DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mylan Institutional Inc.

INN (שם בינלאומי):

DILTIAZEM HYDROCHLORIDE

הרכב:

DILTIAZEM HYDROCHLORIDE 30 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 with acute myocardial infarction and pulmonary congestion documented by X-ray on admission

leaflet_short:

Diltiazem Hydrochloride Tablets, USP are available containing 30 mg, 60 mg, or 90 mg of diltiazem hydrochloride, USP. The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M over 23 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-745-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 60 mg tablets are white, film-coated, round, tablets debossed with M over 45 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-746-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 90 mg tablets are white, film-coated, capsule-shaped tablets debossed with M135 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-747-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12180 R1 3/17

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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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 structural
formula 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
450.99. Each tablet, for oral
administration, contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem
hydrochloride. In addition, each
tablet contains the following inactive ingredients: ethylcellulose,
hypromellose, lactose monohydrate,
magnesium stearate, maltodextrin, polyethylene glycol, and sodium
lauryl sulfate.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem hydrochloride tablets
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 is believed
to act in the following ways:
ANGINA DUE TO CORONARY ARTERY SPASM: Diltiazem hydrochloride tablets
have 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.
EXERTIONAL ANGINA: Diltiazem hydrochloride tablets have 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 the slow inward
(depolarizing) current in excitable tissue. It
causes excitation-contraction uncoupling in v