Regulatory Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION
**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_).
INTRAMUSCULAR
Medical Information
**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.
N05AB04
prochlorperazine
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
AVENTIS PHARMA, DAGENHAM
Sanofi S.r.L.
Active Ingredients
Documents
Package Inserts
Stemetil Injection PI.pdf
Approved: March 15, 2023