingestion of nifedipine. In this case, nifedipine therapy should be ceased.
There is no adequate evidence on safe use of nifedipine in pregnant women, and the drug should be used during pregnancy only when the potential benefit justifies the possible risk to the foetus.
Nifedipine is excreted in breast milk, therefore, it should not be prescribed to nursing mothers.
Effects on ability to drive or operate machinery are not known.
When nifedipine is administered concomitantly with antihypertensive drugs, beta-adrenergic blocking agents and nitrates, their synergistic activity should be taken into account.
Administration of nifedipine with digoxin may increase digoxin levels, therefore, serum digoxin concentrations should be monitored and, when required, digoxin dose adjusted.
Nifedipine may reduce the metabolism of phenytoin, while concomitant administration of cyclosporin or cimetidine may cause increase nifedipine levels.
Concomitant administration of nifedipine and fentanyl may cause severe hypotension, therefore, it is recommended to withhold nifedipine therapy for at least 36 hours prior to anaesthesia (if possible).
Plasma quinidine concentrations may decrease by 50% in patients receiving nifedipine and quinidine concomitantly.
Nifedipine increases blood theophylline level during concomitant administration.
The most common side effects, reported with nifedipine include peripheral oedema, headache, flushing, heat sensation, dizziness, fatigue, constipation and nausea.
In some instances, retrosternal pain may occur after ingestion of nifedipine.
Giddiness, lethargy, hypotension, syncope, palpitations, cardiac decompensation, gingival hyperplasia, cramps in the upper and lower extremities and diarrhoea have been reported.
Dosage & Administration
Dosage of Nifecard XL must be adjusted according to each patient's needs. Therapy should be initiated with 30 mg or 60 mg once daily.
The tablets should be swallowed whole and should not be divided, crushed or bitten.
Dosage should be titrated at 7 to 14 day intervals. Doses above 90 mg daily are not recommended for therapy. If discontinuation of Nifecard XL therapy is necessary, dosage should be decreased gradually.
Overdosage with Nifedipine results in excessive peripheral vasodilation with marked and probably systemic hypotension.
Treatment of overdosage requires use of the standard measures to eliminate the drug from the body and careful monitoring of the vital heart and lung function, and urine output.
Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function.
Since nifedipine is highly protein-bound, dialysis is not likely to be of benefit.
Store the drug at a temperature below 25oC.