OxyCODONE (Lexi-Drugs)

ALERT: US Boxed Warning
  Addiction, abuse, and misuse:
  Opioid analgesic risk evaluation and mitigation strategy (REMS)
  Life-threatening respiratory depression:
  Accidental ingestion:
  Neonatal opioid withdrawal:
  Cytochrome P450 3A4 interaction:
  Risks from concomitant use with benzodiazepines or other CNS depressants:
  Risk of medication errors (oral solution):
Pronunciation

(oks i KOE done)

Brand Names: US

Oxaydo; OxyCONTIN; Roxicodone; RoxyBond; Xtampza ER

Brand Names: Canada

ACT Oxycodone CR; APO-Oxycodone CR; Oxy-IR; OxyNEO; PMS-OxyCODONE; PMS-OxyCODONE CR; Supeudol; Supeudol 10; Supeudol 20

Pharmacologic Category

Analgesic, Opioid

Dosing: Adult

Pain management: Oral: Note: All doses should be titrated to appropriate effect.

Immediate release: Initial: 5 to 15 mg every 4 to 6 hours as needed; dosing range: 5 to 20 mg per dose (APS 2008). For severe chronic pain, administer on a regularly scheduled basis, every 4 to 6 hours, at the lowest dose that will achieve adequate analgesia.

Extended release:

Note: Oxycodone ER capsules are not bioequivalent to ER tablets. Dose of ER capsules is expressed as oxycodone base and the dose of ER tablets is expressed as oxycodone hydrochloride. Oxycodone ER 60 mg and 80 mg tablets are intended for use in opioid-tolerant patients only. Single doses >40 mg (ER tablets) or >36 mg (ER capsules), or a total dose of >80 mg daily (ER tablets) or >72 mg daily (ER capsules) are for use only in opioid-tolerant patients. Opioid tolerance is defined as: Patients already taking at least morphine 60 mg orally daily, oxymorphone 25 mg orally daily, transdermal fentanyl 25 mcg per hour, oxycodone 30 mg orally daily, hydromorphone 8 mg orally daily, hydrocodone 60 mg orally daily or an equivalent dose of another opioid for at least 1 week.

Opioid naive (use as the first opioid analgesic or use in patients who are not opioid tolerant): Initial:

ER tablet: 10 mg every 12 hours

ER capsules: 9 mg every 12 hours

Conversion from other oral oxycodone formulations to oxycodone ER: Initiate oxycodone ER with 50%of the total daily oral oxycodone daily dose (mg/day) administered every 12 hours.

Conversion from other opioids to oxycodone ER: Discontinue all other around-the-clock opioids when oxycodone ER is initiated. Initiate with 10 mg (ER tablets) or 9 mg (ER capsules) every 12 hours. Substantial interpatient variability exists due to patient specific factors, relative potency of different opioids, and dosage forms; therefore, it is preferable to underestimate the initial 24 hour oral oxycodone requirements and utilize rescue medication (immediate-release opioid).

Conversion from transdermal fentanyl patch to oxycodone ER: Note: Remove fentanyl patch at least 18 hours prior to starting oxycodone ER. The manufacturer suggests using the conservative conversion factor of oxycodone ER tablets 10 mg or oxycodone ER capsules 9 mg every 12 hours for each fentanyl 25 mcg/hour transdermal patch; systematic assessment of this suggested conversion has not been completed; monitor patients closely.

Conversion from methadone to oxycodone ER: Close monitoring is required when converting methadone to another opioid. Ratio between methadone and other opioid agonists varies widely according to previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Maintenance dose: Dosage adjustment (titration): After initiation of oxycodone ER, adjust dose in increments (25% to 50%) no more frequently than every 1 to 2 days until desired pain control. Recommended maximum dose of ER capsules is 288 mg/day. Patients may require rescue doses of an immediate-release analgesic during dose titration. Observe for signs and symptoms of opioid withdrawal or signs of over sedation/toxicity; if unacceptable adverse reactions occur, the subsequent dose may be reduced. Note: Some clinicians have reported that in certain chronic pain patients, more frequent dosing (ie, every 8 hours) is required for effective pain relief (Gallagher 2007; Marcus 2004; Nicholson 2006), although dosing more frequently than every 12 hours is not recommended by the manufacturer, and safety and efficacy has not been established.

Dosage adjustment for concomitant therapy: Concomitant CNS depressants: Initiate oxycodone ER with 33% to 50% of the calculated recommended dose. If reduced dose is less than smallest available dosage form consider alternative analgesic.

Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).

Dosage adjustment in debilitated patients (nonopioid tolerant):

Immediate release: Initial: There are no specific dosage adjustments provided in the manufacturer’s labeling; use caution and with a reduced dose.

Extended release: Initial: Initiate oxycodone ER with 33% to 50% of the calculated recommended dose. If reduced dose is less than smallest available dosage form consider alternative analgesic.

Dosing: Geriatric

Refer to adult dosing. Initiate therapy at low end of dosing range and use caution.

Dosing: Renal Impairment: Adult

CrCl ≥60 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling. Oxycodone clearance may decrease in patients with renal impairment; initiate therapy at low end of dosing range.

CrCl <60 mL/minute: Serum concentrations are increased ~50%. Initiate at the low end of the dosage range (use caution); adjust dose as clinically indicated. Alternatively, for both immediate- and extended-release forms, doses of 33% to 50% of usual initial dosing have been recommended (Oxy IR Canadian product labeling; OxyNeo Canadian product labeling). For ER tablets and capsules, if the reduced dose is less than smallest available dosage form, consider alternative analgesic.

Dosing: Hepatic Impairment: Adult

Immediate release: Initiate therapy at 33% to 50% the usual dosage and titrate carefully.

Extended release tablets or Extended release capsules: Initial: Initiate oxycodone ER with 33% to 50% of the calculated recommended dose. If reduced dose is less than smallest available dosage form consider alternative analgesic.

Dosing: Pediatric

Note: Doses should be titrated to appropriate effect. Multiple concentrations of oral solution available (20 mg/mL and 1 mg/mL); the highly concentrated formulation (20 mg/mL) should only be used in opioid tolerant patients (taking ≥30 mg/day of oxycodone or equivalent for ≥1 week). Orders for oxycodone oral solutions (20 mg/mL or 1 mg/mL) should be clearly written to include the intended dose (in mg not mL) and the intended product concentration to be dispensed to avoid potential dosing errors:

Analgesia, moderate to severe pain: Immediate release:

Infants ≤6 months: Limited data available: Oral: Initial dose: 0.025 to 0.05 mg/kg/dose every 4 to 6 hours as needed (Berde 2002)

Infants >6 months, Children, and Adolescents: Oral:

Patient weight <50 kg: Initial dose: 0.1 to 0.2 mg/kg/dose every 4 to 6 hours as needed; for severe pain some experts have recommended an initial dose of 0.2 mg/kg; usual maximum dose range: 5 to 10 mg (American Pain Society 2008; APA 2012; Berde 2002)

Patient weight ≥50 kg: Initial dose: 5 to 10 mg every 4 to 6 hours as needed; for severe pain an initial dose of 10 mg may be used; usual maximum dose: 20 mg/dose (American Pain Society 2008; Berde 2002)

Analgesia, severe pain requiring around-the-clock long-term opioid therapy: Extended release tablets (eg, OxyContin): Note: Use only in pediatric patients ≥11 years of age who are already receiving opioid therapy for at least 5 consecutive days, tolerating a minimum daily opioid dose of at least 20 mg of oxycodone orally or its equivalent at least for the 2 days immediately prior to starting extended release oxycodone tablets, and for which alternative treatment options are inadequate. Prior to initiation, all other around-the-clock opioid therapy must be discontinued.

Initial dose: Children ≥11 years and Adolescents: Oral: Initial dose based on current opioid regimen dose; use the following conversion factor table and equation to convert the current opioid(s) daily dose to the extended release oxycodone tablet daily dose. Note: Substantial interpatient variability exists due to patient specific factors, relative potency of different opioids, and dosage forms; therefore, it is preferable to underestimate the initial 24-hour oral oxycodone requirements and utilize rescue medication (immediate release opioid):

Initial dose of extended release oxycodone tablets administered every 12 hours = (mg/day of current opioid regimen X conversion factor)/2

Dose calculations or adjustments for specific clinical scenarios:

• If rounding is necessary, numerical value should be rounded down to the nearest tablet strength. If calculated daily dose is <20 mg, do not start extended release oxycodone tablet as there is no safe tablet strength available.

• If more than one opioid in the regimen, calculate the approximate extended release oxycodone tablet dose for each opioid and sum the totals for the approximate total daily extended release oxycodone tablet dose, then divide by 2 for the 12-hour extended release oxycodone dose.

• If current opioid regimen includes a fixed-dose opioid/nonopioid dosage form (eg, hydrocodone/acetaminophen), only the mg of opioid should be used in the conversion calculations.

• If patient receiving concomitant CNS depressants, reduce extended release oxycodone tablet starting dose by 1/3 to 1/2 the calculated initial dose.

• If asymmetric dosing, the higher dose should be scheduled as the morning dose, and the lower dose 12 hours later.

Note: The following conversion table should ONLY be used to convert opioid doses to extended release oxycodone tablet (not from extended release oxycodone tablet to other opioids; it is NOT a table of equianalgesic doses as it may overestimate initial dose).

Conversion Factor for Calculating Initial Extended Release Oxycodone Tablet Dose in Pediatric Patients ≥11 years
Current opioid regimen to be converted to extended release oxycodone tablet Conversion Factor
Oral Parenteral*
Oxycodone 1
Hydrocodone 0.9
Hydromorphone 4 20
Morphine 0.5 3
Tramadol 0.17 0.2
* For patients receiving high-dose parenteral opioids, a more conservative conversion factor should be applied (ie, lower numerical conversion factor); for example, for high-dose parenteral morphine, a conversion of 1.5 should be used for calculations instead of 3.

Conversion from fentanyl patch to extended release oxycodone tablet: Limited data available: Children ≥11 years and Adolescents: Note: Remove fentanyl patch at least 18 hours prior to starting extended release oxycodone. Initial dose based on current opioid regimen dose; the manufacturer suggests using the conservative conversion factor of 10 mg every 12 hours of extended release oxycodone tablet for each 25 mcg/hour fentanyl transdermal patch; systemic assessment of this suggested conversion has not been completed, monitor patients closely

Maintenance dose: Dosage adjustment (titration): After initiation of extended release oxycodone tablet, adjust dose in small increments (up to 25% of current total daily dosage) no more frequently than every 1 to 2 days until desired pain control; patients may require rescue doses of an immediate release analgesic during dose titration. Observe for signs and symptoms of opioid withdrawal or signs of oversedation/toxicity; if unacceptable adverse reactions occur, the subsequent dose may be reduced.

Dosing: Renal Impairment: Pediatric

In general, oxycodone clearance may be decreased in patients with renal impairment; initiate therapy at low end of dosing range.

Immediate release: Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following adjustments have been recommended (Aronoff 2007):

GFR ≥50 mL/minute/1.73 m2: No dosage adjustment required

GFR 10 to 50 mL/minute/1.73 m2: Administer 75% of dose

GFR <10 mL/minute/1.73 m2: Administer 50% of dose

Hemodialysis: Administer 50% of dose posthemodialysis

Peritoneal dialysis: Administer 50% of dose

Extended release tablets (eg, Oxycontin): Children ≥11 years and Adolescents: CrCl <60 mL/minute: Serum concentrations are increased ~50%. Initiate at the low end of the dosage range (use caution); adjust dose as clinically indicated. Doses of 33% to 50% of usual initial dosing have been recommended; if the reduced dose is less than smallest available dosage form, consider alternative analgesic.

Dosing: Hepatic Impairment: Pediatric

Immediate release: There are no dosage adjustments provided in the manufacturer’s labeling; based on experience in adult patients, may consider a conservative approach of reduced initial doses; adjust dose based on clinical response.

Extended release tablets (eg, Oxycontin): Children ≥11 years and Adolescents: Initial: One-third (1/3) to one-half (1/2) of the usual starting dose; carefully titrate dose to appropriate effect. If reduced dose is less than smallest available dosage form, consider alternative analgesic.

Use: Labeled Indications

Pain management:

Immediate-release formulations: Management of acute or chronic moderate to severe pain where the use of an opioid analgesic is appropriate and for which alternative treatments are inadequate.

Extended-release formulations:

Capsules: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in adults

Tablets: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in adults and opioid-tolerant pediatric patients ≥11 years of age who are already receiving and tolerating a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.

Limitations of use: Reserve oxycodone for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone ER is not indicated as an as-needed analgesic.

Clinical Practice Guidelines

Diabetic Neuropathy:

Neurology, “Evidence-Based Guideline: Treatment of Painful Diabetic Neuropathy,” April 2011

Patient Safety:

“CDC Guideline for Prescribing Opioids for Chronic Pain,” 2016

Restless Legs Syndrome:

International Restless Legs Syndrome Study Group (IRLSSG), European Restless Legs Syndrome Study Group (ERLSSG), and Restless Legs Syndrome Foundation, “Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: A combined task force of the IRLSSG, ERLSSG and the RLS Foundation, “ May 2016

Administration: Oral

Appropriate laxatives should be administered to avoid the constipating side effects associated with use. Antiemetics may be needed for persistent nausea. Some dosage forms may not be appropriate for administration through feeding tubes (eg, gastric, NG). Refer to product labeling.

Extended release dosage forms:

Tablet: Administer with or without food. Swallow tablet whole. Do not moisten, dissolve, cut, crush, break, or chew extended release tablets. Extended release tablets should be administered one at a time and each followed with water immediately after placing in the mouth.

Capsule: Administer each dose with food and approximately the same amount. For patients with difficulty swallowing, capsule may be opened and the contents sprinkled on soft foods (eg, applesauce, pudding, yogurt, ice cream, jam) or into a cup for administration directly into the mouth. Rinse mouth immediately afterwards to ensure all contents have been swallowed. Contents of capsule may also be administered through a nasogastric (NG) tube or gastrostomy tube (G-tube). Flush tube with water first, then pour capsule contents directly into tube (do not premix capsule contents with fluid that will be used to flush them through the tube). After contents have been placed in tube, flush tube with 15 mL of water, milk, or liquid nutritional supplement once and then repeat twice with 10 mL.

Immediate release dosage forms:

Capsule: Administer without regard to food.

Oral solution: Administer with or without food. Available in two strengths; 1 mg/mL and a concentrated oral solution (20 mg/mL). Precautions should be taken to avoid confusion between the different concentrations; prescriptions should have the concentration specified as well as the dose clearly represented as milligram (mg) of oxycodone, not volume (mL). The enclosed calibrated oral syringe should always be used to administer the concentrated oral solution to ensure the dose is measured and administered accurately. The concentrated oral solution (20 mg/mL) should only be used in opioid-tolerant patients (taking ≥30 mg/day of oxycodone or equivalent for ≥1 week).

Tablets:

Without abuse deterrent: Administer with or without food. When administered with food, onset may be delayed.

With abuse deterrent:

Oxaydo: Administer with or without food. Do not crush, chew, or dissolve the tablets. Due to inactive ingredient that causes nasal burning/throat irritation, the tablet must be swallowed whole with enough water to ensure complete swallowing immediately after placing in the mouth. The tablet should not be wet prior to placing in the mouth.

Administration: Pediatric

Immediate release (capsule, oral solution, tablets): May administer with food to decrease GI upset:

Oral solution: Available in two strengths; 1 mg/mL and a concentrated oral solution (20 mg/mL). Precautions should be taken to avoid confusion between the different concentrations; prescriptions should have the concentration specified as well as the dose clearly represented as milligram (mg) of oxycodone, not volume (mL). The enclosed calibrated oral syringe should always be used to administer the concentrated oral solution to ensure the dose is measured and administered accurately. The concentrated oral solution (20 mg/mL) should only be used in opioid-tolerant patients (taking ≥30 mg/day of oxycodone or equivalent for ≥1 week).

Tablet (Oxaydo): Swallow whole with adequate water to ensure complete swallowing immediately after placing in the mouth; the formulation uses technology designed to discourage common methods of tampering to prevent misuse/abuse. The tablet should not be wet prior to placing in the mouth. Do not crush, chew, or dissolve nor administer via feeding tubes (eg, gastric, NG) due to potential for obstruction.

Extended release:

Capsule (Xtampza ER): Administer each dose with food and approximately the same amount. For patients with difficulty swallowing, capsule may be opened and the contents sprinkled on soft foods (eg, applesauce, pudding, yogurt, ice cream, jam) or into a cup for administration directly into the mouth. Rinse mouth immediately afterwards to ensure all contents have been swallowed. Contents of capsule may also be administered through a nasogastric (NG) tube or gastrostomy tube (G-tube). Flush tube with water first, then pour capsule contents directly into tube (do not premix capsule contents with fluid that will be used to flush them through the tube). After contents have been placed in tube, flush tube with 15 mL of water, milk, or liquid nutritional supplement once and then repeat twice with 10 mL.

Tablet (eg, OxyContin): May administer with food to decrease GI upset. Swallow whole; do not moisten, dissolve, cut, crush, chew, or break as this would result in rapid release of oxycodone and absorption of a potentially fatal dose of drug. Administer one at a time and follow each with water immediately after placing in the mouth. For oral use only, do not administer rectally; increased risk of adverse events due to better rectal absorption.

Dietary Considerations

Instruct patient to avoid high-fat meals when taking some products (food has no effect on the reformulated OxyContin).

Storage/Stability

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, headache, insomnia, itching, lack of appetite, diarrhea, or dry mouth. Have patient report immediately to prescriber severe dizziness, passing out, confusion, severe constipation, severe abdominal pain, severe loss of strength and energy, difficulty breathing, slow breathing, shallow breathing, difficult urination, tachycardia, bradycardia, abnormal heartbeat, seizures, tremors, vision changes, angina, hallucinations, mood changes, memory impairment, abnormal gait, difficulty speaking, swelling of arms or legs, severe fatigue, sexual dysfunction (males), decreased libido, amenorrhea, infertility, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), or signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
REMS Components

Opioids for analgesic use: Elements to Assure Safe Use; Medication Guide

REMS Programs
Contraindications

Hypersensitivity (eg, anaphylaxis, angioedema) to oxycodone or any component of the formulation; significant respiratory depression; hypercarbia; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; GI obstruction, including paralytic ileus (known or suspected).

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other opioids; suspected surgical abdomen (eg, acute appendicitis or pancreatitis); any disease/condition that affects bowel transit; mild pain that can be managed with other pain medications (immediate release); mild, intermittent or short duration pain that can be managed with other pain medications or acute pain (extended release); chronic obstructive airway; status asthmaticus; cor pulmonale; acute alcoholism; delirium tremens; convulsive disorders; severe CNS depression; increased cerebrospinal or intracranial pressure; head injury; monoamine oxidase (MAO) inhibitors (concomitant use or within 14 days of therapy); pregnant women or during labor and delivery; breast-feeding

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Constipation: May cause constipation which may be problematic in patients with unstable angina and patients post-myocardial infarction. Consider preventive measures (eg, stool softener, increased fiber) to reduce the potential for constipation.

• Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration. Avoid use in patients with circulatory shock.

• Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other phenanthrene-derivative opioid agonists (codeine, hydrocodone, hydromorphone, levorphanol, oxymorphone).

• Respiratory depression: [US Boxed Warning]: Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely for respiratory depression, especially during initiation or dose escalation. Swallow ER tablets whole; crushing, chewing, or dissolving can cause rapid release and a potentially fatal dose. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

Disease-related concerns:

• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.

• Adrenocortical insufficiency: Use with caution in patients with adrenocortical insufficiency, including Addison disease; dose adjustment may be required. Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis (Brennan 2013).

• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; may cause constriction of sphincter of Oddi.

• CNS depression/coma: Avoid use in patients with impaired consciousness or coma as these patients are susceptible to intracranial effects of CO2 retention.

• Delirium tremens: Use with caution in patients with delirium tremens.

• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur.

• Hepatic impairment: Use with caution in patients with hepatic impairment; oxycodone clearance may decrease.

• Mental health conditions: Use opioids with caution for chronic pain in patients with mental health conditions (eg, depression, anxiety disorders, post-traumatic stress disorder) due to increased risk for opioid use disorder and overdose; more frequent monitoring is recommended (Dowell [CDC 2016]).

• Obesity: Use with caution in patients who are morbidly obese.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture; dose adjustment may be required.

• Psychosis: Use with caution in patients with toxic psychosis.

• Renal impairment: Use with caution in patients with renal impairment; oxycodone clearance may decrease.

• Respiratory disease: Use with caution and monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, particularly when initiating and titrating therapy; critical respiratory depression may occur, even at therapeutic dosages. Consider the use of alternative nonopioid analgesics in these patients.

• Seizures: Use with caution in patients with a history of seizure disorders; may cause or exacerbate preexisting seizures.

• Sleep-disordered breathing: Use opioids with caution for chronic pain and titrate dosage cautiously in patients with risk factors for sleep-disordered breathing, including HF and obesity. Avoid opioids in patients with moderate to severe sleep-disordered breathing (Dowell [CDC 2016]).

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Benzodiazepines or other CNS depressants: [US Boxed Warning]: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of oxycodone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosage and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

• CYP 3A4 interactions: [US Boxed Warning]: Use with all CYP3A4 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. In addition, discontinuation of a concomitant CYP 3A4 inducer may result in increased oxycodone concentrations. Monitor patients receiving oxycodone and any CYP 3A4 inhibitor or inducer.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Cachectic or debilitated patients: Use with caution in cachectic or debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages. Dose reduction may be required. Consider the use of alternative nonopioid analgesics in these patients.

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Use opioids for chronic pain with caution in this age group; monitor closely due to an increased potential for risks, including certain risks such as falls/fracture, cognitive impairment, and constipation. Clearance may also be reduced in older adults (with or without renal impairment) resulting in a narrow therapeutic window and increasing the risk for respiratory depression or overdose (Dowell [CDC 2016]). Consider the use of alternative nonopioid analgesics in these patients.

• Neonates: Neonatal withdrawal syndrome: [US Boxed Warning]: Prolonged use of opioids during pregnancy can cause neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. 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. Signs and symptoms include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Onset, duration and severity depend on the drug used, duration of use, maternal dose, and rate of drug elimination by the newborn.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Extended-release tablets: Tablets may be difficult to swallow and could become lodged in throat; patients with swallowing difficulties may be at increased risk. Cases of intestinal obstruction or diverticulitis exacerbation have also been reported, including cases requiring medical intervention to remove the tablet; patients with an underlying GI disease (eg, esophageal cancer, colon cancer) may be at increased risk.

• Oral solutions: [US Boxed Warning]: Ensure accuracy when prescribing, dispensing, and administering oxycodone oral solution. Dosing errors due to confusion between mg and mL, and other oxycodone oral solutions of different concentrations can results in accidental overdose.

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Use exposes patients and other users to the risks of addiction, abuse, and misuse, potentially leading to overdose and death. Assess each patient’s risk prior to prescribing; monitor all patients regularly for development of these behaviors or conditions. Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Other factors associated with increased risk for misuse include younger age, concomitant depression (major), and psychotropic medication use. Consider offering naloxone prescriptions in patients with factors associated with an increased risk for overdose, such as history of overdose or substance use disorder, higher opioid dosages (≥50 morphine milligram equivalents/day orally), and concomitant benzodiazepine use (Dowell [CDC 2016]).

• Accidental exposure: [US Boxed Warning]: Accidental ingestion of even one dose, especially in children, can result in a fatal overdose of oxycodone.

• Appropriate use: Chronic pain (outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder) in outpatient setting in adults: Opioids should not be used as first-line therapy for chronic pain management (pain >3-month duration or beyond time of normal tissue healing) due to limited short-term benefits, undetermined long-term benefits, and association with serious risks (eg, overdose, MI, auto accidents, risk of developing opioid use disorder). Preferred management includes nonpharmacologic therapy and nonopioid therapy (eg, NSAIDs, acetaminophen, certain anticonvulsants and antidepressants). If opioid therapy is initiated, it should be combined with nonpharmacologic and non-opioid therapy, as appropriate. Prior to initiation, known risks of opioid therapy should be discussed and realistic treatment goals for pain/function should be established, including consideration for discontinuation if benefits do not outweigh risks. Therapy should be continued only if clinically meaningful improvement in pain/function outweighs risks. Therapy should be initiated at the lowest effective dosage using immediate-release opioids (instead of extended-release/long-acting opioids). Risk associated with use increases with higher opioid dosages. Risks and benefits should be re-evaluated when increasing dosage to ≥50 morphine milligram equivalents (MME)/day orally; dosages ≥90 MME/day orally should be avoided unless carefully justified (Dowell [CDC 2016]).

• Optimal regimen: An opioid-containing analgesic regimen should be tailored to each patient’s needs and based upon the type of pain being treated (acute versus chronic), the route of administration, degree of tolerance for opioids (naive versus chronic user), age, weight, and medical condition. The optimal analgesic dose varies widely among patients; doses should be titrated to pain relief/prevention.

• REMS program: [US Boxed Warning]: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required. Drug companies with approved opioid analgesic products must make REMS-compliant education programs available to health care providers. Health care providers are encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and consider other tools to improve patient, household, and community safety.

• Surgery: Opioids decrease bowel motility; monitor for decreased bowel motility in postop patients receiving opioids. Use with caution in the perioperative setting; individualize treatment when transitioning from parenteral to oral analgesics.

• Withdrawal: Concurrent use of mixed agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol) or partial agonist (eg, buprenorphine) analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. Taper dose gradually when discontinuing.

Geriatric Considerations

The elderly may be particularly susceptible to the CNS depressant and constipating effects of opioids. Prophylactic use of a laxative should be considered. Serum concentrations at a given dose may also be increased relative to concentrations in younger patients.

Pregnancy Considerations

[US Boxed Warning]: Prolonged maternal use of opioids during pregnancy can cause neonatal withdrawal syndrome in the newborn which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If prolonged opioid therapy is required in a pregnant woman, ensure treatment is available and warn patient of risk to the neonate.

Oxycodone crosses the placenta (Kokki 2012). Maternal use of opioids may be associated with birth defects, poor fetal growth, stillbirth, and preterm delivery (CDC [Dowell 2016]). If chronic opioid exposure occurs in pregnancy, adverse events in the newborn (including withdrawal) may occur (Chou 2009). Symptoms of neonatal abstinence syndrome (NAS) following opioid exposure may be autonomic (eg, fever, temperature instability), gastrointestinal (eg, diarrhea, vomiting, poor feeding/weight gain), or neurologic (eg, high-pitched crying, hyperactivity, increased muscle tone, increased wakefulness/abnormal sleep pattern, irritability, sneezing, seizure, tremor, yawning) (Dow 2012; Hudak 2012). Mothers who are physically dependent on opioids may give birth to infants who are also physically dependent. Opioids may cause respiratory depression and psycho-physiologic effects in the neonate; newborns of mothers receiving opioids during labor should be monitored.

Agents other than oxycodone are commonly used to treat maternal pain during labor and immediately postpartum (ACOG 177 2017) as well as chronic noncancer pain in pregnant women or those who may become pregnant (CDC [Dowell 2016]; Chou 2009; Kahan 2011).

Breast-Feeding Considerations

Oxycodone is present in breast milk in variable concentrations.

In one study, oxycodone was measurable in breast milk up to 37 hours after the last maternal dose and therapeutic concentrations were detected in the serum of a breastfeeding infant (Seaton 2007). Oxycodone was also detected in the urine of a breastfed infant (Sulton-Villavasso 2012).

CNS depression, constipation, decreased feeding, and respiratory distress/irregular breathing have been observed in infants exposed to oxycodone via breast milk (Lam 2012; Sulton-Villavasso 2012).

Current guidelines note that nonopioid analgesics are preferred for postpartum pain in breastfeeding women (Montgomery 2012). When an opiate is needed, use of oxycodone in breastfeeding women is not recommended by some guidelines (Sachs 2013). Other guidelines note it may be useful to treat pain in some postpartum women, although prolonged and frequent use may cause neonatal sedation (Montgomery 2012). Maternal doses greater than 30 mg/day are not recommended (ACOG 177 2017). In addition, caution should be used in a woman who may be an ultrarapid metabolizer; oxycodone is a substrate for CYP2D6 and their breastfeeding infants may be at higher risk for adverse events (Montgomery 2012).

When opioids are needed in breastfeeding women, the lowest effective dose for the shortest duration of time should be used to limit adverse events in the mother and breastfeeding infant. In general, a single occasional dose of an opioid analgesic may be compatible with breastfeeding (WHO 2002). Breastfeeding women using opioids for postpartum pain or for the treatment of chronic maternal pain should monitor their infants for drowsiness, sedation, feeding difficulties, or limpness (ACOG 177 2017; Montgomery 2012; Sachs 2013). Withdrawal symptoms may occur when maternal use is discontinued or breastfeeding is stopped.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

As reported with adult patients, unless otherwise noted.

>10%:

Central nervous system: Drowsiness (extended-release: 9% to 23%, extended-release, adolescents: 1% to <5%; immediate-release: ≥3%), headache (extended-release: 14%; immediate-release: ≥3%), dizziness (extended-release: 2% to 13%; immediate-release: ≥3%)

Dermatologic: Pruritus (extended-release: 3% to 13%; immediate-release: ≥3%)

Gastrointestinal: Nausea (extended-release: 11% to 23%; immediate-release: ≥3%), constipation (extended-release: 5% to 23%; extended-release, adolescents: 9%; immediate-release: ≥3%), vomiting (extended-release: 4% to 21%; immediate-release: 3%)

Miscellaneous: Fever (extended-release: 1% to 11%; immediate-release: ≥3%)

1% to 10%:

Cardiovascular: Flushing (extended-release: 1% to 5%), hypertension (extended-release: 1% to 5%), orthostatic hypotension (extended-release: 1% to 5%), oxygen saturation decreased (extended-release, adolescents: 1% to <5%), edema (immediate-release: ≤5%; extended-release: <1%), tachycardia (<5%), cardiac failure (immediate-release: <3%), deep vein thrombosis (immediate-release: <3%), hypotension (<3%), palpitations (<3%; may occur with withdrawal), peripheral edema (immediate-release: <3%; extended-release: <1%), thrombophlebitis (immediate-release: <3%), vasodilatation (<3%)

Central nervous system: Abnormality in thinking (extended-release: 1% to 5%), dysphoria (extended-release: 1% to 5%), insomnia (1% to 5%), irritability (extended-release: 1% to 5%), twitching (extended-release: 1% to 5%), abnormal dreams (extended-release: ≤5%), anxiety (≤5%), chills (≤5%), confusion (≤5%), euphoria (extended-release: ≤5%), fatigue (extended-release: ≤5%), hypoesthesia (≤5%), migraine (≤5%), nervousness (≤5%), withdrawal syndrome (extended-release: ≤5%), agitation (<5%), pain (<5%), depression (extended-release, adolescents: 1% to <5%; extended-release, adults: <1%), lethargy (adolescents: 1% to <5%; extended-release, adults: <1%), paresthesia (extended-release, adolescents: 1% to <5%; extended-release, adults: <1%), procedural pain (extended-release, adolescents: 1% to <5%), hypertonia (<3%), neuralgia (<3%), personality disorder (immediate-release: <3%)

Dermatologic: Excoriation (extended-release: 1% to 5%), diaphoresis (≤5%), hyperhidrosis (≤5%), skin rash (≤5%), skin photosensitivity (immediate-release: <3%), urticaria (<3%)

Endocrine & metabolic: Hypochloremia (extended-release, adolescents: 1% to <5%), hyponatremia (extended-release: 1% to <5%), weight loss (extended-release, adolescents: 1% to <5%), hyperglycemia (≤5%), gout (immediate-release: <3%)

Gastrointestinal: Diarrhea (≤6%), xerostomia (≤6%), gastritis (extended-release: 1% to 5%), hiccups (extended-release: 1% to 5%), upper abdominal pain (extended-release: 1% to 5%), abdominal pain (≤5%), anorexia (≤5%), decreased appetite (≤5%), dyspepsia (≤5%), gastroesophageal reflux disease (extended-release: ≤5%), dysphagia (immediate-release: <3%; extended-release: <1%), gingivitis (immediate-release: <3%), glossitis (immediate-release: <3%)

Genitourinary: Dysuria (extended-release, adolescents: 1% to <5%; extended-release, adults: <1%), urinary retention (extended-release, adolescents: 1% to <5%; extended-release, adults: <1%), urinary tract infection (immediate-release: <3%)

Hematologic & oncologic: Decreased hemoglobin (extended-release, adolescents: 1% to <5%), decreased platelet count (extended-release, adolescents: 1% to <5%), decreased red blood cells (extended-release, adolescents: 1% to <5%), febrile neutropenia (extended-release, adolescents: 1% to <5%), neutropenia (extended-release, adolescents: 1% to <5%), anemia (immediate-release: <3%), hemorrhage (immediate-release: <3%), iron deficiency anemia (immediate-release: <3%), leukopenia (immediate-release: <3%)

Hepatic: Increased serum alanine aminotransferase (extended-release, adolescents: 1% to <5%)

Hypersensitivity: Hypersensitivity reaction (<3%)

Infection: Herpes simplex infection (immediate-release: <3%), infection (immediate-release: <3%), sepsis (immediate-release: <3%)

Neuromuscular & skeletal: Asthenia (1% to 6%), limb pain (extended-release, adolescents: 1% to <5%), arthralgia (≤5%), back pain (≤5%), musculoskeletal pain (extended release: ≤5%), myalgia (≤5%), tremor (≤5%), arthritis (immediate-release: <3%), laryngospasm (immediate-release: <3%), neck pain (immediate-release: <3%), ostealgia (immediate-release: <3%), pathological fracture (immediate-release: <3%)

Ophthalmic: Blurred vision (extended-release: 1% to 5%), amblyopia (immediate-release: <3%)

Respiratory: Cough (≤5%), dyspnea (≤5%), oropharyngeal pain (extended-release: ≤5%), bronchitis (immediate-release: <3%), epistaxis (immediate-release: <3%), flu-like symptoms (immediate-release: <3%), laryngismus (immediate-release: <3%), pharyngitis (immediate-release: <3%), pulmonary disease (immediate-release: <3%), rhinitis (immediate-release: <3%), sinusitis (immediate-release: <3%)

Miscellaneous: Seroma (extended-release, adolescents: 1% to <5%), accidental injury (<3%; extended-release: <1%)

Frequency not defined:

Cardiovascular: Circulatory depression, shock

Central nervous system: Depersonalization

Respiratory: Respiratory depression

<1%, postmarketing, and/or case reports: Abnormal gait, aggressive behavior, amenorrhea, amnesia, chest pain, choking sensation, cholestasis, dehydration, dental caries, depression of ST segment on ECG, diverticulitis of the gastrointestinal tract (exacerbation), drug abuse, drug dependence, drug overdose (may be intentional), dysgeusia, emotional lability, eructation, exfoliative dermatitis, facial edema, flatulence, gag reflex, gastrointestinal disease, hallucination, hematuria, hyperalgesia, hyperkinesia, hypogonadism, hypotonia, impotence, increased appetite, increased gamma-glutamyl transferase, increased heart rate, increased liver enzymes, increased thirst, intestinal obstruction, lymphadenopathy, malaise, memory impairment, mood changes, neonatal withdrawal, night sweats, pharyngeal edema, polyuria, restlessness, seizure, SIADH, sleep disturbance, speech disturbance, stomatitis, stupor, suicidal ideation, suicidal tendencies, syncope, tinnitus, vertigo, visual disturbance, voice disorder, xeroderma

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Alvimopan: Opioid Agonists may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation.Risk D: Consider therapy modification

Amphetamines: May enhance the analgesic effect of Opioid Agonists. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CNS Depressants: May enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May enhance the adverse/toxic effect of OxyCODONE. CYP3A4 Inhibitors (Moderate) may increase the serum concentration of OxyCODONE. Serum concentrations of the active metabolite Oxymorphone may also be increased. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May enhance the adverse/toxic effect of OxyCODONE. CYP3A4 Inhibitors (Strong) may increase the serum concentration of OxyCODONE. Serum concentrations of the active metabolite oxymorphone may also be increased. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Desmopressin: Opioid Agonists may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Diuretics: Opioid Agonists may enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. Risk C: Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk D: Consider therapy modification

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Eluxadoline: Opioid Agonists may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Risk D: Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Opioid Agonists may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: OxyCODONE may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This could result in serotonin syndrome. Management: Seek alternatives when possible. Avoid use of oxycodone/naltrexone during and within 14 days after monoamine oxidase inhibitor treatment. Non-US labeling for some oxycodone products states that such use is contraindicated. Risk D: Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nalmefene: May diminish the therapeutic effect of Opioid Agonists. Management: Avoid the concomitant use of nalmefene and opioid agonists. Discontinue nalmefene 1 week prior to any anticipated use of opioid agonistss. If combined, larger doses of opioid agonists will likely be required. Risk D: Consider therapy modification

Naltrexone: May diminish the therapeutic effect of Opioid Agonists. Management: Seek therapeutic alternatives to opioids. See full drug interaction monograph for detailed recommendations. Risk D: Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Opioids (Mixed Agonist / Antagonist): May diminish the analgesic effect of Opioid Agonists. Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations.Risk X: Avoid combination

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Pegvisomant: Opioid Agonists may diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Ramosetron: Opioid Agonists may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of OxyCODONE. Risk C: Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Serotonin Modulators: Opioid Agonists may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

St John’s Wort: May decrease the serum concentration of OxyCODONE. Risk C: Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Risk D: Consider therapy modification

Succinylcholine: May enhance the bradycardic effect of Opioid Agonists. Risk C: Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Voriconazole: May enhance the adverse/toxic effect of OxyCODONE. Voriconazole may increase the serum concentration of OxyCODONE. Management: A reduced oxycodone dose may be necessary with concurrent voriconazole. Increased frequency and duration of monitoring for oxycodone-related adverse effects is recommended. Risk D: Consider therapy modification

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Test Interactions

Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered.

Gene Testing May Be Considered
Genes of Interest
Monitoring Parameters

Pain relief, respiratory and mental status, blood pressure; bowel function; signs/symptoms of misuse, abuse, and addiction; signs or symptoms of hypogonadism or hypoadrenalism (Brennan 2013)

Alternate recommendations: Chronic pain (long-term therapy outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder): Evaluate benefits/risks of opioid therapy within 1 to 4 weeks of treatment initiation and with dose increases. Re-evaluate benefits/risks every 3 months during therapy or more frequently in patients at increased risk of overdose or opioid use disorder. Urine drug testing is recommended prior to initiation and re-checking should be considered at least yearly (includes controlled prescription medications and illicit drugs of abuse). State prescription drug monitoring program (PDMP) data should be reviewed by clinicians prior to initiation and periodically during therapy (frequency ranging from every prescription to every 3 months) (Dowell [CDC 2016]).

Advanced Practitioners Physical Assessment/Monitoring

Patients who do not receive pain relief may benefit from referral to a pain management specialist.

Nursing Physical Assessment/Monitoring

Monitor for effectiveness of pain relief. Monitor blood pressure, CNS and respiratory status, and degree of sedation at beginning of therapy and periodically thereafter. Assess patient’s physical and/or psychological dependence. For inpatients, implement safety measures (eg, side rails up, call light within reach, instructions to call for assistance). Discontinue slowly after prolonged use. Monitor patient for unintentional or intentional potential for overdose or medication misuse. Monitor for symptoms of opioid withdrawal. Monitor urine toxicology screen results.

Controlled Substance

C-II

Dosage Forms Considerations

Xtampza ER: Strength is expressed in terms of oxycodone base.

9 mg equivalent to 10 mg oxycodone hydrochloride

13.5 mg equivalent to 15 mg oxycodone hydrochloride

18 mg equivalent to 20 mg oxycodone hydrochloride

36 mg equivalent to 40 mg oxycodone hydrochloride

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

Generic: 5 mg

Capsule ER 12 Hour Abuse-Deterrent, Oral:

Xtampza ER: 9 mg (100 ea); 13.5 mg (100 ea); 18 mg (100 ea); 27 mg (100 ea); 36 mg (100 ea)

Concentrate, Oral, as hydrochloride:

Generic: 100 mg/5 mL (15 mL [DSC], 30 mL)

Solution, Oral, as hydrochloride:

Generic: 5 mg/5 mL (5 mL, 15 mL, 473 mL, 500 mL)

Tablet, Oral, as hydrochloride:

Roxicodone: 5 mg [scored]

Roxicodone: 15 mg [scored; contains fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Roxicodone: 30 mg [scored]

Generic: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Tablet Abuse-Deterrent, Oral:

RoxyBond: 15 mg, 30 mg [contains fd&c blue #2 (indigotine)]

Tablet Abuse-Deterrent, Oral, as hydrochloride:

Oxaydo: 5 mg, 7.5 mg

RoxyBond: 5 mg

Tablet ER 12 Hour Abuse-Deterrent, Oral, as hydrochloride:

OxyCONTIN: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg

OxyCONTIN: 80 mg [contains fd&c blue #2 aluminum lake]

Generic: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suppository, Rectal:

Supeudol 10: 10 mg (12ea)

Supeudol 20: 20 mg (12ea)

Tablet, Oral, as hydrochloride:

Oxy-IR: 5 mg, 10 mg, 20 mg

Supeudol: 5 mg, 10 mg, 20 mg

Generic: 5 mg, 10 mg, 20 mg

Tablet ER 12 Hour Abuse-Deterrent, Oral, as hydrochloride:

OxyNEO: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg

OxyNEO: 80 mg [contains FD&C BLUE #2 ALUMINUM LAKE]

Tablet Extended Release 12 Hour, Oral:

Generic: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • N02AA05
Generic Available (US)

May be product dependent

Pricing: US

Capsule ER 12 Hour Abuse-Deterrent (Xtampza ER Oral)

9 mg (per each): $5.35

13.5 mg (per each): $7.87

18 mg (per each): $9.98

27 mg (per each): $13.89

36 mg (per each): $17.09

Capsules (oxyCODONE HCl Oral)

5 mg (per each): $1.84 – $1.85

Concentrate (oxyCODONE HCl Oral)

100 mg/5 mL (per mL): $4.40 – $12.33

Solution (oxyCODONE HCl Oral)

5 mg/5 mL (per mL): $1.05 – $1.73

Tablet Abuse-Deterrent (Oxaydo Oral)

5 mg (per each): $8.81

7.5 mg (per each): $13.20

Tablet Abuse-Deterrent (RoxyBond Oral)

5 mg (per each): $8.00

15 mg (per each): $9.34

30 mg (per each): $12.44

Tablet ER 12 Hour Abuse-Deterrent (oxyCODONE HCl ER Oral)

10 mg (per each): $3.02

15 mg (per each): $4.84

20 mg (per each): $5.64

30 mg (per each): $8.52

40 mg (per each): $8.36 – $9.90

60 mg (per each): $14.85

80 mg (per each): $15.73 – $17.28

Tablet ER 12 Hour Abuse-Deterrent (OxyCONTIN Oral)

10 mg (per each): $4.96

15 mg (per each): $7.29

20 mg (per each): $9.24

30 mg (per each): $12.85

40 mg (per each): $15.81

60 mg (per each): $22.40

80 mg (per each): $27.61

Tablets (oxyCODONE HCl Oral)

5 mg (per each): $0.37 – $0.62

10 mg (per each): $0.63 – $0.89

15 mg (per each): $1.25 – $2.37

20 mg (per each): $1.10

30 mg (per each): $1.67 – $4.49

Tablets (Roxicodone Oral)

5 mg (per each): $2.03

15 mg (per each): $6.23

30 mg (per each): $12.23

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression

Pharmacodynamics/Kinetics

Onset of action: Pain relief: Immediate release: 10 to 15 minutes

Peak effect: Immediate release: 0.5 to 1 hour

Duration: Immediate release: 3 to 6 hours; Extended release: ≤12 hours

Distribution: Vd: Children 2 to 10 years: 2.1 L/kg (range: 1.2 to 3.7 L/kg); Adults: 2.6 L/kg; distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain

Protein binding: 38% to 45%

Metabolism: Hepatically via CYP3A4 to noroxycodone (has weak analgesic), noroxymorphone, and alpha- and beta-noroxycodol. CYP2D6 mediated metabolism produces oxymorphone (has analgesic activity; low plasma concentrations [<15%]), alpha- and beta-oxymorphol.

Bioavailability: Extended release tablet, immediate release: 60% to 87%; Extended release capsule is not bioequivalent to extended release tablet; however AUC, is similar in a fed state

Half-life:

Apparent: Immediate release: 3.2 to ~4 hours; Extended release tablet: 4.5 hours; Extended release capsule: 5.6 hours

Elimination: Children 2 to 10 years: 1.8 hours (range: 1.2 to 3 hours); Adults: 3.7 hours

Adults with CrCl <60 mL/minute: Half-life increases by 1 hour, but peak oxycodone concentrations increase by 50% and AUC increases by 60%

Adults with mild to moderate hepatic impairment: Half-life increases by 2.3 hours, peak oxycodone concentrations increase by 50%, and AUC increases by 95%

Time to peak, plasma: Immediate release: 1.2 to 1.9 hours; Extended release: 4 to 5 hours

Excretion: Urine (~19% as parent; >64% as metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Higher peak plasma oxycodone (50%), and noroxycodone (20%), higher AUC for oxycodone (60%), noroxycodone (50%), and oxymorphone (40%) in patients with CrCl <60 mL/minute. There is an increased half-life elimination for oxycodone elimination of only 1 hour.

Hepatic function impairment: Peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher; AUC values are 95% and 65% higher, respectively, in mild to moderate hepatic impairment. Oxymorphone peak plasma concentration and AUC values are lower by 30% and 40%. The half-life elimination for oxycodone is increased by 2.3 hours.

Dental Use

Treatment of postoperative pain

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

No information available to require special precautions

Dental Usual Dosing

Postoperative pain: Adults: Oral: 5 mg every 6 hours as needed

Index Terms

Dihydrohydroxycodeinone; Oxecta; Oxycodone HCl; Oxycodone Hydrochloride

FDA Approval Date
December 12, 1995
References

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Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016 [published correction appears in MMWR Recomm Rep. 2016;65(11):295]. MMWR Recomm Rep. 2016;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.[PubMed 26987082]

Gallagher RM, Welz-Bosna M, Gammaitoni A. Assessment of dosing frequency of sustained-release opioid preparations in patients with chronic nonmalignant pain. Pain Med. 2007;8(1):71-74.[PubMed 17244106]

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Lam J, Kelly L, Ciszkowski C, et al. Central nervous system depression of neonates breastfed by mothers receiving oxycodone for postpartum analgesia. J Pediatr. 2012;160(1):33-37.[PubMed 21880331]

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Oxy IR (oxycodone) [product monograph]. Pickering, Ontario, Canada: Purdue Pharma; February 2018.

Oxyneo (oxycodone) [product monograph]. Pickering, Ontario, Canada: Purdue Pharma; February 2018.

Roxicodone (oxycodone) [prescribing information]. Hazelwood, MO: Mallinckrodt Pharmaceuticals; September 2018.

Roxybond (oxycodone) [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo Inc; December 2018.

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Brand Names: International

Abtard (GB); Alnagon (RO); Dancex (IE); Endone (AU); Epethinan (IE); Ircodon (KR); Lynlor (GB); M-Oxy (PE); Novacodone (AU); Orionox (NO); Oxycod (IL); OxyContin (AR, AT, BR, CH, CL, CN, CO, CR, CY, CZ, DK, DO, EC, EE, ES, FI, GB, GT, HK, HN, IE, IL, IT, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, SE, SG, SV, VE); Oxycontin (BB, BH, HR, HU, IS, LB, LU, RO, SI, SK, TR, VN); Oxycontin CR (KR); Oxycontin LP (FR); Oxycontin Neo (PH); Oxyfast (JP); Oxygesic (DE); Oxyneo (ID, VN); Oxynorm (AT, AU, BE, CH, CY, DK, EG, ES, FI, FR, GB, HK, ID, IE, IS, MY, NO, NZ, PH, SE, SG, TR); OxyNorm (JP); Oxynorm IV (SG); Plexicodim (MX); Reltebon (GB)

Oxycodone (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(oks i KOE done)

Brand Names: US

Oxaydo; OxyCONTIN; Roxicodone; RoxyBond; Xtampza ER

Brand Names: Canada

Oxy.IR; OxyNEO; Supeudol

Warning
  • All products:
  • This drug may be habit-forming with long-term use.
  • This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your doctor.
  • You will be watched closely to make sure you do not misuse, abuse, or become addicted to this drug.
  • This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
  • The chance of very bad and sometimes deadly breathing problems may be greater when you first start this drug or anytime your dose is raised.
  • Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
  • Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.
  • Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
  • Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
  • All long-acting products:
  • Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death.
  • All liquid products:
  • Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.
  • Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist.
What is this drug used for?
  • It is used to ease pain.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to oxycodone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Long-term use of an opioid drug like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
  • If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
  • This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this drug.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • All long-acting products:
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor.
  • All other products:
  • If you have been taking this drug on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this drug all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
  • Roxybond tablets:
  • You may see something that looks like the tablet in your stool. This is normal and not a cause for concern. If you have questions, talk with your doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Very bad constipation.
  • Very bad belly pain.
  • Feeling very tired or weak.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Trouble passing urine.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Shakiness.
  • Change in eyesight.
  • Chest pain or pressure.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • Memory problems or loss.
  • Trouble walking.
  • Trouble speaking.
  • Swelling in the arms or legs.
  • Feeling very sleepy.
  • Fever.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach or throwing up.
  • Constipation.
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Trouble sleeping.
  • Feeling tired or weak.
  • Itching.
  • Dry mouth.
  • Belly pain.
  • Diarrhea.
  • Not hungry.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take by mouth only.
  • Do not inject or snort this drug. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • All long-acting products:
  • To gain the most benefit, do not miss doses.
  • Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death.
  • Do not use for fast pain relief or on an as needed basis.
  • Do not use for pain relief after surgery if you have not been taking drugs like this drug.
  • Long-acting capsules:
  • Take this drug with food. Always take with the same amount of food each time.
  • You may sprinkle contents of the capsule on applesauce or other soft food. You may also sprinkle the contents of the capsule into a cup and put directly into the mouth. Do not chew. Swallow right away and rinse your mouth to make sure that all capsule contents were swallowed.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Oxaydo and Roxybond tablets, long-acting tablets:
  • Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
  • If you have trouble swallowing, talk with your doctor.
  • Do not put this drug down a feeding tube.
  • Oxaydo and Roxybond tablets:
  • Swallow whole. Do not chew, break, or crush.
  • All liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high.
What do I do if I miss a dose?
  • Long-acting tablets:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Long-acting capsules:
  • Take a missed dose as soon as you think about it, with food.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • All other products:
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Oxycodone (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(oks i KOE done)

Brand Names: US

Oxaydo; OxyCONTIN; Roxicodone; RoxyBond; Xtampza ER

Brand Names: Canada

Oxy.IR; OxyNEO; Supeudol

Warning
  • All products:
  • This drug may be habit-forming with long-term use.
  • This drug is a strong pain drug that can put your child at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your child’s doctor.
  • Your child will be watched closely to make sure your child does not misuse, abuse, or become addicted to this drug.
  • This drug may cause very bad and sometimes deadly breathing problems. Call the doctor right away if your child has slow, shallow, or trouble breathing.
  • The chance of very bad and sometimes deadly breathing problems may be greater when your child first starts this drug or anytime the dose is raised. Talk with your child’s doctor.
  • Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
  • Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.
  • Be sure your child does not drink alcohol or use products that have alcohol. Unsafe and sometimes deadly effects may happen.
  • Get medical help right away if your child does not respond, answer, or react like normal; feels very sleepy or dizzy; passes out; or will not wake up.
  • If your child is pregnant:
  • Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • All long-acting products:
  • Have your child swallow whole. Do not let your child chew, break, crush, or dissolve before swallowing. Do not let your child inject or snort this drug. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • All liquid products:
  • Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.
  • Be sure that you know how to measure your child’s dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your child’s doctor or pharmacist.
What is this drug used for?
  • It is used to ease pain.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If your child is taking any of these drugs: Linezolid or methylene blue.
  • If your child is taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not give this drug with other strong pain drugs or pain patches without talking to your child’s doctor first.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Long-term use of an opioid drug like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in males, no menstrual period in females, lowered interest in sex, or fertility problems. If any of these apply to your child, call your child’s doctor.
  • If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
  • This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to the doctor to see if your child has a greater chance of seizures while taking this drug.
  • If your child is pregnant:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • All long-acting products:
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of signs of withdrawal. If your child needs to stop this drug, you will want to slowly stop it as ordered by the doctor.
  • Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor.
  • All other products:
  • If your child has been taking this drug on a regular basis and stops taking it all of a sudden, your child may have signs of withdrawal. Do not stop giving this drug all of a sudden without calling the doctor. Tell the doctor if your child has any bad effects.
  • Roxybond tablets:
  • You may see something that looks like the tablet in your child’s stool. This is normal and not a cause for concern. If you have questions, talk with your child’s doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Feeling very tired or weak.
  • Very bad constipation.
  • Very bad belly pain.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Trouble passing urine.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Shakiness.
  • Change in eyesight.
  • Chest pain or pressure.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • Memory problems or loss.
  • Trouble walking.
  • Trouble speaking.
  • Swelling in the arms or legs.
  • Feeling very sleepy.
  • Fever.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid pain drug like this drug may lead to a rare but very bad adrenal gland problem. Call your child’s doctor right away if your child has very bad dizziness or passing out, very bad upset stomach or throwing up, or if your child feels less hungry, very tired, or very weak.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach or throwing up.
  • Constipation.
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Trouble sleeping.
  • Feeling tired or weak.
  • Itching.
  • Dry mouth.
  • Belly pain.
  • Diarrhea.
  • Not hungry.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug by mouth only.
  • Do not let your child inject or snort this drug. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • All long-acting products:
  • To gain the most benefit, do not miss giving your child doses.
  • Have your child swallow whole. Do not let your child chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death.
  • Do not give long-acting products for fast pain relief or on an as needed basis.
  • Do not give for pain relief after surgery if your child has not been taking drugs like this drug.
  • Long-acting capsules:
  • Give this drug with food. Always give with the same amount of food each time.
  • You may sprinkle contents of the capsule on applesauce or other soft food. You may also sprinkle the contents of the capsule into a cup and put directly into the mouth. Do not let your child chew. Have your child swallow right away and rinse the mouth to make sure that all capsule contents were swallowed.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Oxaydo and Roxybond tablets, long-acting tablets:
  • Have your child take 1 tablet at a time if the dose is more than 1 tablet. Do not let your child lick or wet the tablet before putting it in the mouth. Have your child swallow the tablet with lots of water right after putting it in the mouth.
  • If your child has trouble swallowing, talk with the doctor.
  • Do not put this drug down a feeding tube.
  • Oxaydo and Roxybond tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • All liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high.
What do I do if my child misses a dose?
  • Long-acting tablets:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Long-acting capsules:
  • Give a missed dose as soon as you think about it, with food.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • All other products:
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.