RVP

Drug Catalog - Product Detail

AMITRIPTYLINE 25MG 100CT TABS

NDC Mfr Size Str Form
57664-0688-88 SUN PHARMACEUTICALS 100 25MG TABLET
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Generic Name
AMITRIPTYLINE HYDROCHLORIDE
Substance Name
AMITRIPTYLINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA089399
Description
DESCRIPTION Amitriptyline HCl is 3-(10,11-dihydro-5 H -dibenzo [ a,d ] cycloheptene-5-ylidene)- N,N -dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20 H 23 N ∙ HCl and its structural formula is: Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake. structure
How Supplied
HOW SUPPLIED Amitriptyline hydrochloride tablets USP, are available as follows: Amitriptyline hydrochloride tablets, 10 mg, pink, round, film coated, debossed MP 10 Bottles of 100 CRC NDC 57664-687-88 Bottles of 1000 NDC 57664-687-18 Amitriptyline hydrochloride tablets, 25 mg, green, round, film coated, debossed MP 25 Bottles of 100 CRC NDC 57664-688-88 Bottles of 1000 NDC 57664-688-18 Amitriptyline hydrochloride tablets, 50 mg, brown, round, film coated, debossed MP 26 Bottles of 100 CRC NDC 57664-689-88 Bottles of 1000 NDC 57664-689-18 Amitriptyline hydrochloride tablets, 75 mg, purple, round, film coated, debossed MP 27 Bottles of 100 CRC NDC 57664-692-88 Amitriptyline hydrochloride tablets, 100 mg, orange, round, film coated, debossed MP 28 Bottles of 100 CRC NDC 57664-690-88 Amitriptyline hydrochloride tablets, 150 mg, peach, capsule shaped, film coated, debossed MP 29 Bottles of 100 CRC NDC 57664-691-88 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Indications & Usage
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Dosage and Administration
DOSAGE AND ADMINISTRATION Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer, to lessen the possibility of relapse. Usage in Pediatric Patients In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age. Plasma Levels Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels. Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241 (23):2530-2533.