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Oxycodone

Medical and Pharmacy Editor:

Brand Name: OxyContin, Xtampza ER, Roxicodone, Oxaydo

Generic Name: Oxycodone

Drug Class: Opioid Analgesics

What Is Oxycodone and How Does It Work?

Oxycodone is indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

Oxycodone is available under the following different brand names: OxyContin, Xtampza ER, Roxicodone, and Oxaydo.

Dosages of Oxycodone

Adult Dosage Forms and Strengths

Capsule, immediate-release: Schedule II

Tablet, immediate-release: Schedule II

  • 5 mg
  • 10 mg
  • 15 mg
  • 20 mg
  • 30 mg

Abuse deterrent tablet, immediate-release (Oxaydo): Schedule II

  • 5 mg
  • 7.5 mg

Abuse deterrent tablet, controlled-release (OxyContin): Schedule II

  • 10 mg
  • 15 mg
  • 20 mg
  • 30 mg
  • 40 mg
  • 60 mg
  • 80 mg

Abuse deterrent capsule, controlled-release (Xtampza): Schedule II

  • 9 mg (equivalent to 10 mg oxycodone HCl)
  • 13.5 mg (equivalent to 15 mg oxycodone HCl)
  • 18 mg (equivalent to 20 mg oxycodone HCl)
  • 27 mg (equivalent to 30 mg oxycodone HCl)
  • 36 mg (equivalent to 40 mg oxycodone HCl)
  • Abuse-deterrent capsule utilizing DETERx technology platform to maintain its extended-release profile after being subjected to common methods of tampering

Oral concentrate: Schedule II

  • 20 mg/mL

Oral solution: Schedule II

  • 5 mg/ 5 mL

Consult your doctor for pediatric and geriatric dosing.

Dosage Considerations – Should be Given as Follows:

  • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
  • Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

Moderate-to-Severe Pain

Immediate-release

  • Opioid-tolerant: 10-30 mg taken orally once every 4-6 hours
  • Opioid-naïve: 5-15 mg taken orally once every 4-6 hours

Chronic Severe Pain

Controlled-release products (e.g., OxyContin, Xtampza ER) are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Initial dosing

OxyContin

  • Opioid-naïve patients: 10 mg taken orally once every 12 hours initially; titrate gradually every 1-2 days, increasing by 25-50% increments, with once every 12 hour dosing interval maintained
  • A single dose greater than 40 mg ER or total dose greater than 80 mg ER are for use only in opioid-tolerant patients

Xtampza ER

  • Opioid-naïve patients: 9 mg taken orally once every 12 hours with food

Conversion from other opioids to OxyContin or Xtampza ER

  • Provide immediate-release opioids for breakthrough pain
  • Monitor patient closely for adverse effects or breakthrough pain during conversion and for several days following
  • Also see Medscape reference topic - Opioid Equivalents

OxyContin

  • Conversion from other oral oxycodone formulations: Administer one-half of the patient's total daily PO oxycodone dose as once every 12 hours
  • Conversion from fentanyl transdermal: Wait 18 hours after patch removed, then initiate conservative dose of approximately 10 mg once every 12 hours oxycodone controlled-release for each 25 mcg/hour fentanyl transdermal patch

Xtampza ER

  • Conversion from other oral oxycodone formulations: Administer one-half of the patient's total daily taken orally oxycodone dose as once every 12 hours with food; because Xtampza ER is not bioequivalent to other oxycodone extended-release products, monitor patients for possible dosage adjustment
  • Conversion from other opioids: Discontinue all other around-the clock opioid drugs; there are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials; initiate dosing using 9 mg once every 12 hours with food and provide immediate-release rescue medication while stabilizing patient on Xtampza ER
  • Conversion from methadone: 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 and methadone has a long half-life and can accumulate in the plasma
  • Conversion from fentanyl transdermal: 18 hours following the removal of the transdermal fentanyl patch, initiate Xtampza ER; there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 9 mg (equivalent to 10 mg oxycodone HCl) once every 12 hours should be initially substituted for each 25 mcg/hour fentanyl transdermal patch

Opioid-tolerant definition

  • Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
  • Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day oral morphine, 25 mcg/hour transdermal fentanyl, 30 mg/day oral oxycodone, 8 mg/day oral hydromorphone, 25 mg/day oral oxymorphone, or an equianalgesic dose of another opioid

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 for patients 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
  • Long-acting opioids are not indicated as an as-needed analgesic

Dosage Modifications

  • Renal impairment (CrCl less than 60 mL/min): Serum concentration may increase by 50%; adjust dosage to response
  • Hepatic impairment: Reduce dosage in liver disease; decrease dosage of extended-release form to one third or one half of usual starting dosage; titrate to response
  • Coadministration with other CNS depressants: Initiate long-acting oxycodone with one-third to one-half the recommended starting dose; monitor for signs of respiratory depression, sedation, and hypotension

What Are Side Effects Associated with Using Oxycodone?

Common side effects of oxycodone include:

Serious side effects of oxycodone include:

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Oxycodone?

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Severe interactions of oxycodone include:

  • alvimopan

Oxycodone has serious interactions with at least 54 different drugs.

Oxycodone has moderate interactions with at least 245 different drugs.

Mild interactions of oxycodone include:

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Oxycodone?

Warnings

Addiction, abuse, and misuse:

  • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
  • Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

Life-threatening respiratory depression:

  • Serious, life-threatening, or fatal respiratory depression may occur
  • Monitor for respiratory depression, especially during initiation or following a dose increase
  • Instruct patients to swallow tablet/capsule whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose

Accidental exposure:

  • Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose

Neonatal opioid withdrawal syndrome:

  • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
  • Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
  • Onset, duration, and severity of neonatal opioid withdrawal syndrome varies based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
  • If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

Cytochrome P450 3A4 interaction

  • Concomitant use of oxycodone ER with all cytochrome P450 (CYP-450) 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression

Oral solutions

  • Concentrated oral solution is available as a 20 mg/mL concentration is indicated for use in opioid-tolerant patients only
  • Take care when prescribing and administering oxycodone oral solution to avoid dosing errors due to confusion between milligrams and milliliter, and other oxycodone solutions with different concentrations

This medication contains oxycodone. Do not take OxyContin, Xtampza ER, Roxicodone, or Oxaydo if you are allergic to oxycodone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Effects of Drug Abuse

Withdrawal symptoms may develop following abrupt discontinuation or with concurrent administration of opioid antagonists.

Long-acting opioids

  • Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present
  • Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (e.g., major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary
  • Serious, life-threatening, or fatal respiratory depression reported
  • Accidental exposure reported, including fatalities
  • Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy
  • Interactions with central nervous system (CNS) depressants (e.g., alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension

Short-Term Effects

  • See "What Are Side Effects Associated with Using Oxycodone?"

Long-Term Effects

  • Prolactin elevations occur and persist during chronic administration.
  • See "What Are Side Effects Associated with Using Oxycodone?"

Cautions

  • Use caution in patients with anemia, cardiac arrhythmias, drug abuse or dependence, emotional lability, gallbladder disease, gout, head injury, renal/hepatic disease or impairment, hypoprothrombinemia, toxic psychosis, hypothyroidism, increased intracranial pressure, prostatic hypertrophy, renal impairment, seizures with epilepsy, thyrotoxicosis, urethral stricture, urinary tract surgery, vitamin K deficiency, anoxia, central nervous system (CNS) depression, hypercapnia, respiratory depression or disease, hypersensitivity to phenantrene-derivative opioid agonists, morbid obesity, untreated myxedema, adrenocortical insufficiency including Addison disease.
  • If crushed, extended-release preparation (OxyContin) can deliver large opiate dose with potential for abuse or overdose; OxyContin reformulated in April 2010 to prevent tablet from being cut, broken, crushed, or dissolved to release more medication; inability to tamper with product reduces potential for abuse.
  • Caution with OxyContin in patients who have difficulty swallowing or have underlying GI disorders that may predispose to obstruction.
  • May obscure diagnosis of acute abdominal conditions.
  • Withdrawal symptoms may develop following abrupt discontinuation or with concurrent administration of opioid antagonists.
  • May cause severe hypotension; use caution in patients with hypovolemia, cardiovascular disease or drugs that may exaggerate hypotensive effects.
  • A single dose greater than 40 mg or total dose greater than 80 mg are for use only in opioid-tolerant patients.
  • May cause constipation, which may be problematic in patients with unstable angina and patients post-myocardial infarction; reduce potential for constipation by administering stool softener or increasing fiber in diet in patients following myocardial infarction and unstable angina.
  • Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; may cause constriction of sphincter of Oddi.
  • Use caution in patients who are morbidly obese.
  • Use caution in patients with thyroid dysfunction.
  • Dose adjustment required when initiating extended release therapy in patients taking other CNS depressants.
  • Use with caution in perioperative setting; individualize treatment when transitioning from parenteral to oral analgesics.
  • Some dosage forms may contain sodium benzoic acid (benzoate), a metabolite of benzyl alcohol; large amounts of benzyl alcohol have been associated with potentially fatal toxicity (gasping syndrome) in neonates.
  • Extended release tablets may be difficult to swallow and could become lodged in throat; patients with swallowing difficulties may be at risk; intestinal obstruction or diverticulitis exacerbation also reported.
  • Long-acting opioids
    • Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present
    • Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (e.g., major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary
    • Serious, life-threatening, or fatal respiratory depression reported
    • Accidental exposure reported, including fatalities
    • Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy
    • Interactions with central nervous system (CNS) depressants (e.g., alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension
    • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients

Pregnancy and Lactation

  • Oxycodone may be acceptable to use during pregnancy. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. Oxycodone should not be used near term. Only use near term in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk. Neonatal opioid withdrawal syndrome has been reported with long-term use during pregnancy.
  • Oxycodone is excreted in breast milk; it is not recommended for use while breastfeeding.
Reviewed on 1/23/2018

References:
Medscape. Oxycodone.
https://reference.medscape.com/drug/oxycontin-xtampza-er-oxycodone-343321

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