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METHADONE ALKALOID is a brand name for Methadone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution therapy for maintenance of opioid dependence in adults in conjunction with appropriate medical, social and psychosocial care.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For oral administration only. This medicinal product should always be taken orally with or without food. This product must not be injected. Dosage should be titrated to individual needs of patients. Local clinical guidance may differ from the posology described hereafter and should be followed.
Substitution treatment with methadone should be prescribed by a doctor with experience in treating opiate/opioid-dependent patients, preferably at centres that have specialised in the treatment of opiate/opioid dependency. The dose is administered exclusively by the doctor or someone appointed by the doctor.
The amount to be taken is never measured by the patient. The appropriate dose is given to the patient for immediate use only and used as directed by the doctor. The dose is based on the occurrence of withdrawal symptoms and must be adjusted for each patient according to his or her individual situation and the way he or she feels.
In general, after adjustment of the dose, the aim is to administer the lowest possible maintenance dose. Adults In general the initial dose will be between 10-30 mg. The first dose given to a patient who has not recently used opioids should be no greater than 10-20 mg.
In cases where tolerance to opioids is high, the normal initial dose will be between 25-40 mg. The patient should be observed 3-4 hours after the first dose has been taken. If the patient is showing signs of overdose, continue to monitor the patient at fifteen- minute intervals.
If the patient enters a coma, administer naloxone as a prolonged infusion. In reaching the maintenance treatment it is recommended that the dose is increased by maximum 10 mg at a time. Dose increases should not be greater than 20 mg per week.
The majority of individuals in maintenance treatment will require 60-120 mg per day for an effective and safe treatment, some may however need a higher dosage. The dosage should be determined based upon the clinical evaluation. Physicians need to be aware of and adhere to currently accepted guidelines regulations and recommendations for treating opioid dependent patients including integrating psychosocial treatments and behaviour modification strategies for optimal results.
Dosing and duration should be individualised based on a careful evaluation of subjective and objective patient data, bearing in mind clinical status, including hepatic or renal function of the patient. Methadone is normally administered once daily.
The adverse effects of methadone are generally the same as with other opioids, most commonly 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.
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. The most serious adverse 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 reactions 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 events Blood and lymphatic system disorders Not known Reversible thrombocytopenia has been reported in opioid-dependent patients with chronic hepatitis. Immune system disorders Not known Anaphylactic reaction Endocrine disorders Not known Raised prolactin levels with long-term administration; adrenal insufficiency Common Fluid retentionMetabolism and nutrition disorders Not known Anorexia, hypokalaemia, hypomagnesaemia, hypoglycaemia Common Euphoria, hallucinations, confusion Uncommon Dysphoria, agitation, insomnia, disorientation, decreased libido Psychiatric disorders Not known Dependence Common Sedation Uncommon Headache, syncope Nervous system disorders Not known Serotonin syndrome.
Methadone has the potential to increase intracranial pressure, particularly in circumstances where it is already raised. Common Blurred vision, miosis, dry eyesEye disorders Not known Nystagmus1, strabismus1, visual acuity reduced1 Common VertigoEar and labyrinth disorders Not known Hearing loss System organ class (MedDRA) Frequency Adverse events Rare Bradycardia, palpitations, cases of prolonged QT interval and torsade de pointes have been reported, especially with high doses of methadone.
It is advisable to reduce the dose for older patients, patients with renal disorders or mild to moderate hepatic disorders, and patients in poor general condition. 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.
Methadone can produce drowsiness and reduce consciousness although tolerance to these effects can occur after repeated use. Abuse or intentional misuse of Methadone Alkaloid 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.
Withdrawal Abrupt cessation of treatment can lead to withdrawal symptoms which, although similar to those with morphine, are less intense but more prolonged. Withdrawal of treatment should therefore be gradual. Respiratory depression Like other opioids, methadone should be used with caution in patients with asthma, chronic obstructive pulmonary disease or cor pulmonale and in patients with very limited respiratory reserve, a pre-existing impairment of respiratory function, hypoxia or hypercapnia.
Even at the usual therapeutic doses for narcotics, these patients can experience a reduction in respiratory activity with a concomitant increase in airway resistance culminating in apnoea. In patients predisposed to such atopic phenomena, pre-existing asthma, skin eruptions and blood count changes (eosinophilia) can be exacerbated.
1; - Use during an acute asthma attack; - Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretions; - Acute alcoholism; - Head injury and raised intracranial pressure; - Concurrent administration with monoamine oxidase (MAO) inhibitors or within 2 weeks of discontinuation of treatment with them; - Absence of dependence on opioid substances; - Individuals with QT prolongation, including congenital long QT syndrome; - 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.
- Ulcerative colitis, since it may precipitate toxic dilatation or spasm of the colon; - Biliary and renal tract spasm. Use during labour is not recommended; the prolonged duration of action increases the risk of neonatal respiratory depression.
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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If administered more frequently, there will be a risk of accumulation and overdose. The highest recommended dose, that rarely should be used, is 150 mg/day (unless national guidelines recommend otherwise). 4). g. buprenorphine), the dose should be reduced gradually when the methadone treatment is initiated.
If the methadone treatment is interrupted and a switch to sublingual buprenorphine treatment is planned (especially in combination with naloxone), the methadone dose should be reduced to 30 mg/day initially to avoid withdrawal symptoms caused by buprenorphine/naloxone.
Treatment discontinuation Treatment discontinuation must always be done very gradually, by weekly steps of 5-10 mg over several weeks to months. During this period of gradual dose reduction, it is necessary to pay attention to any recurrence of withdrawal symptoms which would require a return to the previous dosage, and to any resumption of addictive behaviours.
4). In common with other opioids, methadone may cause confusion in this age group, therefore careful monitoring is advised. Patients with renal impairment Caution should be exercised in the use of Methadone Alkaloid 1 mg/ml in patients with renal impairment.
The dose interval should be lengthened to a minimum of 32 hours if the glomerular filtration rate (GFR) is 10-50 ml/min and to a minimum of 36 hours if the GFR is lower than 10 ml/min. Patients with hepatic impairment Particular care should be taken when Methadone Alkaloid 1 mg/ml is to be used in patients with hepatic impairment as these patients metabolise methadone more slowly than normal patients.
4). Paediatric population There are no data available on the use in patients under 18 years of age. 4). Method of administration Methadone Alkaloid 1 mg/ml oral solution may only be used orally and under medical supervision and it must not be injected.
The patient receives the required dose from the doctor or someone appointed by the doctor and takes it immediately. The required amount is measured exclusively by the doctor or the person appointed by the doctor. Take-home must be prescribed by the doctor.
Take-home prescription is not acceptable if the doctor's tests and findings reveal that the patient consumes substances that are dangerous when combined with the substitution treatment, taking into account the development of tolerance, a stable maintenance dose has not yet been reached, or there is substance abuse by the patient.
Methadone Alkaloid 1 mg/ml oral solution contains sorbitol which may affect the bioavailability of methadone in some individuals. In these individuals switching between Methadone Alkaloid 1 mg/ml oral solution and other methadone products which do not contain sorbitol can result in clinically relevant changes in plasma methadone levels.
Caution is advised in case a need for product switching arises, especially in patients […]
Cardiac disorders Not known Cardiac arrest Uncommon Facial flush, hypotensionVascular disorders Rare Collapse, shock Uncommon Pulmonary oedema, exacerbation of asthma, dry nose, respiratory depression particularly with large doses.
Rare Respiratory arrest Respiratory, thoracic and mediastinal disorders Not known Central sleep apnoea syndrome Very common Nausea, vomiting Common Constipation Uncommon Xerostomia, glossitis Rare Intestinal hypomotility (ileus) Gastrointestinal disorders Not known Acute pancreatitis Uncommon Bile duct dyskinesia (spasm)Hepatobiliary disorders Not known Sphincter of Oddi dysfunction Common Transient rash, sweatingSkin and subcutaneous tissue disorders Uncommon Pruritus, urticaria, other rash and in very uncommon cases bleeding urticaria Uncommon Urinary retention, anti-diuretic effectRenal and urinary disorders Not known Methadone, in common with other opioids may cause spasm of the renal tract.
6). System organ class (MedDRA) Frequency Adverse events Common Fatigue, drowsinessGeneral disorders and administration site condition Uncommon Oedema of the lower extremities, asthenia, oedema, hypothermia Investigations Common Weight increase 1Visual effects have been reported in infants and children exposed to methadone during pregnancy Withdrawal (abstinence) syndrome: Chronic use of opioid analgesics may be associated with the development of physical dependence.
An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued or opioid antagonists administered. Withdrawal symptoms that may be observed after discontinuation of opioid use include: body aches, diarrhoea, piloerection, anorexia, nervousness or restlessness, rhinorrhoea, sneezing, tremors or shivering, abdominal colic, nausea, sleep disturbance, unusual increase in sweating and yawning, weakness, tachycardia and unexplained fever.
With appropriate dose adjustments and gradual withdrawal these symptoms are usually mild. In long term use of methadone, as for maintenance treatment, the undesirable effects diminish successively and progressively during a period of several weeks however, constipation and perspiration often remain.
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.
By reporting of side effects, you can help provide more information on the safety of this medicine.
Asthma may be exacerbated due to histamine release. Respiratory depression is a major risk associated with methadone treatment. Due to the slow accumulation of methadone in the tissues, respiratory depression may not be fully apparent for a week or two.
The symptoms and signs of overdosage and toxicity of methadone are essentially those for morphine, though it is said that methadone has a greater respiratory depressive effect and a lesser sedative effect than an equi-analgesic 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 pruritus associated with methadone administration.
5). 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.
Cardiac arrhythmias Cases of QT interval prolongation and torsades de pointes have been reported during treatment with methadone, particularly at high doses (>100 mg/day). g. e. 5). In patients with these recognised risk factors for QT-prolongation, or in case of concomitant treatment with substances 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 100 mg/day and at seven days after titration. Head injury and increased intracranial pressure The respiratory depressant effects of methadone and its capacity to elevate cerebrospinal-fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increased intracranial pressure.
Furthermore, opioids produce side effects that may obscure the clinical course of patients with head injuries. In such patients, methadone must be used with caution and only if it is deemed essential. Methadone has the potential to increase intracranial pressure especially where it is already raised.
Gastro-intestinal motility Opioids including methadone may cause troublesome constipation, which is particularly dangerous in patients with severe hepatic impairment, and measures to avoid constipation should be initiated early. Hepatobiliary disorders Methadone may cause dysfunction and spasm of the sphincter of Oddi, increasing the risk of biliary tract symptoms and pancreatitis.
Therefore, methadone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. Hypoglycaemia Hypoglycaemia has been observed in the context of methadone overdose or dose escalation. Regular monitoring of blood sugar is recommended during dose […]