Oxycodone and Acetaminophen

Oxycodone and acetaminophen tablets are used to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough, or you cannot tolerate them. This medication is a high-potency combination opioid analgesic available by prescription only.

An opioid pain medicine can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics to balance benefits against risks of addiction and misuse. Prescribers must complete REMS-compliant education, counsel patients on safe use and disposal, ensure patients read Medication Guides, and consider patient-prescriber agreements to enhance safety.

Oxycodone and acetaminophen first gained FDA approval on August 31, 1976 and is available as generic oxycodone and acetaminophen and under the brand name Percocet. It is a Schedule II controlled substance.

Get emergency help or call 911 right away if you take too many oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone and acetaminophen tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking oxycodone and acetaminophen tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your oxycodone and acetaminophen tablets. They could die from taking it. Selling or giving away oxycodone and acetaminophen tablets is against the law.

Store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take oxycodone and acetaminophen tablets if you have:

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or a narrowing of the stomach or intestines.
• Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in oxycodone and acetaminophen tablets

Before taking oxycodone and acetaminophen tablets, tell your healthcare provider if you have a history of:

• Head injury, seizures
• Liver, kidney, thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• Noticing your pain is getting worse. If your pain gets worse after you take oxycodone and acetaminophen tablets, do not take more of oxycodone and acetaminophen tablets without first talking to your healthcare provider. Talk to your healthcare provider. if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking oxycodone and acetaminophen tablets.
• Pregnant or planning to become pregnant. Use of oxycodone and acetaminophen tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Oxycodone and acetaminophen passes into breast milk and may harm your baby. Breastfeeding is not recommended during treatment with oxycodone and acetaminophen tablets.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.

Common Side Effects

The possible side effects of oxycodone and acetaminophen tablets are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Serious Side Effects

Get emergency medical help or call 911 right away if you have:

• Trouble breathing
• Shortness of breath
• Fast heartbeat
• Chest pain
• Swelling of your face, tongue, or throat
• Extreme drowsiness
• Light-headedness when changing positions
• Feeling faint
• Agitation
• High body temperature
• Trouble walking
• Stiff muscles
• Mental changes such as confusion.
• Nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure, which may be signs of a life-threatening problem with your adrenal glands

These are not all the possible side effects of oxycodone and acetaminophen tablets. Call your healthcare provider for medical advice about side effects. You may also request medical information or report suspected adverse reactions to Aurobindo Pharma USA, Inc. at 1-866-850-2876 or the FDA at 1-800-FDA-1088.

Do not change your dose. Take oxycodone and acetaminophen tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

• For acute (short-term) pain, you may only need to take oxycodone and acetaminophen tablets for a few days.
• You may have some oxycodone and acetaminophen tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused oxycodone and acetaminophen tablets.
• If you are taking the oral solution, ask your healthcare provider if you have any questions on how to correctly measure your dose. Always use a calibrated measuring device to correctly measure your dose. A household teaspoon or tablespoon is not an adequate measuring device and could lead to overdosage.

Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking oxycodone and acetaminophen tablets regularly, do not stop taking oxycodone and acetaminophen tablets without talking to your healthcare provider.

Dispose of expired, unwanted, or unused oxycodone and acetaminophen by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of the tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. The oral solution can be disposed of by promptly flushing it down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking oxycodone and acetaminophen tablets, DO NOT:

• Drive or operate heavy machinery until you know how oxycodone and acetaminophen tablets affect you. Oxycodone and acetaminophen tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone and acetaminophen tablets may cause you to overdose and die.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

• Store at 20° to 25°C (68° to 77°F).
• Protect from moisture and light.