DILTIAZEM HYDROCHLORIDE tablet DILTIAZEM HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Diltiazem hydrochloride (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Prieinama:

Oceanside Pharmaceuticals

INN (Tarptautinis Pavadinimas):

Diltiazem hydrochloride

Sudėtis:

Diltiazem hydrochloride 30 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem hydrochloride tablets are contraindicated in:

Produkto santrauka:

Diltiazem hydrochloride 30 mg tablets are supplied in bottles of 100 (NDC 68682-006-10) and 500 (NDC 68682-006-50). Each light green, round tablet is engraved with MARION on one side and 1771 on the other. Diltiazem hydrochloride 60 mg scored tablets are supplied in bottles of 100 (NDC 68682-007-10) and 500 (NDC 68682-007-50). Each light yellow, round tablet is engraved with MARION on one side and 1772 on the other. Diltiazem hydrochloride 90 mg scored tablets are supplied in bottles of 100 (NDC 68682-008-10) and 500 (NDC 68682-008-50). Each light green, capsule-shaped tablet is engraved with CARDIZEM on one side and 90 mg on the other. Diltiazem hydrochloride 120 mg scored tablets are supplied in bottles of 100 (NDC 68682-009-10). Each yellow, capsule-shaped tablet is engraved with CARDIZEM on one side and 120 mg on the other. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada CARDIZEM is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates Rev. 06/2020 9467803

Autorizacija statusas:

New Drug Application Authorized Generic

Prekės savybės

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET
OCEANSIDE PHARMACEUTICALS
----------
DILTIAZEM HYDROCHLORIDE
TABLETS
RX ONLY
DESCRIPTION
Diltiazem hydrochloride 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.
Each tablet contains 30 mg, 60
mg, 90 mg, or 120 mg diltiazem hydrochloride.
Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum
Lake, FD&C Blue #1 Aluminum
Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120
mg), hydroxypropyl
cellulose, hypromellose, lactose, magnesium stearate, methylparaben,
microcrystalline cellulose, and
polyethylene glycol.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem hydrochloride are
believed to be related to its ability
to inhibit the influx of calcium ions during membrane depolarization
of cardiac and vascular smooth
muscle.
MECHANISMS OF ACTION
Although precise mechanisms of its antianginal actions are still being
delineated, diltiazem
hydrochloride is believed to act in the following ways:
•
•
ANGINA DUE TO CORONARY ARTERY SPASM: Diltiazem hydrochloride has been
shown to be a potent
dilator of coronary arteries both epicardial and subendocardial.
Spontaneous and ergonovine-
induced coronary artery spasms are inhibited by diltiazem
hydrochloride.
EXERTIONAL ANGINA: Diltiazem hydrochloride 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 blood pressure at submaximal
and maximal exercise
workloads.
In animal models, diltiazem interferes with th