Calcigard Retard

CALCIGARD RETARD
(Nifedipine 20mg Sustained Release Tablets)
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.

Calcigard (nifedipine) Retard, a dihydropyridine derivative is a specific and potent calcium channel blocker.

CLINICAL PHARMACOLOGY:
Calcigard Retard inhibits influx of calcium through cardiac muscle and vascular smooth muscle cell membrane.
As a specific and potent calcium channel blocker, the main action of Calcigard is to relax arterial smooth muscle both in the coronary and peripheral circulation.
In hypertension, the main action of Calcigard Retard is to cause peripheral vasodilation and thus reduce peripheral resistance.
Calcigard Retard administered twice daily provides 24 hour control of raised blood pressure. Calcigard Retard causes reduction in blood pressure such that the percentage lowering is directly related to its initial height. In normotensive individuals, Calcigard Retard has little or no effect on blood pressure.
Nifedipine is completely absorbed after oral administration. Plasma drug concentrations rise at a gradual, controlled rate after Calcigard Retard tablet dose and plateau is maintained with minimal fluctuations over the 12 hour dosing interval. Nifedipine is extensively metabolized to highly water soluble, inactive metabolites accounting for 60 to 80% of the dose excreted in the urine. The elimination half-life of nifedipine is approximately 2 hours. Less than 0.1 % of the dose of unchanged form can be detected in the urine. The remainder is excreted in the faeces in metabolized form, most likely as a result of biliary excretion. Thus, the pharmacokinetics of nifedipine are not significantly influenced by the degree of renal impairment. Pharmacokinetics of nifedipine may be altered in patients with chronic liver disease.

INDICATIONS:
Calcigard Retard is indicated for the treatment of all grades of hypertension, ischemic heart disease and peripheral vascular diseases.

CONTRAINDICATIONS :
Calcigard Retard should not be administered to patients with known hypersensitivity to nifedipine Calcigard should not be used in patients with cardiogenic shock.

WARNING:
Calcigard Retard may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Calcigard will not prevent possible rebound effects after cessation of other antihypertensive therapy.

PRECAUTION:
Calcigard Retard should be used with caution in patients whose cardiac reserve is poor. Caution should be exercised in patients with severe hypotension.
Ischaemic pain has been reported in a small proportion of patients within 30 to 60 minutes of the introduction of Calcigard Retard therapy. Although a 'steal' effect has not been demonstrated, patients experiencing this effect should discontinue Calcigard Retard.

DRUG INTERACTIONS:
The antihypertensive effect of Calcigard Retard may be potentiated by simultaneous administration of cimetidine. When used in combination with nifedipine, serum quinidine levels have been shown to be suppressed regardless of dosage of quinidine.

USE IN PREGNANCY, LACTATION & CHILDREN:
There are no adequate and well controlled studies of Calcigard Retard in pregnant and lactating women. Calcigard Retard should be used during pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus.
There are no recommendations for the use of Calcigard Retard in children.

ADVERSE REACTION:
Most adverse reactions are consequences of the vasodilator effects of nifedipine and include headache, dizziness and flushing. Gravitational oedema, not associated with heart failure or weight gain, has also been reported. Other less commonly reported side-effects include rash, nausea, lethargy and increased frequency of micturition. There are reports of gingival hyperplasia which may regress on withdrawal of therapy.

DOSAGE & ADMINISTRATION:
The recommended dose of Calcigard Retard is one tablet (20 mg) twice daily swallowed with a little fluid during or after food, with subsequent titration of dosage according to response. These tablets must be swallowed whole and not broken or chewed. The dosage may be adjusted within the range, 20 mg once daily up to 40 mg twice daily, to achieve the desired effect. Treatment may be continued indefinitely.

OVERDOSAGE:
Reports of overdosage are limited and symptoms are not necessarily dose-related. Severe hypotension, bradycardia and unconsciousness have been observed Gastric lavage and charcoal instillation have been employed. Intravenous calcium gluconate or calcium chloride appear most helpful, with intravenous atropine for bradycardia. Metaraminol has been beneficially combined with calcium salts in the experimental situation.

PRESENTATION:
Calcigard Retard tablets are available in strips of 10, each tablet contains nifedipine 20 mg in sustained release form.

Manufactured by :
TORRENT PHARMACEUTICALS LTD.
Indrad-382 721, Dist. Mehsana, INDIA.

Imported by:
PT. Doxa Manggalya Utama, Jakarta, Indonesia.

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