Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Martindale Pharma, Bampton Road, Romford, RM3 8UG, England
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Not to be given to comatose patients or to patients with respiratory depression, obstructive airways disease or acute asthma. It should not be given to patients who are receiving monoamine oxidase inhibitors or moclobemide, or within two weeks of their withdrawal. For full list of interactions with other medicinal products, see section 4.5. Not to be given to patients with a history of hypersensitivity or idiosyncratic response to the drug or any of its constituents.
Pethidine should be avoided in patients exhibiting acute alcoholism, delirium tremens or convulsive disorders, and paralytic ileus. Pethidine depresses respiratory function and should be avoided in patients with respiratory insufficiency and in patients with head injuries, raised intracranial pressure severe hepatic or renal impairment. Patients with phaechromocytoma should not be treated with pethidine.
Use of pethidine should be avoided in patients with diabetic acidosis where there is a danger of coma.
Pethidine should only be given with caution, and in reduced dosage, to neonates and premature infants, elderly or debilitated patients, hypotension, decreased respiratory reserve, biliary tract disorders, hypothyroidism, adrenal cortical insufficiency, shock, prostatic hypertrophy, and supraventricular tachycardia. Use of cough suppressants containing opioid analgesics is not generally recommended in children and should be avoided altogether in those under at least 1 year.
Repeated administration may induce tolerance to the drug, with a tendency to psychological dependence of the morphine type, with withdrawal symptoms after abrupt cessation of therapy. Cross tolerance between narcotic analgesics can occur. In the case of severe continuing pain it may be advisable to try other treatments. A reduction in dose is advisable in cases of renal disease and chronic hepatic disease.
Pethidine hydrochloride tablets contain lactose and sucrose.
Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Concomitant use of Pethidine tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe methadone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Alcohol: Enhanced sedative and hypotensive effects.
Antidepressants, SSRI and Tricyclic: The use of pethidine should be avoided in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal. Increased risk of CNS toxicity. Pethidine may increase potential for both selective serotonin re-uptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) to cause convulsions.
Anxiolytics and Hypnotics: Sedative effects may be enhanced by simultaneous use of pethidine.
Antipsychotics: Increased risk of convulsions with pethidine.
Carbamazepine: Reduces the effects of Pethidine.
Coumarins: Pethidine enhances anticoagulant effects of coumarins.
Digoxin: Risk of digoxin toxicity increased.
Duloxetine: Possible increased serotonergic effects when administered with pethidine.
Selegiline: Caution with pethidine advised by manufacturer of selegiline.
Ciprofloxacin: The manufacturer of ciprofloxacin advises that, if it is used for surgical prophylaxis, opiates should not be used for premedication as this may reduce the plasma concentration of ciprofloxacin.
Cimetidine: The metabolism of pethidine is inhibited (plasma concentrations of pethidine are increased).
Domperidone and metoclopramide: Pethidine antagonises the gastro-intestinal activity of these drugs.
Mexilitine: Pethidine delays the absorption of mexilitine.
Ritonavir: Plasma concentration of pethidine may be increased by ritonavir.
Sedative medicines such as benzodiazepines or related drugs: The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).
There is inadequate evidence of safety of pethidine in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence, and animal studies have not shown any hazard. Nevertheless the established medical practice of prescribing medicaments in early pregnancy should be observed.
Pethidine crosses the placenta and is also secreted in breast milk. This should be borne in mind when considering its use in patients during pregnancy or lactation. Administration in labour may cause respiratory depression of the new-born infant.
There are insufficient fertility data available to indicate whether pethidine hydrochloride has any effect on fertility.
Pethidine may modify the patient’s reactions to a varying extent, depending on dosage, administration and individual susceptibility. If affected or if you are in any doubt that you may be affected do not drive or operate machinery until any effects have worn off.
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 table below presents adverse drug reactions by System Organ Class. Within each System Organ Class, the adverse drug reactions are presented by incidence, using the following convention:
Not known (cannot be estimated from the available data).
Unknown: Euphoria, hallucinations, dysphoria, mood changes, dependance
Unknown: Central Nervous System, excitation, dizziness, vertigo, drowsiness, headache
Unknown: Obtund or abolish the corneal reflex, miosis (pupillary constriction)
Unknown: Bradycardia, tachycardia, palpitations
Unknown: Hypotension, facial flushing
Unknown: Respiratory depression
Unknown: Nausea,vomiting, constipation, dry mouth
Unknown: Biliary spasm
Unknown: Rashes, urticaria, pruritis
Unknown: Muscle rigidity
Unknown: Difficulty in micturition, ureteral spasm
Unknown: Decreased libido or potency
Unknown: Sweating, hypothermia
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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