Usual Adult Dose for Pain

Initial dose: 1 tablet (oxycodone 5 mg/ibuprofen 400 mg) orally every 6 hours as needed for pain
Maximum dose: 4 tablets in 24 hours
Duration of therapy: Not to exceed 7 days

Comments:

• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the short term management of acute to moderate pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain

14 or older:
Initial dose: 1 tablet (oxycodone 5 mg/ibuprofen 400 mg) orally every 6 hours as needed for pain
Maximum dose: 4 tablets in 24 hours
Duration of therapy: Not to exceed 7 days

Comments:

• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the short term management of acute to moderate pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.

Renal Dose Adjustments

Advanced Renal Impairment: Avoid use unless the benefits are expected to outweigh the risk of worsening renal function.

Liver Dose Adjustments

Hepatic Impairment: Caution recommended; consider initiating therapy with a lower dose and titrate carefully

Dose Adjustments

Elderly, Cachectic, or Debilitated Patients: Consider non-opioid analgesics; if used, monitor closely for respiratory depression especially upon initiation

Discontinuation of Therapy in the Physically Dependent Patient:

• Taper dose gradually, by 25% to 50% every 2 to 4 days
• Monitor for signs and symptoms of withdrawal; if they occur, raise the dose to the previous level and taper more slowly
• Do not abruptly discontinue in the physically dependent patient

Precautions

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

• Addiction, Abuse, and Misuse: This drug 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.
• Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly 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.
• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with oxycodone use. Monitor for respiratory depression, especially during initiation or following a dose increase.
• Accidental Ingestion: Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose.
• Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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 will be available.
• CYP450 3A4 Interaction: The concomitant use of CYP450 3A4 inhibitors may result in increased 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 increased oxycodone plasma concentrations. Monitor patients concomitantly receiving any CYP450 3A4 inhibitor or inducer.
• Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for use in patients for whom alternative treatment options are inadequate. If needed, limit dose and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
• CARDIOVASCULAR Thrombotic Events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• GASTROINTESTINAL (GI) Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Safety and efficacy have not been established in patients younger than 14 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally

Storage requirements:

• Protect from light and moisture

General:

• Use should be limited to less than 7 days due to the risks of addiction, abuse and misuse associated with oxycodone use.
• Frequent communication between members of the healthcare team, patients, and their caregiver/family is important during periods of changing analgesic requirements; if the level of pain increases after dose stabilization, an attempt should be made to identify the source of increased pain before increasing the dose of pain medication.
• NSAID use increases the risk of serious cardiovascular thrombotic events.

Monitoring:

• Monitor for respiratory depression, especially during initiation and following any increase in dose; close monitoring will be necessary in patients at increased risk and/or those receiving concomitant medications that increase the risk of respiratory depression
• Monitor blood pressure; monitor for signs of hypotension, fluid retention, and or worsening heart failure.
• Monitor for signs of GI ulceration, bleeding, and constipation
• Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
• Monitor for the development of skin rashes.
• Monitor for the development of behaviors indicative of addiction, abuse, or misuse

Patient advice:

• Patients should be instructed to read the US FDA-approved Medication Guide each time this drug is dispensed; they should understand the safe use, serious risks, and proper storage and disposal of this drug.
• 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 and caregivers should be instructed to get emergency help right away if too much drug is taken or if breathing problems occur.
• Patients should be instructed to check with their healthcare provider before taking any new medications, herbal supplements, and over the counter products; patients should not drink alcohol while taking this drug.
• Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
• 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 talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.