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⬛ Boxed Warning: Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of MARPLAN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. MARPLAN is not approved for use in pediatric patients.
Indication
MARPLAN (isocarboxazid) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of depression. Because of its potentially serious side-effect profile, MARPLAN should be used in patients who have not responded to other antidepressant therapy.
Contraindications
MARPLAN should NOT be administered to patients with:
- Known hypersensitivity to isocarboxazid
- Confirmed or suspected cerebrovascular defect
- Cardiovascular disease or hypertension
- History of headache
- Pheochromocytoma
- History of liver disease or abnormal liver function tests
- Severe renal impairment
- Pediatric patients (<16 years)
MARPLAN should not be used in combination with: other MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); CNS depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative, or anesthetic drugs; bupropion HCl; buspirone HCl; dextromethorphan; tyramine-rich foods (e.g., aged cheeses); or excessive quantities of caffeine.
Warnings & Precautions
- Hypertensive Crisis: The most serious reaction involves hypertensive crises (severe headache, nausea, vomiting, tachycardia) precipitated by ingestion of tyramine-containing foods or co-administration of sympathomimetic agents or certain other drugs. Potentially fatal outcomes have been reported.
- Serotonin Syndrome: Risk with concomitant serotonergic drugs.
- Hypotension: Orthostatic hypotension may occur; caution in patients with known cardiovascular disease.
- Lower Seizure Threshold: Use with caution in patients with a history of epilepsy.
- Hepatotoxicity: May cause altered liver function or jaundice. Periodic liver chemistry tests should be performed; discontinue at first sign of hepatic dysfunction.
- Activation of Mania/Hypomania: Screen patients for bipolar disorder before initiating treatment.
- Drug Interactions: MAO inhibitory effects may persist for a substantial period after discontinuation. Allow at least 10 days after stopping MARPLAN before initiating another therapy. Allow at least 1 week medication-free interval when switching from another MAOI or dibenzazepine-related entity to MARPLAN.
- Pregnancy & Lactation: It is not known whether isocarboxazid can cause embryo-fetal harm. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185.
Common Adverse Reactions
Dizziness, headache, orthostatic hypotension, syncope, sleep disturbance (insomnia or hypersomnia), tremor, myoclonic jerks, hyperreflexia, dry mouth, nausea, constipation, urinary hesitancy, weight gain, and sexual dysfunction.
Dosage & Administration
Initial dose: 10 mg twice daily. Dose may be increased by 10 mg every 2–4 days to achieve the desired effect. Maximum recommended dose: 60 mg/day in divided doses. Refer to the full Prescribing Information for complete dosing guidance. MARPLAN is available only by prescription.
Product Identification
MARPLAN® (isocarboxazid) 10 mg Tablets | New NDC: 72336-032-01