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:

Carilion Materials Management

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 tablets are 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:

Product: 68151-1457 NDC: 68151-1457-1 1 CAPSULE, COATED, EXTENDED RELEASE in a BLISTER PACK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE- DILTIAZEM HYDROCHLORIDE
CAPSULE,
COATED, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
----------
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-
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
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
d