STEMETIL Solution for injection Ref.[27713] Active ingredients: Prochlorperazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

4.1. Therapeutic indications

Stemetil is a potent phenothiazine neuroleptic.

Uses: The treatment of nausea and vomiting and in schizophrenia (particularly the chronic stage) and acute mania.

4.2. Posology and method of administration

Posology

Adults

IndicationDosage
Treatment of nausea and vomiting12.5 mg by deep i.m. injection followed by oral medication 6 hours later if necessary.
Schizophrenia and other psychotic disorders12.5–25 mg b.i.d. or t.d.s. by deep i.m. injection until oral treatment becomes possible.

Paediatric population

Intramuscular Stemetil should not be given to children.

Elderly

A lower dose is recommended (see section 4.4).

Method of administration

For deep intramuscular injection.

4.9. Overdose

Symptoms of phenothiazine overdose include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.

If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice. In severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended. Avoid the use of adrenaline.

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5–10 mg) or orphenadrine (20–40 mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.

Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Keep ampoules in the outer carton, in order to protect from light. Discoloured solutions should not be used.

6.5. Nature and contents of container

Stemetil injection is supplied in colourless glass ampoules in packs of 10 × 1 ml and 10 × 2 ml.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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