PHYSEPTONE MIXTURE Oral solution Ref.[9784] Active ingredients: Methadone

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with methadone in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). 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).

Posology

Addiction

Adults

Initially 10-20mg/day, increasing by 10-20mg/day until there is no sign of withdrawal or intoxication. The usual dose is 40-60mg/day. The dose is adjusted according to the degree of dependence, with the aim of gradual reduction.

Elderly

In the case of the elderly or ill patients, repeated doses should be given with extreme caution.

Paediatric population

Not recommended (see section 4.3).

Method of administration

For oral administration.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Symptoms

Serious overdose is characterised by respiratory depression, extreme somnolence progressing to stupor or coma, maximally constricted pupils, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. In severe overdose, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest and death may occur. Hypoglycaemia has been reported.

Treatment

A patent airway and assisted or controlled ventilation must be assured. Narcotic antagonists may be required but it should be remembered that methadone is a long acting depressant (36-48 hours), whereas antagonists act for 1-3 hours, so that treatment with the latter must be repeated as needed. Observation and supportive measures must be continued for 36-48 hours.

An antagonist should not be administered, however, in the absence of clinically significant respiratory or cardiovascular depression.

Nalorphine (0.1mg/kg) or Levallorphan (0.02mg/kg) should be given intravenously as soon as possible and repeated, if necessary, every 15 minutes. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. In a person physically dependant on narcotics, administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome: use of the antagonist in such a person should be avoided if possible, but if it must be used to treat serious respiratory depression, it should be administered with great care.

• 48 months glass bottles.
• 24 months plastic bottles.

Use within 1 month of opening.

Store below 25°C, protect from light.

Amber glass Winchester bottle with a tamper evident child proof lined cap. 500, 100, 50 and 30ml pack sizes are available. Or HDPE plastic bottle with lined cap. The plastic bottles come in four different sizes; the 1L and 500ml bottles are sealed with a tamper evident and child resistant cap whereas the 2.5 and 5 L bottles are sealed with a tamper evident cap or tamper evidence is provided with a tamper evident sticker.

The product is not supplied with a patient leaflet but patient leaflets are available to the prescriber and dispenser in a tear off pad format.

The material for the construction of the closures is a HDPE with an EP wad.

Not all pack sizes may be marketed.

Methadone is controlled under the Misuse of Drugs Act 1971 (Schedule 2).

Any unused product or waste material should be returned to the pharmacy or doctor for disposal.