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OxyContin

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Oxycontin

Indications
Dosage
How Supplied

INDICATIONS

OXYCONTIN is indicated for the management of pain severe enough to require daily, aroundthe-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve OXYCONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • OXYCONTIN is not indicated as an as-needed (prn) analgesic

DOSAGE AND ADMINISTRATION

Initial Dosing

OXYCONTIN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

OXYCONTIN 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OXYCONTIN [see WARNINGS AND PRECAUTIONS].

OXYCONTIN tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see PATIENT INFORMATION]. Crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].

Use of OXYCONTIN as the First Opioid Analgesic

Initiate treatment with OXYCONTIN with one 10 mg tablet orally every 12 hours.

Use of OXYCONTIN in Patients who are not Opioid Tolerant

The starting dose for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from other Oral Oxycodone Formulations to Oxycontin

Patients receiving other oral oxycodone formulations may be converted to OXYCONTIN by administering one-half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours.

Conversion from other Opioids to Oxycontin

Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated.

There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 10 mg orally every 12 hours.

It is safer to underestimate a patient's 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

Conversion from Methadone to Oxycontin

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Conversion from Transdermal Fentanyl to Oxycontin

Eighteen hours following the removal of the transdermal fentanyl patch, OXYCONTIN treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCONTIN, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

Titration And Maintenance Of Therapy

Individually titrate OXYCONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse and misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dose increase of OXYCONTIN or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OXYCONTIN dose. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

Patients With Hepatic Impairment

For patients with hepatic impairment, start dosing patients at 1/3 to ½ the usual starting dose followed by careful dose titration [see CLINICAL PHARMACOLOGY].

Discontinuation Of Oxycontin

When the patient no longer requires therapy with OXYCONTIN tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.

Administration Of Oxycontin

Instruct patients to swallow OXYCONTIN tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see WARNINGS AND PRECAUTIONS].

Instruct patients to take OXYCONTIN one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms And Strengths

  • 10 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other)
  • 15 mg film-coated extended-release tablets (round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other)
  • 20 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other)
  • 30 mg film-coated extended-release tablets (round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other)
  • 40 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other)
  • 60 mg film-coated extended-release tablets* (round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other)
  • 80 mg film-coated extended-release tablets* (round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other)

* 60 mg and 80 mg tablets for use in opioid-tolerant patients only

Storage And Handling

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-410-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-410-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-415-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-415-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-420-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-420-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-430-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-430-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-440-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-440-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-460-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-460-20).

OXYCONTIN (oxycodone hydrochloride extended-release tablets) 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-480-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-480-20).

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Dispense in tight, light-resistant container.

CAUTION

DEA FORM REQUIRED

Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535. Revised: April 2014

Last reviewed on RxList: 4/30/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Oxycontin - User Reviews

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