PARNATE

PARNATE — tranylcypromine sulfate tablet, film coated
Concordia Pharmaceuticals Inc.

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) ]. PARNATE 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 PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE 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 AND USAGE

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

PARNATE 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 PARNATE
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 PARNATE. 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 PARNATE to reduce the risk of additive effects [ see Contraindications (4.1) and Drug Interactions (7.1)].
Switching from PARNATE to Other MAOIs or Contraindicated Antidepressants
After stopping PARNATE 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 PARNATE therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects. Consider discontinuing PARNATE 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 PARNATE

Prior to initiating treatment with PARNATE:

3 DOSAGE FORMS AND STRENGTHS

Tablets containing tranylcypromine sulfate equivalent to 10 mg tranylcypromine are round, rose‑red, film‑coated, and debossed on one side with “PARNATE” and “SB.”

4 CONTRAINDICATIONS

4.1 Combination with Certain Drugs

Concomitant use of PARNATE 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 PARNATE and contraindicated agents are recommended [ see Dosage and Administration (2.2)and Drug Interactions (7.1)].
Table 1: Products Contraindicated with the Use of PARNATE

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

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