Amitriptyline Hydrochloride

Indications

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 (summary)

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 hydrochloride 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.

Contraindications

CONTRAINDICATIONS 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.

Warnings and precautions

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

Storage and supply

HOW SUPPLIED Product: 50090-4005 NDC: 50090-4005-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-4005-4 60 TABLET, FILM COATED in a BOTTLE NDC: 50090-4005-1 100 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-4005-8 90 TABLET, FILM COATED in a BOTTLE, PLASTIC

Source: Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) — US FDA prescribing information, 2024-06-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.