Drug Catalog - Product Detail
AMIODARONE HCL 200MG TB 60CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0732-60 | AUROBINDO PHARMA | 60 | 200MG | TABLET |
PACKAGE FILES
Generic Name
AMIODARONE HYDROCHLORIDE
Substance Name
AMIODARONE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA204742
Description
11 DESCRIPTION Amiodarone hydrochloride tablets, USP is an antiarrhythmic drug, available for oral administration as white to off-white, scored tablets containing 200 mg of amiodarone hydrochloride USP. The inactive ingredients present are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. Amiodarone hydrochloride is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: Amiodarone hydrochloride USP is a white or almost white, fine crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Amiodarone Hydrochloride Tablets USP, 200 mg are white to off-white, round biconvex uncoated tablets debossed with “8” and “4” separated by a breakline on one side and “A” on the other side. Bottles of 30 NDC 65862-732-30 Bottles of 60 NDC 65862-732-60 Bottles of 90 NDC 65862-732-90 Bottles of 100 NDC 65862-732-01 Bottles of 250 NDC 65862-732-25 Bottles of 500 NDC 65862-732-05 Bottles of 1,000 NDC 65862-732-99 Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.
Indications & Usage
1 INDICATIONS AND USAGE Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone hydrochloride is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment Recommended Dosage: Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Administration: Administer amiodarone hydrochloride tablets consistently with regard to meals [see Clinical Pharmacology (12.3) ] . Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs. Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. ( 2 )