"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Three overdosages with CARDENE or CARDENE SR (nicardipine hydrochloride sustained release capsules) have been reported. Two occurred in adults, 1 of whom ingested 600 mg of CARDENE and the other 2160 mg of CARDENE SR (nicardipine hydrochloride sustained release capsules) . Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion, and slurred speech. All symptoms resolved without sequelae. The third overdosage occurred in a 1-year-old child who ingested half of the powder in a 30-mg CARDENE capsule. The child remained asymptomatic.
Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine.
For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) 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 is contraindicated in patients with hypersensitivity to the drug. Because part of the effect of CARDENE is secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/19/2009
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