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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 49884-829-11), 90 (NDC 49884-829-09) and 500 (NDC 49884-829-05). 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 49884-830-11), 90 (NDC 49884-830-09) and 500 (NDC 49884-830-05). 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 49884-831-11), 90 (NDC 49884-831-09) and 500 (NDC 49884-831-05). 300 mg — Each #00 capsule with dark green opaque cap and light gray opaque body printed with  and 2579 on both cap and body in white ink contains 300 mg of diltiazem hydrochloride, USP. Capsules are supplied in bottles of 30 (NDC 49884-832-11), 90 (NDC 49884-832-09) and 500 (NDC 49884-832-05). 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- DILTIAZEM HYDROCHLORIDE
CAPSULE,
COATED, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
30