TRANYLCYPROMINE SULFATE

TRANYLCYPROMINE SULFATE — tranylcypromine sulfate tablet, film coated
Strides Pharma Science Limited

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) andDrug Interactions (7.1 , 7.2 )].

1 INDICATIONS AND USAGE

Tranylcypromine Sulfate is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine Sulfate is 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 AND ADMINISTRATION

2.1 Recommended Dosage

Tranylcypromine Sulfate Tablets, USP 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 Sulfate

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 sulfate. 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 sulfate to reduce the risk of additive effects [see Contraindications (4.1) and Drug Interactions (7.1)].

Switching from Tranylcypromine Sulfate to Other MAOIs or Contraindicated Antidepressants

After stopping tranylcypromine sulfate 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 sulfate therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing tranylcypromine sulfate 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 Sulfate

Prior to initiating treatment with tranylcypromine sulfate:

  • 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 AND STRENGTHS

Tablets containing tranylcypromine sulfate equivalent to 10 mg tranylcypromine are round, dark pink, film‑coated, and debossed on one side with “250” on one side and “K” on the other side.

4 CONTRAINDICATIONS

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 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)].

5 WARNINGS AND PRECAUTIONS

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.

Table 2: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated
Increases Compared to Placebo
<18 years old 14 additional patients
18 to 24 years old 5 additional patients
Decreases Compared to Placebo
25 to 64 years old 1 fewer patient
≥65 years old 6 fewer patients

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing tranylcypromine sulfate, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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