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Naloxone / Oxycodone Dosage

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.


All doses expressed as oxycodone/naloxone

OPIOID-NAIVE and OPIOID NON-TOLERANT patients:
Initial dose: 10 mg/5 mg orally every 12 hours

CONVERSIONS From Other Oral Oxycodone Formulations:

CONVERSIONS From Other Opioids:

MAINTENANCE DOSE:
Maximum single dose: 40 mg/20 mg
Maximum daily dose: 80 mg/40 mg

Comments:

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.

Renal Dose Adjustments

Mild to Severe Renal Impairment: Reduce initial dose by one-half usual starting dose, titrate carefully; monitor for signs of respiratory depression, sedation, and hypotension

Liver Dose Adjustments

Mild hepatic impairment: Reduce initial dose by one-third to one-half of usual starting dose, titrate carefully; monitor for signs of respiratory depression, sedation, and hypotension
Moderate or severe hepatic impairment: Contraindicated

Dose Adjustments

Elderly, Cachectic, or Debilitated Patients:


DOSE CONVERSIONS:

Dose conversion is a 2-step process:

CONVERSION FROM TRAMADOL: Oxycodone 10 mg/naloxone 5 mg orally every 12 hours
CONVERSION FROM METHADONE: When converting from methadone, close monitoring is of particular importance due to methadone's long half-life and unpredictable pharmacokinetics.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove transdermal fentanyl patch at least 18 hours prior to initiating therapy with oxycodone/naloxone; substitute oxycodone 10 mg/naloxone 5 mg every 12 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited experience with this conversion
CONVERSION FROM TRANSDERMAL BUPRENORPHINE: For patients receiving buprenorphine 20 mcg/hr or less: Initiate with oxycodone 10 mg/naloxone 5 mg every 12 hours; monitor closely as there is limited experience with this conversion

Therapy Discontinuation:

Concomitant Use of CNS Depressants:

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS


CONTRAINDICATIONS:

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:


Missed dose: If a dose is missed, take next dose as scheduled, unless it is more than 8 hours to next regularly scheduled dose in which case, take the missed dose and return to their original schedule; patients should not double up or take extra tablets to make up for missed dose.

Storage requirements:

General:

Monitoring:

Patient advice:

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.