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:

Bryant Ranch Prepack

INN (Mezinárodní Name):

DILTIAZEM HYDROCHLORIDE

Složení:

DILTIAZEM HYDROCHLORIDE 60 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

NDC: 63629-3649-4: 100 Tablets in a BOTTLE NDC: 63629-3649-1: 30 Tablets in a BOTTLE NDC: 63629-3649-2: 90 Tablets in a BOTTLE NDC: 63629-3649-3: 60 Tablets in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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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.
EXERTIONAL ANGINA: Diltiazem has been shown to produce increases in
exercise
tolerance, probably due to its ability to reduce myocardial oxygen
demand. This is
22
26
2
4
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 myocardi