TRAZODONE Film-coated tablet Ref.[7367] Active ingredients: Trazodone

Route of administration

Oral.

Depression

Adults

Initially 150mg/day in divided doses after food or as a single dose on retiring.

This may be increased up to 300mg/day in a single or divided doses. The major portion of a divided dose to be taken on retiring. The dose may be further increased to 600mg/day in divided doses in hospitalised patients.

Elderly

For very elderly or frail patients the recommended initial starting dose is reduced to 100mg/day given in divided doses or as a single night-time dose (see section 4.4).

This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100 mg should be avoided in these patients.

It is unlikely that 300mg/day will be exceeded.

Different formulations may be required if strengths other than 75mg/150mg are needed.

Children

Trazodone hydrochloride 150mg film-coated Tablets are not recommended for use in children below the age of 18 years due to a lack of data on safety.

Depression accompanied by anxiety

As for depression.

Anxiety

75mg/day increasing to 300mg/day as necessary.

A decrease in side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Trazodone hydrochloride 150mg film-coated Tablets after a meal.

Hepatic Impairment

Trazodone hydrochloride undergoes extensive hepatic metabolism, see section 5.2, and has also been associated with hepatotoxicity, see sections 4.4 and 4.8. Therefore caution should be exercised when prescribing for patients with hepatic impairment, particularly in cases of severe hepatic impairment. Periodic monitoring of liver function may be considered.

Renal Impairment

No dosage adjustment is usually necessary, but caution should be exercised when prescribing for patients with severe renal impairment (see also section 4.4 and 5.2).

Features of toxicity

The most frequently reported reactions to overdose have included 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 prolongation and torsade de pointes. Symptoms may appear 24 hours or more after overdose.

Overdoses of Trazodone hydrochloride 150mg film-coated Tablets in combination with other antidepressants may cause serotonin syndrome.

Management

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

Observe for at least 6 hours after ingestion (or 12 hours if a sustained 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. Control frequent or prolonged convulsions with intravenous diazepam (0.1-0.3 mg/kg body weight) or lorazepam (4 mg in an adult and 0.05 mg/kg in a child). If these measures do not control the fits, an intravenous infusion of phenytoin may be useful. Give oxygen and correct acid base and metabolic disturbances as required.

Treatment should be symptomatic and supportive in the case of hypotension and excessive sedation. If severe hypotension persists consider use of inotropes, eg dopamine or dobutamine.

Shelf life: 2 years.

HDPE container:

After opening: within 100 days.

This medicinal product does not require any special storage conditions.

Trazodone Hydrochloride Tablets are available in blisters of Aluminium-PVC/PVDC White Opaque Film containing packs of 20’s, 28’s, 30’s, 56’s, 84’s and 100’s along with leaflet inside.

Not all pack sizes may be marketed.

Trazodone Hydrochloride Tablets are available in white opaque HDPE bottle with white polypropylene child resistant cap containing packs of 100, 250 and 500 tablets.

Not all pack sizes may be marketed.

None.