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METHADONE is a brand name for Methadone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For use in the treatment of opioid drug addictions (as a narcotic abstinence syndrome suppressant).
Verbatim from this product's MHRA label. Tap a section to expand.
4). The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress).
Addiction:
Adults: Initially 10-20 mg per day, increasing by 10-20 mg per day until there are no signs of withdrawal or intoxication. The usual dose is 40-60 mg per day.
Elderly:
In the case of the elderly or ill patients repeated doses should only be given with extreme caution.
Children:
Not recommended for children.
Dosage in pregnancy:
Drug withdrawal needs to be achieved 4-6 weeks before delivery if neonatal abstinence syndrome is to be certain to be avoided, but abrupt withdrawal can cause intrauterine death. Detoxification to abstinence is least stressful to mother and foetus if undertaken during the mid trimester.
Abstinence syndrome may not occur in the neonate for some days after birth. In the event that withdrawal is not possible prior to delivery, methadone administered to the mother may result in prolonged respiratory depression in the neonate and the administration of opioid antagonists may be required.
Method of administration For oral administration only.
FrequencySystem organ class Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from the available data) Endocrine Disorders Raised prolactin levels with long-term administration. 4), confusion particularly at the start of the treatment can occur, changes of mood, including euphoria, and hallucinations are occasionally reported.
Nervous System Disorders Drowsiness and headache. Methadone has the potential to increase intracranial pressure, particularly in circumstances where it is already raised. Eye Disorders Miosis, dry eyes, nystagmus1, strabismus1, visual acuity reduced1.
Ear and labyrinth disorders Vertigo. Cardiac Disorders Bradycardia and palpitations can occur. Cases of QT prolongation and torsades de pointes have been rarely reported. Vascular disorders Orthostatic hypotension, facial flushing. Respiratory, thoracic and mediastinal disorders Central sleep apnoea syndrome, exacerbation of existing asthma, dry nose, respiratory depression particularly with larger doses.
Gastrointestinal disorders Nausea and vomiting particularly at the start of treatment can occur. Constipation, dry mouth. Skin and subcutaneous tissue disorders Rashes. Long-term administration may produce excessive sweating Renal and urinary disorders Micturition difficulties are observed.
Reproductive system and breast disorders Galactorrhoea, dysmenorrhoea, amenorrhoea General disorders and administration site conditions Drug withdrawal syndrome. Hypothermia 1Visual effects have been reported in infants and children exposed to methadone during pregnancy.
Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4. 1 3 PHARMACEUTICAL FORM Oral solution. Clear Green solution. 1 Therapeutic indications For use in the treatment of opioid drug addictions (as a narcotic abstinence syndrome suppressant). 4). The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress).
Addiction:
Adults: Initially 10-20 mg per day, increasing by 10-20 mg per day until there are no signs of withdrawal or intoxication. The usual dose is 40-60 mg per day.
Elderly:
In the case of the elderly or ill patients repeated doses should only be given with extreme caution.
Children:
Not recommended for children.
Dosage in pregnancy:
Drug withdrawal needs to be achieved 4-6 weeks before delivery if neonatal abstinence syndrome is to be certain to be avoided, but abrupt withdrawal can cause intrauterine death. Detoxification to abstinence is least stressful to mother and foetus if undertaken during the mid trimester.
Abstinence syndrome may not occur in the neonate for some days after birth. In the event that withdrawal is not possible prior to delivery, methadone administered to the mother may result in prolonged respiratory depression in the neonate and the administration of opioid antagonists may be required.
Method of administration For oral administration only. 3 Contraindications • Respiratory depression, obstructive airways disease, • Concurrent administration with MAO inhibitors or within 2 weeks of discontinuation of treatment with them.
• Respiratory depression, obstructive airways disease, • Concurrent administration with MAO inhibitors or within 2 weeks of discontinuation of treatment with them. • Use during labour is not recommended; the prolonged duration of action increases the risk of neonatal depression.
• Methadone is not suitable for children. • Hypersensitivity to methadone or any of the excipients. • Patients dependent on non-opioid drugs • Patients with acute alcoholism, head injury and raised intra-cranial pressure. • Patients with ulcerative colitis, since methadone may precipitate toxic dilation or spasm of the colon.
• Patients with severe hepatic impairment as it may precipitate hepatic encephalopathy. • Patients with biliary and renal tract spasm.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methadone in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• Use during labour is not recommended; the prolonged duration of action increases the risk of neonatal depression. • Methadone is not suitable for children. • Hypersensitivity to methadone or any of the excipients. • Patients dependent on non-opioid drugs • Patients with acute alcoholism, head injury and raised intra-cranial pressure.
• Patients with ulcerative colitis, since methadone may precipitate toxic dilation or spasm of the colon. • Patients with severe hepatic impairment as it may precipitate hepatic encephalopathy. • Patients with biliary and renal tract spasm.
4 Special warnings and precautions for use Caution should be exercised in patients with hepatic dysfunction or renal dysfunction. In the case of elderly or ill patients, repeated doses should only be given with extreme caution. Opioid Use Disorder (abuse and dependence) Methadone is an opioid analgesic and is highly addictive in its own right.
It is controlled under the Misuse of Drugs Act 1971 (Schedule 2). It has a long half-life and can therefore accumulate. A single dose which will relieve symptoms may, if repeated on a daily basis, lead to accumulation and possibly death.
As with other opioids, tolerance, physical, and/or psychological dependence may develop upon repeated administration of methadone, even at therapeutic doses. Abuse or intentional misuse of methadone may result in overdose and/or death.
, major depression, anxiety and personality disorders). , too early requests for refills). This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Methadone can produce drowsiness and reduce consciousness although tolerance to these effects can occur after repeated use.
Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with methadone. The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Respiratory depression Due to the slow accumulation of methadone in the tissues, respiratory depression may not be fully apparent for a week or two and may exacerbate asthma due to […]