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Generic Name: oxycodone/acetaminophen

Brand Names: Percocet, Oxycet

Drug Class: Analgesics, Opioid Combos

What is oxycodone/acetaminophen, and what is it used for?

Oxycodone/acetaminophen is a combination pain-relief (analgesic) medication prescribed to treat acute moderate-to-severe pain. Oxycodone is an opioid analgesic, while acetaminophen is a nonopioid drug that reduces pain and fever. Combination analgesic drugs are used when single drug therapy is inadequate to control pain. 

Opioid drugs have a high potential for addiction and have led to an opioid crisis in the U.S. Many opioid formulations, including brands of oxycodone/acetaminophen such as Primlev, Endocet, Roxicet and Xartemis XR have been discontinued in the U.S.

Oxycodone and acetaminophen work in different ways to relieve pain:

• Oxycodone: Oxycodone blocks the transmission of pain signals by binding to protein molecules on nerve cells (neurons) known as opioid receptors. Opioid receptors are involved in many processes including pain modulation, reward system, and addictive behavior. Oxycodone specifically binds to two types of opioid receptors, mu, and kappa, and produces analgesia, sedation, and respiratory depression.
• Acetaminophen: Acetaminophen blocks pain by inhibiting the synthesis of prostaglandin in the central nervous system (CNS). Prostaglandin is a natural substance in the body that plays a prominent role in inflammation which leads to pain, swelling, fever, and other symptoms. Acetaminophen reduces fever by acting on the hypothalamus region of the brain which regulates temperature.

Oxycodone/acetaminophen combination is prescribed for the following:

Adult:

• Management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate
• Moderate to severe pain

Pediatric:

• Not approved for use in pediatric patients, but may be used off-label to treat moderate-to-severe pain

Warnings

• Do not administer oxycodone/acetaminophen to patients who:
  • Are hypersensitive to either of the two drugs or their components
  • Have suspected or confirmed intestinal obstruction, including paralysis of the intestinal muscles (paralytic ileus)
  • Have acute or severe bronchial asthma, high carbon dioxide levels (hypercarbia), chronic obstructive pulmonary disease (COPD), or respiratory depression
• Do not administer oxycodone/acetaminophen simultaneously with benzodiazepines or other central nervous system (CNS) depressants, including alcohol; may result in profound sedation, respiratory depression, coma, and death
• If no alternate treatment is adequate, limit concomitant use with CNS depressants to minimum dosage and duration, and monitor the patient closely
• Do not use concomitantly with monoamine oxidase inhibitors (MAOIs); it can increase the effect of respiratory depression
• Do not use concurrently with drugs that can increase serotonin levels; can lead to serotonin syndrome, a potentially life-threatening condition
• Oxycodone/acetaminophen can cause low blood pressure (hypotension) and positional (orthostatic) hypotension; use with caution in patients with reduced blood volume (hypovolemia)
• Use with caution in patients with head injury and high intracranial pressure; can further increase intracranial pressure
• Use with caution in patients with severe hepatic/renal impairment, hypothyroidism, and Addison's disease
• Can increase seizure frequency in patients with seizure disorders; use with caution
• The risk for fatal or life-threatening respiratory depression is greatest during initiation of therapy and increase of dosage; monitor the patient closely

Oxycodone

• Oxycodone has risk of addiction, abuse, and misuse, and can lead to overdose and death; prescribe after assessing the patient’s risk, and monitor regularly for development of addictive behavior
• Healthcare workers are strongly encouraged to complete opioid analgesic risk evaluation and mitigation strategy (REMS) education program to be able to counsel patients and caregivers appropriately on safe use and disposal of opioid analgesics
• Oxycodone use can cause serious, life-threatening, or fatal respiratory depression, particularly in the elderly
• Oxycodone use can cause adrenal insufficiency; monitor the patient and treat appropriately
• Accidental consumption, especially in children, can result in fatal overdose
• Prolonged use during pregnancy can cause opioid withdrawal syndrome in the newborn, which may be life-threatening if not recognized and treated

Acetaminophen

• Acetaminophen doses of more than 4g/day is toxic to the liver; can cause acute liver failure that can result in liver transplantation or death
• Acetaminophen has a 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)

What are the side effects of oxycodone/acetaminophen?

Common side effects of oxycodone/acetaminophen include:

• Nausea
• Vomiting
• constipation
• Lightheadedness
• Drowsiness or sedation
• Dizziness
• Euphoria
• Feeling of unease (dysphoria)
• Itching (pruritus)
• Hypersensitivity reaction including:
  • Skin eruptions
  • Hives (urticaria)
  • Rashes
  • Erythema (redness)
• Blood disorders including:
  • Low platelet count (thrombocytopenia)
  • Low red blood cell count due to their rapid destruction (hemolytic anemia)
  • Low neutrophil (type of immune cells) count (neutropenia)
  • Low count of all types of blood cells (pancytopenia)
  • Low level of granulocyte immune cells (agranulocytosis), rare
• Serious side effects (dose-dependent) of oxycodone/acetaminophen include:
• Liver damage and liver tissue death (hepatic necrosis), potentially fatal
• Damage to and death of kidney’s tubule cells (renal tubular necrosis)
• Coma due to extremely low blood glucose levels (hypoglycemic coma)
• Less common side effects of oxycodone/acetaminophen include:
• Allergic reactions
• Severe allergic reaction (anaphylaxis) including:
  • Bronchospasm
  • Swelling of tissue under the skin and mucous membranes (angioedema)
  • Swelling of the larynx (laryngeal edema)
• Feeling unwell (malaise)
• Weakness (asthenia)
• Fatigue
• Chest pain
• Fever
• Headache
• Increased sweating
• Thirst
• Low body temperature (hypothermia)
• Cardiovascular effects including:
  • Low blood pressure (hypotension)
  • High blood pressure (hypertension)
  • Drop in blood pressure when standing up from sitting or lying down (orthostatic hypotension)
  • Slow heartbeat (bradycardia)
  • Rapid heartbeat (tachycardia)
  • Palpitations
  • Irregular heart rhythms (dysrhythmia)
• Confusion
• Anxiety
• Hallucinations
• Insomnia 
• Stupor
• Tremor
• Seizures
• Dehydration
• Electrolyte imbalances
• Gastrointestinal effects such as:
  • Indigestion (dyspepsia)
  • Diarrhea
  • Taste disturbances
  • Inflammation of the pancreas (pancreatitis)
  • Intestinal obstruction
• Elevation in liver enzymes
• Jaundice
• Liver inflammation (hepatitis), damage and failure
• Rise or drop in blood glucose levels (hyperglycemia/hypoglycemia)
• Muscle pain (myalgia)
• Breakdown of muscle cells (rhabdomyolysis)
• Ringing in the ears (tinnitus), hearing loss
• Visual disturbances
• Shortness of breath (dyspnea)
• Fluid in the lungs (pulmonary edema)
• Kidney damage
• Urinary retention

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

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What are the dosages of oxycodone/acetaminophen?

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

Tablet, extended-release: Schedule II

Adult dosage only:

• 7.5 mg/325 mg (Xartemis XR)

Adult:

Acute Pain

• 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

• 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

• 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

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

Pediatric:

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

Dosage 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

Dosage 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

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

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

What drugs interact with oxycodone/acetaminophen?

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of oxycodone acetaminophen include:
  • alvimopan
• Oxycodone acetaminophen has serious interactions with at least 52 different drugs.
• Oxycodone acetaminophen has moderate interactions with at least 280 different drugs.
• Oxycodone acetaminophen has mild interactions with at least 69 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Pregnancy and breastfeeding

• Effects of oxycodone/acetaminophen use on fertility are not known.
• It is not known if use of oxycodone/acetaminophen during pregnancy can cause fetal harm; prolonged use during pregnancy can, however, cause physical opioid dependence in the fetus and severe opioid withdrawal symptoms in the newborn; use oxycodone/acetaminophen in pregnancy only if potential benefits outweigh risks.
• Do not use oxycodone/acetaminophen during labor and delivery; it can cross the placenta and cause respiratory depression in the newborn.
• Both oxycodone and acetaminophen are excreted in breast milk in low concentrations; use with caution in nursing mothers; there have been rare reports of sedation and lethargy in the breastfed 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