|Drug Name:||Tranylcypromine Sulfate|
|Manufacturer:||Kali Laboratories, Inc., a wholly owned subsidiary of Par Pharmaceutical Companies, Inc.|
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.
Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
For the treatment of Major Depressive Episode Without Melancholia.Tranylcypromine sulfate should be used in adult patients who can be closely supervised.
It should rarely be the first antidepressant drug given.
Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.The effectiveness of tranylcypromine sulfate has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia.As described in the American Psychiatric Association's Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.The effectiveness of tranylcypromine sulfate in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.
In general, the physician should bear in mind the possibility of a lowered margin of safety when tranylcypromine sulfate is administered in combination with potent drugs.1.
Tranylcypromine sulfate should not be used in combination with some central nervous system depressants such as narcotics and alcohol, or with hypotensive agents.
A marked potentiating effect on these classes of drugs has been reported.2.
Anti-parkinsonism drugs should be used with caution in patients receiving tranylcypromine sulfate since severe reactions have been reported.3.
Tranylcypromine sulfate should not be used in patients with a history of liver disease or in those with abnormal liver function tests.4.Excessive use of caffeine in any form should be avoided in patients receiving tranylcypromine sulfate.
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.