AMITRIPTYLINE HYDROCHLORIDE tablet, film coated AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Dostępny od:

DIRECT RX

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 infarc

Podsumowanie produktu:

Amitriptyline hydrochloride tablets, USP for oral administration are available as: 10 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I1” on one side and plain on other side, and supplied as:

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT RX
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AMITRIPTYLINE HYDROCHLORIDE
SUICIDALITY AND ANTIDEPRESSANT DRUGS:
Antidepressants increased the risk compared to placebo of suicidal
thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term
studies of major depressive
disorder (MDD) and other psychiatric 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. (See 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-5
H-dibenzo[a,d] cycloheptene-Δ 5, γ-
propylamine hydrochloride. It has the following structural formula:
amitriptyline HCl chemical structure
Each tablet for oral administration contains 10, 25, 50, 75, 100, or
150 mg amitriptyline hydrochloride.
Inactive ingredients include colloidal anhydrous silica,
crosca