PHENELZINE SULFATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PHENELZINE SULFATE (UNII: 2681D7P965) (PHENELZINE - UNII:O408N561GF)

Commercializzato da:

Golden State Medical Supply, Inc.

INN (Nome Internazionale):

PHENELZINE SULFATE

Composizione:

PHENELZINE 15 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PHENELZINE SULFATE- PHENELZINE SULFATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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PHENELZINE SULFATE TABLETS, USP
BOXED WARNING
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 Phenelzine
Sulfate 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. Phenelzine Sulfate Tablets is not approved for
use in pediatric patients. (See
Warnings: Clinical Worsening and Suicide Risk, Precautions:
Information for Patients, and
Precautions: Pediatric Use)
DESCRIPTION
Phenelzine Sulfate Tablets, USP (phenelzine sulfate) is a potent
inhibitor of monoamine oxidase (MAO).
Phenelzine sulfate is a hydrazine derivative. It has a molecular
weight of 234.27 and is chemically
described as C H N • H SO . Its chemical structure is shown below:
Each Phenelzine Sulfate Tablets film-coated for oral administration
contains phenelzine sulfate
equivalent to 15 mg of phenelzine base and the following inactive
ingredients: mannitol, USP; colloidal
silicon dioxide, NF; povidones, USP; edetate disodium, USP; magnesium
stearate, NF; purified water,
USP; polyvinyl alcohol-part hyd