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Parnate (Tranylcypromine Sulfate) - Summary

 

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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 PARNATE 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. PARNATE is not approved for use in pediatric patients. (See WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

 

PARNATE SUMMARY

Chemically, tranylcypromine sulfate is (±)- trans -2-phenylcyclopropylamine sulfate (2:1). Each round, rose-red, film-coated tablet is debossed with the product name PARNATE and SB and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine.

PARNATE (tranylcypromine) is indicated for the following:

For the treatment of Major Depressive Episode Without Melancholia.

Parnate (tranylcypromine sulfate) should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.

The effectiveness of Parnate has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association’s Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration and suicidal ideation or attempts.

The effectiveness of Parnate in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.

PARNATE NEWS HIGHLIGHTS

Media Articles Related to Parnate (Tranylcypromine)

Exercise Helps With Body Image, Depression In Pregnancy
Source: Depression News From Medical News Today [2008.09.04]

BioMedEcon Reports Six Times Higher Psychiatric Medication Costs Among Patients With OCD Compared To Patients With Depression
Source: Psychology / Psychiatry News From Medical News Today [2008.09.04]

Inflammatory bowel disease linked to depression (Reuters)
Source: Y! Health Anxiety News [2008.09.04]

Singulair not linked to suicide, depression (Reuters)
Source: Y! Health Depression News [2008.09.03]

3 Questions Can Spot Possible Postpartum Depression
Source: MedicineNet Depression Specialty [2008.09.03]

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Published Studies Related to Parnate (Tranylcypromine)

Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant medication trials for depression: a STAR*D report. [2006.09]

Withdrawal from high-dose tranylcypromine. [2008.03]

Tranylcypromine vs. lamotrigine in the treatment of refractory bipolar depression: a failed but clinically useful study. [2007.05]

Tranylcypromine: new perspectives on an "old" drug. [2006.08]

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Clinical Trials Related to Parnate (Tranylcypromine)

Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions [Completed]

Tranylcypromine, Tranylcypromine Plus Dextroamphetamine and Tranylcypromine Plus Triiodothyronine as Treatment for Refractory Depression [Terminated]

Treatment of Orthostatic Hypotension in Autonomic Failure [Recruiting]

Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) [Completed]

Sequenced Treatment Alternatives to Relieve Depression (STAR*D) [Completed]

more>>

Page last updated: 2008-09-04

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