AMITRIPTYLINE HYDROCHLORIDE- amitriptyline hydrochloride tablet
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-ter studies of major depressive disorder (MDD) and other psyciatric disorders. Anyone considering the use of amitriptyline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amitriptyline hydrochloride is not approved for use in pediatric patients.
WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use )
Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol.
It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-hydrochloride. It has the following structural formula:
Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The
10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg- D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg-FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg-D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg-D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg-D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake.
Amitriptyline HCl is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.
Amitriptyline inhibits the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in adrenergic and serotonergic neurons. Pharmacologically, this action may potentiate or prolong neuronal activity since reuptake of these biogenic amines is important physiologically in terminating transmitting activity. This interference with reuptake of norepinephrine and/or serotonin is believed by some to underlie the antidepressant activity of amitriptyline.
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.
It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.
Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia.
This drug is not recommended for use during the acute recovery phase following myocardial infarction.
Store at 20-25 C(68-77 F)(see USP Controlled Room Temperature).
Dispense in a tight, light-resistant container.
Studies in man following oral administration of 14C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours.
Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.
Ayd, F.J., Jr.: Amitriptyline therapy for depressive reactions, Psychosom. 1: 320-325, Nov.-Dec. 1960.
Diamond, S.: Human metabolization of amitriptyline tagged with carbon 14, Curr. Therap. Res. 7: 170-175, Mar. 1965.
Dorfman, W.: Clinical experiences with amitriptyline (A preliminary report), Psychosom. 1: 153-155, May-June 1960.
Fallette, J.M.; Stasney, C.R.; Mintz, A.A.: Amitriptyline poisoning treated with physostigmine, S. Med. J. 63: 1492-1493, Dec. 1970 (in Soc. Proc.).
Hollister, L.E.; Overall, J.E.; Johnson, M.; Pennington, V,; Katz, G.; Shelton, J.: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients, J. Nerv. and Ment. Dis. 139: 370-375, Oct. 1964.
Hordern, A.; Burt, C.G.; Holt, N.F.: Depressive states. A pharmacotherapeutic study, Springfield, Ill., Charles C. Thomas, 1965.
Jenike, M.A.: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy, J. Geriatr. Psycjoatry 1989; 22(1). 77-112.
Klerman, G.L.; Cole, J.O.: Clinical pharmacology of impiramine and related antidepressant compounds, Int. J. Psychiat. 3:267-304, Apr. 1976.
Liu, B.; Anderson, C.; Mittman, N. et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998; 351 (91 12): 1303-1307.
McConaghy, N.; Joffe, A.D.; Kingston, W.R.; Stevenson, H.G.; Atkinson, I.; Cole, E.; Fennessy, L.A.; Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline, Brit. J. Psychiat. 114: 103-106, Jan. 1968.
McDonald, I.M.; Perkins, M.; Marjerrison, G.; Podilsky, M.: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression, Amer. J. Psychiat. 122: 1427-1431. June 1966 (in Brief Communications).
Slovis, T.; Ott, J.; Teitelbaum, D.; Lipscomb, W.: Physostigmine therapy in acute tricyclic antidepressant poisoning, Clin. Toxicol. 4: 451-459, Sept. 1971.
Symposium on depression with special studies of a new antidepressant, amitriptyline, Dis. Nerv. Syst. 22: 5-56, May 1961 (Sect. 2).
amitriptyline hydrochloride tablet
|Labeler - REMEDYREPACK INC. (829572556)|