DESCRIPTION
id: 94462253-63f7-41b5-a771-d98eeb05c7c4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Amitriptyline hydrochloride USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless or practically odorless, crystalline powder or small crystals and freely soluble in water, alcohol, chloroform and methanol and insoluble in ether.
It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, γ-propylamine hydrochloride.
It has the following structural formula:
Each amitriptyline hydrochloride tablet, USP for oral administration contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients are: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), talc, and titanium dioxide. Additionally,
25 mg tablets contain: D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;
50 mg tablets contain: D&C Yellow #10 Aluminum Lake, iron oxide red and iron oxide yellow;
75 mg tablets contain: FD&C Blue #2 Aluminum Lake and iron oxide yellow;
100 mg tablets contain: D&C Red #27 Aluminum Lake and D&C Yellow #10 Aluminum Lake;
150 mg tablets contain: iron oxide red and iron oxide yellow.
CLINICAL PHARMACOLOGY
id: 1025b081-36d0-4dac-898a-8640db06f02b
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Amitriptyline hydrochloride 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.
INDICATIONS AND USAGE
id: 95d37acc-da21-423a-802e-1ecb30732794
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
CONTRAINDICATIONS
id: e5f69542-1e61-4614-bd4e-27668b34cbf9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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.
PRECAUTIONS
id: 3f06af55-b094-4eb8-96d5-80ad335c6465
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. Depressed patients, particularly those with known manic-depressive illness, may experience a shift to mania or hypomania. In these circumstances the dose of amitriptyline may be reduced or a major tranquilizer such as perphenazine may be administered concurrently.
The possibility of suicide in depressed patients remains until significant remission occurs. Potentially suicidal patients should not have access to large quantities of this drug. Prescriptions should be written for the smallest amount feasible.
Concurrent administration of amitriptyline hydrochloride and electroshock therapy may increase the hazards associated with such therapy. Such treatment should be limited to patients for whom it is essential.
When possible, the drug should be discontinued several days before elective surgery.
Both elevation and lowering of blood sugar levels have been reported.
Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.
ADVERSE REACTIONS
id: fbc5660c-6a56-424e-a5ee-0f36a3b65eee
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.
OVERDOSAGE
id: 3b8c8e60-83a7-4f59-9f9c-9aa8c9030f20
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.
HOW SUPPLIED
id: 6b2c1225-6956-4cb2-9f94-abf3de90903b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Amitriptyline Hydrochloride Tablets USP, 10 mg are white to off white colored, round shaped, biconvex, film-coated tablets debossed with “ZA” over “1” on one side and plain on other side and are supplied as follows:
NDC 70771-1173-1 in bottle of 100 tablets
NDC 70771-1173-0 in bottle of 1,000 tablets
Amitriptyline Hydrochloride Tablets USP, 25 mg are light green colored, round shaped, biconvex, film-coated tablets debossed with “ZA” over “2” on one side and plain on other side and are supplied as follows:
NDC 70771-1174-1 in bottle of 100 tablets
NDC 70771-1174-0 in bottle of 1,000 tablets
Amitriptyline Hydrochloride Tablets USP, 50 mg are brown colored, round shaped, biconvex, film-coated tablets debossed with “ZA” over “3” on one side and plain on other side and are supplied as follows:
NDC 70771-1175-1 in bottle of 100 tablets
NDC 70771-1175-0 in bottle of 1,000 tablets
Amitriptyline Hydrochloride Tablets USP, 75 mg are light blue colored, round shaped, biconvex, film-coated tablets debossed with “12” over “28” on one side and plain on other side and are supplied as follows:
NDC 70771-1176-1 in bottle of 100 tablets
NDC 70771-1176-0 in bottle of 1,000 tablets
Amitriptyline Hydrochloride Tablets USP, 100 mg are orange colored, round shaped, biconvex, film-coated tablets debossed with “12” over “29” on one side and plain on other side and are supplied as follows:
NDC 70771-1177-1 in bottle of 100 tablets
NDC 70771-1177-0 in bottle of 1,000 tablets
Amitriptyline Hydrochloride Tablets USP, 150 mg are cream to beige colored, modified capsule shaped, biconvex, film-coated tablets debossed with “1230” on one side and plain on other side and are supplied as follows:
NDC 70771-1178-1 in bottle of 100 tablets
NDC 70771-1178-0 in bottle of 1,000 tablets
Store at 20º to 25ºC (68º to 77ºF) (see USP Controlled Room Temperature).
Dispense in a tight, light-resistant container.
REFERENCES
id: 0426b068-82c3-402b-b3c1-0d331ccba7fe
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
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: 1,492-1,493, 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. Psychiatry 1989;22(1).77-112.
Klerman, G.L.; Cole, J.O.: Clinical pharmacology of imipramine 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):1,303-1,307.
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: 1,427-1,431. 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).
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: a8af3b05-fb93-4c59-b4eb-93302a5faae6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 70771-1173-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 10 mg
Rx only
100 Tablets
NDC 70771-1174-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 25 mg
Rx only
100 Tablets
NDC 70771-1175-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 50 mg
Rx only
100 Tablets
NDC 70771-1176-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 75 mg
Rx only
100 Tablets
NDC 70771-1177-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 100 mg
Rx only
100 Tablets
NDC 70771-1178-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 150 mg
Rx only
100 Tablets
