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Oxycodone/Acetaminophen
- Brand Name:
Percocet
-
Pronunciation (OX-i-KOE-done/a-SEET-a-MIN-oh-fen)
- Drug Class:
Analgesics, Opioid Combos

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
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:
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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