Oxycodone

Oxycodone is an opioid pain medication used for Moderate-to-Severe Pain and Chronic Severe Pain, requiring daily, around-the-clock, long-term opioid treatment when other treatment options are inadequate.  

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

Common side effects of oxycodone include:

• drowsiness,
• headache, 
• dizziness, 
• tiredness, 
• constipation, 
• stomach pain, 
• nausea, 
• vomiting

Serious side effects of Oxycodone include:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat,
• slow breathing with long pauses, 
• blue colored lips, 
• difficulty to wake up, 
• noisy breathing, 
• sighing, 
• shallow breathing, 
• breathing that stops during sleep, 
• slow heart rate or weak pulse, 
• lightheadedness, 
• confusion, 
• unusual thoughts or behavior, 
• seizure, 
• nausea, 
• vomiting, 
• loss of appetite, 
• dizziness, 
• worsening tiredness or weakness, 
• agitation, 
• hallucinations, 
• fever, 
• sweating, 
• shivering, 
• fast heart rate, 
• muscle stiffness, 
• twitching, 
• loss of coordination, 
• diarrhea 

Rare side effects of Oxycodone include:

• none 

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.

Adult Dosage Forms and Strengths

Capsule, immediate-release: Schedule II

• 5 mg

Tablet, immediate-release: Schedule II

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

pediatric dosage

tablet, immediate-release: Schedule II

• 5mg
• 10mg
• 15mg
• 20mg
• 30mg

capsule, immediate-release: Schedule II

• 5mg

oral concentrate: Schedule II

• 20mg/mL

oral solution: Schedule II

• 5mg/5mL 

Consult your doctor for pediatric and geriatric dosing.

• Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
• Assess each patient's risk before 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 a 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 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 once every 12 hours
• Conversion from fentanyl transdermal: Wait 18 hours after the patch is removed, then initiate a conservative dose of approximately 10 mg once every 12 hours of 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 oxycodone dose orally 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

• The use of higher starting doses in patients who are not opioid-tolerant may cause fatal respiratory depression
• Opioid-tolerant patients 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 the dosage to response
• Hepatic impairment: Reduce dosage in liver disease; decrease the dosage of extended-release form to one-third or one-half of the 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

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.

• Oxycodone has no severe interaction with the drug Alvimopan
• Oxycodone has serious interactions with at least 72 other drugs
• Oxycodone has moderate interactions with at least 258 other drugs  
• Oxycodone has mild interactions with at least 18 different drugs  

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.

Warnings

• Opioid medicine can slow or stop your breathing and death may occur.  A person caring for you should give you Naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up
• Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Known or suspected GI obstruction, including paralytic ileus
• Hypersensitivity (eg, anaphylaxis) to oxycodone
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment 

Effects of drug abuse

• 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

Short-Term Effects

• See “What Are Side Effects Associated with Using Oxycodone?”

Long-Term Effects

• 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 phenanthrene-derivative opioid agonists, 
• morbid obesity, 
• untreated myxedema, 
• adrenocortical insufficiency including Addison's disease

If crushed, extended-release preparation (OxyContin) can deliver a large opiate dose with the potential for abuse or overdose; OxyContin was reformulated in April 2010 to prevent tablets from being cut, broken, crushed, or dissolved to release more medication; inability to tamper with product reduces the 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
• Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy is physically dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients
• Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock A single dose >40 mg or total dose >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 the 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 the 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 the throat; patients with swallowing difficulties may be at risk; intestinal obstruction or diverticulitis exacerbation also reported
• Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected
• In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure the clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma
• Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of the sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
• Therapy may increase the frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy
• Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of the rug and know how they will react to the medication
• While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, the risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within the first 24 to 72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases the risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper
• Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate; if an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response; follow patients closely for signs and symptoms of respiratory depression and sedation; if concomitant use with benzodiazepine or muscle relaxant warranted, consider prescribing naloxone for the emergency treatment of opioid overdose
• Use in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated; patients with significant chronic obstructive pulmonary disease or cor pulmonale, and with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of the decreased respiratory drive including apnea, even at recommended dosages
• Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely
• Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs
• Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency
• Use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and may be useful to monitor renal function
• Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension
• 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 opioids present (see Black Box Warnings)
• Do not abruptly discontinue therapy in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain
• Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, 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 (see Black Box Warnings)
• Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of oxycodone is achieved; similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in oxycodone-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions; when using the drug with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in oxycodone treated patients, monitor patients closely at frequent intervals and consider dosage reduction of oxycodone until stable drug effects are achieved
• Concomitant use of oxycodone with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone; when using oxycodone with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur

Pregnancy and Lactation

• Prolonged use of oxycodone during pregnancy can cause neonatal opioid withdrawal syndrome.  There are no available data in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association between morphine and major birth defects. 
• Oxycodone is excreted in milk, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy. Infants exposed to drugs should be monitored for excess sedation and respiratory depression.  Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.