METHADONE

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. P. - Sugar Free, 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 tissue disorders Not known Rashes, pruritus, urticaria, 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.

P. - Sugar Free, contains benzoic acid and dyes. Benzoic acid is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies. E110 can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

4g of sorbitol. Unsuitable in hereditary fructose intolerance. Can cause stomach upset and diarrhoea. 19% v/v of ethanol. Harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.

May modify the effect of other medicines. 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.

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).