Drug Catalog - Product Detail
DILTIAZEM HCL COATED BCTDS CAP ER 24HR 300MG 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 10370-0832-11 | PAR PHARMACEUTICAL | 30 | 300MG | CAPSULE |
PACKAGE FILES
Generic Name
DILTIAZEM HYDROCHLORIDE
Substance Name
DILTIAZEM HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074984
Description
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. Chemical-Structure
How Supplied
HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP Strength Quantity NDC Number Description 120 mg 30 counts 10370-829-11 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. 90 counts 10370-829-09 500 counts 10370-829-05 180 mg 30 counts 10370-830-11 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. 90 counts 10370-830-09 500 counts 10370-830-05 240 mg 30 counts 10370-831-11 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. 90 counts 10370-831-09 500 counts 10370-831-05 300 mg 30 counts 10370-832-11 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 90 counts 10370-832-09 500 counts 10370-832-05 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature] Avoid excessive humidity. Dist. by: Par Pharmaceutical Cranbury, NJ 08512 U.S.A. Mfg. by: Par Formulations Private Limited, M82 and M83, Industrial Area, SEZ, Phase II, Pithampur, Dhar, MP - 454775, District- DHAR Made in India Mfg. Lic. No.: 25/82/2020 OS829-01-74-01 Issued: 12/2021
Indications & Usage
INDICATIONS AND USAGE 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.
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, USP 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 extended-release capsules therapy. Prophylactic Nitrate Therapy: Diltiazem hydrochloride extended-release capsules may be safely coadministered with short- and long-acting nitrates. Beta-blockers: (see WARNINGS and PRECAUTIONS ). Antihypertensives: Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other.