DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

DILTIAZEM HYDROCHLORIDE

Sudėtis:

DILTIAZEM HYDROCHLORIDE 30 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Diltiazem hydrochloride tablets USP are available as: 30 mg - faint orange, round, film-coated, biconvex, unscored tablets, debossed with "93" and "318" on one side and plain on the other side. 60 mg – orange, round, film-coated, biconvex tablets, scored in half on one side, debossed with "93" and "319" on each side of the score and plain on the other side. 90 mg - faint orange, oblong, film-coated tablets, scored in half on one side, debossed with "93" and "320" on each side of the score and plain on the other side. 120 mg - orange, oblong, film-coated tablets, scored in half on one side, debossed with "93" and "321" on each side of the score and plain on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: PIRAMAL ENTERPRISES LIMITED Pithampur, Madhya Pradesh, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 8/2012

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DILTIAZEM HYDROCHLORIDE TABLETS USP
0318
0319
0320
0321
RX ONLY
DESCRIPTION
Diltiazem hydrochloride tablets USP are a calcium ion cellular influx
inhibitor (slow channel blocker
or calcium antagonist). Chemically, diltiazem hydrochloride, USP 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:
C
H N O S•HCl M.W. 450.98
Diltiazem hydrochloride, USP is a white to off-white crystalline
powder with a bitter taste. It is soluble
in water, methanol, and chloroform.
Each tablet for oral administration contains 30 mg, 60 mg, 90 mg, or
120 mg of diltiazem hydrochloride,
USP. Each tablet also contains the following inactive ingredients:
hypromellose, lactose monohydrate,
magnesium stearate, polyethylene glycol, polysorbate 80, povidone,
titanium dioxide and FD&C yellow
#6 aluminum lake.
Diltiazem hydrochloride tablets meet USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
The therapeutic benefits achieved with diltiazem 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:
1. ANGINA DUE TO CORONARY ARTERY SPASM. Diltiazem has been shown to be
a potent dilator of
coronary arteries both epicardial and subendocardial. Spontaneous and
ergonovine-induced
coronary artery spasm are inhibited by diltiazem.
2. EXERTIONAL ANGINA. Diltiazem 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.
22
26
2
4
In animal models, diltiazem interferes with the slow inward
(d