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Oxycodone/Acetaminophen

Common Brand Name(s): Oxycet, Percocet, Roxicet, Tylox

Common Generic Name(s): oxycodone/acetaminophen, oxycodone HCl/acetaminophen, oxycodone hydrochloride/acetaminophen

Pronunciation: OX-i-KOE-done-and-a-SEET-a-MIN-oh-fen

Drug Classes: opioid analgesic combination

Availability: prescription only, controlled substance, generic available

How is it used? liquid or tablet that is swallowed

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.

Addiction/overdose

Oxycodone has a high potential for addiction, abuse, and misuse, and can lead to overdose. Overdose can cause respiratory depression and extreme drowsiness that can progress to stupor, coma, cardiac arrest and death, unless promptly treated.

Opioid overdose treatment includes:

Supportive care to maintain respiration with assisted ventilation, oxygen, intravenous fluids and medication to increase arterial pressure.

Severe overdose may require respiratory resuscitation and cardiac defibrillation.

Administration of naloxone hydrochloride the antidote used to reverse opioid effects.

Gastric emptying with induced vomiting and lavage to remove unabsorbed drug, and administration of activated charcoal

Overdose of acetaminophen primarily causes liver damage and may also cause kidney damage, drop in blood sugar inducing coma (hypoglycemic coma) and low platelet count.

Treatment includes:

Gastric lavage as soon as overdose is suspected

Liver function tests, based on which N-acetylcysteine, the antidote is administered

Other appropriate symptomatic and supportive care

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 pharmacokinetic 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

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.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

In the US - Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or at http://www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drugs that 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.

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 above?"

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 above?"

Cautions

The extended-release formulation is not interchangeable with other oxycodone/acetaminophen products due to different pharmacokinetic 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.

What else should I know about oxycodone/acetaminophen?

Oxycodone has a high potential for addiction, abuse, and misuse, and can lead to overdose and death; use with caution

Take oxycodone/acetaminophen exactly as prescribed; do not take a higher or more frequent dosage

In case of overdose, seek medical help immediately

Do not drink alcohol or take alcohol-containing drugs while taking oxycodone/acetaminophen; it increases the risk for sedation and respiratory depression

Store oxycodone/acetaminophen well out of reach of children and dispose of unused drug carefully; accidental consumption, especially in children, can result in a fatal overdose.

Do not take a total dosage exceeding 4g/day of acetaminophen

Be careful not to drive or operate dangerous machinery unless you are tolerant to the effects of the drug and know how you will react to it

Get emergency help immediately

if any of the following symptoms of overdose occur:

Bluish lips or skin

change in consciousness

cold, clammy skin

extreme sleepiness

general feeling of discomfort or illness

loss of consciousness

low blood pressure or pulse

slow breathing

unconsciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

One Final Note..

Do not share this medication with others. Sharing it is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

Oxycodone/acetaminophen is a combination pain-relief (analgesic) medication prescribed to treat acute moderate-to-severe pain. Common side effects of oxycodone/acetaminophen include nausea, vomiting, constipation, lightheadedness, drowsiness or sedation, dizziness, euphoria, feeling of unease (dysphoria), itching (pruritus), hypersensitivity reaction, blood disorders, and others. Oxycodone has a high potential for addiction, abuse, and misuse, and can lead to overdose. Consult your doctor before taking oxycodone/acetaminophen if pregnant or breastfeeding.

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Most recent revision July 12, 2025 08:38:11 AM

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