Tranylcypromine

Tranylcypromine sulfate tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine sulfate tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions. 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 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).

Recommended daily dosage is 30 mg in divided doses. If no adequate response, increase dosage in increments of 10 mg per day every 1 to 3 weeks to a maximum dosage of 30 mg twice daily (60 mg per day).Consider more gradual dosage increases in patients at risk for hypotension. Consider discontinuing tranylcypromine sulfate tablets therapy gradually because of the risk for withdrawal effects. Switching from or to other MAOIs or other antidepressants: See full prescribing information for instructions

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. See Full Prescribing Information for the full list of contraindicated products. Pheochromocytoma, other catecholamine-releasing paraganglioma

Boxed warning (suicidal thoughts and behaviors and hypertensive crisis with significant tyramine use): Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Activation of Mania/Hypomania: May be precipitated by antidepressant treatment in patients with bipolar disorder. Screen patients prior to treatment. Hypotension (including syncope): Monitor patients and adjust tranylcypromine sulfate tablets dosage or concomitant medication as necessary. Hypotension and Hypertension during Anesthesia and Perioperative Care: If possible, discontinue tranylcypromine sulfate tablets prior to elective surgery. Hepatitis and Elevated Liver Enzymes: Monitor accordingly

The following adverse reactions are described in greater detail in other sections: Suicidal thoughts and behaviors Hypertensive crisis and hypertension Serotonin syndrome Activation of mania/hypomania Hypotension Hypotension and hypertension during anesthesia and perioperative care Discontinuation syndrome Persistence of MAO inhibition after discontinuation Hepatotoxicity Seizures Hypoglycemia in diabetic patients Aggravation of coexisting symptoms of depression Adverse effects on the ability to drive and operate machinery Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

See Full Prescribing Information for a list of products, foods and beverages that can interact with tranylcypromine sulfate tablets Clinically Significant Drug Interactions Tables 3 and 4 lists drug classes and individual products, respectively, with a potential for interaction with tranylcypromine sulfate tablets, describes the predominant observed or anticipated risks, and provides advice on concomitant use. Given serious adverse reactions with multiple agents, patients should avoid taking over-the-counter medications or dietary supplements without prior consultation with a healthcare provider able to provide advice on the potential for interactions.

Store between 15° and 30°C (59° and 86°F).