⛔ FDA Black Box Warning
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 [ see Warnings and Precautions (5.1) ]. Tranylcypromine sulfate is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ] Hypertensive Crisis with Significant Tyramine Use Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine sulfate or after tranylcypromine sulfate discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine sulfate and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content [ see Warnings and Precautions (5.2) and Drug Interactions ( 7.1 , 7.2 )]. 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 sulfate is 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)
Contraindications
4 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. 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 sulfate or use in rapid succession with the products in Table 1 is contraindicated. Such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome [see Drug Interactions (7.1)]. Medication-free periods between administration of tranylcypromine sulfate and contraindicated agents are recommended [see Dosage and Administration (2.2) and Drug Interactions (7.1)]. Table 1: Products Contraindicated with the Use of Tranylcypromine Sulfate Drug Classes Non-selective H1 receptor antagonists Antidepressants including but not limited to: Other monoamine oxidase inhibitors (MAOIs) Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) Tricyclic antidepressants Other antidepressants (e.g., amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine) Amphetamines and methylphenidates and derivatives Sympathomimetic products (e.g., cold, hay fever or weight-reducing products that contain vasoconstrictors such as pseudoephedrine, phenylephrine, and ephedrine; or dietary supplements that contain sympathomimetics) Triptans Individual Drugs (not included in the above classes) buspirone levodopa s-adenosyl-L-methionine (SAM-e) carbamazepine meperidine tapentadol cyclobenzaprine methyldopa tetrabenazine dextromethorphan milnacipran tryptophan dopamine rasagiline hydroxytryptophan reserpine 4.2 Pheochromocytoma and Catecholamine-Releasing Paragangliomas Tranylcypromine Sulfate is contraindicated in the
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine sulfate during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine sulfate during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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 sulfate and drugs or procedures (e.g., epidural anesthesia) should be taken into account in women who have received tranylcypromine sulfate [see Warnings and Precautions (5.6) and Drug Interactions (7.1)].