LYNLOR Capsule, hard Ref.[8076] Active ingredients: Oxycodone

Posology

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

The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment. The following general dose recommendations apply:

Adults and adolescents over 12 years of age

Dose initiation

In general, the initial dose for opioid naïve patients is 5 mg oxycodone hydrochloride given at intervals of 6 hours. Patients already receiving opioids may start treatment with higher doses taking into account their experience with former opioid therapies.

Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It should be noted that this is a guide to the dose of oxycodone hydrochloride capsules required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Dose adjustment

Increasing severity of pain will require an increased dose of this medicine. The dose should be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. In doing so, the dosing interval may be reduced to 4 hours. The correct dose for any individual patient is that which controls the pain and is well tolerated throughout the dosing period.

The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.

In patients receiving a prolonged-release formulation of oxycodone, this medicine may be used to control breakthrough pain. The dose should be adjusted according to the patient´s need but as a general rule the single dose should amount to 1/8 to 1/6 of the daily dose of the prolonged-release formulation. The rescue medication should not be used more frequently than every 6 hours.

Transferring patients between oral and parenteral oxycodone

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Duration of administration

This medicine 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

Paediatric population

This medicine is not recommended for children under 12 years of age as the safety and efficacy has not been established.

Elderly patients

The lowest dose should be administered with careful titration to pain control.

Patients 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 their clinical situation.

Risk patients

Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially receive half the recommended adult dose if they are opioid naïve.

Therefore, the lowest recommended dose, i.e. 5 mg, may not be suitable as a starting dose.

Dose titration should be performed in accordance with the individual clinical situation and using the appropriate formulation as available.

Method of administration

For oral use.

This medicine should be administered using a fixed schedule at the dose determined but not more often than every 4 to 6 hours.

The capsules may be taken with or without food with a sufficient amount of liquid.

The medicinal product should not be taken with alcoholic beverages.

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.

Acute overdose with oxycodone can be manifested by miosis, respiratory depression, hypotension and hallucinations. Circulatory failure and somnolence progressing to stupor or deepening coma, hypotonia, bradycardia, pulmonary oedema and death may occur in more severe cases.

Treatment of oxycodone overdosage: primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation. The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose. Other supportive measures should be employed as needed.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient’s clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients.

For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected.
• Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.

Blister packs (PVC/PVdC/Al): 3 years.

Child resistant blister packs (PVC/PVdC/Al/PET/paper): 2 years.

Child resistant HDPE containers with threaded neck with PP Cap (Twist off Cap): 2 years.

<[For HDPE container only:]> After opening: 6 months.

Do not store above 30°C.

Blister packs (PVC/PVdC/Al).

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules

Child resistant blister packs (PVC/PVdC/Al/PET/paper).

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules

Child resistant HDPE containers with threaded neck with PP Cap (Twist off Cap).

Pack sizes: 56, 98, 100 and 250 capsules

Not all pack sizes may be marketed.

No special requirements.

Instructions for use of child resistant blisters:

1. Do not push the capsule directly out of the pocket.
2. Separate one blister cell from the strip at the perforations.
3. Carefully peel off the backing to open the pocket.