Indicated for:

Hypertension:

• The treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Angina:

• The management of chronic stable angina and angina due to coronary artery spasm.

Since the safety and efficacy of CD capsules in the management of unstable or vasospastic angina has not been substantiated, use of this formulation for these indications is not recommended.

Treatment at doses above 360 mg/day does not offer increased efficacy, but is associated with a greater risk of adverse reactions. Therefore treatment with doses exceeding 360 mg/day is not recommended.

CARDIZEM prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block.

Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem.

Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function.

Cardizem CD is contraindicated in patients with:

• Sick sinus syndrome except in the presence of a functioning ventricular pacemaker
• Second-or third-degree AV block except in the presence of a functioning ventricular pacemaker
• Hypotension (less than 90 mm Hg systolic)
• Acute myocardial infarction and pulmonary congestion documented by X-ray on admission

Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension.

Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies.

Experience with the use of Cardizem CD in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.

The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, titrate anesthetics and calcium blockers slowly.

Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4- fold and the Cmax by 2-fold, compared to placebo.

Buspirone: In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo.

Carbamazepine: Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine.

Cyclosporine: A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients.

Digitalis: Administration of diltiazem with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%.

Avoid use with ivabradine, rifampin, or any known CYP3A4 inducer.

Statins: Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem.

Avoid consumption of alcohol with Cardizem CD.

Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem.

Amiodarone should be used with caution with Cardizem CD particularly if there is suspicion of underlying dysfunction of the sinus node, such as bradycardia or sick sinus syndrome or if there is partial A-V block.

If co-administration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

Grapefruit juice may increase diltiazem exposure. Patients who consume grapefruit juice should be monitored for increased effects of diltiazem.

There are no well-controlled studies in pregnant women. Animal studies: embryo and fetal death and skeletal abnormalities.

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of CARDIZEM is deemed essential, an alternative method of infant feeding should be instituted. 

• Unstable or vasospastic angina. GoToSource

• Dosage greater than 480 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Atrial fibrillation or atrial flutter. GoToSource

• Migraine prophylaxis. GoToSource

• Duchenne muscular dystrophy. GoToSource 

• Preventing recurrent myocardial infarction. GoToSource 

• Adjunct therapy for prevention of contrast-induced nephropathy. GoToSource 

• Neuroleptic-induced tardive dyskinesia. GoToSource

Sinus bradycardia. GoToSource

Generalized exanthematous pustulosis (skin eruption). GoToSource

Photosensitivity including hyperpigmentation at sun-exposed skin areas. GoToSource

Gingival overgrowth. GoToSource 

Ankle/pedal edema (swelling) and stevens-johnson syndrome (severe skin reaction). GoToSource 

Breast cancer with long-term use. GoToSource 

Myoclonus (involuntary jerking of muscle or muscle groups) with long-term use. GoToSource

Drug hypersensitivity syndrome. GoToSource 

Eosinophilic pleural effusion. GoToSource 

Postural hypotension, palpitations, dizziness and liver injury. GoToSource

Fatigue, sedation and mania. GoToSource 

Paralytic ileus (intestinal blockage). GoToSource 

Male infertility. GoToSource

Lawsuits filed for male infertility.