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Tofranil Generic Name & Formulations
Legal Class
Rx
General Description
Imipramine HCl 10mg, 25mg, 50mg; tabs.
Pharmacological Class
Tricyclic.
How Supplied
Tabs—30, 100; Caps—30
Manufacturer
Tofranil Indications
Indications
Depression.
Tofranil Dosage and Administration
Adult
Outpatients: initially 75mg/day, may increase to 150mg/day; max 200mg/day. Maintenance: 50–150mg/day. Inpatients: initially 100mg/day, may increase to 200mg/day as needed; max 300mg/day. Adolescents or elderly: initially 30–40mg/day; max 100mg/day.
Children
Not established.
Tofranil Contraindications
Contraindications
During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Acute post-MI.
Tofranil Boxed Warnings
Boxed Warning
Suicidality and antidepressant drugs.
Tofranil Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for emergence of serotonin syndrome; discontinue if occurs. Screen for bipolar disorder. Cardiovascular disease. Increased intraocular pressure. Urinary retention. Hyperthyroidism. Seizure disorder. Angle-closure glaucoma. Mania/hypomania. Psychosis. ECT. Diabetes. Renal or hepatic impairment. Perform leukocyte and blood counts if fever and sore throat develops. Discontinue prior to surgery or evidence of pathological neutrophil depression. Write ℞ for smallest amount feasible. Elderly. Pregnancy. Nursing mothers: not recommended.
Tofranil Pharmacokinetics
See Literature
Tofranil Interactions
Interactions
See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiates alcohol, sympathomimetics (eg, epinephrine, norepinephrine), CNS depressants. Potentiated by methylphenidate, CYP2D6 inhibitors; monitor plasma levels with cimetidine, fluoxetine, quinidine, SSRIs, phenothiazines, type 1C antiarrhythmics (eg, propafenone, flecainide). Antagonized by barbiturates, phenytoin. Paralytic ileus with anticholinergics. Blocks guanethidine, clonidine. Possible cardiotoxicity with concomitant thyroid medications.
Tofranil Adverse Reactions
Adverse Reactions
Drowsiness, anticholinergic effects, CNS overstimulation, arrhythmias, extrapyramidal symptoms, hypo- or hypertension, nausea, fatigue, rash, increased perspiration, headache, changes in blood sugar, photosensitivity, edema, blood dyscrasias (discontinue if occurs), jaundice.
Tofranil Clinical Trials
See Literature
Tofranil Note
Not Applicable
Tofranil Patient Counseling
See Literature
Tofranil Generic Name & Formulations
Legal Class
Rx
General Description
Imipramine HCl 10mg, 25mg, 50mg; tabs.
Pharmacological Class
Anticholinergic.
How Supplied
Tabs—30, 100
Manufacturer
Tofranil Indications
Indications
Childhood enuresis.
Tofranil Dosage and Administration
Children
<6yrs: not established. ≥6yrs: initially 25mg daily 1 hour before bedtime; after 1 week, increase to 50mg for children 6–12yrs, up to 75mg for those >12yrs. Early night bedwetters: give 25mg in afternoon and repeat at bedtime. Max 2.5mg/kg per day. Attempt drug-free periods after gradual tapering of dose if drug response favorable.
Tofranil Contraindications
Contraindications
During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Acute post-MI.
Tofranil Boxed Warnings
Boxed Warning
Suicidality and antidepressant drugs.
Tofranil Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for emergence of serotonin syndrome; discontinue if occurs. Screen for bipolar disorder. Cardiovascular disease. Increased intraocular pressure. Urinary retention. Hyperthyroidism. Seizure disorder. Angle-closure glaucoma. Mania/hypomania. Psychosis. ECT. Diabetes. Renal or hepatic impairment. Perform leukocyte and blood counts if fever and sore throat develops. Discontinue prior to surgery or evidence of pathological neutrophil depression. Write ℞ for smallest amount feasible. Elderly. Pregnancy. Nursing mothers: not recommended.
Tofranil Pharmacokinetics
See Literature
Tofranil Interactions
Interactions
See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiates alcohol, sympathomimetics (eg, epinephrine, norepinephrine), CNS depressants. Potentiated by methylphenidate, CYP2D6 inhibitors; monitor plasma levels with cimetidine, fluoxetine, quinidine, SSRIs, phenothiazines, type 1C antiarrhythmics (eg, propafenone, flecainide). Antagonized by barbiturates, phenytoin. Paralytic ileus with anticholinergics. Blocks guanethidine, clonidine. Possible cardiotoxicity with concomitant thyroid medications.
Tofranil Adverse Reactions
Adverse Reactions
Nervousness, sleep disorders, tiredness, GI disturbances, constipation, convulsions, anxiety, emotional instability, syncope, collapse, drowsiness, orthostatic hypotension, ECG changes, restlessness, insomnia, anticholinergic effects, CNS overstimulation, extrapyramidal symptoms, rash, headache, changes in blood sugar, photosensitivity, edema, bone marrow depression (discontinue if occurs), jaundice, urinary frequency.
Tofranil Clinical Trials
See Literature
Tofranil Note
Not Applicable
Tofranil Patient Counseling
See Literature
