Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases
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Cardizem (R) (Diltiazem HC1 for injection) Monvial (R)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Hoechst Marion Roussel
Approval Status: Approved September 1997
Treatment Area: atrial fibrillation
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%).