DILTIAZEM HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Proficient Rx LP

INN (International namn):

DILTIAZEM HYDROCHLORIDE

Sammansättning:

DILTIAZEM HYDROCHLORIDE 120 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Diltiazem hydrochloride tablets USP are available as: 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. Available in bottles of 10,30 and 60.. NDC 63187-769-10– Bottle of 10 NDC 63187-769-30– Bottle of 30 NDC 63187-769-60– Bottle of 60 NDC 63187-769-90– Bottle of 90 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. Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. N 12/2014

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
PROFICIENT RX LP
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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 #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:
•
•
22
26
2
4
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.
EXERTIONAL ANGINA. Diltiazem has been shown to produce increases in
exercise
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