STEMETIL INJECTION 12.5 mg/ml

4.1 Therapeutic indication

STEMETIL is a potent phenothiazine neuroleptic. It is used in vertigo due to Meniere's syndrome, labyrinthitis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine. It may also be used for schizophrenia, (particularly in the chronic stage), acute mania and as an adjunct to the short term management of anxiety.

4.3 Contraindications

• Known hypersensitivity to prochlorperazine, to other phenothiazines or to any of the other ingredients listed in section section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
• The use of Stemetil injection is contraindicated in children as it has been associated with dystonic reactions after the cumulative dose of 0.5 mg/kg.

4.2 Posology and method of administration

ADULTS

Treatment of nausea and vomiting. 12.5mg by deep i.m. injection followed by oral medication six hours later, if necessary.

Schizophrenia and other psychotic disorders. 12.5mg to 25mg two or three times a day by deep i.m. injection until oral treatment becomes possible.

CHILDREN

Intramuscular STEMETIL should not be given to children. When treating children, it is recommended that the syrup or 5mg tablets are used.

STEMETIL is not recommended for children weighing less than 10kg.

ELDERLY

A lower initial dosage is recommended (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).