TRANYLCYPROMINE- tranylcypromine sulfate tablet
Marlex Pharmaceuticals, Inc.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE
Suicidal Thoughts and Behaviors
A ntidepressants 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)].
Hypertensive Crisis with Significant Tyramine Use
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine tablets or after tranylcypromine tablets discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine tablets 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)].
1 INDICATIONS & USAGE
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)].
2 DOSAGE & ADMINISTRATION
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. After stopping treatment with an MAO inhibitor antidepressant, a time period of at least one week or 4 to 5 half-lives of the other MAO inhibitor (whichever is longer) should elapse before starting treatment with tranylcypromine tablets to reduce the risk of additive effects [see Contraindications (4.1) and Drug Interactions (7.1)].
Switching from Tranylcypromine Tablets to Other MAOIs or Contraindicated Antidepressants
After stopping tranylcypromine tablets treatment, at least one week should elapse before starting another MAOI (intended to treat MDD) or other contraindicated antidepressants. Refer to the prescribing information of the subsequently used drug for product-specific advice on a medication-free interval [see Contraindications (4.1) and Drug Interactions (7.1)].
2.3 Discontinuing Treatment
Withdrawal effects, including delirium, have been reported with abrupt discontinuation of tranylcypromine tablets therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing tranylcypromine tablets therapy by slow, gradual dosage reduction [see Warnings and Precautions (5.8) and Drug Abuse and Dependence (9.3)].
2.4 Screen for Bipolar Disorder and Elevated Blood Pressure Prior to Starting Tranylcypromine Tablets
Prior to initiating treatment with tranylcypromine tablets:
- Screen patients for a history of mania [see Warnings and Precautions (5.4)].
- Measure blood pressure [see Warnings and Precautions (5.2, 5.5)].
3 DOSAGE FORMS & STRENGTHS
Tablets containing tranylcypromine sulfate equivalent to 10 mg tranylcypromine are round, red-rose, film coated tablets, debossed with N538 on one side and plain on other side.
4.1 Combination with Certain Drugs
Concomitant use of tranylcypromine tablets 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 tablets 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 Tablets
|Dr ug Classes|
|Non-selective H1 receptor antagonists|
| Antidepressants including but not limited to:
|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)|
|Individual Drugs (not included in the above classes)|
4.2 Pheochromocytoma and Catecholamine-Releasing Paragangliomas
Tranylcypromine tablets are contraindicated in the presence of pheochromocytoma or other catecholamine-releasing paragangliomas because such tumors secrete pressor substances and can lead to hypertensive crisis [see Warnings and Precautions (5.3)].
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