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oxycodone/ibuprofen (Rx)Brand and Other Names:Combunox

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oxycodone/ibuprofen

tablet: Schedule II

  • 5mg/400mg
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Analgesia

Indicated for short-term management of acute, moderate to severe pain

Use lowest effective dose for the shortest duration consistent with individual patient treatment goals

Usual dose: 5 mg/400 mg PO q6 hr PRN

Dosage should not exceed 20 mg/1600 mg (4 tablets) q24 h and should not exceed 7 days duration

Renal Impairment

Not recommended in patients with advanced renal disease

Administration

Not indicated for the treatment of chronic conditions such as osteoarthritis or rheumatoid arthritis

Use extra caution and reduced dosages when treating the elderly or debilitated patients; increased risk of gastrointestinal injury, including fatal events; increased risk of renal toxicity and injury; respiratory depression may occur

Safety and efficacy not established

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Interactions

Interaction Checker

oxycodone/ibuprofen and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (5-19%)

            Drowsiness (7-17%)

            Nausea (9-25%)

            1-10%

            Constipation (1-5%)

            Diarrhea (2%)

            Dyspepsia (1-2%)

            Flatulence (1%)

            Hypotension (1-3%)

            Vomiting (5%)

            Headache (10%)

            Fever (3%)

            Diaphoresis (2%)

            Weakness (1-3%)

            <1%

            Anemia

            Pharyngitis

            Urinary retention

            Syncope

            Hyperkinesias

            Chest pain

            Amblyopia

            Hypokalemia

            Thrombophlebitis

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Coronary artery bypass graft (CABG) surgery, treatment of peri-operative pain; increased incidence of myocardial infarction and stroke

            Hypersensitivity to ibuprofen, other NSAIDs, oxycodone, or any component of the formulation

            ASA allergy

            Acute or severe bronchial asthma

            Significant respiratory depression

            Hypercarbia

            Cautions

            Cardiovascular event risk may increase with duration of use

            Gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal may occur

            Abuse, misuse, diversion, and dependence potential

            Respiratory depression may occur

            Alcohol use or smoking; increased risk of gastrointestinal injury

            Asthma, especially with history of aspirin-sensitive asthma; severe bronchospasm and fatalities may occur

            Coagulation disorder; bleeding time may be prolonged

            Long-term use; increased risk of gastrointestinal or renal injury; anemia may occur

            Use may increase risk of hyperkalemia

            Pregnancy, third trimester use; premature close of ductus arteriosus may occur

            Skin reactions; serious adverse events including exfoliative dermatitis, Stevens Johnson syndrome, toxic epidermal necrolysis

            May mask diagnosis of acute abdominal conditions; use caution

            Use caution in adrenal insufficiency, aseptic meningitis, asthma, biliary tract impairment, patients with CNS depression or coma, history of drug abuse, head injury, severe hepatic impairment, hypertension, obesity, prostatic hyperplasia, psychosis, respiratory disease, thyroid dysfunction, renal impairment, or seizures

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            Pregnancy & Lactation

            Pregnancy Category: C <30 weeks gestation; category D if 30 weeks gestation or greater because of potential for NSAIDs to cause premature closure of the ductus arteriosus

            Lactation: Oxycodone excreted in breast milk, effect on infant unknown; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Half-Life

            Oxycodone: 3-4.5 hr

            Ibuprofen: 2-4 hr

            Duration

            Oxycodone: 3-6 hr

            Ibuprofen: 4-6 hr

            Onset

            Oxycodone: 10-15 min

            Ibuprofen: 0.5 hr

            Absorption

            Oxycodone: 100% bioavailability

            Ibuprofen: 80-90% bioavailability

            Peak Plasma Time

            Oxycodone: 0.5-1 hr

            Ibuprofen: 2 hr

            Protein Bound

            Ibuprofen 90-99%

            Metabolism

            Oxycodone: by liver hepatic P450 enzyme CYP2D6 active prodrug and metabolite

            Ibuprofen: rapid hepatic oxidation to inactive metabolites

            Metabolites: noroxycodone, oxymorphone (and their glucuronide conjugates)

            Pharmacogenomics

            Oxycodone is metabolized to oxymorphone via CYP2D6; CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

            Mechanism of Action

            Fixed combination tablet combines the opioid analgesic agent, oxycodone HCl, with the nonsteroidal anti- inflammatory (NSAID) agent, ibuprofen

            Oxycodone: Binds to opiate receptors within neuronal membranes of synapses, which in turn blocks pain perception in the cerebral cortex; inhibits the flow of pain sensations into the higher centers

            Ibuprofen: Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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