Desipramine Full Prescribing Information

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Brand Name: Norpramin
Generic Name: Desipramine

Norpramin, Desipramine is a tricyclic antidepressant used to treat depression, the depressed phase of manic depressive illness, and is an antibulimic. Usage, dosage, side-effects of Norpramin.

Outside U.S., Brand Names also known as: Pertofrane

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Norpramin patient information (in plain English)

Description

Norpramin (Desipramine) is a tricyclic antidepressant used to treat depression. It may also be used to treat other conditions as determined by your doctor.

Pharmacology

The anticholinergic actions of desipramine are responsible for many of the commonly observed side effects of the drug. Desipramine causes ECG changes which are seen most frequently in elderly patients. Desipramine is known to lower the convulsive threshold.

Desipramine increases the percentage of Stage 4 sleep (deep sleep) and decreases the percentage of REM sleep. A partial recovery of REM sleep is seen after 3 to 5 weeks of drug administration. However, in spite of this recovery, a REM rebound occurs following rapid drug withdrawal, which is experienced as an increase in dreaming.

A significant antidepressant effect should not be expected before the end of the second week.

Category of Use: Antidepressant; Antipanic Agent; Antineuralgic; Anticataplectic; Antibulimic

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Indications and Usage

Norpramin (Desipramine) is used for the treatment of endogenous depressive illness, including the depressed phase of manic depressive illness, involutional melancholia and psychotic depression. It may also be indicated in the management of depression of a nonpsychotic degree such as in selected cases of depressive neurosis. Patients with transient mood disturbances or normal grief reaction are not expected to benefit from tricyclic antidepressants.

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Contraindications

Desipramine should not be given in conjunction with, or within 2 weeks of, treatment with a MAO inhibitor.

Hyperpyretic crises, severe convulsions and death have occurred in patients receiving MAO inhibitors and tricyclic antidepressants. When desipramine is substituted for an MAO inhibitor, at least 2 weeks should elapse between the treatments. Administration of desipramine should then be started cautiously and should be increased gradually.

The drug is contraindicated in the acute recovery period following myocardial infarction or in cases of poorly controlled cardiac decompensation. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.

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Warnings

Extreme caution should be used when desipramine is given in the following situations:

  1. In patients with cardiovascular disease;
  2. In patients with a history of urinary retention or glaucoma;
  3. In patients with thyroid disease or those taking thyroid medication;
  4. In patients with a history of seizure disorder. Desipramine has been shown to lower the seizure threshold.

Children: Not recommended for pediatric use.

Do not stop taking this medicine without first checking with your doctor.

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Precautions

Desipramine should be dispensed in the least possible quantities to depressed outpatients, since suicide has been accomplished with this class of drug.

Desipramine therapy in patients with manic-depressive (bipolar) illness may induce a hypomanic state after the depressive phase terminates.

The drug may cause exacerbation of psychosis in schizophrenic patients.

Both elevation and lowering of blood sugar levels have been reported.

ALCOHOL, HOT WEATHER, EXERCISE, AND FEVER can increase dizziness. To prevent dizziness or fainting, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness or weakness.

Desipramine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine.

BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.

The effects of this medicine may last for 3 to 7 days after you stop taking it. Make sure you continue to follow the precautions during this time.

Pregnancy and Withdrawl: Safety for use during pregnancy and nursing has not been established. It should be kept in mind when administering desipramine, the possible benefits must be weighed against the possible hazards to mother and child.

Interference with Cognitive or Motor Performance:Desipramine may cause drowsiness, dizziness, or lightheadedness. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.

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Drug Interactions

Norpramin may potentiate the effect of a variety of drugs. Close supervision and careful adjustment of dosage are required when this drug is administered concomitantly with anticholinergic or sympathomimetic drugs.

INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes carbamazepine, cimetidine, dicumarol, clonidine, mibefradil, paroxetine, tramadol, other medicines for depression or emotional disorders, and medicines for seizures or thyroid conditions. Inform your doctor of any other medical conditions including heart conditions, allergies, pregnancy, or breast-feeding.

Desipramine can exaggerate your response to alcoholic beverages or other CNS depressants.

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Adverse Reactions

Side effects, that may go away during treatment, include dry mouth, constipation, urinary retention, blurred vision, drowsiness, dizziness, headache, nausea, unpleasant taste, or an increased appetite especially for sweets. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Common side effects include: difficulty sleeping or drowsiness, dizziness, headache, nausea, stomach pain, or loss of appetite.

Physical/Psychological Dependence:
After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance. These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2-7 days following cessation of chronic therapy with tricyclic antidepressants.

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Overdose

Signs and Symptoms

Symptoms of overdose may include flushing, fast or irregular heartbeat, dry mouth, drowsiness, confusion, agitation, enlarged pupils, seizures, and loss of consciousness.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

The treatment for an overdosage is evacuation of the ingested material and/or the use of activated charcoal.

Physostigmine salicylate is presently considered the treatment of choice in the reversal of the more severe CNS and cardiovascular complications of poisoning from tricyclic antidepressants.

Prolonged observation of at least a week is strongly recommended since deaths attributed to arrhythmias have been reported many days following an apparent recovery from a tricyclic antidepressant overdose.

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Dosage

After starting use of this medicine, several weeks may pass before you feel the full benefit. DO NOT STOP TAKING THIS MEDICINE without checking with your doctor.

If your symptoms do not improve after taking this medicine for 4 weeks, inform your doctor.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, away from heat and light.
  • Continue to take this medicine even if you feel better. Do not miss any doses.
  • If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take missed dose the next morning.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

Adults: The usual adult dose is 100 to 200 mg/day. In more severely ill patients, dosage may be further increased gradually to 300 mg/day if necessary. Dosages above 300 mg/day are not recommended.

Elderly and Debilitated Patients: 25 to 100 mg daily. Dosage should be initiated at a lower level and increased according to tolerance and clinical response to a usual maximum of 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day. Doses above 150 mg/day are not recommended in these patients.

Children: Not recommended for use in children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

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How Supplied

10 mg, 25 mg, 50 mg, 75 mg, 100 mg tablets.

Make sure you contact your doctor for a refill before you run out of the medication.

Norpramin Patient Information (in plain English)

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.

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