Tranylcypromine Sulfate

TRANYLCYPROMINE SULFATE

Manufacturer: Actavis Pharma, Inc.

Score: 141.0

Quick Summary

Tranylcypromine sulfate tablets are a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. The recommended dosage is 30 mg per day, with increases in increments of 10 mg per day every 1 to 3 weeks to a maximum of 60 mg per day. Tranylcypromine sulfate tablets have several important safety considerations, including the risk of suicidal thoughts and behaviors, hypertensive crisis, serotonin syndrome, and interactions with various medications and foods. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations and precautions for each group.

Key Clinical Findings and Indications

Tranylcypromine sulfate tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants.
The mechanism of action of tranylcypromine sulfate tablets as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).

Important Safety Information

Warning

Tranylcypromine sulfate tablets can cause serious side effects, including suicidal thoughts and behaviors, hypertensive crisis, and serotonin syndrome.

Contraindications

Concomitant use or use in rapid succession with other MAOIs, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, sympathomimetic drugs, and numerous other drugs.
Pheochromocytoma or other catecholamine-releasing paraganglioma.

Adverse Reactions

Suicidal thoughts and behaviors
Hypertensive crisis
Serotonin syndrome
Mania or hypomania
Low blood pressure (hypotension)
Changes in blood pressure during surgery and perioperative care
Withdrawal symptoms
Liver problems
Seizures
Low blood sugar (hypoglycemia) in diabetic patients

Dosing Recommendations

General Guidance

Consider more gradual dosage increases in patients at risk for hypotension, and consider discontinuing tranylcypromine sulfate tablets therapy gradually to avoid withdrawal symptoms.

Major depressive disorder (MDD)

Adult Dose

30 mg per day, with increases in increments of 10 mg per day every 1 to 3 weeks to a maximum of 60 mg per day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine sulfate tablets during pregnancy.
Advise pregnant women of the potential risk to a fetus.

Nursing Mothers

Tranylcypromine sulfate passes into breast milk.
Do not breastfeed during treatment with tranylcypromine sulfate tablets.

Pediatric Use

Safety and effectiveness of tranylcypromine sulfate tablets in the pediatric population have not been established.
All risks associated with the use of tranylcypromine sulfate tablets, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients.

Geriatric Use

Older patients may be at greater risk of postural hypotension and other serious adverse reactions.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

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