Tranylcypromine Sulfate
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Chemically, tranylcypromine sulfate is (±)-trans-2-phenylcyclopropylamine sulfate (2:1).
Each round, dark pink, film-coated tablet is debossed with “250” on one side and “K” on the other side and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, talc, and Opadry® II pink 85F14289. Opadry pink is used for purposes of coating and contains the following: FD&C Red # 40, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
Sources
Tranylcypromine Sulfate Manufacturers
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Par Pharmaceutical, Inc.
![Tranylcypromine Sulfate (Tranylcypromine Sulfate) Tablet [Par Pharmaceutical, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tranylcypromine Sulfate | Par Pharmaceutical, Inc.
Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy.
The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.
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Rising Pharmaceuticals, Inc.
Tranylcypromine Sulfate | Rising Pharmaceuticals, Inc.
Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy.
The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.
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Golden State Medical Supply, Inc.
Tranylcypromine Sulfate | Golden State Medical Supply, Inc.
Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy.
The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.
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Remedyrepack Inc.
Tranylcypromine Sulfate | Remedyrepack Inc.
Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy.
The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.
![Tranylcypromine Sulfate (Tranylcypromine Sulfate) Tablet [Rising Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8c8dd7fc-7cd1-47ac-a06d-d82604638b08&name=f1959810-01c4-4cfd-a729-97d7b37d6654-01.jpg)
![Tranylcypromine Sulfate Tablet [Golden State Medical Supply, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cd45db80-3cf3-4714-989b-de11f249bdfb&name=cd45db80-3cf3-4714-989b-de11f249bdfb-01.jpg)
![Tranylcypromine Sulfate Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ff66e751-2379-4275-9b51-9992756ed015&name=MM1.jpg)
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