Imipramine 10mg

Antidepressant, Tricyclic (Tertiary Amine)

“Alert: Black Box Warning

Suicidal Ideations 

Antidepressants increased the risk compared with placebo of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of imipramine 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 with placebo in adults older than 24 years; there was a reduction in risk with antidepressants compared with placebo in adults 65 years 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 health care provider. Imipramine is not approved for use in pediatric patients except for patients with nocturnal enuresis.”

CSA NA – FDA Approved – REMS (N) – Can Ship     

Imipramine, Tofranil increases the synaptic concentration of serotonin and/or norepinephrine in the central nervous system by inhibition of its reuptake by the presynaptic neuronal membrane. Additional receptor effects have been found including desensitization of adenyl cyclase, down regulation of beta-adrenergic receptors, and down regulation of serotonin receptors.

Major Depressive Disorder; Childhood Enuresis

Before starting Imipramine, Tofranil make sure your physician is aware of any allergies, medications you currently take, if you have alcohol use disorder, cardiovascular disease, diabetes, hepatic impairment, mania/hypomania, myasthenia gravis, narrow angle glaucoma, renal impairment, a seizure disorder, a history of suicidal ideation, are pregnant, or breastfeeding.  Imipramine, Tofranil use has been associated with potentially serious adverse reactions including anticholinergic effects, CNS depression, increased risk of fracture, hematologic reactions, orthostatic hypotension, photosensitization, and serotonin syndrome.

Depression: 25mg to 300mg once daily given in divided doses or as a single bedtime dose

Enuresis:  6 to <12 years old :10mg once daily at bedtime to a maximum of the lesser of 2.5mg/kg/day or 50mg/day 

 ≥12 years old: 10mg once daily at bedtime to a maximum of 75mg/day

How to Take: Follow instructions provided by physician/pharmacy label, take consistently at same times each day unless otherwise directed, store at room temperature. Generally taken 1-3 hour prior to bed to minimize daytime drowsiness.

You Need to Avoid: Do not stop this medication without tapering dose down over time to prevent withdrawal symptoms (nausea, diarrhea, sweating, headaches, agitation, insomnia, anxiety, tremor, vertigo, dizziness, tingling in extremities). Tolerance to sedation may develop however caution operating heavy machinery or driving if feeling impaired. May increase the central nervous system depressant effects of alcohol so caution if alcohol is to be consumed.

The frequency of side effects is not well defined but can include the following and are based on reports for other agents in this same pharmacologic class, and may not be specifically reported for Imipramine, Tofranil: 

cardiac arrhythmia, cardiac failure, cerebrovascular accident, ECG changes, heart block, hypertension, myocardial infarction, orthostatic hypotension, palpitations, tachycardia, agitation, anxiety, ataxia, confusion, delusions, disorientation, dizziness, drowsiness, EEG pattern changes, extrapyramidal reaction, falling, fatigue, hallucination, headache, hypomania, insomnia, nightmares, numbness, paresthesia, peripheral neuropathy, psychosis, restlessness, seizure, taste disorder, tingling sensation, alopecia, diaphoresis, pruritus, skin photosensitivity, skin rash, urticaria, decreased libido, decreased serum glucose, galactorrhea, gynecomastia, increased libido, increased serum glucose, SIADH, weight gain, weight loss, abdominal cramps, anorexia, constipation, diarrhea, epigastric distress, intestinal obstruction, melanoglossia, nausea, stomatitis, sublingual adenitis, vomiting, xerostomia, breast hypertrophy, impotence, testicular swelling, urinary hesitancy, urinary retention, urinary tract dilation, agranulocytosis, eosinophilia, petechia, purpura, thrombocytopenia, cholestatic jaundice, increased serum transaminases, hypersensitivity (eg, drug fever, edema), tremor, weakness, accommodation disturbance, angle-closure glaucoma, blurred vision, mydriasis, tinnitus

1. What do I do if side effects are intolerable?
   If you are just starting this medication or just had a dosage increase, then it is common to have more prominent side effects for 2 weeks or so and if any remain at that point they will likely remain.  If the symptoms are causing a lot of distress speak to your physician as soon as possible to discuss how to manage the side effects or to consider therapy modification.
2. What do I do if my mood worsens on this medication and I feel much worse?
   Contact your physician immediately, it is rare however antidepressant medications can cause suicidal ideation, generally in those under the age of 24.
3. What is serotonin syndrome?
   Serotonin syndrome is a rare, but potentially life-threatening condition of serotonin toxicity from too much of it in your system generally from the use of certain medications and supplements.  Usually multiple agents are at play or high doses are involved.  The signs and symptoms include agitation, hallucinations, delirium, coma, tachycardia (rapid heart rate), diaphoresis (excessive sweating), tremor, muscle rigidity, nausea, vomiting, diarrhea, and/or seizures.  If serotonin syndrome is suspected, discontinue any serotonergic medications, and seek immediate medical attention.