Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.
Sedation and treatment of insomnia in adults.
As an adjunct in preoperative sedation in surgery and obstetrics.
As a paediatric sedative.
Intramuscular or intravenous (after dilution)
The usual dose is 25-50 mg by deep intramuscular injection, or, in emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use.
Maximum parenteral dose 100 mg.
No specific dosage recommendations.
6.25-12.5 mg for children from 5-10 years by deep intramuscular injection. Not for use in children under 2 years of age (see section 4.3).
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.
Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.
3 years.
Store in the original carton in order to protect from light.
Cardboard carton containing either 10 × 1 ml ampoules or 10 × 2 ml ampoules.
Not all pack sizes may be marketed.
Discoloured solutions should not be used.
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