Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
PuraCap Laboratories LLC
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 360 mg
ORAL
PRESCRIPTION DRUG
Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina. Diltiazem is 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 severe 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 Strength Description Quantity NDC# 120 mg #3 lavender/lavender capsule imprinted: 120 90’s 30’s 24658-170-90 24658-170-30 180 mg #2 white/blue-green capsule imprinted: 180 90’s 30’s 24658-171-90 24658-171-30 240 mg #1 blue-green/lavender capsule imprinted: 240 90’s 30’s 24658-172-90 24658-172-30 300 mg #0 white/lavender capsule imprinted: 300 90’s 30’s 24658-173-90 24658-173-30 360 mg #0 blue-green/blue-green capsule imprinted: 360 90’s 30’s 24658-174-90 24658-174-30 420 mg #00 white/white capsule imprinted: 420 90’s 24658-346-90 Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Rx Only. Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, Manitoba R5G 1Z7, Canada For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807, USA Distributed by: Blu Pharmaceuticals 301 Robey St. Franklin, KY 42134 Made in Canada Rev. 10/2016 170-10-2016
New Drug Application Authorized Generic
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE PURACAP LABORATORIES LLC ---------- DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES DESCRIPTION Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). 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 and has a molecular weight of 450.98. Diltiazem Hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem Hydrochloride extended-release capsules also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. For oral administration. CLINICAL PHARMACOLOGY The therapeutic effects of diltiazem hydrochloride 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 effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The magnitude of blood pressure reduction is related to the degree of hypertension: thus hypertensive individuals experience an antihypertensive effect, whereas there is only a modest fall in blood pressure in normotensives. ANGINA: Diltiazem HCl has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic Прочитайте повний документ