Linked Life Data

PARNATE (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3203

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
PARNATE (Tablet, Film Coated)
dailymed-instance:dosage
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.
dailymed-instance:descripti...
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 containstranylcypromine 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.
dailymed-instance:activeIng...
dailymed-instance:contraind...
PARNATE is contraindicated:
dailymed-instance:supply
PARNATE 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 a desiccant. 10 mg 100's: NDC 0007-4471-20 Store between 15��and 30��C (59��and 86��F). ____________________ metrizamide, The Sanofi-Aventis Group. disulfiram, Odyssey Pharmaceuticals, Inc.<br/>Medication Guide: Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions PARNATE' (PAR-nate) (tranylcypromine sulfate) Tablets Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Call a 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: What else do I need to know about antidepressant medicines? This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. June 2007 PRT:3MG GlaxoSmithKline Research Triangle Park, NC 27709 ��2007, GlaxoSmithKline. All rights reserved. June 2007 PRT:L72PI
dailymed-instance:boxedWarn...
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 PARNATE 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. PARNATE 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.)
dailymed-instance:activeMoi...
dailymed-instance:inactiveI...
dailymed-instance:precautio...
Hypotension: Hypotension has been observed during therapy with PARNATE. 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 a major side effect and may result in syncope. Dosage increases should be made more gradually in patients showing a 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 PARNATE is combined with those phenothiazine derivatives or other compounds known to cause hypotension, the possibility of additive hypotensive effects shouldbe 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 a 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. As with other MAO inhibitors, PARNATE 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 a warning of myocardial ischemia. The usual precautions should be observed in patients with impaired renal function since there is a 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, PARNATE should be used with caution in the elderly population. Although excretion of PARNATE is rapid, inhibition of MAO may persist up to 10 days following discontinuation. Because the influence of PARNATE 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, PARNATE should be used with caution in diabetics using these drugs. PARNATE may aggravate coexisting symptoms in depression, such as anxiety and agitation. Use PARNATE with caution in hyperthyroid patients because of their increased sensitivity to pressor amines. PARNATE should be administered with caution to patients receiving Antabuse. In a single study, rats given high intraperitoneal doses of d or l 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 (PARNATE) and disulfiram produced no adverse interaction.<br/>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 PARNATE and should counsel them in its appropriate use. A patient Medication Guide about���Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions���is available for PARNATE. 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 PARNATE.<br/>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 a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially ifthey 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.<br/>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 PARNATE in a child or adolescent must balance the potential risks with the clinical need.
dailymed-instance:overdosag...
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. A 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.<br/>Treatment: Gastric lavage is helpful if performed early. Treatment should normally consist of general supportive measures, close observation of vital signs and steps to counteract specific symptoms as they occur, 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 PARNATE 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 PARNATE may be delayed or prolonged following the last dose of the drug. Therefore, the patient should be closely observed for at least a week. It is not known if tranylcypromine is dialyzable.
dailymed-instance:genericMe...
tranylcypromine sulfate
dailymed-instance:fullName
PARNATE (Tablet, Film Coated)
dailymed-instance:adverseRe...
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.<br/>Post-Introduction Reports: The following are spontaneously reported adverse events temporally associated with use of PARNATE. No clear relationship between PARNATE 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.
dailymed-instance:warning
Hypertensive Crisis: The most important reaction associated with PARNATE 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 PARNATE, 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 PARNATE. These signs may be prodromal of a hypertensive crisis.<br/>Important:<br/>Recommended treatment in hypertensive crises: If a hypertensive crisis occurs, PARNATE 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 anexcessive 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.
dailymed-instance:represent...
dailymed-instance:routeOfAd...
dailymed-instance:name
PARNATE