oxycodone/acetaminophen (Rx)

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Brand and Other Names:Percocet, Tylox, more...Primlev, Roxicet, Endocet, Xartemis XR

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oxycodone/acetaminophen

tablet: Schedule II

  • 2.5mg/325mg
  • 5mg/300mg; 5mg/325mg
  • 7.5mg/300mg; 7.5mg/325mg
  • 10mg/300mg; 10mg/325mg

oral solution: Schedule II

  • (5mg/325mg)/5mL

tablet, extended release: Schedule II

  • 7.5mg/325mg (Xartemis XR)
more...

Acute Pain

Indicated for management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate

Extended-release tablet (Xartemis XR): 2 tab PO q12hr without regard to food

The second dose of 2 tablets may be administered as early as 8 hr after the initial dose if analgesia required at that time; subsequent doses are to be administered 2 tablets q12hr

Not to exceed total 4 g/day of acetaminophen (total daily dose from any source)

Moderate-to-Severe Pain

2.5 mg/325 mg: 1-2 tablets PO q6hr

5 mg/325 mg, 7.5 mg/500 mg, 10 mg/650 mg: 1 tablet PO q6hr

Not to exceed total 4 g/day of acetaminophen (total daily dose from any source)

Chronic pain: Administer as scheduled dosing around the clock

Intermittent or breakthrough pain: Administer as needed   

Dosing Modifications

Hepatic impairment: Reduce dose in cases of severe impairment

Renal impairment: Elimination half-life prolonged with end-stage renal impairment; dose reduction may be required

Dosing Considerations

Adjust dose according to severity of pain and patient response

Extended-release (Xartemis XR) is a bilayer formulation of oxycodone and acetaminophen (contains immediate- and extended-release layers) which is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles

Administration

Extended-release tablet: Swallow whole with enough water to ensure complete swallowing after placing in mouth; do not break, chew, cut, crush, dissolve or split the tablets

Discontinuation: Opioid tolerance may occur; gradually taper dose when discontinuing if patient treated for more than a few weeks

Dosage Forms & Strengths

tablet: Schedule II

  • 2.5mg/325mg
  • 5mg/300mg; 5mg/325mg
  • 7.5mg/300mg; 7.5mg/325mg
  • 10mg/300mg; 10mg/325mg

oral solution: Schedule II

  • (5mg/325mg)/5mL
more...

Pain (Off-Label)

Initial dose

  • Initial dose based on oxycodone component
  • Moderate pain: 0.05-0.1 mg/kg/dose PO q4-6hr PRN 
  • Severe pain: 0.3 mg/kg/dose PO q6hr

Maximum dose

  • Maximum dose based on acetaminophen component
  • <45 kg: Not to exceed acetaminophen 90 mg/kg/day PO
  • >45 kg: Not to exceed acetaminophen 4 g/day PO

Dosing Considerations

Adjust dose according to pain severity and patient response

In cases of severe pain or if tolerant to the analgesic effects, a higher dose may be required

For chronic pain, administer scheduled doses around-the-clock; otherwise may take as needed for intermittent pain

Discontinuation: Opioid tolerance may occur; gradually taper dose when discontinuing if treated for more than a few weeks

Dosing Modifications

Hepatic impairment: Reduce dose in cases of severe impairment

Renal impairment: Elimination half-life prolonged with end-stage renal impairment; dose reduction may be required

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Interactions

Interaction Checker

and oxycodone/acetaminophen

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            Adverse Effects

            Frequency Not Defined

            Lightheadedness

            Dizziness

            Drowsiness or sedation

            Nausea and vomiting

            Euphoria

            Dysphoria

            Constipation

            Pruritus

            Skin and urticarial eruptions

            Fatal hepatic necrosis (rare; associated with high/chronic acetaminophen use)

            Renal tubular necrosis

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            Warnings

            Black Box Warnings

            Oxycodone

            • Risk of addiction, abuse, and misuse, which can lead to overdose and death; assess patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions
            • Serious, life-threatening, or fatal respiratory depression may occur
            • Accidental consumption, especially in children, can result in fatal overdose
            • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated

            Acetaminophen

            • Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products
            • Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplantation or death
            • New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen
            • Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times a day (12 dosage units) and still not exceed the maximum daily dose of acetaminophen of 4 g/day

            Contraindications

            Hypersensitivity

            Suspected or known paralytic ileus

            Acute or severe bronchial asthma or hypercarbia

            Significant respiratory depression (bronchial asthma, hypercarbia, COPD)

            Cautions

            Extended release formulation is not interchangeable with other oxycodone/acetaminophen products due to differing pharmacokinetic parameters

            Use caution in head injury and increased intracranial pressure, severe hepatic/renal impairment, hypothyroidism, and Addison's disease

            Individuals with history of addiction; tolerance and physical dependence may occur

            May cause hypotension, particularly if the patient has depleted blood volume or if the medication is used concurrently with drugs that compromise vasomotor tone (eg, phenothiazines)

            Caution with other CNS depressants (eg, alcohol, sedatives, antiemetics, general anesthetics); consider dose reduction of 1 or both drugs

            Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)

            Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

            FDA is asking manufacturers to limit acetaminophen in prescription products to 325 mg/dosage unit; manufacturers have until January 14, 2014, to comply

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Oxycodone and acetaminophen are excreted into breast milk in low concentration; use caution; possibility of sedation or respiratory depression in the infant

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Oxycodone: Opioid agonist that is relatively selective for mu and kappa opioid receptors; inhibits ascending pain pathways, which causes alteration in response to pain; produces analgesia, respiratory depression, and sedation

            Acetaminophen: Nonopioid, nonsalicylate analgesic; may work peripherally to block pain impulse generation; acts on hypothalamus to produce antipyresis

            Absorption

            Bioavailability: Oxycodone (87%); acetaminophen (100%)

            Onset: Oxycodone (10-15 min)

            Duration: Oxycodone (3-6 hr)

            Peak plasma time: Oxycodone (0.5-1 hr)

            Distribution

            Protein bound: Acetaminophen (20-50%); oxycodone (45%)

            Vd: 2.6 L/kg (oxycodone)

            Metabolism

            Oxycodone

            • Metabolized via hepatic P450 enzyme CYP2D6 and CYP3A4
            • Active prodrug metabolized to oxymorphone (active metabolite) via CYP2D6
            • CYP2D6 poor metabolizers may not achieve adequate analgesia because of decreased conversion to active metabolite
            • Ultrarapid metabolizers (up to 7% of whites and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

            Acetaminophen

            • Metabolized in liver by microsomal enzyme systems
            • 80-85% conjugated, principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine
            • 4% metabolized by CYP450 to toxic metabolite (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone [NAPQI]), which is detoxified by conjugation with glutathione; high doses may deplete fixed amount of glutathione in body, causing NAPQI accumulation  

            Elimination

            Oxycodone

            • Half-life: 3.5 hr
            • Excretion: Primarily in urine (8-14% as free oxycodone)

            Acetaminophen

            • Half-life: 2-4 hr
            • Excretion: 90-100% in urine (principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate)
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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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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