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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 oral use as an analgesic for moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Posology Adults:
Usual adult dose 5-10 mg. Owing to its long plasma half-life caution with repeated dosage should be observed in the very ill or elderly. The usual initial dose should be 5-10 mg, 6-8 hourly, later adjusted to the degree of pain relief obtained.
Paediatric population Not suitable. Elderly Use caution with repeated dosage in elderly and ill patients. Method of administration For oral administration only. Treatment goals and discontinuation Before initiating treatment with Methadone, a treatment strategy including treatment duration and treatment goals should be agreed together with the patient in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4). 4).
The undesirable effects of methadone treatment are in general the same as when treated with other opioids. The most common side effects are nausea and vomiting that is observed in approximately 20 % of the patients that go through methadone outpatient treatment, where the medicinal control is often unsatisfactory.
The most serious side effect of methadone is respiratory depression, which may emerge during the stabilisation phase. Apnoea, shock and cardiac arrest have occurred. Adverse reactions listed below are classified according to frequency and system organ class.
These side effects are more frequently observed in non-opioid-tolerant individuals.
Frequency groupings are defined according to the following convention:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). System organ class (MedDRA) Frequency Adverse event Blood and lymphatic system disorders Not known Reversible thrombocytopenia has been reported in opioid dependent patients with chronic hepatitis.
4) Common SedationNervous system disorders Uncommon Headache, syncope Eye disorders Common Blurred vision, miosis, Ear and labyrinth disorders Common Vertigo Cardiac disorders Rare Bradycardia, palpitations, cases of prolonged QT interval and torsade de pointes have been reported, especially with high doses of methadone.
Vascular disorders Uncommon Facial flush, hypotension Uncommon Pulmonary oedema, respiratory depression particularly with large doses, Respiratory, thoracic and mediastinal disorders Not known Central sleep apnoea syndrome. Very common Nausea, vomiting Common Constipation Uncommon Xerostomia, glossitis Gastrointestinal disorders Not known Acute pancreatitis Uncommon Bile duct dyskinesiaHepatobiliary disorders Not known Sphincter of Oddi dysfunction Common Transient rash, sweatingSkin and subcutaneous tissue disorders Uncommon Pruritis, urticaria, other rash and in very uncommon cases bleeding urticaria Endocrine disorders Not known Hyperprolactinaemia Renal and urinary disorders Uncommon Urinary retention, antidiuretic effect Reproductive system and breast disorders Uncommon Reduced potency, galactorrhoea, dysmenorrhoea and amenorrhoea Common Fatigue,General disorders and administration site conditions Uncommon Oedema of the lower extremities, asthenia, oedema, drug withdrawal syndrome Investigations Common Weight increase In long term use of methadone, as for maintenance treatment, the undesirable effects diminish successively and progressively during a period of several weeks however, obstipation and perspiration often remain.
Tolerance and dependence of the morphine type may occur, though it is said that methadone has a greater respiratory depressive effect and a lesser sedative effect than an equianalgesic dose of morphine. Toxic doses are highly variable, regular usage giving tolerance.
Pulmonary oedema is a frequent corollary of overdosage whilst the dose-related histamine-releasing property of methadone may account for at least some of the urticaria and pruritis associated with methadone administration. Methadone may lead to an increase in intracranial pressure.
Adverse effects occurring more rarely in patients being treated for opioid addiction are as follows: (a) A number of heroin patients have been reported to die within a few days of starting a methadone maintenance programme. Evidence of chronic persistent hepatitis was detected in ten heroin patients, who died within 2-6 days of starting methadone treatment.
The mean prescribed dose at the time of death was about 60mg. It has been suggested that these sudden deaths may have arisen as a result of accumulation of methadone over several days resulting in death from complications such as cardiac arrhythmias or cardiovascular collapse as methadone, like dextropropoxyphene, has membrane stabilising activity and can block nerve conduction.
In view of the possibility of reduced clearance and raised plasma levels it is recommended that liver function tests and urine tests be carried out prior to maintenance and that lower starting doses of methadone be used. (b) Evidence of hypoadrenalism has been found in chronic methadone patients.
Findings consistent with both deficient ACTH production and subsequent secondary hypoadrenalism and methadone induced primary adrenal cortical hypofunction have been reported. (c) Choreic movements involving the upper limbs, torso and speech mechanisms have been reported in a 25-year-old man receiving methadone hydrochloride maintenance therapy (45-60 mg/day) for 2 years.
1. • Respiratory depression, obstructive airways disease. • In cases of acute alcoholism, • Head injury or raised intracranial pressure. • It is not recommended during an asthma attack or where there is a risk of paralytic ileus. • Concurrent administration with monoamine oxidase inhibitors (including moclobemide), or within 2 weeks of discontinuation of treatment with them.
Concurrent use of other central nervous system depressants. 2). Babies born to mothers receiving methadone may suffer withdrawal symptoms. 4) • As with all opioid analgesics, this product should not be administered to patients with severe hepatic impairment as it may precipitate Porto- systemic Encephalopathy in patients with severe liver damage.
• As with other opioid drugs, methadone may cause constipation which is particularly dangerous in patients with severe hepatic impairment and measures to avoid constipation should be initiated early.
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.
Long-term use of methadone may lead to morphine-like dependence. The abstinence syndromes are similar to the ones observed with morphine and heroine, however less intense, but more long-lasting. 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.
Discontinuation of methadone resulted in complete alleviation of the abnormal movements with no recurrence during the subsequent eight months. (d) The function of the secondary sex organs was found to be markedly impaired in 29 male participants in a methadone maintenance programme.
9 mg) were reduced by over 50% compared to 16 heroin patients and 43 opioid-free controls. Serum testosterone levels were also approximately 43% lower in those on methadone. Whilst the sperm counts of the methadone users were more than twice the control level, reflecting a lack of sperm dilution by secondary sex organ secretion, the sperm motility of these subjects was markedly lower than normal.
Methadone should be given with caution to patients with asthma, convulsive disorders, depressed respiratory reserve, hypotension, hypothyroidism or prostatic hypertrophy. In cases of hepatic or renal impairment the use of methadone should be avoided or given in reduced doses.
Opioid Use Disorder (abuse and dependence) Methadone is an opioid analgesic and is highly addictive in its own right. 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 possible death.
As with other opioids, tolerance, physical, and/or psychological dependence may develop upon repeated administration of methadone. When used for the treatment of pain, repeated use of methadone can lead to Opioid Use Disorder (OUD).
A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.
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. 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. For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.
g. major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance […]