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For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
DOSAGE AND ADMINISTRATION
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.
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.
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. Adjustment in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.**
10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. They are supplied as follows:
Bottles of 30: NDC 0603-2212-16
Bottles of 90: NDC 0603-2212-02
Bottles of 100: NDC 0603-2212-21
Bottles of 1000: NDC 0603-2212-32
25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows:
Bottles of 90: NDC 0603-2213-02
Bottles of 100: NDC 0603-2213-21
Bottles of 1000: NDC 0603-2213-32
Bottles of 2500: NDC 0603-2213-30
50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. They are supplied as follows:
Bottles of 100: NDC 0603-2214-21
Bottles of 1000: NDC 0603-2214-32
75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. They are supplied as follows:
Bottles of 100: NDC 0603-2215-21
Bottles of 300: NDC 0603-2215-25
100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. They are supplied as follows:
Bottles of 100: NDC 0603-2216-21
Bottles of 300: NDC 0603-2216-25
150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. They are supplied as follows:
Bottles of 100: NDC 0603-2217-21
Bottles of 300: NDC 0603-2217-25
Storage And Handling
Store in a well-closed container. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. In addition, amitriptyline tablets must be protected from light and stored in a well-closed, light-resistant container
Ayd FJ Jr: Amitriptyline therapy for depressive reactions. Psychosomatics 1960;1:320–325.
Diamond S: Human metabolizer of amitriptyline tagged with carbon 14. Curr Ther Res, Mar 1965, pp 170–175.
Dorfman W: Clinical experiences with amitriptyline: A preliminary report. Psychosomatics 1960;1:153– 155.
Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated with physostigmine. South Med J 1970;63:1492–1493.
Hollister LE, Overall JE, Johnson M, et al: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients. J Nerv Ment Dis 1964;139:370–375.
Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, Ill, Charles C. Thomas, 1965. Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989; 22(1):77–112.
Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267–304.
McConaghy N, Joffe AD, Kingston WA, et al: Correlation of clinical features of depressed out-patients with response to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103–106.
McDonald IM, Perkins M, Marjerrison G, et al: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression. Am J Psychiatry 1966;122:1427–1431.
Slovis T, Ott J, Teitelbaum D, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451–459.
Symposium on depression with special studies of a new antidepressant, amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp 5–56.
*Based on a maximum recommended amitriptyline dose of 150 mg/day or 3 mg/kg/day for a 50 kg patient.
**Hollister LE: Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530–2533.
Elavil 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows: Bottles of 100: NDC 69874-422-10
Manufactured by: Qualitest Pharmaceuticals/Vintage Pharmaceuticals, Huntsville, AL 35811. Manufactured for: Thompson Medical Solutions, Birmingham, AL 35242. Revised: Apr 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/2/2016
Additional Elavil Information
- Elavil Drug Interactions Center: amitriptyline oral
- Elavil Side Effects Center
- Elavil Overview including Precautions
- Elavil FDA Approved Prescribing Information including Dosage
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