DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 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 reasonable period (up to weeks), then the dosage may be increased in 10 mg per day increments at intervals of to weeks; the dosage range may be extended to maximum of 60 mg per day from the usual 30 mg per day.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Tranylcypromine Sulfate is supplied as round, rose-red, film-coated tablets debossed with the product name PARNATE and SB and contains Tranylcypromine Sulfate equivalent to 10 mg of tranylcypromine, in bottles of 100 with desiccant.10 mg 100s: NDC 64980-183-01Store between 15 and 30C (59 and 86F). Amipaque, Nycomed Inc.+ Antabuse, TEVA Womens Health, Inc.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Overstimulation which may include increased anxiety, agitation, and manic symptoms is usually evidence of excessive therapeutic action. Dosage should be reduced, or 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.. Post-Introduction Reports:. 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.

BOXED WARNING SECTION.

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 of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Tranylcypromine Sulfate or any other antidepressant in 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 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 .).

CLINICAL PHARMACOLOGY SECTION.

ACTION. Tranylcypromine is non-hydrazine monoamine oxidase inhibitor with rapid onset of activity. It increases the concentration of epinephrine, norepinephrine, and serotonin in storage sites throughout the nervous system and, in theory, this increased concentration of monoamines in the brain stem is the basis for its antidepressant activity. When tranylcypromine is withdrawn, monoamine oxidase activity is recovered in to days, although the drug is excreted in 24 hours.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Tranylcypromine Sulfate is contraindicated:1. In patients with cerebrovascular defects or cardiovascular disordersTranylcypromine Sulfate should not be administered to any patient with confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease or hypertension.2. In the presence of pheochromocytomaTranylcypromine Sulfate should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances.3. In combination with MAO inhibitors or with dibenzazepine-related entitiesTranylcypromine Sulfate should not be administered together or in rapid succession with other MAO inhibitors or with dibenzazepine-related entities. Hypertensive crises or severe convulsive seizures may occur in patients receiving such combinations.In patients being transferred to Tranylcypromine Sulfate from another MAO inhibitor or from dibenzazepine-related entity, allow medication-free interval of at least week, then initiate Tranylcypromine Sulfate using half the normal starting dosage for at least the first week of therapy. Similarly, at least week should elapse between the discontinuance of Tranylcypromine Sulfate and the administration of another MAO inhibitor or dibenzazepine-related entity, or the readministration of Tranylcypromine Sulfate.The following list includes some other MAO inhibitors, dibenzazepine-related entities and tricyclic antidepressants.Other MAO InhibitorsGeneric NameFurazolidoneIsocarboxazidPargyline HClPargyline HCl and methyclothiazidePhenelzine sulfateProcarbazine HClDibenzazepine-Related and Other TricyclicsGeneric Name Amitriptyline HCl Perphenazine and amitriptyline HCl Clomipramine hydrochloride Desipramine HCl Imipramine HCl Nortriptyline HCl Protriptyline HCl Doxepin HCl Carbamazepine Cyclobenzaprine HCl Amoxapine Maprotiline HCl Trimipramine maleate 4. In combination with bupropionThe concurrent administration of an MAO inhibitor and bupropion hydrochloride is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride.5. In combination with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs)As general rule, Tranylcypromine Sulfate should not be administered in combination with any SSRI or SNRI. There have been reports of serious,sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving SSRI (e.g., fluoxetine) or SNRI (e.g., venlafaxine) in combination with monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued SSRI or SNRI and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignantsyndrome. Therefore SSRIs and SNRIs should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.Since fluoxetine and its major metabolite have very long elimination half-lives, at least weeks should be allowed after stopping fluoxetine before starting an MAOI.At least weeks should be allowed after stopping sertraline or paroxetine before starting an MAOI.At least one week should be allowed after stopping SNRI (e.g., venlafaxine) before starting MAOI. 6. In combination with buspironeTranylcypromine Sulfate should not be used in combination with buspirone HCl, since several cases of elevated blood pressure have been reported in patients taking MAO inhibitors who were then given buspirone HCl. At least 10 days should elapse between the discontinuation of Tranylcypromine Sulfate and the institution of buspirone HCl.7. In combination with sympathomimeticsTranylcypromine Sulfate should not be administered in combination with sympathomimetics, including amphetamines which may be found in many herbal preparations as well as over-the-counter drugs such as cold, hay fever or weight-reducing preparations that contain vasoconstrictors.During therapy with Tranylcypromine Sulfate, it appears that certain patients are particularly vulnerable to the effects of sympathomimetics when the activity of certain enzymes is inhibited. Use of sympathomimetics and compounds such as guanethidine, methyldopa, reserpine, dopamine, levodopa, and tryptophan with Tranylcypromine Sulfate may precipitate hypertension, headache, and related symptoms. Cerebral hemorrhage may also occur. The combination of MAOIs and tryptophan has been reported to cause behavioral and neurologic syndromes including disorientation, confusion, amnesia, delirium, agitation, hypomanic signs, ataxia, myoclonus, hyperreflexia, shivering, ocular oscillations, and Babinskis signs.8. In combination with meperidineDo not use meperidine concomitantly with MAO inhibitors or within or weeks following MAOI therapy. Serious reactions have been precipitated with concomitant use, including coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse, and death. It is thought that these reactions may be mediated by accumulation of 5-HT (serotonin) consequent to MAO inhibition.9. In combination with dextromethorphanThe combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.10. In combination with cheese or other foods with high tyramine contentWhen excessive amounts of tyramine are consumed in conjunction with tranylcypromine, or within weeks of stopping treatment, serious and sometimes fatal hypertensive reaction may occur. Tyramine occurs naturally in some foods or may occur from the bacterial breakdown of protein in foods which are fermented, aged, or spoiled. Foods that have reliably been shown to contain high tyramine content and may also have been reported to induce serious hypertensive reaction when consumed with tranylcypromine are: all matured or aged cheeses (note: all cheeses are considered matured or aged except fresh cottage cheese, cream cheese, ricotta, and processed cheese. All non-cheese dairy products can be consumed providing they are fresh) all aged, cured or fermented meat, fish, or poultry (note: meat, fish, or poultry that has not undergone aging, curing or fermenting and that is bought fresh, stored correctly and eaten fresh is not contraindicated) all fermented soybean products (e.g., soy sauce, miso, fermented tofu) sauerkraut fava or broad bean pods banana peel (but not the pulp) concentrated yeast extracts (e.g., Marmite or Vegemite spread) all tap/draught beers (note: some bottled beers, including non-alcoholic beer, may also pose risk). Patients should be advised to minimize or avoid use of all alcoholic beverages while taking Tranylcypromine Sulfate. Patients should be advised to adhere to the following dietary guidance about eating fresh foods: Foods may be deliberately aged as part of their processing and these are contraindicated (see list above). Foods may also naturally age over time, even if they are refrigerated. It is therefore extremely important that patients are instructed to buy and eat only fresh foods or those which have been properly frozen. They should avoid eating foods if they are unsure of their storage conditions or freshness and they should be cautious of foods of unknown age or composition even if refrigerated. The longer food is left to deteriorate and the larger the quantity of food eaten, the greater the potential quantity of tyramine ingested. Where there is any doubt, patients should be advised to either avoid the food or consume it in strict moderation if it is not otherwise contraindicated. Patients should also be warned that tyramine levels may vary by brand or even batch and person may absorb different amounts of tyramine from particular food at different times. Therefore, if they have accidentally consumed prohibited food on one occasion and not had reaction, this does not mean that they will not have serious hypertensive reaction if they consume the same food on different occasion. 11. In patients undergoing elective surgeryPatients taking Tranylcypromine Sulfate should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of Tranylcypromine Sulfate and spinal anesthesia should be kept in mind. Tranylcypromine Sulfate should be discontinued at least 10 days prior to elective surgery.. all matured or aged cheeses (note: all cheeses are considered matured or aged except fresh cottage cheese, cream cheese, ricotta, and processed cheese. All non-cheese dairy products can be consumed providing they are fresh) all aged, cured or fermented meat, fish, or poultry (note: meat, fish, or poultry that has not undergone aging, curing or fermenting and that is bought fresh, stored correctly and eaten fresh is not contraindicated) all fermented soybean products (e.g., soy sauce, miso, fermented tofu) sauerkraut fava or broad bean pods banana peel (but not the pulp) concentrated yeast extracts (e.g., Marmite or Vegemite spread) all tap/draught beers (note: some bottled beers, including non-alcoholic beer, may also pose risk).

DESCRIPTION SECTION.

DESCRIPTION. Chemically, tranylcypromine sulfate is (+-)-trans-2-phenylcyclopropylamine sulfate (2:1).Each round, rose-red, film-coated tablet is debossed with the product name PARNATE and SB and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of cellulose, citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, and trace amounts of other inactive ingredients.

INDICATIONS & USAGE SECTION.

INDICATIONS 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 depressive illness which would correspond to diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Associations Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies prominent and relatively persistent (nearly every day for at least weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least of the following 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.

INFORMATION FOR PATIENTS SECTION.

Information for Patients:. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Tranylcypromine Sulfate and should counsel them in its appropriate use. patient Medication Guide about Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions is available for Tranylcypromine Sulfate. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Tranylcypromine Sulfate.

OVERDOSAGE SECTION.

OVERDOSAGE. Symptoms:. The characteristic symptoms that may be caused by overdosage are usually those described above.However, an intensification of these symptoms and sometimes severe additional manifestations may be seen, depending on the degree of overdosage and on individual susceptibility. Some patients exhibit insomnia, restlessness and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence. Hypotension, dizziness, weakness, and drowsiness may occur, progressing in severe cases to extreme dizziness and shock. few patients have displayed hypertension with severe headache and other symptoms. Rare instances have been reported in which hypertension was accompanied by twitching or myoclonic fibrillation of skeletal muscles with hyperpyrexia, sometimes progressing to generalized rigidity and coma.. Treatment:. Because strategies for the management of overdose are continually evolving, it is advisable to contact Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. Telephone numbers for the certified Poison Control Centers are listed in the Physicians Desk Reference (PDR). Treatment should normally consist of general supportive measures, close observation of vital signs and steps to counteract specific symptoms as theyoccur, since MAO inhibition may persist. The management of hypertensive crises is described under WARNINGS in the HYPERTENSIVE CRISES section.External cooling is recommended if hyperpyrexia occurs. Barbiturates have been reported to help relieve myoclonic reactions, but frequency of administration should be controlled carefully because Tranylcypromine Sulfate may prolong barbiturate activity. When hypotension requires treatment, the standard measures for managing circulatory shock should be initiated. If pressor agents are used, the rate of infusion should be regulated by careful observation of the patient because an exaggerated pressor response sometimes occurs in the presence of MAO inhibition. Remember that the toxic effect of Tranylcypromine Sulfate may be delayed or prolonged following the last dose of the drug. Therefore, the patient should be closely observed for at least week. It is not known if tranylcypromine is dialyzable.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL, 10 MG 100 TABLETS. Rising (R) NDC 64980-183-01Tranylcypromine Sulfate Tablets10 mgFederal Law requires dispensing of TRANYLCYPROMINE SULFATE with the Medication Guide under this label.100 Tablets Rx only. container label.

PEDIATRIC USE SECTION.

Pediatric Use:. Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS--Clinical Worsening and Suicide Risk). Anyone considering the use of Tranylcypromine Sulfate in child or adolescent must balance the potential risks with the clinical need.

PRECAUTIONS SECTION.

PRECAUTIONS. Hypotension:. Hypotension has been observed during therapy with Tranylcypromine Sulfate. Symptoms of postural hypotension are seen most commonly but not exclusively in patients with pre-existent hypertension; blood pressure usually returns rapidly to pretreatment levels upon discontinuation of the drug. At doses above 30 mg daily, postural hypotension is major side effect and may result in syncope. Dosage increases should be made more gradually in patients showing tendency toward hypotension at the beginning of therapy. Postural hypotension may be relieved by having the patient lie down until blood pressure returns to normal.Also, when Tranylcypromine Sulfate is combined with those phenothiazine derivatives or other compounds known to cause hypotension, the possibility of additive hypotensive effects should be considered.There have been reports of drug dependency in patients using doses of tranylcypromine significantly in excess of the therapeutic range. Some of these patients had history of previous substance abuse. The following withdrawal symptoms have been reported: restlessness, anxiety, depression, confusion, hallucinations, headache, weakness, and diarrhea.Drugs which lower the seizure threshold, including MAO inhibitors, should not be used with Amipaque(R). As with other MAO inhibitors, Tranylcypromine Sulfate should be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours postprocedure.MAO inhibitors may have the capacity to suppress anginal pain that would otherwise serve as warning of myocardial ischemia.The usual precautions should be observed in patients with impaired renal function since there is possibility of cumulative effects in such patients.Older patients may suffer more morbidity than younger patients during and following an episode of hypertension or malignant hyperthermia. Older patients have less compensatory reserve to cope with any serious adverse reaction. Therefore, Tranylcypromine Sulfate should be used with caution in the elderly population.Although excretion of Tranylcypromine Sulfate is rapid, inhibition of MAO may persist up to 10 days following discontinuation.Because the influence of Tranylcypromine Sulfate on the convulsive threshold is variable in animal experiments, suitable precautions should be taken if epileptic patients are treated.Some MAO inhibitors have contributed to hypoglycemic episodes in diabetic patients receiving insulin or oral hypoglycemic agents. Therefore, Tranylcypromine Sulfate should be used with caution in diabetics using these drugs.Tranylcypromine Sulfate may aggravate coexisting symptoms in depression, such as anxiety and agitation.Use Tranylcypromine Sulfate with caution in hyperthyroid patients because of their increased sensitivity to pressor amines.Tranylcypromine Sulfate should be administered with caution to patients receiving Antabuse(R)+. In single study, rats given high intraperitoneal doses of or isomers of tranylcypromine sulfate plus disulfiram experienced severe toxicity including convulsions and death. Additional studies in rats given high oral doses of racemic Tranylcypromine Sulfate and disulfiram produced no adverse interaction.. Information for Patients:. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Tranylcypromine Sulfate and should counsel them in its appropriate use. patient Medication Guide about Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions is available for Tranylcypromine Sulfate. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Tranylcypromine Sulfate.. Clinical Worsening and Suicide Risk:. 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 day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patients prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patients presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate need for very close monitoring and possibly changes in the medication. Pediatric Use:. Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS--Clinical Worsening and Suicide Risk). Anyone considering the use of Tranylcypromine Sulfate in child or adolescent must balance the potential risks with the clinical need.

SPL MEDGUIDE SECTION.

Medication Guide. Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or ActionsTranylcypromine Sulfate TabletsRead the Medication Guide that comes with you or your family members antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family members, healthcare provider about: All risks and benefits of treatment with antidepressant medicinesAll treatment choices for depression or other serious mental illnessWhat is the most important information should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actionsAntidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first fewmonths of treatment.Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have aparticularly high risk of having suicidal thoughts or actions. These include people who have (or have family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.How can watch for and try to prevent suicidal thoughts and actions in myself or family member Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.Call healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:Thoughts about suicide or dyingAttempts to commit suicideNew or worse depressionNew or worse anxietyFeeling very agitated or restlessPanic attacksTrouble sleeping (insomnia)New or worse irritabilityActing aggressive, being angry, or violentActing on dangerous impulsesAn extreme increase in activity and talking (mania)Other unusual changes in behavior or moodWhat else do need to know about antidepressant medicines Never stop an antidepressant medicine without first talking to healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your childs healthcare provider for more information. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.July 2012 100075Rising(R) Manufactured for Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Manufactured by GlaxoSmithKlineMississauga, ON, Canada L5N 6L4(C)2012, Rising Pharmaceuticals, Inc. All rights reserved.July 2012 100075 A108097. All risks and benefits of treatment with antidepressant medicines. All treatment choices for depression or other serious mental illness. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first fewmonths of treatment.. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have aparticularly high risk of having suicidal thoughts or actions. These include people who have (or have family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.. How can watch for and try to prevent suicidal thoughts and actions in myself or family member Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.. Thoughts about suicide or dying. Attempts to commit suicide. New or worse depression. New or worse anxiety. Feeling very agitated or restless. Panic attacks. Trouble sleeping (insomnia). New or worse irritability. Acting aggressive, being angry, or violent. Acting on dangerous impulses. An extreme increase in activity and talking (mania). Other unusual changes in behavior or mood. Never stop an antidepressant medicine without first talking to healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your childs healthcare provider for more information.

SPL UNCLASSIFIED SECTION.

SUMMARY OF CONTRAINDICATIONS. Tranylcypromine Sulfate should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative, or anesthetic drugs; bupropion HCl; buspirone HCl; dextromethorphan; cheese or other foods with high tyramine content; or excessive quantities of caffeine.Tranylcypromine Sulfate should not be administered to any patient with confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache.(For complete discussion of contraindications and warnings, see below.).

WARNINGS SECTION.

WARNINGS. Hypertensive Crisis:. 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 hypertensive crisis.. Important:. Recommended treatment in hypertensive crisesIf 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 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.