Diltiazem Hydrochloride

Indications

INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Capsules, USP at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials.

Contraindications

CONTRAINDICATIONS Diltiazem hydrochloride tablets are contraindicated in patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, patients with hypotension (less than 90 mm Hg systolic), patients who have demonstrated hypersensitivity to the drug, and patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admissio…

Warnings and precautions

WARNINGS Cardiac Conduction: Diltiazem hydrochloride tablets prolong 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 (13 of 3290 patients or 0.40%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.

Pregnancy

Pregnancy Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities.

Storage and supply

HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP Strength Quantity NDC Number Description 120 mg 30 counts 63629-2154-1 Hard gelatin capsules light gray opaque cap and light gray opaque body imprinted with “par” on the cap and “C829” on the body in black ink. Each capsule contains white to off white coated pellets.

Source: Diltiazem Hydrochloride (Diltiazem Hydrochloride Extended-Release) — US FDA prescribing information, 2024-01-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.