DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

diltiazem hydrochloride (UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)

Available from:

Avera McKennan Hospital

INN (International Name):

diltiazem hydrochloride

Composition:

diltiazem hydrochloride 240 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- DILTIAZEM HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
----------
DILTIAZEM HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES
USP DRUG RELEASE TEST 6
RX ONLY
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker). Chemically,
diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,
3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,
3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The
chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, methanol and chloroform and has a molecular weight of 450.98.
Diltiazem hydrochloride
extended-release capsules contain diltiazem hydrochloride in
extended-release beads at doses of 120,
180, 240, 300, 360 and 420 mg.
Diltiazem Hydrochloride extended-release capsules also contain: black
iron oxide, D&C Red No. 28,
ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue
No. 1, FD&C Green No. 3,
FD&C Red No. 40, gelatin, hypromellose, magnesium stearate,
microcrystalline cellulose, polysorbate,
povidone, simethicone, sucrose stearate, talc, and titanium dioxide.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability to inhibit the
cellular influx of calcium ions during membrane depolarization of
cardiac and vascular smooth muscle.
MECHANISMS OF ACTION
HYPERTENSION: Diltiazem produces its antihypertensive effect primarily
by relaxation of vascular
smooth muscle and the resultant decrease in peripheral vascular
resistance. The magnitude of blood
pressure reduction is related to the degree of hypertension: thus
hypertensive individuals experience an
antihypertensive effect, whereas there is only a modest fall in blood
pressure in normotensives.
ANGINA: Diltiazem HCl has been shown to produce increases in exercise
tolerance, probably due to its
ability to reduce myocardial oxygen demand. This is accomplished