PARNATE Film-coated tablet Ref.[10919] Active ingredients:

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:

• Screen patients for a history of mania [see Warnings and Precautions (5.4)].
• Measure blood pressure [see Warnings and Precautions (5.2, 5.5)].

10.1 Overdosage Symptoms, Signs, and Laboratory Abnormalities

Overdose of PARNATE can cause the adverse reactions generally associated with PARNATE 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 PARNATE 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 PARNATE. For current information on the management of poisoning or overdosage, contact a poison control center at 1-800-222-1222.

Abrupt withdrawal of PARNATE following overdosage can precipitate withdrawal symptoms, including delirium [see Warnings and Precautions 5.9) and Drug Abuse and Dependence (9.3)].

Medical management should normally consist of general supportive measures, close observation of vital signs, and steps to counteract specific manifestations as they occur [see Warnings and Precautions (5)]. The toxic effects of PARNATE may be delayed or prolonged following the last dose of the drug [see Clinical Pharmacology (12.2)]. Therefore, the patient should be closely observed for at least 1 week.

Data on the dialyzability of tranylcypromine are lacking.

Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.