Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom
Cardene is indicated in adults for the prophylaxis of patients with chronic stable angina. For the treatment of hypertension considered to be mild to moderate in severity.
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.
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).
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.
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.
Cardene capsules are for oral administration.
The capsules should be taken with a little water and swallowed whole.
Symptoms may include marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion and slurred speech. In laboratory animals, overdosage also resulted in reversible hepatic function abnormalities, sporadic focal hepatic necrosis and progressive atrioventricular conduction block.
For treatment of overdose, standard measures including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.
Cardene 20mg:
Securitainer: 5 years.
Blister packs of 21, 100 and 200 capsules: 5 years.
Blister packs of 56 and 84 capsules: 3 years.
Cardene 30mg:
Securitainer: 5 years.
Blister packs of 21, 56, 60, 100 and 200 capsules: 5 years.
Blister packs of 84 capsules: 3 years.
Do not store above 25°C.
Cardene 20mg: Securitainer packs of 50 and 100. PVC/aluminium foil blister strips of 21, 56, 84, 100 and 200 capsules.
Cardene 30mg: Securitainer packs of 50 and 100. PVC/aluminium foil blister strips of 21, 56, 60, 84, 100 and 200 capsules.
Not all pack sizes may be marketed.
Not applicable.
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