METHADONE MIXTURE

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).

4). Posology Adults: 10 - 20mg (10 - 20ml) should be taken as an initial daily dose by oral administration. The dose should be increased cautiously by 10 - 20mg daily until no signs of withdrawal or intoxication occur. The usual dose for maintenance is 40 - 60mg daily.

The dose can then be gradually decreased, when appropriate, until total withdrawal is achieved.

Elderly:

Methadone mixture should be used cautiously in elderly patients. 3). Method of administration For oral administration only

Tabulated list of adverse reactions Adverse reactions frequency are defined using 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).

4), hallucinations, confusion, mood changes including dysphoria, decreased libido Nervous system disorders Not known Methadone may increase intra-cranial pressure, particularly when it is already raised. Dizziness, headache, drowsiness Eye disorders Not known Miosis, nystagmus1, strabismus1, visual acuity reduced1 Ear and labyrinth disorders Not known Vertigo Cardiac disorders Not known Cases of QT prolongation and torsade de pointes have been rarely reported.

Bradycardia, palpitations, tachycardia Vascular disorders Not known Hypotension, facial flushing Respiratory, thoracic and mediastinal disorders Not known Respiratory depression, Exacerbation of existing asthma, central sleep apnoea syndrome Gastrointestinal disorders Not known Nausea, vomiting, constipation, dry mouth, acute pancreatitis Hepatobiliary disorders Not known Biliary spasm, sphincter of Oddi dysfunction Skin and subcutaneous Not known Rashes, pruritus, urticaria, tissue disorders excessive sweating Renal and urinary disorders Not known Difficulty in micturation, ureteric spasm, antidiuretic effect Reproductive system and breast disorders Not known Erectile dysfunction, reductions in the ejaculate volume and seminal vesicular and prostatic secretions Unknown Drug withdrawal syndrome.

In prolonged use it should not be administered more than twice daily to avoid the risk of accumulation and overdosage. General disorders and administration site conditions Not known Hypothermia. Investigations Not known Globulins increased, blood albumin increased 1Visual effects have been reported in infants and children exposed to methadone during pregnancy.

In the case of elderly or ill patients, repeated doses should only be given with extreme caution. Methadone is a drug of addiction and is controlled under the Misuse of Drugs Act 1971 (Schedule 2). Tolerance and dependence of the morphine type may occur.

3), convulsive disorders, depressed respiratory reserve, hypotension, shock, prostatic hyperplasia, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, myasthenia gravis or hypothyroidism. 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 torsade de pointes have been reported during treatment with methadone, particularly at high doses (>100mg/d). g. e. 5). In patients with recognised risk factors of 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. 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.

Abuse or intentional misuse of Methadone mixture 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. 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 histamine release Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of methadone and sedative drugs such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

1. • Respiratory depression, obstructive airways disease and during an acute asthma attack, • Patients dependent on non-opioid drugs, • Concurrent administration with monoamine oxidase inhibitors (including moclobemide) or within 2 weeks of discontinuation of them.

8). • Where there is a risk of paralytic ileus. 5). • Use during labour (prolonged duration of action increases the risk of neonatal depression). • Methadone is not suitable for children (serious risk of toxicity).