Nifecard XL

Nifecard XL

nifedipine

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Nifedipine.
Action
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 dilation, 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 in high percentage bound to plasma proteins. The elimination half-life is approximately 2 hrs. 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 hrs after the first dose. For subsequent dose, constant plasma concentrations at this plateau are maintained with minimal fluctuations over the 24-hr dosing period.
Indications/Uses
Arterial hypertension. Coronary disease (stable angina pectoris and vasospastic angina pectoris).
Dosage/Direction for Use
Therapy should be initiated with 30 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 >90 mg daily are not recommended for therapy. If discontinuation of Nifecard XL is necessary, dosage should be decreased gradually.
Overdosage
Overdosage with nifedipine results in excessive peripheral vasodilation with marked and probably prolonged 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 proteinbound, dialysis is not likely to be of benefit.
Contraindications
Hypersensitivity to nifedipine; arterial hypotension, severe aortic valve stenosis, obstructive cardiomyopathy and porphyria.
Special Precautions
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 (rarely) increased frequency, severity and duration of angina pectoris attack after ingestion of nifedipine. In this case, nifedipine therapy should be ceased.
Effects on the Ability to Drive or Operate Machinery: Not known.
Use in pregnancy: 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 fetus.
Use in lactation: Nifedipine is excreted in breast milk, therefore, it should not be prescribed to nursing mothers.
Use In Pregnancy & Lactation
Use in pregnancy: 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 fetus.
Use in lactation: Nifedipine is excreted in breast milk, therefore, it should not be prescribed to nursing mothers.
Adverse Reactions
The most common side effects reported with nifedipine include peripheral edema, 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 diarrhea have been reported.
Drug Interactions
When nifedipine is administered concomitantly with antihypertensive drugs, β-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 should be adjusted.
Nifedipine may reduce the metabolism of phenytoin, while concomitant administration of cyclosporin or cimetidine may cause increased nifedipine levels. Concomitant administration of nifedipine and fentanyl may cause severe hypotension, therefore, it is recommended to withhold nifedipine therapy for at least 36 hrs prior to anesthesia (if possible). Plasma quinidine concentrations may decrease by 50% in patients receiving nifedipine and quinidine concomitantly. Nifedipine increases blood theophylline level during concomitant administration.
Storage
Store below 25°C.
MIMS Class
ATC Classification
C08CA05 - nifedipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
ER tab 30 mg x 30's.
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