Surmontil (Trimipramine Maleate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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.

REPORTS OF SUSPECTED SURMONTIL SIDE EFFECTS / ADVERSE REACTIONS

Possible Surmontil side effects / adverse reactions in 61 year old female

Reported by a consumer/non-health professional from United States on 2011-11-17

Patient: 61 year old female weighing 68.0 kg (149.7 pounds)

Reactions: Insomnia, Chills, Withdrawal Syndrome, Hyperhidrosis, Tremor

Suspect drug(s):
Surmontil

Possible Surmontil side effects / adverse reactions in 80 year old female

Reported by a pharmacist from Switzerland on 2011-12-09

Patient: 80 year old female weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Therapeutic Response Increased, Medication Error, Hyponatraemia, Drug Interaction, Disorientation, Delirium, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Oxycontin
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-01
    End date: 2011-02-08

Dormicum Tablet ^roche^
    Dosage: unk
    Start date: 2011-01-01

Oxazepam
    Dosage: 15 mg, 1x/day in the morning
    Administration route: Oral
    End date: 2011-02-09

Surmontil
    Dosage: 25 mg, 1x/day in evening
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-02-01

Dormicum Tablet ^roche^
    Dosage: 7.5 mg, 4x/day
    Administration route: Oral
    End date: 2011-01-01

Buprenorphine
    Dosage: 52.2 ug, 1x every 96 hours
    Indication: Pain
    Start date: 2011-01-01

Lyrica
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    End date: 2011-02-08

Other drugs received by patient possibly interacting with the suspect drug:
Torsemide
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-02-08

Ramipril
    Dosage: 1.25 mg, 1x/day
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2011-02-08

Metolazone
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2011-01-01
    End date: 2011-02-08

Torsemide
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    End date: 2011-02-01

Other drugs received by patient: Paragol; Acetylsalicylic Acid; Concor; Pantoprazole Sodium; Duspatalin Retard; Magnesiocard; Fragmin; Calcimagon-D3; Vitalux; Perenterol; Novalgin; Duphalac

Possible Surmontil side effects / adverse reactions in 80 year old female

Reported by a pharmacist from Switzerland on 2011-12-22

Patient: 80 year old female weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Therapeutic Response Increased, Medication Error, Drug Interaction, Hyponatraemia, Disorientation, Delirium, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Surmontil
    Dosage: 25 mg, 1x/day in evening
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-02-01

Lyrica
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    End date: 2011-02-08

Oxazepam
    Dosage: 15 mg, 1x/day in the morning
    Administration route: Oral
    End date: 2011-02-09

Midazolam HCL
    Dosage: 7.5 mg, 4x/day
    Administration route: Oral
    End date: 2011-01-01

Midazolam HCL
    Dosage: 15 mg daily
    Administration route: Oral
    Start date: 2011-01-01

Oxycontin
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-01
    End date: 2011-02-08

Buprenorphine
    Dosage: 52.5 ug one every 96 hours
    Indication: Pain
    Start date: 2011-01-01

Other drugs received by patient possibly interacting with the suspect drug:
Torsemide
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    End date: 2011-02-01

Ramipril
    Dosage: 1.25 mg, 1x/day
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2011-02-08

Metolazone
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2011-01-01
    End date: 2011-02-08

Torsemide
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-02-08

Other drugs received by patient: Aspirin; Paragol; Duspatalin Retard; Perenterol; Calcimagon D3; Novalgin; Duphalac; Bisoprolol Fumarate; Vitalux; Fragmin; Magnesiocard; Pantoprazole Sodium