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acetaminophen and oxycodone

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Narcotic analgesic combinations


Pronunciation

What is acetaminophen and oxycodone?

Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Acetaminophen and oxycodone is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and oxycodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen and oxycodone?

Oxycodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Narcotic pain medicine may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Oxycodone may cause life-threatening addiction and withdrawal symptoms in a newborn.

Do not take more of this medicine than recommended. An acetaminophen overdose can damage your liver or cause death.

What should I discuss with my healthcare provider before taking acetaminophen and oxycodone?

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or oxycodone, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications. You should not use Xartemis XR if you have severe asthma or breathing problems, or a bowel obstruction called paralytic ileus.

To make sure this medicine is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • diarrhea, inflammatory bowel disease, or a blockage in your stomach or intestines;

  • kidney disease, urination problems;

  • low blood pressure, or if you are dehydrated;

  • problems with your gallbladder, pancreas, or thyroid; or

  • a history of head injury, brain tumor, or seizures;

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. Oxycodone may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medicine during pregnancy. Tell your doctor if you are pregnant.

Acetaminophen and oxycodone may pass into breast milk and could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take acetaminophen and oxycodone?

Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away acetaminophen and oxycodone is against the law.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and oxycodone.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

Store at room temperature away from moisture and heat. Keep the medicine in a place where others cannot get to it. After you have stopped using this medication, flush any unused pills down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Never crush or break an acetaminophen and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using this medicine without a prescription.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking acetaminophen and oxycodone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with acetaminophen and oxycodone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Acetaminophen and oxycodone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

  • shallow breathing, slow heartbeat;

  • a light-headed feeling, like you might pass out;

  • confusion, unusual thoughts or behavior;

  • seizure (convulsions);

  • problems with urination; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Acetaminophen and oxycodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects include:

  • headache, drowsiness, tiredness;

  • nausea, vomiting, stomach pain, constipation;

  • blurred vision; or

  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Acetaminophen and oxycodone dosing information

Usual Adult Dose for Pain:

Initial dose:
One tablet or capsule (acetaminophen/oxycodone 325 mg-5 mg), (acetaminophen/oxycodone 500 mg-5 mg), or (acetaminophen/oxycodone 500 mg-10 mg) orally every 6 hours as needed, or 5 mL (acetaminophen/oxycodone 325 mg-5 mg) oral elixir every 6 hours as needed.

Alternatively, the following dosage combinations may be used:
one or two tablets of acetaminophen-oxycodone 300 mg-2.5 mg every six hours (maximal daily dose is 12 tablets), or
one tablet of acetaminophen-oxycodone 300 mg-5 mg every six hours (maximal daily dose is 12 tablets), or
one tablet of acetaminophen-oxycodone 300 mg-7.5 mg every six hours (maximal daily dose is 8 tablets), or
one tablet of acetaminophen-oxycodone 300 mg-10 mg every six hours (maximal daily dose is 6 tablets), or
one or two tablets of acetaminophen-oxycodone 400 mg-2.5 mg every six hours (maximal daily dose is 10 tablets), or
one tablet of acetaminophen-oxycodone 400 mg-5 mg every six hours (maximal daily dose is 10 tablets), or
one tablet of acetaminophen-oxycodone 400 mg-7.5 mg every six hours (maximal daily dose is 8 tablets), or
one tablet of acetaminophen-oxycodone 400 mg-10 mg every six hours (maximal daily dose is 6 tablets) as needed.

Usual Geriatric Dose for Pain:

Initial dose: 1/2 tablet (acetaminophen/oxycodone 163-250 mg-2.5 mg) orally every 6 hours as needed or
2.5 mL (acetaminophen/oxycodone 163 mg-2.5 mg) oral elixir every 6 hours as needed.

Usual Pediatric Dose for Pain:

Dosage calculations are based on oxycodone: 0.05 - 0.15 mg/kg/dose, given every 4 to 6 hours as needed. Severe pain dosage up to 0.2 mg/kg/dose, given every 3 to 4 hours.

What other drugs will affect acetaminophen and oxycodone?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen and oxycodone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not take Xartemis XR if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about acetaminophen and oxycodone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 15.07. Revision Date: 2014-10-17, 8:45:12 AM.

Not all side effects for acetaminophen / oxycodone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by acetaminophen / oxycodone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / oxycodone:

More common
  • Abdominal or stomach pain
  • black, tarry stools
  • chills
  • dark urine
  • dizziness
  • fever
  • headache
  • itching
  • light-colored stools
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin
Rare
  • Cough or hoarseness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • lower back or side pain
  • painful or difficult urination
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
Incidence not known
  • Back, leg, or stomach pains
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blue lips and fingernails
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • clay-colored stools
  • cloudy urine
  • clumsiness
  • confusion
  • constipation
  • coughing that sometimes produces a pink frothy sputum
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased awareness or responsiveness
  • decreased frequency or amount of urine
  • decreased urination
  • difficult or labored breathing
  • difficult or painful urination
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • extremely shallow or slow breathing
  • fainting
  • fast or deep breathing
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • general body swelling
  • greatly decreased frequency of urination or amount of urine
  • increased sweating
  • increased thirst
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • muscle aches
  • muscle tremors
  • muscle weakness
  • nervousness
  • noisy breathing
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, deep breathing
  • rapid, shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • restlessness
  • seizures
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • shivering
  • skin blisters
  • skin rash, hives, or welts
  • sleepiness
  • slow or irregular breathing
  • sore throat
  • stomach cramps
  • stomach pain, continuing
  • sudden decrease in the amount of urine
  • sunken eyes
  • sweating
  • swelling in the legs and ankles
  • swelling of the face, fingers, or lower legs
  • thirst
  • tightness in the chest
  • tiredness
  • troubled breathing
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting
  • weak or feeble pulse
  • weakness or heaviness of the legs
  • weight gain
  • wrinkled skin

If any of the following symptoms of overdose occur while taking acetaminophen / oxycodone, get emergency help immediately:

Symptoms of overdose
  • Bluish lips or skin
  • change in consciousness
  • cold, clammy skin
  • extreme sleepiness
  • general feeling of discomfort or illness
  • loss of consciousness
  • no blood pressure or pulse
  • not breathing
  • stopping of heart
  • unconsciousness

Some of the side effects that can occur with acetaminophen / oxycodone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Relaxed and calm
Incidence not known
  • Acid or sour stomach
  • agitation
  • bad or unusual or unpleasant (after) taste
  • belching
  • change in taste
  • cold sweats
  • constricted, pinpoint, or small pupils (black part of the eye)
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • depression
  • diarrhea
  • difficulty with moving
  • disturbed color perception
  • double vision
  • excess air or gas in the stomach or intestines
  • false or unusual sense of well-being
  • flushed, dry skin
  • fruit-like breath odor
  • full feeling
  • general feeling of discomfort or illness
  • halos around lights
  • hearing loss
  • heartburn
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle cramps or spasms
  • muscle pain or stiffness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • passing gas
  • red eye
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness
  • sleepiness or unusual drowsiness
  • slurred speech
  • stomach discomfort, upset, or pain
  • stomach fullness
  • sweating
  • swollen joints
  • thirst
  • trouble sleeping
  • tunnel vision
  • unexplained weight loss
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release

General

Psychosis has also been reported during withdrawal from oxycodone.[Ref]

In general, acetaminophen is well tolerated when administered in therapeutic doses. Oxycodone may be habit forming. Withdrawal symptoms after either abrupt cessation or fast tapering may occur and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, piloerection, blurred vision, vomiting, and sweating.[Ref]

Dermatologic

Dermatologic side effects including general erythematous skin rashes associated with acetaminophen have been reported, but are rare. Cases of bullous erythema and purpura fulminans associated with acetaminophen have been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). Oxycodone may produce pruritus.[Ref]

Gastrointestinal

Gastrointestinal side effects with acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely. Nausea, vomiting, and constipation occur commonly with oxycodone.[Ref]

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hepatic

Hepatic side effects have included hepatic dysfunction which may occur after overdose. In this setting, severe and sometimes fatal dose-dependent hepatitis has been reported. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity[Ref]

Hepatotoxicity may be increased by thyroid drugs, zidovudine, fasting, or alcohol use.

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. Hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote n-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.[Ref]

Nervous system

Severe adverse effects of oxycodone, such as respiratory depression, can be treated with the opioid antagonist, naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary to a maximum of 10 mg. The dose is usually administered intravenously, but in an emergency may be given intramuscularly, subcutaneously, or sublingually.)[Ref]

Nervous system side effects with oxycodone containing products are common and include drowsiness, sedation, dizziness, and lightheadedness. Respiratory depression has also been reported.[Ref]

Psychiatric

Psychiatric side effects of oxycodone reported include paranoia, psychosis, and hallucinations.[Ref]

Renal

Acetaminophen related acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use.

A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two tablets per day.[Ref]

Renal side effects of acetaminophen are rare and include acute tubular necrosis and interstitial nephritis. Additional adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Respiratory

Respiratory side effects have included a case of eosinophilic pneumonia which has been associated with acetaminophen.[Ref]

Cardiovascular

Two cases of hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Cardiovascular side effects have included at least two cases of hypotension which have been reported following the administration of acetaminophen.[Ref]

Metabolic

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

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