Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Pethidine hydrochloride may be used as an analgesic for the relief of moderate to severe pain including: obstetric analgesia; pre-operative medication and analgesia during anaesthesia; post-operative analgesia.
The following single doses may be used and should not usually be repeated more frequently than four hourly; Subcutaneous or intramuscular injection: 25-100mg. Intravenous injection: 25-50mg.
The initial dose should not exceed 25mg, because of the particular sensitivity among elderly or debilitated patients to the central depressant effects of pethidine.
The usual single dose is 0.5 to 2mg/kg body weight by intramuscular injection. If necessary, this dose may be repeated, allowing a minimum of four hours between doses. Use of a small graduated syringe is recommended for the accurate administration of dosages in children. In the absence of graduated syringes, the solution should be diluted with Water for Injections before measuring the dose.
Pethidine Injection may be administered by subcutaneous, intramuscular or slow intravenous injection.
Signs of acute overdosage may include respiratory depression, CNS depression with extreme somnolence progressing to incoordination, stupor or coma, convulsions, CNS stimulation, cyanosis, miosis, skeletal muscle flaccidity or tremors, cold, clammy skin, hypothermia, bradycardia and hypotension. and shock.
In severe overdosage, apnoea, circulatory collapse, pulmonary oedema, mydriasis, cardiac arrest and death may occur.
Treatment is supportive. Primary attention should be directed at correcting respiratory failure and shock. A patent airway should be established and assisted or controlled ventilation should be provided. If signs of CNS toxicity are exhibited the use of pethidine should be discontinued. Narcotic antagonists may be required if there is evidence of significant respiratory or cardiovascular depression.
Naloxone is a specific antidote used to counteract respiratory depression and coma resulting from opioid overdosage. Naloxone should be given intravenously as soon as possible and repeated every 2-3 minutes if necessary.
Intravenous fluids, oxygen, vasopressors and other supportive measures may be required in the management of shock. An anticonvulsant may be required if seizures occur.
4 years.
If only part used, discard the remaining solution.
Do not store above 25°C. Keep in outer carton.
1ml and 2ml clear glass ampoules, glass type 1 Ph. Eur. packed in cardboard cartons to contain 10 × 1ml or 10 × 2ml ampoules.
CD (2)
For S/C., I/M., or I/V injection.
Use as directed by the physician.
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