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Drug Details

ADIPINE MR

• Drug Class Description
  Calcium-channel blockers (class II calcium antagonists).
• Generic Name
  Nifedipine - angina
• Presentation
  Tablets, nifedipine 10 mg , 20 mg .
• Description
  Adipine MR 10: each modified release tablet contains 10 mg of Nifedipine Adipine MR 20: each modified release tablet contains 20 mg of Nifedipine
• Indications
  

  Hypertension Prophylaxis of chronic stable angina pectoris

• Adult Dosage
  

  The treatment should be as individual as possible according to the seriousness of the disease and the responsiveness of the patient.

  Dependent on the respective clinical picture stabilisation with reference to the final dose should be made slowly.

  Nifedipine should be taken with a little water.

  The recommended starting dose of nifedipine is 10 mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40 mg every 12 hours.

  The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients.

  Nifedipine is metabolised primarily by the liver and therefore patients with liver dysfunction should be carefully monitored. Patients with renal impairment should not require adjustment of dosage.

  The simultaneous intake of food delays, but does not reduce overall absorption.

  The intervals between the recommended individual maximal daily doses of nifedipine should be not less than 4 hours. Discontinuation of Adipine MR especially from high doses should be made gradually.

  Treatment may be continued indefinitely.

• Child Dosage
  

  Nifedipine is not recommended for use in children.

• Contra Indications
  

  Hypersensitivity to nifedipine or other dihydropyridines because of the theoretical risk of cross reactivity.

  Nifedipine should not be used in clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction.

  Nifedipine must not be administered in cases of cardiogenic shock.

  Nifedipine should not be used for the treatment of acute attacks of angina.

  The safety of nifedipine in malignant hypertension has not been established.

  Nifedipine should not be used for secondary prevention of myocardial infarction.

  Nifedipine should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction.

  Caution is required in cases of markedly low blood pressure (severe hypotension with less than 90 mm Hg systolic) as well as in cases of cardiac failure.

• Special Precautions
  

  None

• Interactions
  

  The hypotensive effect of Nifedipine can be increased by other hypotensive drugs as well as by tricyclic antidepressants. When combined with nitrates the effects on blood pressure and heart rate increase.

  When administering Nifedipine and beta-receptor blockers at the same time, careful surveillance of the patient is necessary as this might produce a major lowering of the blood pressure; occasional cardiac failure has also been observed.

  Adipine MR is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal. Any such withdrawal should be a gradual reduction of the dose of the beta blocker preferably over 8 to 10 days.

  Adipine MR will not prevent possible rebound effects after cessation of other hypertensive therapy.

  Certain calcium antagonists may increase the negatively inotropic effect of antiarrhythmics such as amiodarone and quinidine. In this connection, no observations were made with Nifedipine. In individual cases, Nifedipine causes a drop of the quinidine plasma level or after discontinuation of Nifedipine a marked increase of the quinidine plasma level so that in combined therapy the control of the quinidine plasma level is recommended.

  Nifedipine may cause an increase of theophylline plasma levels so that the control of the latter is recommended.

  Cimetidine and, to a lesser extent, ranitidine may lead to an increase in the Nifedipine plasma level and thus to a more intensive action of Nifedipine.

  As with other dihydropyridines, nifedipine should not be taken with grapefruit juice because bioavailability is increased.

  The simultaneous administration of nifedipine and digoxin may lead to reduced digoxin clearance and hence an increase in the plasma digoxin. Digoxin levels should be monitored and, if necessary, the digoxin dose reduced.

  Nifedipine should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction (see Contraindications).

• Adverse Drug Reactions
  

  Especially at the beginning of therapy Nifedipine often might cause temporary headaches and flushing with a sensation of warmth (erythema, erythromelalgia).

  Occasionally, tachycardia, palpitations as well as lower leg oedema due to vasodilatation may occur. Furthermore, vertigo and fatigue have been observed. Also occasionally, there may be paraesthesia and a drop in blood pressure.

  In rare cases, treatment with Nifedipine may cause gastro-intestinal disturbances such as nausea, a sensation of fullness and diarrhoea. Furthermore, hypersensitivity reactions of the skin such as pruritis, urticaria and rashes, and in individual cases exfoliative dermatitis, have been observed.

  Reductions in the blood count such as anaemia, leucopenia, thrombopenia, thrombocytic purpura after the administration of Nifedipine have been described.

  Very rarely, after long-term treatment, alterations of the gingiva (hyperplasia of the gingiva) might occur which disappear completely after stopping treatment.

  In individual cases, liver dysfunctions (intrahepatic cholestasis, increases of transaminases) have been observed which disappear after stopping treatment.

  Rarely, especially in elderly patients, gynaecomastia has been described in connection with long-term therapy, which so far has disappeared in all cases after discontinuation of the treatment.

  In individual cases - especially with higher doses - courbature, trembling of the fingers (tremor) as well as a minor temporary alteration of optical perception have been observed.

  In individual cases an increase in the blood sugar level in the serum (hyperglycaemia) has been observed. This should be taken into account above all with patients suffering from diabetes mellitus.

  Exacerbation of angina pectoris may occur frequently at the start of treatment with sustained release formulations of nifedipine. The occurrence of myocardial infarction has been described although it is not possible to distinguish such an event from the natural course of ischaemic heart disease.

  In dialysis patients with malignant hypertension and hypovolaemia, caution is required as due to vasodilatation a marked drop in the blood pressure may be produced. Also, during the first weeks of therapy, daily urine volume may be increased.

  In case of renal insufficiency during the administration of Nifedipine renal function may be temporarily impaired.