DILTIAZEM HYDROCHLORIDE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

INN (국제 이름):

DILTIAZEM HYDROCHLORIDE

구성:

DILTIAZEM HYDROCHLORIDE 30 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Diltiazem hydrochloride tablets, USP are available as: 30 mg - light orange, round, film-coated, biconvex, unscored tablets, debossed with "93" and "318" on one side and plain on the other side. Available in NDC: 70518-0040-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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DILTIAZEM HYDROCHLORIDE TABLETS, USP
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 No. 6
aluminum lake.
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:
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 spasms are inhibited by diltiazem.
22
26
2
4
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.
In animal models, diltiazem interferes with the slow inward
(depolarizing) current in
excitable tissue. It causes excitation-contraction uncoupling in
various myocardial