Oxycodone is an opioid pain medication sometimes called a narcotic.

Oxycodone is used to treat moderate to severe pain.

The extended-release form of oxycodone is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain.

You should not use oxycodone if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

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

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

Oxycodone can slow or stop your breathing. This is more likely in elderly or ill patients, but can occur in anyone taking this medicine.

Oxycodone comes as a solution (liquid), a concentrated solution, a tablet, a capsule, an extended-release (long-acting) tablet (Oxycontin) and an extended-release capsule (Xtampza ER) to take by mouth. The solution, concentrated solution, tablet, and capsule are taken usually with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablets (Oxycontin) are taken every 12 hours with or without food. The extended-release capsules (Xtampza ER) are taken every 12 hours with food; eat the same amount of food with each dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxycodone exactly as directed.

If you are taking Oxaydo brand tablets, swallow the tablets one at a time with plenty of water. Swallow the tablet or right after putting it in your mouth. Do not presoak, wet, or lick the tablets before you put them in your mouth. Do not chew or crush Oxaydo brand tablets. and do not give them through a nasogastric tube (NG tube; a tube threaded through the nose to deliver food and medication directly to the stomach).

If you have trouble swallowing extended-release capsules (Xtampza ER), you can carefully open the capsule and sprinkle the contents on soft foods such as applesauce, pudding, yogurt, ice cream, or jam, then consume the mixture immediately. Dispose of the empty capsule shells right away by flushing them down a toilet. Do not store the mixture for future use.

If you have a feeding tube, the extended-release capsule contents can be poured into the tube. Ask your doctor how you should take the medication and follow these directions carefully.

If you are taking the concentrated solution, your doctor may tell you to mix the medication in a small amount of juice or semisolid food such as pudding or applesauce. Follow these directions carefully. Swallow the mixture right away; do not store it for later use.

Your doctor will likely start you on a low dose of oxycodone and may increase this dose over time if your pain is not controlled. After you take oxycodone for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose to control your pain. Your doctor may decrease your dose if you experience side effects. Talk to your doctor about how you are feeling during your treatment with oxycodone.

Do not stop taking oxycodone without talking to your doctor. If you stop taking this medication suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, sneezing, yawning, sweating, chills, muscle or joint aches or pains, weakness, irritability, anxiety, depression, difficulty falling asleep or staying asleep, cramps, nausea, vomiting, diarrhea, loss of appetite, fast heartbeat, and fast breathing. Your doctor will probably decrease your dose gradually.

Take oxycodone exactly as prescribed. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of oxycodone.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Stop taking all other around-the-clock opioid pain medicines when you start taking extended-release oxycodone.

Take with food.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Never crush or break an oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You should not stop using oxycodone suddenly. Follow your doctor's instructions about gradually decreasing your dose.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not use oxycodone if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

You should not use this medicine if you are already using a similar opioid medicine and are tolerant to it. Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine or have received a methylene blue injection.

Most brands of oxycodone are not approved for use in people under the age of 18. OxyContin should not be given to a child younger than 11 years old.

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

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, or mental illness;

• lung disease;

• liver or kidney disease;

• thyroid disorder;

• adrenal disease (such as Addison's disease;

• urination problems; or

• problems with your gallbladder or pancreas.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. Tell your doctor if you are pregnant before using oxycodone. If you become pregnant while taking oxycodone, do not stop your medication suddenly without talking to your doctor. You may need to decrease your medicine gradually.

Ask a doctor before using oxycodone if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since oxycodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy.

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

Opioid medicine, including oxycodone, can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a slow heart rate or weak pulse;

• cold, clammy skin;

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

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

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

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication, such as oxycodone, may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common oxycodone side effects may include:

• drowsiness, dizziness, tiredness;

• headache;

• constipation, stomach pain, nausea, vomiting; or

• itching, red eyes, or flushing.

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.

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:

• other opioids - opioid pain medicine or prescription cough medicine;

• sedative medications including alprazolam or Xanax, clonazepam or Klonopin, diazepam or Valium, lorazepam or Ativan, temazepam or Restoril and others;

• sleeping pills;

• muscle relaxants or tranquilizers;

• medicine for depression, anxiety, or other mental illness;

• medicine for Parkinson’s disease;

• migraine headache treatment; or

• medications used for the prevention of nausea and vomiting.

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

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

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to oxycodone.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking oxycodone.

This prescription is not refillable. If you continue to have pain after you finish the oxycodone, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Combunox® (containing Ibuprofen, Oxycodone)
• Endocet® (containing Acetaminophen, Oxycodone)
• Endodan® (containing Aspirin, Oxycodone)
• Lynox® (containing Acetaminophen, Oxycodone)
• Magnacet® (containing Acetaminophen, Oxycodone)
• Narvox® (containing Acetaminophen, Oxycodone)
• Oxycet® (containing Acetaminophen, Oxycodone)
• Percocet® (containing Acetaminophen, Oxycodone)
• Percodan® (containing Aspirin, Oxycodone)
• Perloxx® (containing Acetaminophen, Oxycodone)
• Primlev® (containing Acetaminophen, Oxycodone)
• Roxicet® (containing Acetaminophen, Oxycodone)
• Roxiprin® (containing Aspirin, Oxycodone)
• Taxadone® (containing Acetaminophen, Oxycodone)
• Tylox® (containing Acetaminophen, Oxycodone)
• Xolox® (containing Acetaminophen, Oxycodone)