NICARDIPINE

Nicardipine should only be administered by specialists in well controlled environments, such as hospitals and intensive care units, with continuous monitoring of blood pressure. Posology The antihypertensive effect will depend on the administered dose.

The dosage regimen to achieve the desired blood pressure can vary depending on the targeted blood pressure, the response of the patient, and the age or status of the patient. 2 for details of compatible solutions) Adults Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes.

5 or 1 mg every 15 minutes. The infusion rate should not exceed 15 mg/h.

Maintenance dose:

When the target pressure is reached, the dose should be reduced progressively, usually to between 2 and 4 mg/h, to maintain the therapeutic efficacy. Transition to an oral antihypertensive agent: discontinue nicardipine or titrate downward while appropriate oral therapy is established.

When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent’s affect. Continue blood pressure monitoring until desired effect is achieved. A switch can also be made to oral nicardipine 20 mg capsules at dosage of 60 mg/day in 3 daily doses, or to nicardipine 50 mg extended-release tablets, at dosage of 100 mg/day, in 2 daily doses.

Older patients Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to nicardipine effects because of impaired renal and/or hepatic function.

It is recommended to provide a continuous infusion of nicardipine starting at the dose of 1 to 5 mg/h, depending on the blood pressure and clinical situation. 5 mg/h. The rate should not exceed 15 mg/h. Pregnancy It is recommended to provide a continuous infusion of nicardipine starting at 1 to 5 mg/h, depending on the blood pressure and clinical situation.

5 mg/h. Doses higher than 4 mg/h are generally not exceeded in the treatment of pre- eclampsia, however the rate should not exceed 15 mg/h. 8) Hepatic Impairment Nicardipine should be used with particular caution in these patients. Since nicardipine is metabolized in the liver, it is recommended to use the same dose regimens as for elderly patients in patients with impaired liver function or reduced hepatic blood flow.

Summary of the safety profile The majority of undesirable effects are the consequence of the vasodilator effects of nicardipine. The most frequent events are headache, dizziness, peripheral oedema, palpitations and flushing. Tabulated list of adverse reactions Adverse reactions listed below have been observed during clinical studies and/or during marketed use and are based on clinical trial data and classified according to MedDRA System Organ Class.

Frequency categories are defined according to the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). System organ class Frequency Adverse reactions Blood and lymphatic system disorders Not known Thrombocytopenia Immune system disorders Not known Anaphylactic reaction Very common HeadacheNervous system disorders Common Dizziness Common Lower limb oedema, palpitations Common Hypotension, tachycardia Cardiac disorders Not known Atrioventricular block, angina pectoris Common Hypotension, orthostatic hypotension Vascular disorders Not known Flushing Respiratory, thoracic and mediastinal disorders Not known pulmonary oedema* Common Nausea, vomitingGastrointestinal disorders Not known Paralytic ileus Skin and subcutaneous tissue disorders Not known Erythema, cutaneous rash General disorders and administration site conditions Not known Phlebitis Investigations Not known Hepatic enzyme increased.

6) 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.

Warnings It is recommended to administer nicardipine with caution to avoid an excessive drop in blood pressure. Indeed, rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia. If either occurs with nicardipine, consider decreasing the dose by half or stopping the infusion.

Bolus administration or intravenous administration not controlled by the use of an electronic syringe driver or a volumetric pump is not recommended and can increase the risk of serious hypotension, particularly in the elderly, in children, in patients with renal or hepatic impairment and in pregnancy.

Cardiac failure Nicardipine 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.

3). Nicardipine 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 dosage, or during the course of treatment.

Pregnancy Due to the risk of severe maternal hypotension and potentially fatal foetal 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.

As some cases of acute pulmonary oedema have been reported during pregnancy, nicardipidine should be administered with caution in pregnant women, and these should be closely monitored for the possible development of acute pulmonary oedema.

In case of acute pulmonary oedema, nicardipine should be stopped immediately, and appropriate treatment should be initiated. Patients with history of hepatic dysfunction or impaired hepatic function Rare cases of abnormal hepatic function possibly associated with the use of nicardipine have been reported.

1. e. in case of an arteriovenous shunt or aortic coarctation Unstable angina Within 8 days after myocardial infarction.