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Uses

Acute Pain

Relief of moderate to moderately severe pain.

Usually, temporary relief of moderate to moderately severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.

Additive analgesic effects with combinations of oxycodone and NSAIAs or acetaminophen because of differing mechanisms of action.

Consider around-the-clock dosing of analgesics in the initial stages of acute pain to avoid wide swings in pain and sedation often associated with as-needed dosing regimens.

Extended-release tablets are not intended for use on an as-needed (“prn”) basis, but when a continuous, around-the-clock analgesic is needed for an extended period of time.

Chronic Pain

For relief of malignant (cancer) pain and chronic nonmalignant pain.

In the management of chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Analgesic therapy must be individualized and titrated according to patient response and tolerance.

When opiate therapy is indicated, usually initiate with a mild, oral opiate like oxycodone.

Although consideration of the dependence potential of opiate agonists has often limited their effective use by many clinicians in terminally ill patients with severe, chronic pain, such consideration is irrelevant in the context of terminal illness.

Treatment of continuous or frequently recurring pain is best accomplished by the use of “around-the-clock” dosing regimens designed to prevent pain and minimize fluctuations in serum analgesic concentrations.

If pain severity increases, switching to more potent analgesics may be necessary; also consider alternative analgesic adjuncts such as tricyclic antidepressants or anticonvulsants (e.g., in the treatment of chronic nonmalignant pain such as neurogenic pain).

Dosage and Administration

General

Extended-release Tablets

• Adjust dosage according to patient tolerance and response; provide supplemental analgesia in the form of conventional preparations or another suitable short-acting analgesic for breakthrough pain or to prevent pain that occurs predictably (e.g., incident pain associated with certain activities).
• Only use the 80- and 160-mg formulations in opiate-tolerant patients whose opiate requirement is equivalent to a daily oxycodone dosage of 160 mg or more for the 80-mg tablet or 320 mg or more for the 160-mg tablet.
• Supplemental analgesia may be necessary during therapy with extended-release tablets for breakthrough pain; discontinue any other existing around-the-clock opiate regimens when extended-release oxycodone therapy is initiated.
• When therapy with oxycodone extended-release tablets is discontinued, it should be done gradually to avoid precipitation of withdrawal symptoms.

Administration

Oral Administration

Administer orally.

Extended-release Tablets

Swallow tablets whole; do not divide, crush, or chew. (See Boxed Warning.)

Food does not substantially affect the extent of oral absorption from extended-release tablets; however, patients receiving 160-mg tablets (currently not commercially available in the US) should be cautioned about administration with high-fat meals. (See Pharmacokinetics.)

Rectal Administration

Suppositories are not commercially available in the US.

When rectal administration was preferred, conventional oral tablets or solution have been administered rectally†.

If administered rectally†, insert the dosage form just inside the rectal sphincter for optimal systemic absorption of unmetabolized drug. Administration high in the rectal vault can result in rapid first-pass hepatic metabolism, with greatly diminished efficacy.

Not usually suitable for long-term administration due to rectal irritation from repeated dosing.

Although the manufacturer states that extended-release tablets should not be administered rectally, rectal administration of extended-release formulations are used widely for opiate delivery in palliative care.

Dosage

Available as oxycodone hydrochloride and oxycodone terephthalate; dosage expressed in terms of the respective salt.

Pediatric Patients

Conventional Preparations

Oral

Children <50 kg: Usually, initiate with 0.1–0.2 mg/kg every 3–4 hours as needed. Adjust according to response and tolerance.

Children ≥50 kg: Usually, initiate with 5–10 mg every 3–4 hours as needed. Adjust according to response and tolerance.

Children 6–12 Years of Age: 0.61 mg of the combined salts every 6 hours.

Children ≥12 Years of Age: 1.22 mg of the combined salts every 6 hours.

Adults

Conventional Preparations

Oral

Usually, initiate with 5–15 mg every 4–6 hours as needed. Adjust according to response and tolerance.

4.88 mg every 6 hours as the combined salts.

Extended-release Tablets

Initial Therapy with Extended-release Tablets

Oral

Initially, 10 mg every 12 hours. Patients previously receiving nonopiate analgesics may continue these drugs as dosage of the extended-release tablets is titrated to provide adequate analgesia.

Switching from Conventional Oxycodone Preparations to Extended-release Tablets

Oral

Calculate the total daily dosage of the conventional preparation and give as extended-release tablets in 2 divided doses at 12-hour intervals.

Switching from Other Opiates to Extended-release Tablets

Oral

The equivalent total daily dosage of oxycodone hydrochloride should be calculated based on standard conversion factors suggested by the manufacturer (table below) and administered as extended-release tablets in 2 divided doses at 12-hour intervals. Round down to the nearest whole tablet any calculated doses that do not correspond to an available tablet strength.

Table to be used only for conversion to oral oxycodone.

More conservative conversion for patients receiving high-dose parenteral opiates (e.g., use 0.5 instead of 3 as multiplication factor for high-dose parenteral morphine).

Patients receiving fentanyl transdermal systems may receive extended-release tablets beginning 18 hours after removal of the transdermal system. Initially, dosage of approximately 10 mg every 12 hours as extended-release tablets can be substituted for each 25-mcg/hour increment in fentanyl transdermal system dosage. Monitor patient closely as clinical experience with this dosage conversion ratio is limited.

Switching from Extended-release Tablets

Oral

When patients are switched from extended-release tablets to a parenteral opiate, conservative dose conversion ratios should be used to avoid toxicity.

Special Populations

Dosage in Hepatic Impairment

Extended-release Tablets

Initially, 33–50% of the usual dosage; titrate dosage carefully.

Dosage in Renal Impairment

Extended-release Tablets

Consider reduction of the initial dosage and adjust according to the clinical situation in impaired renal function (Cl_cr <60 mL/minute).

Geriatric Patients

Consider dosage reduction.