See Supplemental Patient Information
- Worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior may occur in patients with major depressive disorder (MDD); risk may persist until significant remission occurs
- Children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders are more prone to suicidality; suicidality risk did not increase in patients >24 yrs of age, and risk decreased in patients >65 yrs of age
- Monitor and closely observe patients for clinical worsening, suicidality, or unusual changes in behavior specially during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have occurred in adults and pediatric patients
- Consider changing the therapeutic regimen or discontinuation of therapy on persistent worsening of depression, on experiencing emergent suicidality or abrupt onset of severe symptoms suggesting worsening of depression or suicidality or that were not part of the patient's presenting symptoms
- Advise families and caregivers of patient to remain alert for the need of monitoring patients for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality and the other symptoms. Instruct them to promptly report such symptoms to health care providers
- Prescribe smallest quantity to reduce the risk of overdose
- Consider in detail psychiatric history, including a family history of suicide, bipolar disorder, and depression before initiating therapy
- Imipramine is unapproved for use in treating bipolar depression
- This drug is associated with enhancing the CNS depressant effects of alcohol
- Perform ECG recording prior to the initiation of higher than usual doses of imipramine and thereafter at appropriate intervals until achieving steady state
- Geriatrics, patients with cardiac disease or having prior history of cardiac disease are at special risk for developing the cardiac abnormalities associated with the use of this drug
- Carefully supervise seriously depressed patients during the early phase of treatment
- Patients with cyclic disorders are more prone to hypomanic or manic episodes. Discontinue therapy on development of such episodes. If essential resume therapy on ceasing of such episodes
- Psychosis may be activated in schizophrenic patients requiring reduction of dosage and the addition of a phenothiazine. Concurrent use with electroshock therapy increases such hazards
- Advise patients to avoid excessive exposure to sunlight as risk of photosensitization exists
- Both elevation as well as lowering of blood sugar levels have occurred with use of this drug
- Perform leukocyte and differential blood counts in patients having fever and a sore throat during therapy with imipramine. Discontinue therapy on evidence of pathological neutrophil depression
- Discontinue therapy prior to elective surgery for as long as the clinical situation allows
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiovascular disease
- Diabetes mellitus
- Schizophrenia
- Bipolar disorder
- Electroconvulsive therapy
- Concomitant use of medications that lower seizure threshold
- Parkinson disease
- Seizure disorder
- GU obstruction
- Urinary retention
- Prostatic hypertrophy
- GI obstruction
- Asthma
- Thyroid disease
- Increased IOP
- Angle-closure glaucoma
- Alcohol use
- Risk of suicide
- <24yrs patients
- Geriatrics
Supplemental Patient Information
- Advise patients to refrain from activities requiring mental alertness such as operating a hazardous machinery or driving an automobile
- Advise families and caregivers of the need for close observation and communication with the prescriber
- Inform patients/caregivers about the benefits and risks associated with therapy and counsel them in its appropriate use
- Instruct patients/caregivers to read the medication guide and assist them in understanding its contents
- Advise caregivers to remain alert to clinical worsening of symptoms and risk of suicidality
- Advise patients to refrain from activities requiring mental alertness such as operating a hazardous machinery or driving an automobile
- Advise patients to notify their physicians if they become pregnant or intend to become pregnant during therapy
Pregnancy Category:D
Breastfeeding: Low levels of imipramine and its metabolite are detected in the serum of breastfed infants. Use of imipramine during breastfeeding is unexpected to cause any adverse effects in breastfed infants, especially if the infant is >2 months. Prefer other agents when large doses are required or while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 March 2011). According to manufacturer's data woman taking a drug should not nurse as possibility exists that the drug may be excreted in breast milk and be harmful to the child.
Pricing data from www.DrugStore.com in U.S.A.
- Tofranil 50 MG TABS [Bottle] (MALLINCKRODT)
30 mg = $191.51
90 mg = $534.24 - Tofranil-PM 125 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $560.42
90 mg = $1540.26 - Tofranil-PM 75 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $558.44
90 mg = $1530.02 - Tofranil-PM 150 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $558.44
90 mg = $1530.2 - Tofranil 25 MG TABS [Bottle] (MALLINCKRODT)
30 mg = $161.28
90 mg = $443.49
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
