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:

Zydus Lifesciences Limited

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules 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, 120 mg are white to off white pellets filled in size "2" empty hard gelatin capsules with opaque light green colored cap & opaque white colored body imprinted with "595" in black ink and are supplied as follows: NDC 70771-1030-3 in bottles of 30 capsules with child-resistant closure NDC 70771-1030-9 in bottles of 90 capsules with child-resistant closure NDC 70771-1030-1 in bottles of 100 capsules NDC 70771-1030-5 in bottles of 500 capsules NDC 70771-1030-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 180 mg are white to off white pellets filled in size "0" empty hard gelatin capsules with opaque light blue colored cap & opaque grey colored body imprinted with "596" in black ink and are supplied as follows: NDC 70771-1031-3 in bottles of 30 capsules with child-resistant closure NDC 70771-1031-9 in bottles of 90 capsules with child-resistant closure NDC 70771-1031-1 in bottles of 100 capsules NDC 70771-1031-5 in bottles of 500 capsules. NDC 70771-1031-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 240 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light blue colored cap & opaque white colored body imprinted with "597" in black ink and are supplied as follows: NDC 70771-1032-3 in bottles of 30 capsules with child-resistant closure NDC 70771-1032-9 in bottles of 90 capsules with child-resistant closure NDC 70771-1032-1 in bottles of 100 capsules NDC 70771-1032-5 in bottles of 500 capsules NDC 70771-1032-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 300 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light green colored cap & opaque grey colored body imprinted with "598" in black ink and are supplied as follows: NDC 70771-1033-3 in bottles of 30 capsules with child-resistant closure NDC 70771-1033-9 in bottles of 90 capsules with child-resistant closure NDC 70771-1033-1 in bottles of 100 capsules NDC 70771-1033-5 in bottles of 500 capsules NDC 70771-1033-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Diltiazem Hydrochloride Extended-release Capsules USP, 360 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque grey colored cap & opaque white colored body imprinted with "599" in black ink and are supplied as follows: NDC 70771-1034-3 in bottles of 30 capsules with child-resistant closure NDC 70771-1034-9 in bottles of 90 capsules with child-resistant closure NDC 70771-1034-1 in bottles of 100 capsules NDC 70771-1034-5 in bottles of 500 capsules NDC 70771-1034-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in a tight container as defined in the USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured  by: Zydus Lifesciences Ltd., Ahmedabad, India       Rev.: 10/23

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
ONCE-A-DAY DOSAGE
RX ONLY
DESCRIPTION
Diltiazem hydrochloride 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, odourless, crystalline powder
or small crystals. It
is freely soluble in chloroform, in formic acid, in methanol, and in
water; sparingly soluble
in dehydrated alcohol; insoluble in ether. It has a molecular weight
of 450.98.
Diltiazem hydrochloride extended-release capsule, USP is formulated as
a once-a-day
extended-release capsule containing 120 mg diltiazem hydrochloride,
USP (equivalent to
110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent
to 165.45 mg
diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6
mg diltiazem), 300
mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem),
or 360 mg
diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem).
Each capsule contains the following inactive ingredients: acetyl
tributyl citrate, ammonio
methacrylate copolymer type A, ammonio methacrylate copolymer type B,
colloidal
silicon dioxide, gelatin, hypromellose, sodium lauryl sulfate, sugar
sphere, talc and
titanium dioxide. Additionally each 120 mg capsule shell contains D &
C yellow # 10, FD
& C blue # 1 and FD & C red # 40; each 180 mg capsule shell contains
FD & C blue # 1,
FD & C red # 3 and iron oxide black; each 240 mg capsule shell
contains FD & C blue #
1 and FD & C red # 3; each 300 mg capsule shell contains D & C yellow
# 10, FD & C
blue # 1, FD & C red # 40 and iron oxide black; each 360 mg capsule
shell contains iron
oxide black. Each capsule is printed with black pharmaceutical ink
which contains bl