DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 120 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 blistercards of 30 (NDC 0615-1324-39). 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 blistercards of 30 (NDC 0615-1341-39), and 31 (NDC 0615-1341-31). 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 blistercards of 30 (0615-1342-39) and 31 (NDC 0615-1342-31). 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 blistercards of 30 (NDC 0615-1355-39). 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 by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-8791 Revised — June 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
DESCRIPTION
Diltiazem hydrochloride, 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 methacrylate copolymer NF, type A, ammonio
methacrylate copolymer NF