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:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International namn):

DILTIAZEM HYDROCHLORIDE

Sammansättning:

DILTIAZEM HYDROCHLORIDE 30 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: - 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

Produktsammanfattning:

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. Available in blistercards of 30. NDC 0615-8032-39 – Blistercard of 30 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. Available in blistercards of 30. NDC 0615-8033-39 – Blistercard of 30 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]. 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 Rev. O 11/2016

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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.
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.
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
22
26
2
4
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