Europe's CHMP: Restrict IV Nicardipine to Proven Scenarios

Shelley Wood

Disclosures

October 25, 2013

LONDON, UK — Intravenous nicardipine should be used only to treat acute life-threatening high blood pressure or control high blood pressure after surgery, the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) has concluded after conducting an EU-wide review [1].

In a press release issued this morning, the EMA also specified that nicardipine agents should be given only by specialists in a hospital or intensive-care unit and only by continuous venous infusion with continuous blood-pressure monitoring.

The EMA notes that nicardipine had been used in some EU countries for controlled hypotension during anesthesia, controlling hypertension during surgery, and treating acute severe hypertension with left ventricular decompensation and pulmonary edema. "These uses are no longer recommended because the available data are insufficient to support use in these conditions," the EMA states.

The review was requested by regulators in the UK faced with a request from a company seeking approval of a generic form of IV nicardipine. That submission failed to adequately document the risk/benefits of the drug.

The EMA release today specified that, in adults, "treatment should start with a continuous administration of nicardipine at a rate of 3 to 5 mg/h. The rate can then be increased but should not exceed 15 mg/h. When the target blood pressure is reached, the dose should be reduced progressively. Nicardipine should be used with caution and at lower doses in specific patient populations, including patients with liver and kidney problems and children."

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