CARTIA XT- 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:

Actavis Pharma, Inc.

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem hydrochloride extended-release capsules (once-a-day dosage) 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:

Diltiazem Hydrochloride Extended-release Capsules, USP (Once-a-day dosage) Strength Quantity NDC Number Description 120 mg 90’s 500’s 62037-597-90 62037-597-05 White/orange opaque capsule imprinted with "Andrx 597" on one end and "120 mg" on the other. 90’s 500’s 62037-598-90 62037-598-05 90’s 500’s 62037-599-90 62037-599-05 90’s 500’s 62037-600-90 62037-600-05 NOTE: THE PRODUCT MAY HAVE AN ODOR. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.  Dispense in tight, light resistant container as defined in USP.  Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 8/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARTIA XT- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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CARTIA XT
BRAND OF DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-DAY DOSAGE)
RX ONLY
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 120 mg diltiazem hydrochloride (equivalent to 110.3 mg
diltiazem), 180 mg
diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg
diltiazem
hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem
hydrochloride
(equivalent to 275.75 mg diltiazem).
In addition, each capsule contains the following inactive ingredients:
acetyltributyl citrate,
ammonio methacrylate copolymer-NF, black iron oxide, cornstarch, D & C
Red #28, D &
C Yellow #10, D & C Yellow #10 Aluminum Lake, ethylcellulose, FD & C
Blue #1
Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40, FD & C
Red #40
Aluminum Lake, gelatin-NF, magnesium stearate, methacrylic acid
copolymer-NF,
propylene glycol, polysorbate 80-NF, sucrose, talc USP, and titanium
dioxide. The 180
mg and 240 mg capsules contain yellow iron oxide. In addition, the 240
mg capsule also
contains red iron oxide.
For oral administration.
®
This drug meets USP Drug Release 9.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem 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 produces its antihypertensive effe