País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
Actavis Pharma, Inc.
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 120 mg
ORAL
PRESCRIPTION DRUG
Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) 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 (Once-a-day dosage) Strength Quantity NDC Number Description 120 mg 90’s 500’s 62037-597-90 62037-597-05 White/orange opaque capsule imprinted with "Andrx 597" on one end and "120 mg" on the other. 90’s 500’s 62037-598-90 62037-598-05 90’s 500’s 62037-599-90 62037-599-05 90’s 500’s 62037-600-90 62037-600-05 NOTE: THE PRODUCT MAY HAVE AN ODOR. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in tight, light resistant container as defined in USP. Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 8/2020
Abbreviated New Drug Application
CARTIA XT- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- CARTIA XT BRAND OF DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) RX ONLY DESCRIPTION Diltiazem hydrochloride, 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, USP 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, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). In addition, each capsule contains the following inactive ingredients: acetyltributyl citrate, ammonio methacrylate copolymer-NF, black iron oxide, cornstarch, D & C Red #28, D & C Yellow #10, D & C Yellow #10 Aluminum Lake, ethylcellulose, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40, FD & C Red #40 Aluminum Lake, gelatin-NF, magnesium stearate, methacrylic acid copolymer-NF, propylene glycol, polysorbate 80-NF, sucrose, talc USP, and titanium dioxide. The 180 mg and 240 mg capsules contain yellow iron oxide. In addition, the 240 mg capsule also contains red iron oxide. For oral administration. ® This drug meets USP Drug Release 9. CLINICAL PHARMACOLOGY The therapeutic effects of diltiazem 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 produces its antihypertensive effe Llegiu el document complet