LEGAL RESOURCES AND THE LATEST LEGAL DEVELOPMENTS RELATED TO OXYCONTIN®, INCLUDING ....

NARCOTIC ANALGESICS

OxyContin® (oxycodone hydrochloride) C-II

Tablets (controlled-release): 10, 20, 40, 80 mg

Manufacturer: Purdue Pharma

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Indications/Dosage/Administration

Moderate to severe pain: In patients not already taking opioids, 10 mg q12h; a nonopioid analgesic or a NSAID may be continued. If the current nonopioid is discontinued, early upward dose titration may be needed. In patients taking fixed ratio opioid/nonopioid combination drugs, if patients are taking 1-5 tablets/capsules/caplets daily of a regular strength drug, 10-20 mg q12h. For patients taking 6-9 tablets/capsules/caplets daily of a regular strength drug, consider using 20-30 mg q12h. For those taking 10-12 tablets/capsules/caplets daily, consider using 30-40 mg q12h. The nonopioid may be continued as a separate drug, or a different nonopioid may be selected. If the current nonopioid is discontinued, early upward dose titration may be needed.

Drug is indicated for moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.

Administration: Swallow tablets whole; do not break, chew, or crush. Using broken, chewed, or crushed tablets could lead to rapid release and absorption of a potentially toxic dose of oxycodone. Rectal administration of tablets is not recommended.

Initiation of therapy: When starting therapy, consider patient's general condition and medical status; daily dose, potency, and type of analgesic(s) the patient has been taking; reliability of conversion estimate used to calculate oxycodone dose; patient's opioid exposure and tolerance (if any), and balance between pain control and adverse experiences.

Titration of dosage: Titrate to mild or no pain with regular use of no more than 2 doses of supplemental analgesia/24h. Have rescue medication available. Because steady-state plasma concentrations are approximated within 24-36 h, dosage may be adjusted every 1-2 days. It is appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. Except for increase from 10 mg to 20 mg q12h, the total daily oxycodone dose usually can be increased by 25-50% of the current dose at each increase. If signs of excessive adverse experiences are seen, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given, or nonopioid analgesics may be used. Adjust dose to obtain an appropriate balance between pain relief and opioid-related adverse effects.

Use of 80-mg controlled-release tablets: This dosage strength is for use only in opioid-tolerant patients requiring daily oxycodone-equivalent dosages of 160 mg or more; use caution. Advise patients against use by others than for whom it was prescribed; such inappropriate use may have severe medical consequences.

Dosing intervals: While symmetric, around-the-clock, q12h dosing is appropriate for many patients, some patients may benefit from asymmetric dosing tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

Elderly or debilitated patients: Reduce starting dose to 33-50% of usual dose in debilitated, nontolerant patients.

Hepatic impairment: Reduce starting dose to 33-50% of usual dose and carefully titrate dose.

Renal impairment: In patients with Ccr < 60 ml/min, concentrations of oxycodone in plasma are ~ 50% higher than those with normal function. Conservatively start therapy, and adjust dosage according to clinical situation.

Gender differences: In pharmacokinetic studies, opioid-naive females demonstrated up to 25% higher average plasma concentrations and greater frequency of adverse events than males, even after adjustment for body weight; clinical relevance is low.

Patients currently on opioid therapy: If a patient has been receiving opioid-containing medications before controlled-release oxycodone therapy, determine total daily dose of other opioids. Using standard conversion ratio estimates, multiply mg/day of previous opioids by appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone.