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METHADONE HYDROCHLORIDE is a brand name for Methadone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe pain where morphine may be a reasonable alternative, such as severe cancer pain.
Verbatim from this product's MHRA label. Tap a section to expand.
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. The product is for oral use only and must not be injected.
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 stabilization 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.
Metabolism and nutrition Common Fluid retention disorders Not known Anorexia, hypokalaemia, Hypomagnesaemia Common Euphoria, hallucinationsPsychiatric disorders Uncommon Dysphoria, dependence, agitation, insomnia, disorientation, reduced libido 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 depointes have been reported, especially with high doses of methadone.
Vascular disorders Uncommon Facial flush, hypotension Respiratory, thoracic and mediastinal disorders Uncommon Pulmonary oedema, respiratory depression particularly with large doses. Very common Nausea, vomiting Common Constipation Gastrointestinal disorders Uncommon Xerostomia, glossitis Hepatobiliary disorders Uncommon Bile duct dyskinesia Common Transient rash, sweatingSkin and subcutaneous tissue disorders Uncommon Pruritis, urticaria, other rash and in very uncommon cases bleeding urticaria.
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 pruritic 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. • Obstetric use is not recommended, because in labour the prolonged duration of action increases the risk of neonatal respiratory depression. 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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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 FatigueGeneral disorders and administration site conditions Uncommon Oedema of the lower extremities, asthenia, oedema, Investigations Common Weight increase Ear and labyrinth disorders Common Vertigo Eye disorders Common Sedation Common Blurred vision, miosisNervous system disorders Uncommon Headache, syncope Common Transient rash, sweatingSkin and subcutaneous tissue disorders Uncommon Pruritus, urticaria, other rash and in very uncommon cases bleeding urticaria.
Common FatigueGeneral disorders and administration site conditions Uncommon Oedema of the lower extremities, asthenia, oedema Hepatobiliary disorders Uncommon Bile duct dyskinesia Vascular disorders Uncommon Facial flush, hypotension Cardiac disorders Rare Bradycardia, palpitations, cases of prolonged QT intervals and “torsade de pointes” have been reported in treatment with methadone, especially with high doses.
Reproductive system and breast disorders Uncommon Reduced potency and amenorrhea 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.
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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.
Cases of QT interval prolongation and torsades de pointes have been reported during treatment with methadone, particularly at high doses (> 100 mg/d). g. e. 5). In patients with recognised risk factors for QT-prolongation, or in case of concomitant treatment with drugs that have a potential for QT-prolongation, ECG monitoring is recommended prior to methadone treatment, with a further ECG test at dose stabilisation.
ECG monitoring is recommended, in patients without recognised risk factors for QT prolongation, before dose titration above 100mg/d and at seven days after titration. Paediatric population Children are more sensitive than adults and intoxication may follow a low dose intake of methadone.
To avoid such intoxication following dose administration by mistake, methadone should be kept in a safe place out of reach by children when located at home. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.