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Use with caution in patients with liver disease, decreased respiratory reserve or those receiving other CNS depressant drugs. Should not be used in the presence of Phenobarbitone or any other enzyme inducing agents. May produce dependence. Administration during labour may cause respiratory depression in the newborn infant. Use with caution in patients taking MAO inhibitors. Must be given cautiously to patients with supraventricular tachycardia. Not usually given pre-operatively to children under 1 year of age. Should be given with extreme care to newborn or premature infants, in elderly and debilitated patients.
Pethidine should be used with caution in patients with head injuries, severe hepatic or renal impairment, biliary tract disorders, hypothyroidism, adrenocortical insufficiency, shock, prostatic hypertrophy. Caution is also required in patients exhibiting acute alcoholism, raised intracranial pressure or convulsive disorders. Pethidine depresses respiratory function and should be administered with particular care in patients with respiratory insufficiency. Concomitant administration of pethidine with Phenothiazines may induce severe hypotension. Pethidine induced neurotoxicity may be seen in patients with renal failure, cancer or sickle anaemia, during concomitant administration with anticholinergics or during chronic administration of increasing pethidine doses. Patient should be instructed to avoid alcohol while under treatment, since the individual response cannot be foreseen. Pethidine may modify patient's reaction (driving ability, operation of machinery, etc) to a varying extent, depending on dosage, administration and individual susceptibility. Repeated administration of pethidine may induce tolerance to the drug with a tendency to increasing dosage requirements to obtain the desired effect, or to physical and psychological dependence of the morphine type, with the development of withdrawal symptoms after abrupt cessation of therapy. Cross-tolerance between narcotic analgesics can occur.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Pethidine with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Pethidine is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (see Interactions).
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of pethidine hydrochloride with serotonergic drugs (see Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) and can be fatal (see Interactions). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue pethidine hydrochloride if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Sexual Function/Reproduction: Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as low libido, erectile dysfunction, or infertility (see Post Marketing Experience under Side Effects).
Effects on Ability to Drive and Use Machine: Pethidine may cause drowsiness, impair the mental and/or physical abilities required for driving or for operating machinery. If affected patients should be advised accordingly and warned not to drive or operate machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: The medicine is likely to affect the patient's ability to drive.
Do not drive until the patient knows how the medicine affects a patient.
It is an offence to drive while under the influence of this medicine.
However, the patient would not be committing an offence (called 'statutory defence') if: The medicine has been prescribed to treat a medical or dental problem and; the patient has taken it according to the instructions given by the prescriber and in the information provided with the medicine and; it was not affecting the patient's ability to drive safely.
