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tranylcypromine sulf 10 mg tab generic parnate

In stock Manufacturer ACTAVIS/TEVA 00591559001
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Major Depressive Disorder

Tranylcypromine is used in the treatment of major depressive disorder. Tranylcypromine has been shown to be effective in adult outpatients with major depressive episodes without melancholia; effectiveness of the drug for the treatment of major depressive episodes with melancholia (endogenous features) has not been established. Because of the potential for serious adverse effects, monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) generally are not used as initial therapy in the management of major depressive disorder, but are reserved for patients who do not respond adequately to other antidepressant agents (e.g., selective serotonin-reuptake inhibitors [SSRIs], tricyclic antidepressants) or in whom other therapies are contraindicated. Patient response to antidepressant agents is variable, and patients who do not respond to one drug may be successfully treated with a different agent.

Dosage and Administration


Tranylcypromine sulfate is administered orally.


Dosage of tranylcypromine sulfate is expressed in terms of tranylcypromine.

Major Depressive Disorder

Dosage of tranylcypromine must be carefully adjusted according to individual requirements and tolerance, using the lowest possible effective dosage.

Patients should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment.

For the symptomatic treatment of major depressive disorder, the usual adult dosage of tranylcypromine is 30 mg daily, usually given in 2 divided doses in the morning and in the afternoon. If no signs of therapeutic response appear after a reasonable period (up to 2-3 weeks), dosage may be increased in increments of 10 mg daily at 1- to 3-week intervals until optimum therapeutic response or a dosage of 60 mg daily is achieved. An increase in the frequency and severity of adverse effects should be anticipated when dosages in excess of 30 mg daily are used. Once an adequate response has been achieved, it may be possible to reduce dosage to a lower maintenance level. To avoid recurrence of depressive symptoms and/or manifestations of withdrawal (e.g., restlessness, anxiety, depression, confusion, hallucinations, headache, weakness, diarrhea), a gradual reduction in dosage is recommended during withdrawal of tranylcypromine therapy.


Tranylcypromine shares the toxic potentials of other MAO inhibitors, and the usual precautions and contraindications associated with these drugs should be observed. Patients should be fully advised about the risks, especially hypertensive crisis and suicidal thinking and behavior (suicidality), associated with MAO inhibitor therapy..

Pediatric Precautions

Safety and efficacy of tranylcypromine in pediatric patients have not been established.

The US Food and Drug Administration (FDA) has determined that antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders. However, FDA also states that depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide. Anyone considering the use of tranylcypromine in a child or adolescent for any clinical use must balance the potential risk of therapy with the clinical need. (See Cautions: Precautions and Contraindications and Cautions: Pediatric Precautions, in the Monoamine Oxidase Inhibitors General Statement 28:16.04.12.)


Following oral administration of a 20-mg dose, tranylcypromine sulfate is rapidly absorbed, achieving peak plasma concentrations of about 110 ng/mL (range: 65-190 ng/mL) within about 1.5 hours (range: 0.7-3.5 hours). GI absorption of the drug shows interindividual variation and may be biphasic in some individuals, achieving an initial (highest) peak within about 1 hour and a secondary peak within 2-3 hours. It has been suggested that this apparent biphasic absorption in some individuals may represent different absorption rates for the stereoisomers of the drug, but additional study is necessary.

Following oral administration of a single dose of tranylcypromine sulfate in a limited number of depressed patients with normal renal and hepatic functions, the volume of distribution of the drug ranged from 1.1-5.7 L/kg. In these patients, the elimination half-life averaged 2.5 hours (range: 1.5-3.2 hours).

The onset of pharmacologic action of tranylcypromine is more rapid than that of hydrazine-derivative MAO inhibitors, and unlike the hydrazine-derivative MAO inhibitors, tranylcypromine does not produce a prolonged inhibitory effect on the enzyme. In one study, maximum orthostatic decrease in blood pressure and increase in heart rate occurred at about 2 hours after a single oral dose of the drug. Following discontinuance of tranylcypromine, the drug is excreted within 24 hours; however, urinary tryptamine concentrations, which are used to measure MAO activity, return to normal within 72-120 hours.

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