DILTIAZEM HYDROCHLORIDE capsule, extended release DILTIAZEM HYDROCHLORIDE capsule, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

OCEANSIDE PHARMACEUTICALS

INN (Internationale Bezeichnung):

Diltiazem hydrochloride

Zusammensetzung:

Diltiazem hydrochloride 120 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem 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.

Produktbesonderheiten:

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg Light green opaque capsule 90 btl 68682-993-98 Imprinted with BVF 120 180 mg Dark green opaque/light green 90 btl 68682-994-98 opaque capsule imprinted with BVF 180 240 mg Dark green opaque capsule 90 btl 68682-997-98 imprinted with BVF 240 300 mg Ivory opaque/dark green opaque 90 btl 68682-998-98 capsule imprinted with BVF 300 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
OCEANSIDE PHARMACEUTICALS
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-DAY DOSAGE)
R 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
Extended-Release Capsule (Once-a-Day Dosage), is formulated as a
once-a-day extended-release
capsule containing 120 mg, 180 mg, 240 mg, or 300 mg diltiazem
hydrochloride.
Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose,
magnesium stearate,
microcrystalline cellulose, ethyl acrylate and methyl methacrylate
copolymer, polysorbate, povidone,
simethicone emulsion, sucrose stearate, talc, and titanium dioxide.
Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution
Test 12.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of Diltiazem Hydrochloride Extended-Release
Capsules (Once-a-Day Dosage)
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 i