DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- diltiazem hydrochloride capsule, coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NuCare Pharmaceuticals, Inc.

INN (Tên quốc tế):

DILTIAZEM HYDROCHLORIDE

Thành phần:

DILTIAZEM HYDROCHLORIDE 240 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP 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.

Tóm tắt sản phẩm:

Diltiazem Hydrochloride Extended-Release Capsules, USP are supplied as follows: 240 mg — Each #0EL capsule with dark green opaque cap and body printed with and 2578 on both cap and body in white ink contains 240 mg of diltiazem hydrochloride, USP. Capsules are supplied in bottles of 30 NDC 68071-3079- Dispense in tight, light-resistant containers as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Avoid excessive humidity. Manufactured for: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 U.S.A. Issued: 09/2012 OS829-01-10-01 40-9216

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- DILTIAZEM HYDROCHLORIDE
CAPSULE,
COATED, EXTENDED RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
DILTIAZEM HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-DAY DOSAGE)
RX ONLY
DESCRIPTION
Diltiazem Hydrochloride Extended-Release Capsules, USP 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 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
either 120 mg, 180 mg, 240 mg, or
300 mg diltiazem hydrochloride.
Each diltiazem extended-release capsule, for oral administration,
contains the following inactive
ingredients:
120 mg — ammonio methacrylate copolymer NF, type A, ammonio
methacrylate copolymer NF, type B,
ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl
cellulose, pharmaceutical glaze,
propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate,
sugar spheres, talc, titanium
dioxide, triethyl citrate
180 mg — ammonio methacrylate copolymer NF, type A, ammonio
methacrylate copolymer NF, type B,
ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3,
gelatin, hydroxypropyl
cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide,
simethicone, sodium lauryl sulfate,
sugar spheres, talc, titanium dioxide, triethyl citrate
240 mg — ammonio methacrylate copolymer NF, type A, ammonio
methacrylate copolymer NF, type B,
ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin,
hydroxypropyl cellulose,
pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone,
sodium lauryl sulfate, sugar
spheres, talc, titanium dioxide, triethyl citrate
300 mg— ammonio m