Surmontil

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

The usual starting dose for adults is 50 to 75 mg per day, split into equal, smaller doses (for example, 25 mg three times daily). Doses are gradually increased every 2 to 3 weeks.

Usual doses for long-term therapy may range from 50 to 150 milligrams daily and doses may be increase up to 200 mg per day if needed.

Hospitalized patients may receive up to 300 mg daily. This total daily dosage may be taken once daily at bedtime or spread throughout the day. Beneficial effects may not be seen until treatment at an appropriate dose is given for two to four weeks.

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Your pharmacist can provide more information about trimipramine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when SURMONTIL is administered. Some of the adverse reactions included in this listing have not in fact been reported with SURMONTIL.

Cardiovascular

Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.

Psychiatric

Confusional states (especially the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurological

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Anticholinergic

Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis, constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization, edema of face and tongue.

Hematologic

Bone marrow depression including agranulocytosis, eosinophilia; purpura; thrombocytopenia. Leukocyte and differential counts should be performed in any patient who develops fever and sore throat during therapy; the drug should be discontinued if there is evidence of pathological neutrophil depression.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine

Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels.

Other

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness, and fatigue; headache; parotid swelling; alopecia.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Read the entire FDA prescribing information for Surmontil (Trimipramine)

Trimipramine is a prescription medication used to treat depression.

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

• Duramed Pharmaceuticals, Inc.

• Odyssey Pharmaceuticals, Inc.

• TEVA Pharmaceuticals USA Inc.

• Teva Select Brands

You should not use this medicine if you have recently had a heart attack.

Do not use trimipramine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In the U.S.

• Surmontil

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Surmontil® (trimipramine maleate) Capsules 25 mg, 100s Label Text

NDC 51285-538-02

Surmontil®

(Trimipramine Maleate)

25 mg*

PHARMACIST: PLEASE DISPENSE WITH

MEDICATION GUIDE

SEALED FOR YOUR PROTECTION

Rx only

100 CAPSULES

TEVA

LactMed Record Number

308

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.