DILTIAZEM HYDROCHLORIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

McKesson Corporation dba SKY Packaging

INN (Mezinárodní Name):

DILTIAZEM HYDROCHLORIDE

Složení:

DILTIAZEM HYDROCHLORIDE 30 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Product: 63739-079 NDC: 63739-079-10 10 TABLET, FILM COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-080 NDC: 63739-080-10 10 TABLET, FILM COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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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 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 myocard