DILTIAZEM HYDROCHLORIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Carilion Materials Management

INN (Διεθνής Όνομα):

DILTIAZEM HYDROCHLORIDE

Σύνθεση:

DILTIAZEM HYDROCHLORIDE 60 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Product: 68151-2886 NDC: 68151-2886-1 1 TABLET, FILM COATED in a BLISTER PACK

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
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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:
•
•
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
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 tolerance,
probably due to its ability to reduce myocardial oxygen demand. This
is accomplished via
reductions in heart rate and systemic blood pressure at