Drug Catalog - Product Detail
DILTIAZEM HCL CD CAP 120MG 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0595-16 | ZYDUS PHARMACEUTICALS (USA) | 90 | 120MG | CAPSULE |
PACKAGE FILES
Generic Name
DILTIAZEM HYDROCHLORIDE
Substance Name
DILTIAZEM HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA206534
Description
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 black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Diltiazem Hydrochloride Extended-release Capsule, USP meets USP Dissolution Test 3. For oral administration. figure
How Supplied
HOW SUPPLIED 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 68382-595-06 in bottles of 30 capsules with child-resistant closure NDC 68382-595-16 in bottles of 90 capsules with child-resistant closure NDC 68382-595-01 in bottles of 100 capsules NDC 68382-595-05 in bottles of 500 capsules NDC 68382-595-77 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 68382-596-06 in bottles of 30 capsules with child-resistant closure NDC 68382-596-16 in bottles of 90 capsules with child-resistant closure NDC 68382-596-01 in bottles of 100 capsules NDC 68382-596-05 in bottles of 500 capsules NDC 68382-596-77 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 68382-597-06 in bottles of 30 capsules with child-resistant closure NDC 68382-597-16 in bottles of 90 capsules with child-resistant closure NDC 68382-597-01 in bottles of 100 capsules NDC 68382-597-05 in bottles of 500 capsules NDC 68382-597-77 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 68382-598-06 in bottles of 30 capsules with child-resistant closure NDC 68382-598-16 in bottles of 90 capsules with child-resistant closure NDC 68382-598-01 in bottles of 100 capsules NDC 68382-598-05 in bottles of 500 capsules NDC 68382-598-77 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 68382-599-06 in bottles of 30 capsules with child-resistant closure NDC 68382-599-16 in bottles of 90 capsules with child-resistant closure NDC 68382-599-01 in bottles of 100 capsules NDC 68382-599-05 in bottles of 500 capsules NDC 68382-599-77 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 Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/22
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina: Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period. Concomitant Use with Other Cardiovascular Agents: Sublingual NTG: May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy. Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short-and long-acting nitrates. Beta-blockers: (See WARNINGS and PRECAUTIONS . ) Antihypertensives: Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.