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Oxycodone Dosage

Applies to the following strength(s): 5 mg/5 mL ; 20 mg/mL ; 5 mg ; 15 mg ; 30 mg ; 10 mg ; 20 mg ; 40 mg ; 80 mg ; 60 mg ; 160 mg ; 7.5 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
-Oxycodone oral solution is available in 2 concentrations (5 mg/mL and 20 mg/mL); to avoid dosing errors, include total dose in mg and mL when prescribing and dispensing.

Initial dose in opioid-naive patients:
-Immediate Release: 5 to 15 mg orally every 4 to 6 hours
-Oral solution 5 mg/mL: 5 to 15 mg orally every 4 to 6 hours
-Titrate according to patient's pain response and tolerability

-Oxycodone Oral Solution 100 mg per 5 mL (20 mg/mL) is for use in opioid-tolerant patients only; it may be used in patients who have been titrated to a stable analgesic regimen and who could benefit from the use of a smaller volume of oral solution.

Comments:
-When selecting the initial dose, take into account the patient's degree of opioid tolerance, patient's general condition and medical status, concurrent medications, type and severity of the pain, and risk factors for abuse, addiction, or diversion.
-When converting patients to oxycodone from other opioids or from other controlled-release oral oxycodone products, it is important to account for the inter-patient variability in the potency of opioid drugs and their formulations; it is best to underestimate a patients oral oxycodone requirement and provide rescue medication than to overestimate and manage an overdose; the manufacturer's product information and/or local protocol may be consulted for guidance.

Use: For the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic.

Usual Adult Dose for Chronic Pain

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
-Oxycodone extended-release 60 and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.

Initial dose for opioid-naive and opioid non-tolerant patients:
-Extended-Release: 10 mg orally every 12 hours
-Titrate every 1 to 2 days according to patient's pain response and tolerability

Comments:
-Extended-release oxycodone products are reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; these products are not intended to be used as as-needed (prn) analgesics.
-When selecting the initial dose, take into account the patient's degree of opioid tolerance, patient's general condition and medical status, concurrent medications, type and severity of the pain, and risk factors for abuse, addiction, or diversion.

DOSE CONVERSIONS: Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response; the manufacturer's product information and/or local protocol may be consulted for guidance.

Oxycodone Extended-Release (ER) TABLETS:
-The 60 and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are reserved for opioid tolerant individuals.
-Discontinue all other around the clock opioid drugs when initiating therapy with extended-release oxycodone.
CONVERSION FROM OTHER ORAL OXYCODONE FORMULATIONS:
-Administer one-half the patient's total daily oxycodone dose as extended-release oxycodone every 12 hours.
CONVERSION FROM OTHER ORAL OPIOIDS:
-Published potency tables can be used to estimate a patient's 24-hour oral oxycodone requirement; however, due to substantial inter-patient variability, it is best to underestimate a patient's 24-hour requirement and provide rescue medication as the dose is titrated.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove the transdermal fentanyl patch and 18 hours later initiate oxycodone extended-release capsules at 10 mg every 12 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited documented experience with this conversion.
CONVERSION FROM METHADONE:
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Usual Geriatric Dose for Chronic Pain

Dosing for geriatric patients should be conservative, generally starting at the lower end of the dosing range.

Extended-release: For geriatric patients who are debilitated and not opioid tolerant: Initial doses should be one-third to one-half the recommended starting doses; titrate carefully

Usual Pediatric Dose for Chronic Pain

Prior to initiating therapy with this drug, patients must be receiving and tolerating opioids for at least 5 consecutive days, and for the 2 days immediately preceding initiation, patients must be taking a minimum of 20 mg of oxycodone per day or its equivalent

-Age: 11 years and older: Extended-release tablets only
-Discontinue all around-the-clock opioid drugs when initiating oxycodone extended-release tablets
-Usual dose: One-half of calculated total daily dose orally every 12 hours

TO CALCULATE DOSAGE: Multiply total daily dose of prior opioid by the appropriate conversion factor (CF) provided below; divide by 2 to get the every 12-hour oxycodone extended-release dose; if rounding is necessary, always round down to the nearest tablet strength available
--For prior opioid use of OXYCODONE: Oral CF is 1
--For prior opioid use of HYDROCODONE: Oral CF is 0.9
--For prior opioid use of HYDROMORPHONE: Oral CF is 4; Parenteral CF is 20*
--For prior opioid use of MORPHINE: Oral CF is 0.5; Parenteral CF is 3*
--For prior opioid use of TRAMADOL: Oral CF is 0.17; Parenteral CF is 0.2*
*For patients receiving high-dose parenteral opioids, a more conservative CF is warranted (e.g., for high-dose parenteral morphine, use a CF of 1.5 instead of a CF of 3)
-The CFs listed above are to convert from prior opioid use to oxycodone extended-release tablets and not to convert from oxycodone extended-release tablets to another opioid as doing so will result in an over-estimation of the new opioid dose and possibly a fatal overdose.

CONVERSION FROM TRANSDERMAL FENTANYL: Remove patch 18 hours prior to starting oxycodone extended-release.
-Substitute 10 mg oxycodone extended-release every 12 hours for each 25 mcg per hour fentanyl transdermal patch

Titration and Maintenance:
-Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments can be made every 1 to 2 days; when a dose increase is clinically indicated, it is suggested that the total daily oxycodone dose not be increased by more than 25% at a time.
-Patients who experience breakthrough pain may require rescue medication or a dose increase; if the pain level increases after dose stabilization; attempt to identify the source of increased pain before increasing the dose.

Comments:
-Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response; it is preferable to underestimate a patient's 24-hour oral oxycodone requirement and provide rescue medication than to overestimate and manage an adverse reaction.
-Extended-release oxycodone products are reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; these products are not intended to be used as as-needed (prn) analgesics.
-When selecting the initial dose, take into account the patient's degree of opioid tolerance, patient's general condition and medical status, concurrent medications, type and severity of the pain, and risk factors for abuse, addiction, or diversion.

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

Renal Dose Adjustments

CrCl less than 60 mL/minute: Start conservatively and titrate dosage carefully to desired effect

Liver Dose Adjustments

Hepatic impairment: Start conservatively and titrate dosage carefully to desired effect

Extended-release tablets: Initial dose: Give one-third to one-half of the usual dose; titrate dosage carefully to desired effect.

Dose Adjustments

Treatment may require cautious initiation and adjustment according to the severity of pain, history of opioid tolerance, patient response, and tolerance of side effects. Parenteral therapy may also require adjustments according to additional monitoring of respiratory rate and sedation score.

Dosage reductions may be required with concomitant CNS depressant therapy.
-Oxycodone extended-release tablets: Initial dose should be one-third to one-half the recommended starting dose with concomitant use of CNS depressants

As needed "rescue doses" of immediate release oral oxycodone may be needed for patients with cancer pain. The need for more than 2 rescue doses per day may require a review of the controlled release dose.

Oxycodone should not be ceased abruptly; the daily dose should be gradually tapered to minimize or prevent withdrawal symptoms.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics. The REMS consists of a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/REMS

BOXED WARNING: RISK OF MEDICATION ERRORS
-Oxycodone Oral Solution is available as a 100 mg/5 mL (20 mg/mL) concentration and is indicated for use in opioid-tolerant patients only.
-Take care when prescribing and administering to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.
-Keep oxycodone oral solution out of the reach of children, In case of accidental ingestion, seek emergency medical help immediately.

BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION:
-Addiction, Abuse, and Misuse: Oxycodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase. Instruct patients to swallow tablets whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose.
-Accidental Ingestion: Accidental ingestion of even 1 dose of extended-release oxycodone, especially by children, can result in a fatal overdose.
-Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment should be available.
-Cytochrome P450 3A4 Interaction: The concomitant use with CYP450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone and any CYP450 3A4 inhibitor or inducer.

Safety and efficacy of the immediate-release products have not been established in patients younger than 18 years. Established local clinical guidelines should be consulted before initiating use in these patients.
Safety and efficacy of oxycodone extended-release tablets have not been established in patients younger than 11 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:
Oral solution:
-Oxycodone oral solution is available in 2 concentrations (5 mg/mL and 20 mg/mL); to avoid dosing errors, include total dose in mg and mL when prescribing and dispensing; reserve use of 20 mg/mL strength for opioid-tolerant patients.
-To ensure accuracy in dosing, use the supplied calibrated oral measuring cup (5 mg/mL) or oral syringe (20 mg/mL)

Immediate-release tablets:
-Swallow whole, take with enough water to ensure complete swallowing

Extended-release tablets:
-Reserve use of extended-release 60 and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg for opioid-tolerant patients.
-Swallow whole; do not break, chew, crush, or dissolve as this may lead to rapid release and absorption of a potentially fatal dose
-Take with enough water to ensure complete swallowing; do not pre-soak, lick or otherwise wet tablet prior to swallowing.

General:
-Extended-release oxycodone should be prescribed by a healthcare professional that is knowledgeable in the use of potent opioids for the management of chronic pain.
-Due to the risk of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, extended-release oxycodone is for use in patients for whom alternative treatment options (non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
-For patients receiving other opioid analgesics and switching to this drug or the extended-release tablet formulation, it is safer to underestimate a patient's 24-hour oral requirement and provide rescue medication than overestimate and manage an adverse reaction; there is substantial inter-patient variation in the relative potency of different opioid drugs that conversion tables are not able to capture.
-During chronic therapy, periodically reassess the continued need for opioid analgesics.
-Oxycodone oral solution 100 mg per 5 mL (20 mg/mL) is for use in opioid-tolerant patients only; it may be used to treat moderate to severe acute and chronic pain in opioid-tolerant patients who have been titrated to a stable analgesic regimen and who could benefit from the use of a smaller volume of oral solution; to avoid dosing errors, include total dose in mg and mL when, prescribing, dispensing oral oxycodone solution.

Monitoring:
-Cardiovascular: Monitor for signs of hypotension upon initiating therapy and following dose increases, especially those whose blood pressure is compromised.
-Respiratory: Monitor for respiratory depression.
-Gastrointestinal: Monitor for constipation and decreased bowel motility, especially in post-operative patients.
-General: Monitor routinely for maintenance of pain control and incidence of adverse reactions.
-Psychiatric: Patients should be monitored for the development of addiction, abuse, or misuse.

Patient advice:
-Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child is a medical emergency and can result in death.
-Patients should understand that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect their drug from theft or misuse.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest; patients should be made aware that crushing, chewing, or dissolving capsules will result in uncontrolled delivery of oxycodone and can lead to overdose or death.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
-Patients should be instructed in proper disposal.

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