Hoeschst Marion Roussel announced that Cardizem (R) (diltiazem HC1 for injection) Monovial (R) has been cleared for use in the U.S. by the FDA. Cardizem Monovial is an advanced infusion delivery system for Cardizem Injectable, a widely prescribed compound for treatment of certain heartbeat irregularities.
Cardizem Monovial is indicated for maintenance heart rate control in patients with atrial fibrillation or atrial flutter for up to 24 hours. Cardizem Monovial is expected to be available beginning in early 1998.
The most commonly reported adverse events are asymptomatic hypotension (4.3%), symptomatic hypotension (3.2%), injection site reaction (3.9%), flushing (1.7%), and arrhythmia (1.0%).