OXYACT Film-coated tablet Ref.[27781] Active ingredients: Oxycodone

Posology

The dose depends on the pain intensity and the patient’s individual susceptibility to the treatment.

For doses not realisable/practicable with this strength other strengths of this medicinal product are available.

The following general dose recommendations apply:

Adults and adolescents (≥12 years of age)

Dose titration and adjustment

The initial dose for opioid-naïve patients is usually 5 mg oxycodone hydrochloride given at intervals of every 6 hours. The dose may be increased in steps of 25% to 50% of the respective dose. The aim is a patient-specific dose which allows for adequate analgesia with tolerable undesirable effects. Therefore, the dosing interval may be shortened to 4 hours if needed.

However, Oxyact should not be taken more often than 6 times a day.

Some patients receiving prolonged-release oxycodone medicinal products according to a fixed time schedule may require immediate-release analgesics as rescue medication for the management of breakthrough pain. Oxyact is appropriate for the management of breakthrough pain. Single doses of the rescue medication should be adjusted based on the patients' individual requirements. In general, 1/8 to 1/6 of the daily prolonged-release oxycodone dose is appropriate.

The requirement of rescue medication more than twice daily may indicate that higher doses of prolonged-release oxycodone are necessary. The aim is to establish a patient-specific dosage which ensures adequate analgesia with tolerable undesirable effects and as low rescue medication as possible for as long as pain medication is necessary in patients receiving prolonged-release oxycodone treatment twice daily.

Patients already receiving opioids may start treatment with higher doses taking into account their experience with former opioid therapies.

10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the film-coated formulation.

Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with oxycodone hydrochloride after conversion from other opioids, with 50-75% of the calculated oxycodone dose.

In general, patients should be titrated individually until pain relief is achieved, provided that undesirable adverse events can be adequately managed.

If long-term pain treatment is required, the patients should be switched to oxycodone hydrochloride prolonged-release tablets.

Duration of treatment

Oxycodone hydrochloride should not be taken longer than necessary. If long- term treatment is necessary due to the type and severity of the illness, careful and regular monitoring is required to determine whether and to what extent treatment should be continued. If opioid therapy is no longer indicated it may be advisable to reduce the daily dose gradually in order to prevent symptoms of a withdrawal syndrome.

Special populations

Elderly patients

Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.

vPatients with renal or hepatic impairment

The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to his/her clinical situation.

Other patients at risk

Patients with low body weight or slow metabolisers who are also opioid naïve, should initially be treated with half the dose usually recommended for adults.

Paediatric population

The safety and efficacy of Oxyact in children under 12 years of age has not been established. Therefore use of Oxyact is not recommended in this age group.

Method of administration

Oral Use.

Oxyact film-coated tablets should be taken every 4-6 hours based on a fixed schedule at the dosage determined.

The film-coated tablets may be taken with or independent of meals with a sufficient amount of liquid.

Oxyact film-coated tablets should not be used with alcoholic bevarages.

Symptoms

Acute overdose with oxycodone can be manifested by miosis, respiratory depression, somnolence progressing to stupor or coma, reduced skeletal muscle tone and drop in blood pressure. In severe cases circulatory collapse, bradycardia and non-cardiogenic lung oedema may occur; abuse of high doses of strong opioids such as oxycodone can be fatal.

Therapy

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In case of overdose, intravenous administration of an opioid antagonist (e.g. 0.4-2 mg intravenous naloxone) may be indicated. Administration of single doses must be repeated depending on the clinical situation at intervals of 2 to 3 minutes. Intravenous infusion of 2 mg of naloxone in 500 ml sodium chloride 9 mg/ml (0.9%)or glucose 50 mg/ml (5%) solution (corresponding to 0.004 mg naloxone/ml) is possible. The rate of infusion should be adjusted to the previous bolus injections and the response of the patient.

Gastric lavage can be taken into consideration. The adminsitration of activated charcoal (50 g for adults, 10 -15 g for children) should be considered within 1 hour, if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for film-coated preparations; however there is no evidence to support this.

For speeding up the passage a suitable laxative (e.g. a PEG-based solution) may be useful.

Supportive measures (artificial respiration, oxygen supply, administration of vasopressors and infusion therapy) should, if necessary, be applied in the treatment of accompanying circulatory shock. Upon cardiac arrest or cardiac arrhythmias, cardiac massage or defibrillation may be indicated. If necessary, assisted ventilation as well as maintenance of water and electrolyte balance.

5 years.

This medicinal product does not require any special storage conditions.

Child resistant PVC/PVdC/aluminium blisters containing 10, 20, 30, 56 and 60, film-coated tablets.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.