Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
Surmontil has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses a 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.
The route of administration is oral.
The usual daily dose is 50-100 mg daily as a single dose, 2 hours before retiring. In more severe depression, dosage should be increased gradually until the optimum therapeutic response is achieved (usually 150-300 mg daily) then reduced after 4-6 weeks to a maintenance level of 75-150 mg daily.
Initially, a low dosage is recommended, generally half the minimum recommended dose (see Pharmacokinetic Data). Increasing dosage, if required, must take place gradually under clinical supervision: the side effects of imipramines may have serious consequences in elderly patients (falls, confusion).
Surmontil should not be used in the treatment of children or adolescents under the age of 18 years (see section 4.4 and 4.8).
In patients with hepatic and renal insufficiency a lower dosage is recommended (see section 5.2).
Convulsions.
QT interval prolongation, torsades de pointes.
Overdose may result in fatal outcome.
Symptoms of overdosage may include excitement, restlessnes with marked antimuscarinic effect including dry mouth, dilated pupils tachycardia, urinary retention and intestinal stasis. Severe symptoms include hypotensive collapse,convulsions, unconsciousness, acidosis, respiratory and cardiac depression as well as life threatening arrhythmias.
Provided coma is not present, gastric lavage should be carried out without delay although some time may have passed since the drug was ingested.
Patients in 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. Electro-cardiography 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 supra-ventricular tachycardia develops, pyridostigmine bromide 1 mg (adults) intravenously or propranolol 1 mg (adults) intravenously should be administered at intervals as required.
Care must include symptomatic treatment and vital functions, particularly the cardiac and respiratory functions, must be monitored for at least five days.
3 years.
Do not store above 25°C. Keep the container tightly closed in order to protect from light.
Surmontil 25 mg tablets are marketed in Grey 50 ml High density polyethylene (h.d.p.e.) bottles. Each bottle contains 50 tablets.
No special requirements.
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