Tofranil

Tofranil is a prescription medication used to treat the symptoms of depression and to prevent bedwetting in children. This medication belongs to a group of drugs called tricyclic antidepressants (TCAs), which treat the symptoms of depression by adjusting the levels of natural chemicals in the brain. The exact way Tofranil works to prevent bedwetting is unknown.

Tofranil comes as an oral (by mouth) tablet and may be taken once or several times a day, depending on your doctor’s instructions. When Tofranil tablets are used to prevent bedwetting in children, they are usually taken one hour before bedtime, or as one dose in the afternoon and another dose at bedtime.

Common side effects of Tofranil include nausea, weakness and dry mouth. Tofranil can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how it affects you. 

Tofranil is a prescription medication used to treat depression and bedwetting in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Mallinckrodt, Inc.

Common side effects include:

• nausea
• drowsiness
• weakness or tiredness
• excitement or anxiety
• confusion
• nightmares
• dry mouth
• sun sensitivity
• weight loss or gain
• constipation
• difficulty urinating
• frequent urination
• blurred vision
• changes in sex drive or ability
• excessive sweating

This is not a complete list of Tofranil side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)
• cimetidine (Tagamet)
• quinidine
• fluoxetine (Prozac, Sarafem)
• barbiturates such as phenobarbital
• phenytoin (Dilantin)
• epinephrine
• norepinephrine
• alcohol
• medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, atomoxetine
• linezolid (Zyvox)
• intravenous methylene blue

This is not a complete list of Tofranil drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tofranil including the following:

• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Tofranil. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:
  • feeling faint
  • lightheadedness
  • dizziness
  • feeling like your heart is beating irregularly or quickly
• Serotonin Syndrome. Serotonin syndrome has been reported with Tofranil, alone but particularly with concomitant use of other serotonergic medications. Tell your healthcare provider right away if you have some or all of the following symptoms of serotonin syndrome.
  • mental status changes ( agitation, hallucinations, delirium, and coma)
  • autonomic instability (tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia)
  • neuromuscular changes (tremor, rigidity, myoclonus, hyperreflexia, incoordination)
  • seizures
  • gastrointestinal symptoms (nausea, vomiting, diarrhea).
• Clinical Worsening and Suicide Risk. Tell your healthcare provider right away if you have any of the following signs or symptoms especially if they are new, worse, or worry you:
  •   thoughts about suicide or dying
  •   attempts to commit suicide
  •   new or worse depression/anxiety
  •   feeling very agitated or restless
  •   panic attacks
  •   trouble sleeping (insomnia)
  •   acting on dangerous impulses
  •   other unusual changes in behavior or mood

Tofranil can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Tofranil affects you.

Do not take Tofranil if you:

• are allergic to Tofranil or to any of its ingredients
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take a MAOI, including the antibiotic linezolid.
• stopped taking a MAOI in the last 2 weeks unless directed to do so by your physician.
• are in an acute recovery period after a myocardial infarction.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tofranil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tofranil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tofranilor to any of its ingredients
• have liver problems
• have heart problems
• have kidney problems
• have diabetes
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women. However, there have been clinical reports of congenital malformations associated with the use of the drug. Tofranil should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Limited data suggest that Tofranil is likely to be excreted in human breast milk. Because of the possibility for adverse reactions in nursing infants from Tofranil, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Tofranil exactly as prescribed.

Tofranil comes in tablet form and may be taken once or several times a day, depending on your doctor’s instructions.

When Tofranil tablets are used to prevent bedwetting in children, they are usually taken one hour before bedtime, or as one dose in the afternoon and another dose at bedtime.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Tofranil at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your weight

The recommended dose range of Tofranil (imipramine) for the treatment of depression is 75 mg-300 mg/day.

The recommended dose range of Tofranil (imipramine) for the treatment of childhood enuresis is 25mg-50 mg/day in children under 12 years old.

The recommended dose range of Tofranil (imipramine) for the treatment of childhood enuresis is 25mg-75 mg/day in children over 12 years old.

If you take too much Tofranil, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tofranil tablets at 15°C-25°C (59°-77°F).
• Keep this and all medicines out of the reach of children.

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 Tofranil 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. Tofranil is not approved for use in pediatric patients.