CARDENE

Posology Prophylaxis of chronic stable angina:

Starting dose: 20 mg every 8 hours titrating upwards as required. Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day). Allow at least 3 days before increasing the dose of Cardene to ensure steady state plasma levels have been achieved.

Hypertension:

Starting dose: 20 mg every 8 hours titrating upwards as required. Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day). Use in elderly Starting dose is 20 mg 3 times a day. Titrate upwards with care as nicardipine may lower systolic pressure more than diastolic pressure in these patients.

Paediatric population The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established. Cardene is not recommended in patients under the age of 18. Method of administration Cardene capsules are for oral administration.

The capsules should be taken with a little water and swallowed whole.

Majority are not serious and are expected consequences of the vasodilator effects of Cardene. The most frequent side-effects reported are headache, oedema peripheral, heat sensation and/or flushing, palpitations, nausea and dizziness.

Other side-effects noted in clinical trials include the following:

Cardiac disorders Tachycardia As with the use of other short-acting dihydropyridines in patients with ischaemic heart disease, exacerbation of angina pectoris may occur frequently at the start of treatment with nicardipine capsules.

The occurrence of myocardial infarction has been reported although it is not possible to distinguish such an event from the natural course of ischaemic heart disease. 6) Skin and subcutaneous tissue disorders Erythema Pruritis Rash Vascular disorders Hypotension Orthostatic hypotension Immune system disorders Anaphylactic reaction Frequency: Unknown Investigations Hepatic enzyme increased Frequency: Unknown Rarely, depression, impotence and thrombocytopenia have been reported.

The above mentioned listed adverse reactions have been observed during clinical studies and/or during marketed use. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

When Cardene is used as monotherapy, caution is advised to avoid an excessive decrease in blood pressure. If used in combination with diuretics or beta-blockers, careful titration of Cardene is advised. Caution should be exercised when using nicardipine in combination with a beta-blocker in patients with decreased cardiac function.

If switching from beta-blockers to Cardene, gradually reduce the beta-blocker dose (preferably over 8 - 10 days) since nicardipine gives no protection against the dangers of abrupt beta-blocker withdrawal. Stop Cardene in patients experiencing ischaemic pain within 30 minutes of starting therapy or after increasing the dose.

Ischemic heart disease:

Short-acting dihydropyridines are associated with an increased risk of ischemic cardiovascular events.

Use in patients with congestive heart failure or poor cardiac reserve:

Haemodynamic studies in patients with heart failure have shown that nicardipine reduces afterload and improves overall haemodynamics. In one study, intravenous nicardipine reduced myocardial contractility in patients with severe heart failure despite increases in cardiac index and ejection fraction noted in the same patients.

Since nicardipine has not been extensively studied in patients with severe left ventricular dysfunction and cardiac failure one must consider that worsening of cardiac failure may occur.

Use in patients with impaired hepatic or renal function:

Since Cardene is subject to first-pass metabolism, use with caution in patients with impaired liver function or reduced hepatic blood flow. Patients with severe liver disease showed elevated blood levels and the half-life of nicardipine was prolonged.

Pregnancy and lactation. 1. Because part of the effect of nicardipine is secondary to reduced afterload, the drug should not be given to patients with severe aortic stenosis. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial infarction.

Cardene should not be used in cardiogenic shock, clinically significant aortic stenosis, unstable angina, and during or within one month of a myocardial infarction. Cardene should not be used for acute attacks of angina. Cardene should not be used for secondary prevention of myocardial infarction.