Oxycodone Acetaminophen: Side Effects, Uses, Dosage, Interactions, Warnings (2024)

• Uses
  • What Is Oxycodone Acetaminophen and How Does It Work?
• Dosage
  • What Are Dosages of Oxycodone Acetaminophen?
• Side Effects
  • What Are Side Effects Associated with Using Oxycodone Acetaminophen?
• Drug Interactions
  • What Other Drugs Interact with Oxycodone Acetaminophen?
• Warnings and Precautions
  • What Are Warnings and Precautions for Oxycodone Acetaminophen?

What Is Oxycodone Acetaminophen and How Does It Work?

Oxycodone acetaminophen is a prescription drug used for management of moderate to severe pain.

Oxycodone acetaminophen is available under the following different brand names: Percocet, Tylox, Primlev, Roxicet, Endocet, and Xartemis XR.

What Are Dosages of Oxycodone Acetaminophen?

Dosages of Oxycodone Acetaminophen:

Adult and pediatric dosages:

Tablet: Schedule II

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

Oral Solution: Schedule II

• (5 mg/325 mg)/5 ml

Adult dosage only:

Tablet, extended-release: Schedule II

• 7.5 mg/325 mg (Xartemis XR)

Dosage Considerations – Should be Given as Follows:

Acute Pain

• Indicated for management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate
• The extended-release tablet (Xartemis XR): 2 tablets orally every 12 hours without regard to food
• The second dose of 2 tablets may be administered as early as 8 hours after the initial dose if analgesia is required at that time; subsequent doses are to be administered 2 tablets every 12 hours
• Not to exceed a total of 4 g/day of acetaminophen (total daily dose from any source)

Moderate-to-Severe Pain

• 2.5 mg/325 mg: 1-2 tablets orally every 6 hours
• 5 mg/325 mg, 7.5 mg/500 mg, 10 mg/650 mg: 1 tablet orally every 6 hours
• Not to exceed a total of 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

Dosage Modifications

• Adult and pediatric
• 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

Dosage Considerations

• Adult Considerations:
  • Adjust dose according to the 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 pharmaco*kinetic profiles
• Pediatric 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

Administration

• Extended-release tablet: Swallow whole with enough water to ensure complete swallowing after placing in the 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

Pain (off-label)

Initial dose

• Initial dose based on oxycodone component
• Moderate pain: 0.05-0.1 mg/kg/dose orally every 4-6 hours as needed
• Severe pain: 0.3 mg/kg/dose orally every 6 hours

Maximum dose

• Maximum dose based on acetaminophen component
• Children under 45 kg: Not to exceed acetaminophen 90 mg/kg/day orally
• Children over 45 kg: Not to exceed acetaminophen 4 g/day orally

What Are Side Effects Associated with Using Oxycodone Acetaminophen?

Common side effects of Oxycodone Acetaminophen include:

• lightheadedness
• dizziness
• drowsiness or sedation
• nausea
• vomiting
• euphoria
• state of unease
• constipation
• severe itching
• skin rash and hives
• kidney damage
• shallow breathing
• slow heartbeat
• feeling lightheaded
• fainting
• confusion
• unusual thoughts or behavior
• seizures
• problems with urination
• upper stomach pain
• itching
• loss of appetite
• dark urine
• clay-colored stools
• yellowing of the skin or the eyes
• blurred vision
• dry mouth

Rare side effects of oxycodone acetaminophen include:

• kidney failure (associated with high chronic acetaminophen use)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Oxycodone Acetaminophen?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe interactions of oxycodone acetaminophen include:

• alvimopan

Oxycodone acetaminophen has serious interactions with at least 54 different drugs.

Oxycodone acetaminophen has moderate interactions with at least 256 different drugs.

Oxycodone acetaminophen has mild interactions with at least 75 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

What Are Warnings and Precautions for Oxycodone Acetaminophen?

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 the development of these behaviors or conditions.
• Serious, life-threatening, or fatal respiratory depression may occur.
• Accidental consumption, especially in children, can result in a 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 as-needed doses and over-the-counter products.
• Acetaminophen is associated with cases of acute liver failure, at times resulting in liver transplantation or death.
• The 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.

This medication contains oxycodone acetaminophen. Do not take Percocet, Tylox, Primlev, Roxicet, Endocet, or Xartemis XR if you are allergic to oxycodone acetaminophen or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Suspected or known paralytic ileus
• Acute or severe bronchial asthma or hypercarbia
• Significant respiratory depression (bronchial asthma, hypercarbia, chronic obstructive pulmonary disease [COPD])

Effects of Drug Abuse

• Risk of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing, and monitor regularly for the development of these behaviors or conditions.

Short-Term Effects

• See "What Are Side Effects Associated with Using Oxycodone Acetaminophen?"

Long-Term Effects

• Risk of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing, and monitor regularly for the development of these behaviors or conditions.
• See "What Are Side Effects Associated with Using Oxycodone Acetaminophen?"

Cautions

• The extended-release formulation is not interchangeable with other oxycodone/acetaminophen products due to different pharmaco*kinetic parameters.
• Use caution in head injury and increased intracranial pressure, severe hepatic/renal impairment, hypothyroidism, and Addison's disease.
• For individuals with a history of addiction; tolerance and physical dependence may occur.
• May cause low blood pressure (hypotension), particularly if the patient has depleted blood volume or if the medication is used concurrently with drugs that compromise vasomotor tone (phenothiazines).
• Caution with other central nervous system depressants (alcohol, sedatives, antiemetics, general anesthetics); consider a dose reduction of 1 or both drugs.
• Acetaminophen is 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 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.

Pregnancy and Lactation

• Use oxycodone acetaminophen during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Oxycodone and acetaminophen are excreted into breast milk in low concentrations; use caution if breastfeeding. There is a possibility of sedation or respiratory depression in the infant.