Oxycodone & Acetaminophen

Oxycodone/acetaminophen is a prescription medication used to treat moderate to severe pain. Oxycodone/acetaminophen belong to a group of drugs called analgesics, which work by altering the way the brain and nervous system senses pain.

This medication comes in tablet, capsule, and oral (by mouth) solution forms and is taken up to 4 times a day, with or without food.

Common side effects of oxycodone/acetaminophen include fatigue, nausea, vomiting, mood fluctuations, and itching. Oxycodone/acetaminophen can also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how oxycodone/acetaminophen affects you.

Oxycodone/acetaminophen is a prescription medication used to treat moderate to severe pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oxycodone & Acetaminophen may be found in some form under the following brand names:

• Percocet

• Roxicet

• Xartemis XR

Common side effects of oxycodone/acetaminophen in adults include:

• constipation
• dizziness
• very high or very low moods
• lightheadedness
• nausea or vomiting
• shallow breathing
• sedation
• rash or itching

This is not a complete list of oxycodone/acetaminophen side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you take or use:

• naltrexone (Vivitrol)
• opioids such as morphine (MS Contin), oxycodone (OxyContin), and methadone (Dolophine)
• macrolide antibiotics, including azithromycin (Zithromax, Z-Pak), clarithromycin (Biaxin), and erythromycin  
• muscle relaxants such as cyclobenzaprine (Flexeril), carisoprodol (Soma), and diazepam (Valium)
• metoclopramide (Reglan)
• antidepressants such as fluoxetine (Prozac), paroxetine (Paxil), and citalopram (Celexa)
• anti-nausea agents such as promethazine (Phenergan) and prochlorperazine (Compazine)
• alcohol
• propranolol (Inderal)
• probenecid
• lamotrigine (Lamictal)

This is not a complete list of oxycodone/acetaminophen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with oxycodone/acetaminophen including:

• increased tolerance and physical dependence. Oxycodone/acetaminophen is also a high-risk medication for addiction.
  • Tolerance - the need for increasing doses of this medication to maintain pain relief (in the absence of worsening disease or other factors)
  • Physical dependence - when withdrawal symptoms occur due to suddenly discontinuation of this medication
    • Withdrawal symptoms include: restlessness, excessive tears formation, runny nose, yawning, sweating, chills, muscle aches, irritability, or anxiety
  • Addiction: abnormal or compulsive use of a substance for non-medical needs
• hypersensitivity reaction to oxycodone or acetaminophen. Tell your healthcare provider right away if you have some or all of the following symptoms of...
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• respiratory depression. Tell your healthcare provider right away if you have difficulty of breathing while taking this medication.
• head injury. Oxycodone/acetaminophen may worsen the adverse of effects in patients with a previous head injury (e.g. change in mental function, increased difficulty in breathing).
• orthostatic hypotension (low blood pressure when rising). Tell your healthcare provider right away if  have symptoms of …
  • dizziness after rising from sitting or laying down
  • low blood pressure
• liver toxicity. This may occur with excessive use of acetaminophen (greater than 4 grams per day or with alcohol use/abuse). Tell your healthcare provider right away if  have symptoms of …
  • nausea
  • vomiting
  • sweating
  • fatigue
• serious skin reactions. Symptoms may include skin reddening, rash, blisters, and the upper surface of the skin may become separated from the lower layers. This can occur even if you have taken acetaminophen in the past without any problems. If you develop any skin rash or reaction while using a medication containing acetaminophen, including this medication, stop the medication and seek medical attention immediately. If you have had a serious skin reaction with acetaminophen, do not take it or any products containing acetaminophen again. Doing so could cause you to have another serious skin reaction.

Do not take :

• are allergic to oxycodone/acetaminophen or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of oxycodone/acetaminophen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking oxycodone/acetaminophen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have an allergy to oxycodone or acetaminophen or to any other ingredients in this formulation
• have liver problems
• have had a brain injury
• have a history of seizures
• have asthma, COPD, or any other respiratory problems
• have kidney problems
• have had or will soon have surgery
• have had pancreatic or biliary problems
• have reduced bowel function
• have a history or alcohol use, dependence, or abuse
• have a history of opioid use, dependence, or abuse

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Oxycodone/acetaminophen falls into category C. Oxycodone/acetaminophen should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

In addition, it is known that opioids (oxycodone) are able to cross the placental barrier and have the potential to cause neonatal respiratory problems. Opioid use during pregnancy could result in a physically drug-dependent unborn baby. After birth, the baby may suffer severe withdrawal symptoms.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Oxycodone may pass into breast milk in low amounts, and reports of increased fatigue in babies of nursing mothers taking this medication has been reported. Acetaminophen is also excreted in breast milk in low amounts as well.

Take oxycodone/acetaminophen as prescribed by your doctor.

This medication comes in tablet, capsule, and oral (by mouth) solution forms and is taken up to 4 times a day, with or without food.

The risk of liver failure is greater in those who drink alcohol while taking acetaminophen.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of oxycodone/acetaminophen at the same time.

Take oxycodone/acetaminophen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The oxycodone/acetaminophen dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

The recommended dose for oxycodone/acetaminophen tablet or capsule every 6 hours as needed for pain. Do not exceed 4 grams (4000 mg) of acetaminophen per day.

The recommended dose for oxycodone/acetaminophen oral (by mouth) solution is 5 mL (one teaspoon) every 6 hours as needed for pain. Do not exceed 4 grams (4000 mg) of acetaminophen per day. Maximum daily dose is 12 teaspoonfuls or 60 mL per day.

If you take too much oxycodone/acetaminophen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Oxycodone/acetaminophen comes in a variety of forms, including:

• capsules 500 mg/5 mg
• solution 325 mg and 5 mg per 5 mL liquid
• tablets 300 mg/2.5 mg, 300 mg/5 mg, 300 mg/7.5 mg, 300 mg/10 mg, 325 mg/2.5 mg, 325 mg/5 mg, 325 mg/7.5 mg, 325 mg/10 mg, 400 mg/2.5 mg, 400 mg/5 mg, 400 mg/7.5 mg, 400 mg/10 mg, 500 mg/5 mg, 500/7.5 mg, 650 mg /10 mg

Store at room temperature.

Dispense in a tight, light-resistant container with a child-resistant closure.

Keep this medication in a secure place out of reach from children.

Hepatotoxicity:

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.