DILTIAZEM HYDROCHLORIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Mylan Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

DILTIAZEM HYDROCHLORIDE

Kompozīcija:

DILTIAZEM HYDROCHLORIDE 30 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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:

Produktu pārskats:

Diltiazem Hydrochloride Tablets, USP are available containing 30 mg, 60 mg, 90 mg or 120 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 0378-0023-01 bottles of 100 tablets NDC 0378-0023-05 bottles of 500 tablets 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 0378-0045-01 bottles of 100 tablets NDC 0378-0045-05 bottles of 500 tablets 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 0378-0135-01 bottles of 100 tablets NDC 0378-0135-05 bottles of 500 tablets The 120 mg tablets are white, film-coated, capsule-shaped tablets debossed with M525 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0525-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 1/2017 DILT:R12

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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:
•
•
In animal models, diltiazem interferes with the slow inward
(depolarizing) current in excitable tissue. It
causes excitation-contraction uncoupling in various myocardial tissues
without changes in the
configuration of the action potential. Diltiazem produces relaxation
of coronary vascular smooth
muscle and dilation of both large and small coronary arteries at drug
levels which cause little or no
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 t