Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Trimipramine has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days.
For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day.
10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.
Not recommended.
Route of administration is oral.
Acute overdosage may be accompanied by hypotensive collapse, convulsions, coma, QT interval prolongation, torsades de pointes. Overdose may result in a fatal outcome.
Provided coma is not present, gastric lavage should be carried out without delay even though some time may have passed since the drug was ingested. Patients in a coma should have an endotracheal tube passed before gastric lavage is started. Absorption of trimipramine is slow but, as cardiac effects may appear soon after the drug is absorbed, a saline purge should be given. Electrocardiography monitoring is essential.
It is important to treat acidosis as soon as it appears with, for example, 20 ml per kg of M/6 sodium lactate injection by slow intravenous injection. Intubation is necessary and the patient should be ventilated before convulsions develop. Convulsions should be treated with diazepam administered intravenously.
Ventricular tachycardia or fibrillation should be treated by electrical defibrillation. If supraventricular tachycardia develops, pyridostigmine bromide 1 mg (adults) intravenously or propranolol 1mg (adults) should be administered at intervals as required.
Treatment should be continued for at least three days even if the patient appears to have recovered.
Shelf life: 3 years.
Keep the blister in the outer carton in order to protect from light.
HDPE bottles or Securitainers of 50 tablets and cartons containing PVDC/coated UPVC/aluminium foil blister packs of 56, 84 or 28 tablets.
Not all pack sizes may be marketed.
No special requirements.
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