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Drug Catalog - Product Detail

AMOXAPINE TB 150MG 30

NDC Mfr Size Str Form
00591-5716-30 ACTAVIS PHARMA 30 150MG TABLET
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Generic Name
AMOXAPINE
Substance Name
AMOXAPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA072691
Description
DESCRIPTION Amoxapine is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl)dibenz[ b,f ][1,4]oxazepine. The structural formula is represented below: C 17 H 16 CIN 3 O M.W. 313.78 Amoxapine is supplied for oral administration as 25 mg, 50 mg, 100 mg and 150 mg tablets. Amoxapine Tablets USP, 25 mg, 50 mg, 100 mg and 150 mg contain: dibasic calcium phosphate, magnesium stearate, starch (corn), and stearic acid. Amoxapine Tablets USP, 50 mg and 150 mg also contain: FD&C Yellow No. 6. Amoxapine Tablets USP, 100 mg also contain: FD&C Blue No. 2. Amoxapine structural formula
How Supplied
HOW SUPPLIED Amoxapine Tablets USP, 25 mg are 8/32", scored, round, white tablets imprinted DAN 25 and 5713 supplied in bottles of 100. Amoxapine Tablets USP, 50 mg are 10/32", scored, round, orange tablets imprinted DAN 50 and 5714 supplied in bottles of 100. Amoxapine Tablets USP, 100 mg are 11/32", scored, round, blue tablets imprinted DAN 100 and 5715 supplied in bottles of 100. Amoxapine Tablets USP, 150 mg are 12/32", scored, round, orange tablets imprinted DAN 150 and 5716 supplied in bottles of 30. Dispense in a tight container with child-resistant closure. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2015
Indications & Usage
INDICATIONS AND USAGE Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.
Dosage and Administration
DOSAGE AND ADMINISTRATION Effective dosage of amoxapine may vary from one patient to another. Usual effective dosage is 200 to 300 mg daily. Three weeks constitutes an adequate period of trial providing dosage has reached 300 mg daily (or lower level of tolerance) for at least two weeks. If no response is seen at 300 mg, dosage may be increased, depending upon tolerance, up to 400 mg daily. Hospitalized patients who have been refractory to antidepressant therapy and who have no history of convulsive seizures may have dosage raised cautiously up to 600 mg daily in divided doses. Amoxapine may be given in a single daily dose, not to exceed 300 mg, preferably at bedtime. If the total daily dosage exceeds 300 mg, it should be given in divided doses. Initial Dosage for Adults Usual starting dosage is 50 mg two or three times daily. Depending upon tolerance, dosage may be increased to 100 mg two or three times daily by the end of the first week. (Initial dosage of 300 mg daily may be given, but notable sedation may occur in some patients during the first few days of therapy at this level.) Increases above 300 mg daily should be made only if 300 mg daily has been ineffective during a trial period of at least two weeks. When effective dosage is established, the drug may be given in a single dose (not to exceed 300 mg) at bedtime. Elderly Patients In general, lower dosages are recommended for these patients. Recommended starting dosage of amoxapine is 25 mg two or three times daily. If no intolerance is observed, dosage may be increased by the end of the first week to 50 mg two or three times daily. Although 100 to 150 mg daily may be adequate for many elderly patients, some may require higher dosage. Careful increases up to 300 mg daily are indicated in such cases. Once an effective dosage is established, amoxapine may conveniently be given in a single bedtime dose, not to exceed 300 mg. Maintenance Recommended maintenance dosage of amoxapine is the lowest dose that will maintain remission. If symptoms reappear, dosage should be increased to the earlier level until they are controlled. For maintenance therapy at dosages of 300 mg or less, a single dose at bedtime is recommended.