pharmacopeia
GET
/api/v1/drug/tranylcypromine

Boxed warning

SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE See full prescribing information for complete boxed warning. • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Tranylcypromine tablets are not approved for use in pediatric patients. ( 5.1 , 8.4 ) • Excessive consumption of foods or beverages with significant tyramine content or certain drugs can precipitate hypertensive crisis. Monitor blood pressure, allow for medication free intervals, and advise patients to avoid foods and beverages with high tyramine content. ( 5.2 , 7.1 , 7.2 ) 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 [see Warnings and Precautions (5.1) ] . Tranylcypromine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] .

Mechanism of action

Sourced from openFDA

The mechanism of action of tranylcypromine 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).

Monoamine OxidaseNorepinephrine UptakeSerotonin Uptake

Indications

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  • Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine 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 [see Contraindications (4) , Warnings and Precautions (5) , and Drug Interactions (7) ] .ICD-10: F32.9

Contraindications

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  • • 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 ( 4.1 , 7.1 ) • Pheochromocytoma, other catecholamine-releasing paraganglioma ( 4.2 ) 4.1 Combination with Certain Drugs Concomitant use of tranylcypromine tablets or use in rapid succession with the products in Table 1 is contraindicated.contraindicated

Dosage & administration

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• Recommended daily dosage is 30 mg in divided doses ( 2.1 ) • 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 ( 2.1 ) • Consider discontinuing tranylcypromine tablets therapy gradually because of the risk for withdrawal effects ( 2.3 , 5.8 , 9.3 ) • Switching from or to other MAOIs or other antidepressants: See full prescribing information for instructions ( 2.2 , 7.1 ) 2.1 Recommended Dosage Tranylcypromine tablets are for oral use. The recommended dosage is 30 mg per day (in divided doses). If patients do not have an adequate response, increase the dosage in increments of 10 mg per day every 1 to 3 weeks to a maximum 30 mg twice daily (60 mg per day). Dosage increases should be made more gradually in patients at risk for hypotension (e.g., geriatric patients) [see Warnings and Precautions (5.5) ] . 2.2 Switching to or from Other Antidepressants Switching from Contraindicated Antidepressants to Tranylcypromine Tablets After stopping treatment with contraindicated antidepressants, a time period of 4 to 5 half-lives of the other antidepressant or any active metabolite should elapse before starting treatment with tranylcypromine tablets.

Warnings & precautions

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• Activation of Mania/Hypomania : May be precipitated by antidepressant treatment in patients with bipolar disorder. Screen patients prior to treatment ( 5.4 ) • Hypotension (including syncope) : Monitor patients and adjust tranylcypromine tablets dosage or concomitant medication as necessary ( 5.5 ) • Hypotension and Hypertension during Anesthesia and Perioperative Care : If possible, discontinue tranylcypromine tablets prior to elective surgery ( 5.6 ) • Hepatitis and Elevated Liver Enzymes : Monitor accordingly ( 5.10 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.

Adverse reactions

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The following adverse reactions are described in greater detail in other sections: • Suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] • Hypertensive crisis and hypertension [see Warnings and Precautions (5.2) ] • Serotonin syndrome [see Warnings and Precautions (5.3) ] • Activation of mania/hypomania [see Warnings and Precautions (5.4) ] • Hypotension [see Warnings and Precautions (5.5) ] • Hypotension and hypertension during anesthesia and perioperative care [see Warnings and Precautions (5.6) ] • Discontinuation syndrome [see Warnings and Precautions (5.8) ] • Persistence of MAO inhibition after discontinuation [see Warnings and Precautions (5.9) ] • Hepatotoxicity [see Warnings and Precautions (5.10) ] • Seizures [see Warnings and Precautions (5.11) ] • Hypoglycemia in diabetic patients [see Warnings and Precautions (5.12) ] • Aggravation of coexisting symptoms of depression [see Warnings and Precautions (5.13) ] • Adverse effects on the ability to drive and operate machinery [see Warnings and Precautions (5.14) ] 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. Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%).

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine tablets during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine tablets during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal embryo-fetal development studies were not conducted with tranylcypromine; however, published animal reproduction studies report placental transfer of tranylcypromine in rats and a dose-dependent decrease in uterine blood flow in pregnant sheep. Advise pregnant women of the potential risk to a fetus. Clinical Considerations Labor or Delivery During labor and delivery, the potential for interactions between tranylcypromine tablets and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine tablets [see Warnings and Precautions (5.6) and Drug Interactions (7.1) ] . 8.2 Lactation Risk Summary Tranylcypromine is present in human milk. There is no available information on the effects of tranylcypromine on milk production.

Overdosage

Sourced from openFDA

10.1 Overdosage Symptoms, Signs, and Laboratory Abnormalities Overdose of tranylcypromine tablets can cause the adverse reactions generally associated with tranylcypromine tablets administration [see Warnings and Precautions (5) , Adverse Reactions (6) and Drug Interactions (7.1) ] . However, these reactions may be more severe, including fatal reactions. Effects reported with overdosage of tranylcypromine tablets and/or other MAOIs include: • Insomnia, restlessness, and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence; delirium; seizures • Hypotension, dizziness, weakness, and drowsiness, progressing in severe cases to extreme dizziness and shock • Hypertension with severe headache and other symptoms/complications • Twitching or myoclonic fibrillation of skeletal muscles, with hyperpyrexia, sometimes progressing to generalized rigidity and coma 10.2 Overdosage Management There are no specific antidotes for tranylcypromine tablets. For current information on the management of poisoning or overdosage, contact a poison control center at 1-800-222-1222.

Approval history

Sourced from openFDA
  • Feb 21, 1961NDANDA012342Advanz Pharma
  • Jun 29, 2006ANDAANDA040640Strides Pharma Intl
  • Apr 17, 2018ANDAANDA206856Novitium Pharma
  • Jun 27, 2022ANDAANDA213503Crossmedika Sa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,111 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Interaction14313%
  2. 2Drug Ineffective12511%
  3. 3Depression11911%
  4. 4Headache918.2%
  5. 5Contraindicated Product Administered827.4%
  6. 6Hypertensive Crisis817.3%
  7. 7Insomnia817.3%
  8. 8Nausea746.7%
  9. 9Hypertension686.1%
  10. 10Suicidal Ideation665.9%
  11. 11Fatigue635.7%
  12. 12Anxiety625.6%
  13. 13Serotonin Syndrome615.5%
  14. 14Hyperhidrosis585.2%
  15. 15Dizziness575.1%

Literature

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Recent PubMed references pinned to Tranylcypromine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Tranylcypromine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tranylcypromine work?
The mechanism of action of tranylcypromine 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).
What is Tranylcypromine used for?
According to FDA labeling, Tranylcypromine carries indications including: Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine 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 [see Contraindications (4) , Warnings and Precautions (5) , and Drug Interactions (7) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tranylcypromine?
Tranylcypromine is classified as Monoamine oxidase inhibitors, non-selective, Monoamine Oxidase Inhibitor, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors, Increased Blood Pressure, Increased Dopamine Activity, Increased Norepinephrine Activity, Increased Serotonin Activity, Increased Sympathetic Activity.
What are the brand names for Tranylcypromine?
Tranylcypromine is marketed under brand names including Parnate.
What are the contraindications for Tranylcypromine?
Tranylcypromine labeling lists contraindications including: • 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 ( 4.1 , 7.1 ) • Pheochromocytoma, other catecholamine-releasing paraganglioma ( 4.2 ) 4.1 Combination with Certain Drugs Concomitant use of tranylcypromine tablets or use in rapid succession with the products in Table 1 is contraindicated.. Always consult the full prescribing information and a clinician.
Note. Data for tranylcypromine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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