"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
(Generic versions may still be available.)
- Patient Information:
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.
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.
Initially, 20 to 30 mg (2 to 3 ml) four times a day.
When amitriptyline HCl injection is administered intramuscularly, the effects may appear more rapidly than with oral administration.
When amitriptyline HCl injection is used for initial therapy in patients unable or unwilling to take amitriptyline HCl tablets, the tablets should replace the injection as soon as possible.
Usage in Pediatric Patients: In view of the lack of experience with the use of this drug in children, 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. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.14
Elavil (amitriptyline) , 10 mg, are blue, round, film coated tablets, identified with "40" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 25 mg, are yellow, round, film coated tablets, identified with "45" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 50 mg, are beige, round, film coated tablets, identified with "41" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 75 mg, are orange, round, film coated tablets, identified with "42" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 100 mg, are mauve, round, film coated tablets, identified with "43" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 150 mg, are blue, capsule shaped, film coated tablets, identified with "47" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 10 mg/ml, is a clear, colorless solution, and is supplied in 10 ml vials:
Storage: Store amitriptyline HCl tablets in a well-closed container. Avoid storage at temperatures above 30°C (86°F). In addition, amitriptyline HCl tablets 10 mg must be protected from light and stored in a well-closed, light-resistant container.
Protect amitriptyline HCl injection from freezing and avoid storage above 30°C (86°F).
1. Ayd FJ Jr: Amitriptyline therapy for depressive reactions. Psychosomatics 1960;1:320-325.
2. Diamond S: Human metabolizer of amitriptyline tagged with carbon 14. Curr Ther Res, Mar 1965, pp 170-175.
3. Dorfman W: Clinical experiences with amitriptyline: A preliminary report. Psychosomatics 1960;1:153-155.
4. Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated with physostigmine. South Med J 1970;63:1492-1493.
5. 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.
6. Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, III, Charles C. Thomas, 1965.
7. Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989;22(1):77-112.
8. Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267-304.
9. Liu B, Anderson G, Mittman N, et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998;351(9112):1303-1307.
10. McConaghy N, Joffe AD, Kingston WR, et al: Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103-106.
11. 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.
12. Slovis T, Ott J, Teitelbaum, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451-459.
13. Symposium on depression with special studies of a new antidepressant, amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp 5-56.
14. Hollister LE: JAMA 1979;241:2350-2533.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Elavil Information
- Elavil Drug Interactions Center: amitriptyline oral
- Elavil Side Effects Center
- Elavil Overview including Precautions
- Elavil FDA Approved Prescribing Information including Dosage
Elavil - User Reviews
Elavil User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on therapy and treatment.