Country: United States
Language: English
Source: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
American Health Packaging
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 120 mg
ORAL
PRESCRIPTION DRUG
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. Diltiazem hydrochloride tablets are contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Diltiazem Hydrochloride Extended-Release Capsules, USP Strength Quantity NDC Number Description 120 mg Unit dose packages of 100 (10 x 10) 60687-195-01 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. 180 mg Unit dose packages of 100 (10 x 10) 60687-206-01 Hard gelatin capsules with dark green opaque cap and blue opaque body imprinted with “par” on the cap and “C830” on the body in black ink. Each capsule contains white to off white coated pellets. 240 mg Unit dose packages of 100 (10 x 10) 60687-217-01 Hard gelatin capsules with dark green opaque cap and dark green opaque body imprinted with “par” on the cap and “C831” on the body in black ink. Each capsule contains white to off white coated pellets. 300 mg Unit dose packages of 100 (10 x 10) 60687-228-01 Hard gelatin capsules with dark green opaque cap and light gray opaque body imprinted with “par” on the cap and “C832” on the body in black ink. Each capsule contains white to off white coated pellets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature] Avoid excessive humidity. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE- DILTIAZEM HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE AMERICAN HEALTH PACKAGING ---------- DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 8419501/0817 RX ONLY DESCRIPTION Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 _H_)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- _cis_-. The chemical structure is: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11. CLINICAL PHARMACOLOGY The therapeutic effects of diltiazem hydrochloride extended-release capsules are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. _MECHANISMS OF ACTION_ HYPERTENSION: Diltiazem hydrochloride extended-release capsules produce its antihypertensive effect primarily by relaxation of vascular smooth muscle and the re Read the complete document