DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

זמין מ:

REMEDYREPACK INC.

INN (שם בינלאומי):

DILTIAZEM HYDROCHLORIDE

הרכב:

DILTIAZEM HYDROCHLORIDE 60 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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: - 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 - Patients which acute myocardial infarction and pulmonary congestion documents by x-ray on admission

leaflet_short:

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 green, oblong 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 light 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. ©Valeant Pharmaceuticals North America LLC Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Valeant Pharmaceuticals International, Inc. Laval, Quebec H7L 4A8, Canada CARDIZEM is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates ©Valeant Pharmaceuticals North America LLC Rev. 03/2017 9467802 20000936C

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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DILTIAZEM HYDROCHLORIDE
DIRECT COMPRESSION 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 wi