DILTIAZEM HYDROCHLORIDE capsule, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Rebel Distributors Corp

INN (الاسم الدولي):

Diltiazem Hydrochloride

تركيب:

Diltiazem Hydrochloride 120 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They 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 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.

ملخص المنتج:

Diltiazem Hydrochloride Extended-release Capsules, USP are supplied as follows: 120 mg — Each #2 capsule with light gray opaque cap and body printed with and 2588 on both cap and body in white ink contains 120 mg of diltiazem hydrochloride, USP. Capsules are supplied in bottles of 30 (NDC 21695-403-30). 180 mg — Each #0 capsule with dark green opaque cap and aqua blue opaque body printed with and 2577 on both cap and body in white ink contains 180 mg of diltiazem hydrochloride, USP. Capsules are supplied in bottles of 30 (NDC 21695-404-30). 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 21695-803-30). Dispense in tight, light-resistant containers as defined in the USP. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive humidity. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
REBEL DISTRIBUTORS CORP
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DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
DESCRIPTION
Diltiazem hydrochloride is a calcium ion 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 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 methacrylate copolymer NF, type A, ammonio
methacrylate copolymer NF, type B,
ammonium hydroxide, black iron oxide