Tofranil (Imipramine) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Tofranil

Depression »

Depression facts

A depressive disorder is a syndrome (group of symptoms) that reflects a sad, blue mood exceeding normal sadness or grief.
Depressive disorders are characterized not only by negative thoughts, moods, and behaviors but also by specific changes in bodily functions (for example, eating, sleeping, and sexual activity).
One in 10 people will have a depressive disorder in their lifetime, and in one of 10 cases, the depression is a fatal disease as a result of suicide.
Some types of depression, especially bipolar depression, run in families.
While there are many social, psychological, and environmental risk factors for developing depression, some are particularly prevalent in one gender or the other, or in particular age or ethnic groups.
There can be some differences in symptoms of depression depending on age, gender, and ethnicity.
Depression is diagnosed only clinicall...

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Tofranil®
(imipramine hydrochloride) Tablets USP (10 mg, 25 mg, and 50 mg)

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 hydrochloride 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 hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: INFORMATION FOR PATIENTS, and PRECAUTIONS: Pediatric Use).

DRUG DESCRIPTION

Tofranil (imipramine) is supplied in tablet form for oral administration.

Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-3-(Dimethylamino)propyl-10,11-dihydro-5H-dibenz[b,f]-azepine monohydrochloride. Its structural formula is:

Tofranil® (imipramine hydrochloride) Structural Formula Illustration

Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Inactive Ingredients: Calcium phosphate, cellulose compounds, docusate sodium, iron oxides, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, sucrose, talc, and titanium dioxide.

What are the possible side effects of imipramine (Tofranil, Tofranil-PM)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have...

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What are the precautions when taking imipramine (Tofranil)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have had: a recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, chronic bronchitis), certain eye problems (e.g., glaucoma, increased intraocular pressure), diabetes, eating disorders (e.g., bulimia), heart...

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Last reviewed on RxList: 5/15/2012
This monograph has been modified to include the generic and brand name in many instances.