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:

AvKARE

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 is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is 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 Strength Quantity NDC Number Description 120 mg 90 counts 42291-184-90 Hard gelatin capsules light gray opaque cap and light gray opaque body imprinted with “par” on the cap and “C829” on the body in black ink. Each capsule contains white to off white coated pellets. 500 counts 42291-184-50 180 mg 90 counts 42291-185-90 Hard gelatin capsules with dark green opaque cap and blue opaque body imprinted with “par” on the cap and “C830” on the body in black ink. Each capsule contains white to off white coated pellets. 500 counts 42291-185-50 240 mg 90 counts 42291-186-90 Hard gelatin capsules with dark green opaque cap and dark green opaque body imprinted with “par” on the cap and “C831” on the body in black ink. Each capsule contains white to off white coated pellets. 500 counts 42291-186-50 300 mg 90 counts 42291-187-90 Hard gelatin capsules with dark green opaque cap and light gray opaque body imprinted with “par” on the cap and “C832” on the body in black ink. Each capsule contains white to off white coated pellets 500 counts 42291-187-50 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature] Avoid excessive humidity. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg.Rev. 02/17 AV Rev. 07/18 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE- DILTIAZEM
HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE
AVKARE
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DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
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-Benzothiazepin4(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 Extended-Release Capsules, USP is formulated
as a once-a-day
extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg
diltiazem
hydrochloride.
Each diltiazem hydrochloride extended-release capsule, contains the
following inactive
ingredients: ammonio methacrylate copolymer NF, type A, ammonio
methacrylate
copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl
cellulose, propylene
glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc,
titanium dioxide, triethyl
citrate and black iron oxide. In addition, the 180 mg capsules
contains D&C yellow #10,
FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10,
FD&C green
#3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C
green #3.
For oral administration.
This drug product conforms to USP Drug release test #11.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride extended-release
capsules are
believed to be related to its ability to inhibit the cellular influx
of calcium ions during
membrane depolarization of cardiac and vascular smooth muscle.
_MECHANISMS OF ACTION_
HYPERTENSION: Diltiazem hydrochloride extended-release capsules
produce its
antihypertensive effect primarily by relaxation of vascular smooth
muscle and the
resultant decrease in peripheral va