(i)
ROUTE OF ADMINISTRATION
Oral
DOSAGE AND ADMINISTRATION
Capsules
should be swallowed with a little fluid, during or after food.The dosage should
be established by titration. Excessive doses can result in hypotension.
Dose range for the treatment of both angina and hypertension is 30 mg to 80
mg/day. The starting dose is 5 mg thrice daily and this is gradually increased
over 7 to 14 days as required.
For rapid relief in angina or in hypertensive crisis, the capsule is bitten
and the contents retained in the mouth. In hypertensive crisis 20 mg nifedipine
can be administered sublingually.
In the elderly Initially 5 mg thrice daily.
In impaired hepatic function
The patient should commence therapy at 5 mg thrice daily with careful monitoring
Health 2000 Nifedipine SR administered
twice daily provides a 24 hour control of raised blood pressure. These tablets
should be swallowed whole and should not be crushed or chewed.
(ii)
THERAPEUTIC / DIAGNOSTIC CLAIMS
Health 2000 Nifedipine SR is
indicated in the prophylaxis and treatment of angina, all grades of hypertension
and Raynaud's phenomenon .
(iii) DESCRIPTION OF DOSAGE FORM
Nifedipine is a calcium channel blocker and inhibits the transmembranous influx of calcium in the cardiac and vascular smooth muscles. Nifedipine dilates arteries, reduces peripheral resistance and blood pressure.
(iv) CONTRAINDICATIONS
Hypersensitivity to the drug.
WARNING
AND PRECAUTIONS
DRUG INTERACTIONS
Betablockers: Concomitant administration of nifedipine with betablockers is
usually well tolerated, but in rare cases, the combination may increase the
likelihood of congestive cardiac failure, severe hypotension or exacerbation
of angina.
Digitalis: Administration of nifedipine with digoxin may elevate digoxin levels.
Hence, it would be advisable to monitor the digoxin levels when initiating,
adjusting and discontinuing health 2000 Nifedipine SR therapy.
Theophylline, phenytoin and cimetidine may increase the plasma levels and
bioavailability of nifedipine.
PREGNANCY
Health 2000 Nifedipine SR should be used during pregnancy only when potential
benefits justify possible risks to the foetus
NURSING MOTHERS Nifedipine is secreted in breast
milk. Therefore a decision should be made to discontinue nursing or to discontinue
the drug, taking into account the importance of the drug to the mother
PAEDIATRIC USE Safety and effectiveness in children have not been established.
IN THE ELDERLY See Dosage and Administration.
IN IMPAIRED HEPATIC FUNCTION See Dosage and Administration.
OTHERS
Because nifedipine causes decrease in peripheral vascular resistance, careful
monitoring of blood pressure during the initial stage of therapy is suggested.
(v) SIDE EFFECTS
Though adverse effects may be frequent, they are not serious and rarely require
discontinuation of therapy. Potential adverse effects are dizziness, flushing,
headache and weakness. Mild to moderate peripheral oedema primarily in the
lower extremities may be observed.
(vi) TOXIC EFFECTS
The toxic effects of Nifedipine may result in a depression of myocardial contractility,
a decrease of sinus autamacity & atrioventricular conduction & a decrease
of systemic vascular resistances. Nifedipine increases heart rate.