FDA label 45ee2ba3-7f96-7234-e054-00144ff8d46c

BOXED WARNING Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Tranylcypromine Sulfate 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Tranylcypromine Sulfate is not approved for use in pediatric patients. (See WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use .)

WARNINGS The most important reaction associated with Tranylcypromine Sulfate is the occurrence of hypertensive crises which have sometimes been fatal. These crises are characterized by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), and photophobia. Either tachycardia or bradycardia may be present, and associated constricting chest pain and dilated pupils may occur. Intracranial bleeding, sometimes fatal in outcome, has been reported in association with the paradoxical increase in blood pressure. In all patients taking Tranylcypromine Sulfate, blood pressure should be followed closely to detect evidence of any pressor response. It is emphasized that full reliance should not be placed on blood pressure readings, but that the patient should also be observed frequently. Therapy should be discontinued immediately upon the occurrence of palpitation or frequent headaches during therapy with Tranylcypromine Sulfate. These signs may be prodromal of a hypertensive crisis. Recommended treatment in hypertensive crises If a hypertensive crisis occurs, Tranylcypromine Sulfate should be discontinued and therapy to lower blood pressure should be instituted immediately. Headache tends to abate as blood pressure is lowered. On the basis of present evidence, phentolamine is recommended. (The dosage reported for phentolamine is 5 mg I.V.) Care should be taken to administer this drug slowly in order to avoid producing an excessive hypotensive effect. Fever should be managed by means of external cooling. Other symptomatic and supportive measures may be desirable in particular cases. Do not use parenteral reserpine.

ADVERSE REACTIONS Overstimulation which may include increased anxiety, agitation, and manic symptoms is usually evidence of excessive therapeutic action. Dosage should be reduced, or a phenothiazine tranquilizer should be administered concomitantly. Patients may experience restlessness or insomnia; may notice some weakness, drowsiness, episodes of dizziness or dry mouth; or may report nausea, diarrhea, abdominal pain, or constipation. Most of these effects can be relieved by lowering the dosage or by giving suitable concomitant medication. Tachycardia, significant anorexia, edema, palpitation, blurred vision, chills, and impotence have each been reported. Headaches without blood pressure elevation have occurred. Rare instances of hepatitis, skin rash, and alopecia have been reported. Impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has been reported. Tinnitus, muscle spasm, tremors, myoclonic jerks, numbness, paresthesia, urinary retention, and retarded ejaculation have been reported. Hematologic disorders including anemia, leukopenia, agranulocytosis, and thrombocytopenia have been reported. The following are spontaneously reported adverse events temporally associated with use of Tranylcypromine Sulfate. No clear relationship between Tranylcypromine Sulfate and these events has been established. Localized scleroderma, flare-up of cystic acne, ataxia, confusion, disorientation, memory loss, urinary frequency, urinary incontinence, urticaria, fissuring in corner of mouth, akinesia.