oxycodone hydrochloride

15 mg tablet contains 13.5 mg of oxycodone as 15 mg of oxycodone hydrochloride. 30 mg tablet contains 27 mg of oxycodone as 30 mg of oxycodone hydrochloride. 60 mg tablet contains 54 mg of oxycodone as 60 mg of oxycodone hydrochloride. 120 mg tablet contains 108 mg of oxycodone as 120 mg of oxycodone hydrochloride. Also contains lactose monohydrate.

Prolonged release, round, convex tablet. The 15 mg tablets are grey, marked OC on one side and 15 on the other. The 30 mg tablets are brown, marked OC on one side and 30 on the other. The 60 mg tablets are red, marked OC on one side and 60 on the other. The 120 mg tablets are purple, marked OC on one side and 120 on the other.

For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed.

Elderly and adults over 18 years:

OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.

OxyContin is not intended for use as a prn analgesic.

Increasing severity of pain will require an increased dosage of OxyContin tablets using individual tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made, where possible, in 25% - 50% increments. The need for escape medication more than twice a day indicates that the dosage of OxyContin tablets should be increased.

The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12-hourly. However, a few patients may require higher doses. Doses in excess of 1000 mg have been recorded.

Patients receiving oral morphine before OxyContin 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 must be emphasised that this is a guide to the dose ofOxyContin tablets required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Children under 18 years:

OxyContin should not be used in patients under 18 years of age.

Adults with mild to moderate renal impairment and mild hepatic impairment:

The plasma concentration in this population may be increased. Therefore dose initiation should follow a conservative approach. Patients should be started on OxyContin 5 mg 12-hourly or OxyNorm liquid 2.5 mg 6-hourly and titrated to pain relief as described above.

Use in non-malignant pain:

Opioids are not first line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals.

Cessation of therapy:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Children under 18 years:

OxyContin should not be used in patients under 18 years of age.

OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.

 Hypersensitivity to any of the constituents, respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known oxycodone sensitivity or in any situation where opioids are contra-indicated, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10 ml/min), chronic constipation, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for pre-operative use or for the first 24 hours post-operatively. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy.

The major risk of opioid excess is respiratory depression. As with all narcotics, a reduction in dosage may be advisable in hypothyroidism. Use with caution in patients with raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic disease or severe pulmonary disease, and debilitated, elderly and infirm patients. OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued immediately. As with all opioid preparations, patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to the intervention. If further treatment with OxyContin tablets is indicated then the dosage should be adjusted to the new post-operative requirement.

OxyContin 60 mg, 80 mg and 120 mg tablets should not be used in patients not previously exposed to opioids. These tablet strengths may cause fatal respiratory depression when administered to opioid naïve patients.

As with all opioid preparations, OxyContin tablets should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.

For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities. A crucial part of the assessment of a patient with chronic non-malignant pain is the patient's addiction and substance abuse history. There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone. OxyContin tablets, like all opioids, should be avoided in patients with a history of, or present alcohol and drug abuse.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects. There must be frequent contact between physician and patient so that dosage adjustments can be made. It is strongly recommended that the physician defines treatment outcomes in accordance with pain management guidelines. The physician and patient can then agree to discontinue treatment if these objectives are not met.

OxyContin has an abuse profile similar to other strong opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders.

As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed OxyContin tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see Section 4.9).

Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided.

Abuse of the tablets by parenteral administration can be expected to result in other serious adverse events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, which may be fatal.

OxyContin, like other opioids, potentiates the effects of tranquillisers, anaesthetics, hypnotics, anti-depressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression with hypertensive or hypotensive crisis.

Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be avoided.

Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone C_maxby 11%, AUC by 13%, and t_½elim. by 14%. Also an increase in noroxycodone level was observed, (C_max by 50%; AUC by 85%, and t_½elim. by 42%). The pharmacodynamic effects of oxycodone were not altered. This interaction may be observed for other potent inhibitors of cytochrome P450-2D6 enzyme. Cimetidine and inhibitors of cytochrome P450-3A such as ketoconazole, voriconazole and erythromycin may inhibit the metabolism of oxycodone.

Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see Tolerance and Dependence, below). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic.

Common (incidence of 1%) and uncommon (incidence of 1%) adverse drug reactions are listed in the table below.

Tolerance and Dependence:

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of OxyContin tablets may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. The opioid abstinence or withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, respiratory rate or heart rate.

Napp Pharmaceuticals Limited

POM – Prescription Medicine Only

23 November 2011