DILTIAZEM HYDROCHLORIDE capsule, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Actavis Pharma, Inc.

INN (International ime):

DILTIAZEM HYDROCHLORIDE

Sastav:

DILTIAZEM HYDROCHLORIDE 360 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem hydrochloride 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.

Proizvod sažetak:

Diltiazem hydrochloride extended-release capsules, USP are supplied as follows: 360 mg — Each #00 capsule with blue opaque cap and white opaque body imprinted with and 2918 on both cap and body in black ink contains 360 mg of diltiazem hydrochloride, USP. Capsules are supplied in bottles of 90 (NDC 0228-2918-09). Dispense in tight, light-resistant containers as defined in the USP. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Avoid excessive humidity. Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 11/2020

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ACTAVIS PHARMA, INC.
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-DAY DOSAGE)
RX ONLY
DESCRIPTION
Diltiazem hydrochloride extended-release capsules, 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 chemical structure is:
Diltiazem hydrochloride, USP 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, USP
is formulated as a once-a-day extended release capsule containing 360
mg diltiazem hydrochloride,
USP (equivalent to 330.9 mg diltiazem).
Each diltiazem hydrochloride extended-release capsule, USP, for oral
administration, contains the
following inactive ingredients: ammonio methacrylate copolymer NF,
type A, ammonio methacrylate
copolymer NF, type B, hydroxypropyl cellulose, sodium lauryl sulfate,
sugar spheres, talc, triethyl
citrate. The capsule shells contain FD&C Blue #1, gelatin and titanium
dioxide. The capsules are
imprinted with black Tek-Print ink SW-9008 or SW-9009 which contain
black iron oxide, potassium
hydroxide, propylene glycol, and shellac.
This product meets Disolution Test 20.
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 the