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.

This medicine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share acetaminophen and oxycodone with another person.

Oxycodone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

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.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness.

Do not drink alcohol. Dangerous side effects or death could occur.

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.

Get emergency medical help if you have 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.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

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;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

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

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

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.

Immediate-release:
Oxycodone 2.5 mg/acetaminophen 300 or 325 mg: 1 to 2 tablets every 6 hours
Maximum dose: 12 tablets in 24 hours

Oxycodone 5 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 12 tablets in 24 hours

Oxycodone 7.5 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 8 tablets in 24 hours

Oxycodone 10 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 6 tablets in 24 hours

Oral Solution: Oxycodone 5 mg/acetaminophen 325 mg per 5 mL:
Usual dose: Oxycodone 5 mg/acetaminophen 325 mg (5 mL) orally every 6 hours as needed for pain
Maximum dose: Oxycodone 60 mg/acetaminophen 3900 mg (60 mL) in 24 hours
-Verify dose in mg and mL prior to administration

EXTENDED-RELEASE (ER) DOSING:
As First Opioid Analgesic: 2 tablets orally every 12 hours (each ER tablet contains oxycodone 7.5 mg/acetaminophen 325 mg)
-The second dose may be administered as early as 8 hours after initial dose if needed; however, subsequent doses should be administered every 12 hours

Comments:
-Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.
-Oxycodone/acetaminophen ER Tablets are not interchangeable with other oxycodone/acetaminophen products.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Immediate-release:
-Use with caution; therapy should be initiated with a lower than usual dose; titrate carefully

Extended-release (ER):
Initial dose: Oxycodone 7.5 mg/Acetaminophen 325 mg ER: 1 tablet orally every 12 hours; adjust does as needed

• Acetaminophen/oxycodone is a combination of two different pain-relief medicines with two different mechanisms of action.
• Experts aren't sure exactly how acetaminophen works but suspect it blocks a specific type of cyclooxygenase (COX) enzyme, located mainly in the brain.
• Oxycodone binds to specific receptors known as mu opioid receptors that block pain signals on their way to the brain.
• Acetaminophen/oxycodone belongs to the group of medicines known as combination narcotic analgesics. It may also be called a combination opioid analgesic.