DILTIAZEM HCL CD- diltiazem hydrochloride capsule, coated, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Diltiazem Hydrochloride (UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)

Fáanlegur frá:

Oceanside Pharmaceuticals

INN (Alþjóðlegt nafn):

Diltiazem Hydrochloride

Samsetning:

Diltiazem Hydrochloride 360 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Diltiazem Hydrochloride CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride CD is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Vörulýsing:

360 mg 90 count 68682-521-01 Light blue/white capsule imprinted with “cardizem CD 360 mg” on body. Storage Conditions: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.

Leyfisstaða:

New Drug Application

Vara einkenni

DILTIAZEM HCL CD- DILTIAZEM HYDROCHLORIDE CAPSULE, COATED, EXTENDED
RELEASE
OCEANSIDE PHARMACEUTICALS
----------
DILTIAZEM HYDROCHLORIDE CD EXTENDED-RELEASE CAPSULES
RX ONLY
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or calcium
antagonist). Chemically, diltiazem hydrochloride is
1,5-Benzothiazepin-4(5_H_)-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. It has a molecular weight of 450.98.
Diltiazem Hydrochloride CD is
formulated as a once-a-day extended-release capsule containing 360 mg
diltiazem hydrochloride
(equivalent to 330.9 mg diltiazem).
Capsules also contain: FD&C Blue #1, gelatin, hypromellose, magnesium
stearate, microcrystalline
cellulose, ethyl acrylate and methyl methacrylate copolymer,
polysorbate, povidone, simethicone
emulsion, sucrose stearate, talc, and titanium dioxide.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem 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 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 workloads. Diltiazem
has been shown to be a potent
di