Generic Name and Formulations:
Tranylcypromine (as sulfate) 10mg; tabs.
Concordia Pharmaceuticals Inc.
Indications for PARNATE:
Major depressive disorder in adults who have not responded adequately to other antidepressants (not for initial treatment).
30mg daily in divided doses. If inadequate response, may increase in 10mg/day increments every 1–3 weeks; usual max 60mg/day. Switching to/from other antidepressants: see full labeling.
See Interactions. Pheochromocytoma. Catecholamine-releasing paragangliomas. To avoid potentially severe or fatal interactions, allow sufficient drug-free interval (at least 1 week or 4–5 half lives; see full labeling) between tranylcypromine and non-selective H1 receptor antagonists, other MAOIs (eg, linezolid, IV methylene blue), SSRIs (eg, fluoxetine), SNRIs, tricyclic antidepressants, amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine, amphetamines, methylphenidates and derivatives, sympathomimetics, triptans, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, dopamine, hydroxytryptophan, levodopa, methyldopa, meperidine, milnacipran, rasagiline, reserpine, s-adenosyl-L-methionine (SAM-e), tapentadol, tetrabenazine, tryptophan, mirtazapine.
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes in all patients. Hypertensive crisis with significant tyramine use; monitor and discontinue if occurs. Hyperthyroidism. Hypertension. Cardiovascular or cerebrovascular disorders. History of headaches. Assess BP prior to initiation and monitor closely during treatment. Screen for bipolar disorder, mania, or hypomania. Depression. Monitor for hepatotoxicity; discontinue if occurs. Possible increased risk of CNS effects in those with cirrhosis. Diabetes (monitor glucose). Discontinue at least 10 days before elective surgery. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy. Nursing mothers: not recommended.
See Contraindications. Do not start within 5 weeks of fluoxetine. Avoid high-tyramine foods and beverages (eg, aged cheese, aged/fermented meats, salami, pickled herring, chocolate, beer, yeast extract, sauerkraut, soybean products, broad beans) during and for 2 weeks after discontinuation. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort, SAM-e, other MAOIs); discontinue if occurs. Caution with hypotensive drugs, β-blockers, CNS depressants (eg, opioids, alcohol, sedatives, hypnotics), altretamine, chlorpromazine, droperidol, entacapone, tolcapone, methadone, metoclopramide, oxcarbazepine. Increased hypoglycemia with concomitant insulin, antidiabetic agents; may need lower dose of these.
Dry mouth, dizziness, insomnia, sedation, headache, overexcitement, constipation, blurred vision, tremor; hypertensive crises, hypertension, postural hypotension, syncope, hepatitis, elevated liver enzymes, seizures (monitor).
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