TRITTICO Film-coated tablet Ref.[115939] Active ingredients: Trazodone

Posology

The dosage should be determined with caution and treatment initiated with the minimum effective dose.

The patient should be reassessed regularly. It is recommended to start treatment with a night-time dose and increasing daily doses. The course of treatment should last at least one month.

Tablets:

The tablets can be split to enable gradual dosing with divided doses, depending on the severity of the disease and the patient's weight, age and general condition.

Adults

Initially 75-150 mg daily, administered in divided doses after meals. The night-time dose must be taken before bedtime

The dose may be increased to up to 300 mg daily, to be taken in divided doses, with the largest part taken at bedtime.

In hospitalised patients, the dose may be increased further, to up to 600 mg daily in divided doses.

Elderly and frail patients

The recommended starting dose is 100 mg daily, administered in a single daily dose or divided into several doses. The daily dose may be increased to up to 150 mg daily if well tolerated. Patients should not exceed the maximum dose of 300 mg per day.

Paediatric population

Trittico is contraindicated in children and adolescents (see section 4.3).

Hepatic and renal impairment

Caution should be exercised in the event of hepatic impairment or severe renal impairment (see section 4.4).

Method of administration

Take the tablet with water or other liquid. Should preferably be taken on a full stomach.

Taking Trittico after meals reduces the occurrence of undesirable effects.

Features of toxicity

The most frequently reported reactions to overdose include drowsiness, dizziness, nausea and vomiting.

In more serious cases coma, tachycardia, hypotension, hyponatraemia, convulsions and respiratory failure have been reported.

Cardiac features may include bradycardia, QT interval prolongation and "torsades de pointes".

Symptoms may appear within 24 hours or more after overdose.

Overdoses of trazodone in combination with other antidepressants may cause serotonin syndrome.

Treatment

There is no specific antidote to trazodone. Activated charcoal may be used in adults who have ingested more than 1 g of trazodone, or in children who have ingested more than 150 mg of trazodone, within 1 hour of presentation of symptoms. Alternatively, in adults, gastric lavage may be considered within one hour of ingestion of a potentially life-threatening overdose.

In the event of overdose, patients must be monitored for at least 6 hours after ingestion (or 12 hours if a prolonged-release preparation has been taken).

Monitor BP, pulse and Glasgow Coma Scale (GCS). Monitor oxygen saturation if GCS is reduced.

Cardiac monitoring is appropriate in symptomatic patients.

Single brief convulsions do not require treatment. Frequent or prolonged convulsions must be controlled with intravenous diazepam (0.1-0.3 mg/kg body weight) or lorazepam (4 mg in adults and 0.05 mg/kg in children).

If these measures do not control the fits, administer an intravenous infusion of phenytoin.

Provide oxygen and correct acid-base and metabolic disturbances as required.

Treatment is symptomatic and supportive in the case of hypotension and excessive sedation. If severe hypotension persists, consider use of inotropes, such as dopamine or dobutamine.

TRITTICO 50 mg film-coated tablets: 4 years.

This medicinal product does not require any special storage conditions.

TRITTICO 50 MG FILM-COATED TABLETS: 2 PVC/aluminium blisters, each containing 15 tablets, pack of 30 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.