DILTIAZEM HYDROCHLORIDE capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Zydus Pharmaceuticals (USA) Inc.

INN (Међународно име):

DILTIAZEM HYDROCHLORIDE

Састав:

DILTIAZEM HYDROCHLORIDE 120 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg are white to off white pellets filled in size "2" empty hard gelatin capsules with opaque light green colored cap & opaque white colored body imprinted with "595" in black ink and are supplied as follows: NDC 68382-595-06 in bottles of 30 capsules with child-resistant closure NDC 68382-595-16 in bottles of 90 capsules with child-resistant closure NDC 68382-595-01 in bottles of 100 capsules NDC 68382-595-05 in bottles of 500 capsules NDC 68382-595-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 180 mg are white to off white pellets filled in size "0" empty hard gelatin capsules with opaque light blue colored cap & opaque grey colored body imprinted with "596" in black ink and are supplied as follows: NDC 68382-596-06 in bottles of 30 capsules with child-resistant closure NDC 68382-596-16 in bottles of 90 capsules with child-resistant closure NDC 68382-596-01 in bottles of 100 capsules NDC 68382-596-05 in bottles of 500 capsules NDC 68382-596-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 240 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light blue colored cap & opaque white colored body imprinted with "597" in black ink and are supplied as follows: NDC 68382-597-06 in bottles of 30 capsules with child-resistant closure NDC 68382-597-16 in bottles of 90 capsules with child-resistant closure NDC 68382-597-01 in bottles of 100 capsules NDC 68382-597-05 in bottles of 500 capsules NDC 68382-597-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 300 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light green colored cap & opaque grey colored body imprinted with "598" in black ink and are supplied as follows: NDC 68382-598-06 in bottles of 30 capsules with child-resistant closure NDC 68382-598-16 in bottles of 90 capsules with child-resistant closure NDC 68382-598-01 in bottles of 100 capsules NDC 68382-598-05 in bottles of 500 capsules NDC 68382-598-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 360 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque grey colored cap & opaque white colored body imprinted with "599" in black ink and are supplied as follows: NDC 68382-599-06 in bottles of 30 capsules with child-resistant closure NDC 68382-599-16 in bottles of 90 capsules with child-resistant closure NDC 68382-599-01 in bottles of 100 capsules NDC 68382-599-05 in bottles of 500 capsules NDC 68382-599-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in a tight container as defined in the USP. Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088. Manufactured  by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534                                                                                                                          Rev.: 11/22

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
ONCE-A-DAY DOSAGE
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, USP is a white, odourless, crystalline powder
or small crystals. It
is freely soluble in chloroform, in formic acid, in methanol, and in
water; sparingly soluble
in dehydrated alcohol; insoluble in ether. It has a molecular weight
of 450.98.
Diltiazem hydrochloride extended-release capsule, USP is formulated as
a once-a-day
extended-release capsule containing 120 mg diltiazem hydrochloride,
USP (equivalent to
110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent
to 165.45 mg
diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6
mg diltiazem), 300
mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem),
or 360 mg
diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem).
Each capsule contains the following inactive ingredients: acetyl
tributyl citrate, ammonio
methacrylate copolymer type A, ammonio methacrylate copolymer type B,
colloidal
silicon dioxide, gelatin, hypromellose, sodium lauryl sulfate, sugar
sphere, talc and
titanium dioxide. Additionally each 120 mg capsule shell contains D &
C yellow # 10, FD
& C blue # 1 and FD & C red # 40; each 180 mg capsule shell contains
FD & C blue # 1,
FD & C red # 3 and iron oxide black; each 240 mg capsule shell
contains FD & C blue #
1 and FD & C red # 3; each 300 mg capsule shell contains D & C yellow
# 10, FD & C
blue # 1, FD & C red # 40 and iron oxide black; each 360 mg capsule
shell contains iron
oxide black. Each capsule is printed with black pharmaceutical ink
which conta