SYNASTONE

Treatment goals and discontinuation:

Before initiating treatment with Synastone 10mg/ml, solution for injection, 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).

Method of administration:

Intramuscular or subcutaneous injection. The intramuscular route is preferred when repeated administration is required. Volumes greater than 2ml (20mg) may need to be given in divided doses at different sites.

Adults:

In the treatment of drug addiction Initially 10-20mg per day, increasing by 10-20mg per day until there are no signs of withdrawal or intoxication. The usual dose is 40-60mg per day. The dose should be adjusted according to the individual needs of the patient with the aim of gradual reduction.

Providing a dosage schedule is difficult as it is largely subjective based on the addict’s reported drug use and a clinical assessment of their dependence. A cautious approach is usually adopted starting at a low dose and following with incremental increases as judged appropriate bearing in mind the general health of the patient.

5 below) In the treatment of moderate to severe pain Usually 5-10mg every 6-8 hours although doses should be adjusted according to response. In prolonged use it should not be administered more than twice a day.

Elderly and debilitated patients:

If repeated doses are required, use with caution due to the long plasma half- life. There may be a greater risk of respiratory depression, with or without any associated renal or hepatic impairment in this age group.

Children:

As methadone has not been studied in children, it should not be used in children under the age of 16 years until further data become available.

Methadone is associated with undesirable effects similar to other opioid analgesics. There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as “frequency unknown”.

Endocrine Disorders:- Hyperprolactinaemia. Metabolism and nutrition disorders:- Hypoglycaemia. 4), confusion, mood change including euphoria and dysphoria, hallucinations, restlessness, sleep disturbances. Nervous System Disorders:- Drowsiness, dizziness, vertigo.

Eye Disorders:- Dry eyes, visual disturbances such as miosis, nystagmus1, strabismus1, visual acuity reduced1. Cardiac Disorders:- Bradycardia, tachycardia, palpitations, QT prolongation, torsades de pointes. Vascular Disorders:- Orthostatic hypotension.

9 overdose), central sleep apnoea syndrome, dry nose. Gastrointestinal Disorders:- Nausea, vomiting (particularly at the start of treatement), constipation, biliary spasm, dry mouth. Skin & Subcutaneous tissue Disorders:- Sweating, facial flushing, rashes (urticaria, pruritus), oedema.

Musculoskeletal, Connective Tissue & Bone Disorders:- Muscle rigidity. Renal & Urinary Disorders:- Micturition difficulties, urinary retention, ureteric spasm. Reproductive System & Breast Disorders:- Decreased libido, dysmenorrhoea, amenorrhoea, sexual dysfunction.

General Disorders & Administration Site Disorders:- Uncommon: drug withdrawal syndrome Not known: hypothermia. 1Visual effects have been reported in infants and children exposed to methadone during pregnancy. 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.

Opioid Use Disorder (abuse and dependence) Methadone is an opioid analgesic and is highly addictive in its own right. It is controlled under the Misuse of Drugs Act 1971 (Schedule 2). 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.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. When used for the treatment of pain, repeated use of Synastone solution for injection 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 Synastone 10mg/ml solution for injection 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. Drug withdrawal syndrome When used for substitution or maintenance therapy 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).

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

1. Patients with known hypersensitivity to methadone. 2. Patients with respiratory depression and obstructive airways disease. 3. Use during an acute asthma attack. 4. Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of discontinuation of treatment with them.

5. Phaeochromocytoma. Opiates may induce the release of endogenous histamine and stimulate catecholamine release. 6. Risk of paralytic ileus. 7. Comatose patients.