OxyIR is an opioid pain medication 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.

OxyIR may also be used for purposes not listed in this medication guide.

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

Taking opioid medicine 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.

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

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 OxyIR.

Take OxyIR 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 OxyIR 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 OxyIR suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. OxyIR 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 OxyIR 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 OxyIR unless you are already using a similar opioid medicine and are tolerant to it.

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

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, or seizures;

• drug or alcohol addiction, or mental illness;

• liver or kidney disease;

• urination problems; or

• problems with your gallbladder, pancreas, or thyroid.

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.

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

Since OxyIR 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 opioid 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.

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

Avoid driving or operating machinery until you know how OxyIR 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine 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.

OxyIR may cause serious side effects. 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;

• 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.

Common side effects of OxyIR may include:

• drowsiness, headache, dizziness, tiredness; or

• constipation, stomach pain, nausea, vomiting.

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:

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

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

• other opioids--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; or

• 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 and many other drugs may affect OxyIR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.