Generally well-tolerated therapy
Hypertensive Study — Most common adverse events greater than placebo1,2
* There is limited general clinical experience with doses above 360 mg, but the safety and efficacy of doses as high as 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases, with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
- In hypertension, discontinuation due to adverse events with CARDIZEM LA was 3.2%
and with placebo was 4.3%.1
Angina Study – Most common adverse events experienced by CARDIZEM LA patients in clinical trials1
INDICATIONS
CARDIZEM LA is indicated for the treatment of hypertension and management of chronic stable angina.
IMPORTANT SAFETY INFORMATION
CARDIZEM LA is contraindicated in patients with sick sinus syndrome or 2° or 3° AV block (except in the presence of a functioning ventricular pacemaker), hypotension (<90 mm Hg systolic), demonstrated hypersensitivity to the drug, and acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Worsening of congestive heart failure has been reported in patients with pre-existing impairment of ventricular function. Caution should be exercised in these patients when diltiazem is used in combination with β-blockers. In rare instances, elevations in LFT enzymes have been noted.
Concomitant use of diltiazem with ß-blockers or digitalis may result in additive effects on cardiac conduction. Patients taking buspirone, quinidine and drugs that are substrates or inhibitors of CYP450 3A4 (i.e. cimetidine, midazolam, triazolam, cyclosporine, carbamazepine, lovastatin, rifampin), or patients with renal and/or hepatic impairment should be monitored and may require dosage adjustment when starting or stopping concomitantly administered diltiazem.
In hypertension, the most common adverse events (greater than placebo) reported for the 120 mg to 360 mg dose were lower-limb edema (5%), sinus congestion (1%), and rash (1%).
In chronic stable angina, the most common adverse events (>2% and greater than placebo) were lower-limb edema (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), and 1° AV block (3.2%).
References:
1. CARDIZEM LA Prescribing Information. Abbott Laboratories.
2. Glasser SP, Neutel JM, Gana TJ, Albert KS. Efficacy and safety of a once daily graded-release diltiazem formulation in essential hypertension.
Am J Hypertens. 2003;16:51-58.
