TOFRANIL (Imipramine) 75MG

What is Tofranil and how is it used?

Tofranil is a prescription medicine used to treat the symptoms of Depression. Tofranil may be used alone or with other medications.

Tofranil belongs to a class of drugs called Antidepressants, TCAs.

It is not known if Tofranil is safe and effective in children younger than 6 years of age.

What are the possible side effects of Tofranil?

Tofranil may cause serious side effects including:

• mood or behavior changes,
• anxiety,
• panic attacks,
• trouble sleeping,
• impulsive behavior,
• irritableness,
• agitation,
• hostility,
• aggression,
• restlessness,
• hyperactivity (mentally or physically),
• more depression,
• suicidal thoughts,
• blurred vision,
• tunnel vision,
• eye pain or swelling,
• seeing halos around lights,
• lightheadedness,
• new or worsening chest pain,
• pounding heartbeats,
• fluttering in your chest,
• sudden numbness or weakness,
• problems with vision, speech or balance,
• fever,
• sore throat,
• confusion,
• hallucinations,
• unusual thoughts or behavior,
• painful or difficult urination,
• seizures, and
• yellowing of the skin or eyes (jaundice)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Tofranil include:

• tingly feeling,
• weakness,
• lack of coordination,
• dry mouth,
• nausea,
• vomiting,
• constipation,
• diarrhea,
• vision changes,
• ringing in your ears,
• breast welling (both men and women),
• decreased sex drive,
• impotence, and
• difficulty having an orgasm

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tofranil. For more information, ask your doctor or pharmacist.

DESCRIPTION

Tofranil™ 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-5Hdibenz [b,f]-azepine monohydrochloride. Its structural formula is:

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.

DOSAGE AND ADMINISTRATION

Depression

Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.

Usual Adult Dose

Hospitalized Patients

Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250 to 300 mg/day.

Outpatients

Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day.

Adolescent And Geriatric Patients

Initially, 30 to 40 mg/day; it is generally not necessary to exceed 100 mg/day.

Childhood Enuresis

Initially, an oral dose of 25 mg/day should be tried in children aged 6 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.

A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.

The safety and effectiveness of Tofranil as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.