IMPORTANT RISK INFORMATION
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 imipramine pamoate 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. Imipramine pamoate is not approved for use in pediatric patients.
- Tofranil-PM is contraindicated:
- in patients with a known hypersensitivity to this compound. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.
- within 14 days of stopping an MAOI intended to treat psychiatric disorders. The use of MAOIs intended to treat psychiatric disorders with Tofranil-PM or within 14 days of stopping treatment with Tofranil-PM is also contraindicated because of an increased risk of serotonin syndrome.
- in patients who are being treated with linezolid or intravenous methylene blue because of an increased risk or serotonin syndrome.
- during the acute recovery period after a myocardial infarction.
WARNINGS and PRECAUTIONS
- All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
- Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
- Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders.
- Extreme caution should be used in
- patients with cardiovascular disease because of the possibility of conduction defects, arrhythmias, congestive heart failure, myocardial infarction, strokes, and tachycardia. These patients require cardiac surveillance at all dosage levels of the drug.
- patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug's anticholinergic properties
- hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity
- patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold
- patients receiving guanethidine, clonidine, or similar agents, since Tofranil-PM may block the pharmacologic effects of these drugs
- patients receiving methylphenidate hydrochloride. Since methylphenidate hydrochloride may inhibit the metabolism of Tofranil-PM, downward dosage adjustment of Tofranil-PM may be required when given concomitantly with methylphenidate hydrochloride.
- Since Tofranil-PM may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.
- Tofranil-PM may enhance the CNS depressant effects of alcohol or other CNS depressants. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. Deaths may occur from overdosage with this class of drugs.
- The development of serotonin syndrome has been reported with use of serotonin/norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) , including Anafranil, alone but particularly with concomitant use of other serotonergic drugs (triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, busiprone, and St. John's Wort) or medications that impair metabolism of serotonin (e.g. MAOIs, including linezolid and intravenous methylene blue).
- Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of Tofranil-PM.
- An activation of the psychosis may occasionally be observed in schizophrenic patients.
- Concurrent administration of Tofranil-PM with electroshock therapy may increase the hazards.
- Patients taking Tofranil-PM should avoid excessive exposure to sunlight since there have been reports of photosensitization.
- Both elevation and lowering of blood sugar levels have been reported with Tofranil-PM use.
- Patients who develop a fever and a sore throat during therapy with Tofranil-PM should have leukocyte and differential blood counts performed. Tofranil-PM should be discontinued if there is evidence of pathological neutrophil depression.
- Prior to elective surgery, Tofranil-PM should be discontinued for as long as the clinical situation will allow.
- Serious adverse reactions may include clinical worsening of depression and suicidal ideation, hypotension, hypertension, arrhythmias, heart block, tachycardia, congestive heart failure, myocardial infarction, strokes, confusion, seizures, serotonin syndrome, and withdrawal symptoms with abrupt discontinuation of Tofranil-PM including nausea, headache, and malaise.
- Other adverse reactions may include anticholinergic effects (such as dry mouth, constipation, blurred vision, and urinary retention); gastrointestinal complaints; nausea; vomiting; anorexia; peculiar taste, anorexia; sleep disorders; and anxiety. See full prescribing information for full listing of adverse reactions.
USE IN SPECIFIC POPULATIONS
- The safety and effectiveness in pediatric patients has not been established.
- Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
- Tofranil-PM should be used with caution in patients with significantly impaired renal or hepatic function.
Ivory Body/Coral Cap
imipramine pamoate capsules
Ivory body imprinted in black "M" in a box and coral cap imprinted in black "Tofranil-PM 125 mg"
For additional information on Tofranil-PM™ (imipramine pamoate) Capsules, 125 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.