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Home , Mexiletine, Norpethidine

PACKAGE LEAFLET: INFORMATION FOR THE USER Injection must not be used with drugs used to treat TECHNICAL PRESCRIBING INFORMATION Renal impairment may result in accumulation of the potentially severe depression, such as rasagiline or moclobemide, or if you toxic metabolite norpethidine, particularly with repeat dosing. All Pethidine 50mg/ml & 100mg/2ml are within 2 weeks of discontinuing them. Pethidine 50mg/ml & 100mg/2ml of these patient groups may experience increased or prolonged Solution for Injection These drugs are known as Monoamine Oxidase Inhibitors Solution for Injection effects of the product. (MAOI’s), Pethidine should be used with caution in patients with shock, Composition/excipients: Pethidine Hydrochloride Other medicines which may interact with Pethidine Injection hypothyrodism, adreno-corticol insufficiency and a history of Pethidine injection is a sterile aqueous solution of 5% w/v include: convulsive disorders. Read all of this leaflet carefully before you are given this Pethidine Hydrochloride. It also contains Water for Injections and • selegiline, a medicine used to treat Parkinson’s disease Although less spasmogenic than , pethidine may medicine because it contains important information for you. may contain Sodium Hydroxide as a pH adjuster. • Keep this leaflet.You may need to read it again. • , a medicine used to treat HIV precipitate spasm of the ureter or Sphincter of Oddi. Subsequently • If you have any further questions, ask your doctor, nurse • cimetidine, a medicine used to treat stomach ulcers Indications: it should be used with caution in patients with prostatic • medicines used to reduce anxiety (anxiolytics) (eg. Relief of moderate to severe pain, as a premedication, obstetric hypertrophy and biliary tract disorders including those with pain

D05459 or midwife. • If you get any side effects, talk to your doctor or pharmacist . such as diazepam) analgesia and enhancement of analgesia. secondary to gallbladder pathology. This includes any possible side effects not listed in this leaflet. • medicines used to help you to sleep (hypnotics) Pethidine should be used with caution in patients with existing See section 4. • CNS depressants (drugs that act on the brain and make you Dose: hypotension as it may reduce the blood pressure further. feel drowsy or faint). These include sleeping pills, Adults. In addition it should be avoided in patients with severe What is in this leaflet anti-histamines (medicines used to treat allergies) that make For moderate or severe pain. inflammatory bowel disease due to its effects on the 1. What Pethidine Injection is and what it is used for you drowsy, medicines used to treat certain mental disorders. Normal single dose (usually not to be repeated more often than 4 gastrointestinal tract where it may precipitate toxic megacolon. 2. Before you are given Pethidine Injection • , a medicine used to treat fits hourly) Risk from concomitant use of sedative medicines such as 3. How Pethidine Injection will be given • medicines used to treat serious mental disorders By intramuscular or subcutaneous injection 25 - 100 mg. benzodiazepines or related drugs: 4. Possible side effects (phenothiazines) By slow intravenous injection 25 - 50 mg. Concomitant use of Pethidine and sedative medicines such 5. How to store Pethidine Injection • citalopram, a medicine used to treat depression For obstetric analgesia. as benzodiazepines or related drugs may result in sedation, 6. Contents of the pack and other information • medicines for depression (eg. tricyclic such as By intramuscular or subcutaneous respiratory depression, coma and death. Because of these risks, ) injection repeated 1 – 3 hours later. 50 - 100 mg. concomitant prescribing with these sedative medicines should 1. What Pethidine Injection is and what it is • sedatives, sleeping tablets or (eg. phenobarbitone Maximum of 400mg in 24 hours. be reserved for patients for whom alternative treatment options used for for epilepsy) As a premedication. are not possible. If a decision is made to prescribe Pethidine • and (used for disorders of the Pethidine is a drug with powerful pain relieving properties. By intramuscular injection one hour prior concomitantly with sedative medicines, the lowest effective dose gastrointestinal tract) to the operation. 50 - 100mg should be used, and the duration of treatment should be as short • pain relievers and other medicines Pethidine Injection is used for the relief of moderate to severe For the enhancement of analgesia. as possible. • ciprofloxacin, an antibiotic used to treat a number of bacterial pain and is used for pain relief during labour. It may also be used By slow intravenous injection. 10 -25mg as required. The patients should be followed closely for signs and symptoms of to stop you from feeling pain before and during an operation and infections Elderly or debilitated patients. respiratory depression and sedation. In this respect, it is strongly to provide continuous pain relief if needed • mexiletine, a medicine used to treat seriously irregular heartbeats Initial doses should not exceed 25mg as this group of patients may recommended to inform patients and their caregivers to be aware be specially sensitive to the central depressant effect of the drug. of these symptoms. 2. Before you are given Pethidine Injection Concomitant use of Pethidine Injection and sedative medicines Children such as benzodiazepines or related drugs increases the risk of You should not be given Pethidine Injection if: For moderate or severe pain. Interactions : drowsiness, difficulties in breathing (respiratory depression), • you are allergic (hypersensitive) to Pethidine Hydrochloride or By intramuscular injection 0.5 - 2 mg per Kg of body weight. Pethidine should not be administered to patients receiving: coma and may be life-threatening. Because of this, concomitant to any of the ingredients of this medicine (listed in section 6) Monoamine Oxidase Inhibitors • you suffer from asthma, shallow breathing or other breathing use should only be considered when other treatment options are As a premedication. The concurrent use of MAOIs (including moclobemide) is contra- difficulties not possible. By intramuscular injection one indicated as they may result in CNS excitation or depression. • you are suffering from severe headaches or have suffered a hour prior to the operation 1 - 2 mg per Kg of body weight. However, if your doctor does prescribe Pethidine together Pethidine should not be administered to patients receiving head injury Method of administration with sedative medicines the dose and duration of concomitant monoamine oxidase inhibitors or moclobemide or within two • you suffer from alcoholism Intramuscular, intravenous or subcutaneous injection. treatment should be limited by your doctor. weeks of their withdrawal. • you suffer from a convulsive disorder (fits) such as epilepsy • you have any or problems Please tell your doctor about all sedative medicines you are Contraindications: CNS depressants taking and follow your doctor’s dose recommendation closely. It CNS depressants such as , hypnotics, anxiolytics and • you are suffering from a condition known as delirium tremens, Hypersensitivity to the active substance or to any of the excipients could be helpful to inform friends or relatives to be aware of the sedatives, barbiturates and tricyclic antidepressants may increase caused by withdrawal from alcohol listed in section 6.1 • your heartbeat is faster than usual signs and symptoms stated above. Contact your doctor when the general depressant effects of pethidine and should therefore experiencing such symptoms. Severe respiratory depression, severe obstructive airways disease be used with caution. • you suffer from a tumour of the adrenal gland known as or acute asthma. phaeochromocytoma Opioid If you are in any doubt please tell your doctor of any It should not be administered to patients with severe renal • you suffer from diabetes Additive effects on CNS depression, respiratory depression and you are taking. impairment or severe hepatic impairment. • you are taking or have recently taken any drugs used to treat hypotension can occur with concomitant use of opioid depression known as Monoamine Oxidase Inhibitors (MAOI’s) Pregnancy, breast-feeding and fertility Should be avoided in patients with acute alcoholism, delirium . (see ‘Taking other medicines) If you are pregnant or breast-feeding, think you may be pregnant tremens, raised intracranial pressure or in those with convulsive MAO-B inhibitors or are planning to have a baby, ask your doctor or pharmacist for states such as status epilepticus. Patients in a coma should not be given this medicine Concomitant use of MAO-B inhibitors such as selegiline or advice before using this medicine. It should not be administered to patients receiving monoamine rasagiline is contraindicated as this may lead to hyperpyrexia Warnings and precautions Pethidine can pass into your baby either through your blood oxidase inhibitors (including moclobemide, and the monoamine and CNS toxicity. Rasagiline should not be given with pethidine Talk to your doctor or pharmacist before being given Pethidine (during pregnancy and labour) or through your breast milk. This B inhibitors selegiline and rasagiline) or within two weeks of their as there is risk of CNS toxicity, its use should be avoided for two Injection if you: can cause breathing problems in newborn babies. Your doctor withdrawal. Pethidine should not be administered to patients weeks after taking rasagiline. • are in shock, the symptoms of which include sweating, a fast will be aware of this and will correct the problem and discuss receiving ritonavir. pulse and cold, clammy skin feeding with you. Use of pethidine should be avoided in patients with Administration of phenytoin may cause an increase in hepatic • suffer from thyroid problems supraventricular tachycardia. of pethidine and subsequently increased levels of • suffer from problems related to your adrenal gland (the organ Driving and using machines: Use of pethidine in patients with phaechromocytoma may result norpethidine (a toxic metabolite). responsible for stress levels), including adrenocortical This medicine can affect your ability to drive and operate in hypertensive crisis. Antipsychotics insufficiency (a lack of the hormones produced by the adrenal machinery. Do not drive or operate machinery if you feel drowsy Concomitant use of phenothiazines and pethidine can induce gland) or cannot think clearly. Use of pethidine should be avoided in patients with diabetic severe hypotension. • suffer from low blood pressure acidosis where there is danger of coma. This medicine can affect your ability to drive and operate In comatose patients Anti-virals • suffer from problems with your prostate machinery as it may make you sleepy or dizzy. • suffer from problems with your gallbladder In patients with a risk of paralytic ileus Plasma concentrations of pethidine may be decreased by • Do not drive while taking this medicine until you know how it concomitant administration of ritonavir, however levels of • suffer from problems with your bowel In patients with head injuries. affects you. norpethidine (a toxic metabolite) may rise. Concomitant • have weak muscular movement • It is an offence to drive if this medicine affects your ability to • have lung problems Warnings : administration of ritanovir and pethidine should be avoided. drive. Histamine H2 antagonists If you are elderly or ill, or your baby or child is being given • However, you would not be committing an offence if: Repeated use may result in dependence of the morphine type. Cimetidine can reduce the metabolism of pethidine resulting in Pethidine Injection, special care will be taken. • The medicine has been prescribed to treat a medical or Pethidine should be used with caution in patients with acute or increased plasma concentration. dental problem and chronic airflow obstruction including asthma. If any of the above apply to you or your child, please tell your Effects of pethidine on other drugs • You have taken it according to the instructions given by the Pethidine should be used with caution or in reduced doses in doctor before being given Pethidine Injection. Pethidine may have an effect on the activities of other drugs, for prescriber or in the information provided with the medicine patients with myasthenia gravis. Other medicines and Pethidine Injection and example domperidone, as a consequence of reduced gastro- Pethidine should only be given with caution and in reduced intestinal motility. Tell your doctor, nurse or midwife if you are taking, have recently • It was not affecting your ability to drive safely doses to neonates, premature infants, patients who are elderly taken or might take any other medicines including medicines or debilitated or those with impaired hepatic or renal function. obtained without a prescription. Continued overleaf Continued overleaf

5459-B The plasma levels of ciprofloxacin may be reduced in the presence stimulation, cyanosis, miosis, skeletal muscle flaccidity or tremors, Talk to your doctor or pharmacist if you are not sure whether it is • sweating of premedicants. cold, clammy skin, hypothermia, bradycardia and hypotension. safe for you to drive while taking this medicine. • a fast or slow heartbeat Plasma levels of mexiletine may also be reduced in the presence In severe overdosage, apnoea, circulatory collapse, pulmonary Having Pethidine Injection with food, drink and alcohol • palpitations (an irregular heart rhythm or missed beats) of opioid analgesics. oedema, mydriasis, cardiac arrest and death may occur. You are advised not to drink alcohol during your treatment with • low blood pressure, the symptoms of which include feeling Possible increased serotonergic effects when pethidine is given Management: this medicine. dizzy or light-headed, feeling weak and fainting. with SSRI’s. Treatment is supportive. A patent airway must be established • high blood pressure with assisted or controlled ventilation. If signs of CNS toxicity are 3. How Pethidine Injection will be given • pin-point pupils Sedative medicines such as benzodiazepines or related drugs: • a feeling of dizziness or spinning exhibited the use of pethidine should be discontinued. Narcotic Your doctor will give Pethidine Injection to you as an injection The concomitant use of with sedative medicines such as • fainting antagonists may be required if there is evidence of significant into a vein (intravenously), under the skin (subcutaneously) or benzodiazepines or related drugs increases the risk of sedation, • feeling weak respiratory or cardiovascular depression. into a muscle (intramuscularly). Your doctor will determine how respiratory depression, coma and death because of additive CNS • hallucinations (seeing or hearing things that aren’t real) depressant effect. The dose and duration of concomitant use Naloxone should be given intravenously as soon as possible and much you need. repeated every 2-3 minutes if necessary (refer to naloxone product • mood changes (symptoms include feeling tense and restless) should be limited. Adults literature for details). • headache For the relief of moderate to severe pain: Anti-convulsive therapy, oxygen, intravenous fluids, vasopressors • feeling faint on standing up from a seated position Pregnancy and Lactation: The usual initial dose is 25-100mg either into a muscle or under • slowed breathing Pregnancy and other supportive measures should be employed as indicated. the skin, or 25-50mg if given into a vein. The dose is given at a • a red, itchy rash There is inadequate evidence of safety in human pregnancy, but minimum of four hourly intervals if needed. • reduced sex drive the drug has been in widely use for many years without apparent Incompatibilities: For pain relief during labour: • difficulty achieving or maintaining an erection ill consequence. Animal studies have not shown any hazard. Pethidine is incompatible with salts and with other The usual dose is 50-100mg either into a muscle or under the skin • pain, redness or itching at the injection site As with all drugs during pregnancy care should be taken in drugs including aminophylline, heparin sodium, methicillin every 1-3 hours during labour up to a maximum of 400mg in 24 • hypothermia, the symptoms of which include shivering, assessing the risk to benefit ratio. Administration during labour sodium, morphine sulphate, nitrofurantoin sodium, phenytoin hours. drowsiness and feeling weak may cause respiratory depression in the new-born infant. sodium, sulphadiazine sodium, sodium iodide, sulphafurazole • feeling of intense happiness (euphoria) diethanolamine. Incompatibility has also been observed between For pain relief before and during an operation: Lactation: • difficulty in passing urine pethidine hydrochloride and acyclovir sodium, imipenem, The usual dose is 50-100mg into a muscle one hour before the Pethidine crosses the placental barrier and is excreted in breast operation. • spasms in the lower abdomen milk. Patients should be advised to discontinue breast-feeding frusemide and idarubicin. For continuous pain relief: • addiction during treatment with pethidine Colour changes or precipitation have been observed on The usual dose is 10-25mg by slow injection into the vein as • confusion mixing pethidine with the following drugs, minocycline needed. • tremor or involuntary shaking Side Effects: • convulsions hydrochloride, tetracycline hydrochloride, cefoperazone sodium, The elderly and ill There are no modern clinical studies available that can be used to • dry eye mezlocillin sodium, nafcillin sodium and liposomal doxorubicin It is recommended that a reduced dose be used. The usual initial determine the frequency of undesirable effects. Therefore, all the • dizziness hydrochloride. dose is up to a maximum of 25mg. undesirable effects listed are classified as “frequency unknown” • muscle twitching (cannot be estimated from the available data). Pharmacodynamics: Children For the relief of moderate to severe pain: Reporting of side effects The undesirable effects listed below include class effects for Pethidine is a synthetic opioid similar to morphine If you get any side effects, talk to your doctor or pharmacist or opioid analgesics and effects related to the pharmacologically The usual dose is 0.5-2mg per kilogram of body weight by although less potent and shorter acting. Its analgesic effect intramuscular injection. nurse. This includes any possible side effects not listed in this active metabolite, norpethidine. usually lasts for 2 to 4 hours. The analgesic effect occurs after leaflet. You can also report side effects directly via Yellow Card For pain relief before and during an operation: Immune system disorders: about 10 minutes following parenteral administration. It acts on Scheme. Website: www.mhra.gov.uk/yellowcard or search for The usual dose is 1-2mg per kilogram of body weight into the General hypersensitivity reactions the CNS system and smooth muscles via the peripheral nervous MHRA Yellow Card in the Google Play or Apple App Store. By muscle one hour before the operation. Psychiatric disorders: system. However, it has a weaker action on smooth muscle than reporting side effects you can help provide more information on morphine and therefore has less effect on cough, bowel motility, If you are given too much of Pethidine Injection: the safety of this medicine. Dependence, confusion, mood altered, mild euphoria, The symptoms and signs of taking too much of this medicine hallucinations, dysphoria biliary tone and secretion of pituitary hormones. Pethidine also causes the release of histamine from mast cells resulting in a include shallow breathing, drowsiness, incoordination, coma, 5. How to Store Pethidine Injection Nervous system disorders: seizures, blue skin and lips, eye closure (miosis), shaking, cold, number of allergic-type reactions. Keep this medicine out of the sight and reach of children. Drowsiness, dizziness, tremor, convulsions, headache, fainting, clammy skin, drop in body temperature, slow heartbeat and low Pethidine is a narcotic analgesic with similar actions to morphine. CNS excitation blood pressure. You should not be given Pethidine Injection after the expiry date Eye disorders: : This medicine will be given to you in hospital so it is unlikely you which is stated on the ampoule and carton label. The expiry date Dry eye, miosis, corneal reflex decreased will receive too much. Your doctor has information on how to refers to the last day of that month. The doctor or nurse will check Pethidine is rapidly absorbed following intramuscular or recognise and treat an overdose. that the product has not passed this date. Ear and labyrinth disorders: subcutaneous injection, however, there are wide inter-individual Vertigo variations. It is widely distributed in the tissues with a volume of If you feel unwell after being given this medicine, or are at all Do not store above 25°C. distribution of 200-300 litres and is extensively protein bound concerned you have been given too much, tell your doctor or Keep the ampoules in the outer carton. Protect from light. Cardiac disorders: nurse. Tachycardia, bradycardia, palpitations (60-80%). Pethidine is metabolised in the liver and excreted via the urine If you have any further questions on the use of this product, ask 6. Contents of the pack and other information Vascular disorders: (70% in 24hours). One of the metabolites, norpethidine, is your doctor or nurse. What Pethidine Injection contains Orthostatic hypotension, flushing, hypotension, hypertension, pharmacologically active and its accumulation can result in Active Ingredient: Pethidine Hydrochloride 5%w/v vasodilation toxicity. Urinary is pH-dependent, the lower the pH the 4. Possible Side Effects Other Ingredients: sodium hydroxide and water for injections. Respiratory, thoracic and mediastinal disorders: Like all medicines this medicine can cause side effects, although greater the clearance. At normal urinary pH only a small What Pethidine Injection looks like and contents of the pack: Respiratory depression not everybody gets them. amount of pethidine is excreted unchanged. Pethidine Injection is a sterile solution, supplied in clear glass Gastrointestinal disorders: Pethidine has a plasma elimination half-life of about 3 to 6 hours. Repeated use of pethidine can result in tolerance and ampoules. Each ampoule contains 1ml or 2ml of the solution. Nausea, vomiting, dry mouth, constipation The metabolite norpethidine is eliminated more slowly with a addiction Marketing Authorisation Holder: half-life of up to 20 hours and may accumulate with chronic use, If any of the following symptoms occur, contact your doctor or Hepatobiliary disorders: Martindale Pharma, Bampton Road, Harold Hill, especially in the presence of renal impairment. nearest accident and emergency department immediately. Biliary spasm or Ureteric spasm Romford, RM3 8UG, United Kingdom. Pethidine crosses the placenta and is excreted in breast milk. These are symptoms of a serious allergic reaction. Skin & subcutaneous tissue disorders: Both pethidine and norpethidine cross the blood/brain barrier Not known (frequency cannot be estimated from the Manufacturers: Sweating, rash, urticaria, pruritus and are found in the cerebrospinal fluid. available data): Macarthys Laboratories Limited, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom. Musculoskeletal and connective tissue disorders: Shelf Life: 36 months. • sudden wheeziness and tightness of chest Muscle twitching • swelling of eyelids, face or lips Renal & urinary disorders: Storage: Store below 25°C. • skin lumps or hives Product Licence Number: Difficulty in micturition, renal colic Keep the ampoules in the outer carton. Protect from light. • skin rash (red spots), itchiness, fever PL 01883/6150R • collapse Reproductive system and breast disorders: Product licence numbers: PL 01883/6150R This leaflet was last revised in: March 2021 Sexual dysfunction This leaflet was last revised in March 2021 Other side effects that may occur include: General disorders & administration site conditions: Not known (frequency cannot be estimated from the Hypothermia, weakness, injection site reactions including available data): induration and irritation • restlessness • drowsiness Overdose: • constipation • dry mouth Symptoms: • feeling sick (nausea) Respiratory depression, CNS depression with extreme somnolence • being sick (vomiting) progressing to incoordination, stupor or coma, convulsions, CNS • facial flushing

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