Cardiac Failure: Nicardipine hydrochloride should be used with caution in patients with congestive heart failure or pulmonary oedema, particularly when these patients are receiving concomitant beta-blockers, as worsening of cardiac insufficiency may occur.
Ischaemic Cardiovascular Disease: Nicardipine hydrochloride is contraindicated in unstable angina and immediately following myocardial infarction. Nicardipine hydrochloride should be used with caution in patients with suspected coronary ischemia. Occasionally, patients have developed an increased frequency, duration, or severity of angina upon starting or increasing Nicardipine hydrochloride dosage, or during the course of treatment.
Patients with a History of Hepatic Dysfunction or Impaired Hepatic Function: Rare cases of abnormal hepatic function possibly associated with the use of Nicardipine hydrochloride have been reported. Potential risk groups are patients with a history of hepatic dysfunction or those with impaired hepatic function at the initiation of treatment with Nicardipine hydrochloride.
Patients with Portal Hypertension: Intravenous Nicardipine hydrochloride at high doses has been reported to worsen portal vein hypertension and portal-systemic collateral blood flow index in cirrhotic patients.
Patients with Pre-existing Elevated Intracranial Pressure: Intracranial pressure should be monitored, to allow calculation of the cerebral perfusion pressure.
Patients with Stroke: Nicardipine hydrochloride should be used with caution in patients with acute cerebral infarction. A hypertensive episode which often accompanies a stroke is not an indication of emergency antihypertensive therapy. The use of antihypertensive drugs is not recommended in ischemic stroke patients unless acute hypertension precludes the administration of an adequate treatment (e.g. thrombolysis) or there is other end-organ damage which is life-threatening in the short term.
Combination with Beta-blockers: Caution should be exercised when using Nicardipine hydrochloride in combination with a beta-blocker in patients with decreased cardiac function. In such case, the posology of the beta blocker should be individualized to the clinical situation.
Injection Site Reactions: Infusion site reactions can occur, particularly with prolonged duration of administration and in peripheral veins. It is advised to change the infusion site in case of any suspicion of infusion site irritation. The use of a central venous line or of a greater dilution of the solution could reduce the risk of occurrence of infusion site reaction.
Excipient warnings: This product contains sorbitol. Patients with rare hereditary problem of fructose intolerance should not take this medicine.
Use in Pregnancy: Due to the risk of severe maternal hypotension and potentially fatal fetal hypoxia, the decrease in blood pressure should be progressive and always closely monitored. Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulphate is used concomitantly.
Use in Children: The safety and efficacy of Nicardipine hydrochloride have not been tested in controlled clinical trials in infants or children, thus special care is required in this population.
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