Oxycodone

Why is this medicine prescribed?

Oxycodone is used to relieve severe pain.Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Are there other uses for this medicine?

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

How should this medicine be used?

Oxycodone comes as a solution (liquid), a tablet, a capsule, an extended-release (long-acting) tablet, and an extended-release capsule to take by mouth. The solution, tablet, and capsule are taken with or without food every 4 to 6 hours as needed for pain.The extended-release tablets and capsules are prescribed when pain relief is needed around the clock and are taken every 12 hours. The capsules should be taken with food but the tablets can be taken with or without food.

If you are taking the extended-release tablets, swallow the tablets one at a time with plenty of water. Swallow the tablet 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 extended-release tablets.

If you have trouble swallowing extended-release capsules, carefully open the capsule and sprinkle the contents on soft foods such as applesauce, pudding, yogurt, ice cream, or jam. 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.

Your doctor may adjust your dose of oxycodone during your treatment, depending on how well your pain is controlled and on the side effects that you experience.Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with oxycodone. Do not take more of it or take it more often than prescribed by your doctor.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while taking oxycodone.Rescue medications can reverse the life-threatening effects of an opioid overdose and are available over the counter or with a prescription.Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives.Your doctor or pharmacist will show you and others how to use it.If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives.If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

If you have been taking oxycodone regularly, do not stop taking oxycodone or rapidly decrease the dose without talking to your doctor.If you stop taking oxycodone 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.

What special precautions should I follow?

Before taking oxycodone,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with oxycodone. Make sure you have discussed anymedications you are currently taking or plan to take before starting oxycodone with your doctorand pharmacist. Before starting, stopping, or changing any medications while taking oxycodone,please get the advice of your doctor or pharmacist.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.

• the following nonprescription or herbal products may interact with oxycodone: St. John's wort and tryptophan.Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking oxycodone. Do not start these medications while taking oxycodone without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems, a blockage or narrowing of your stomach or intestines.Your doctor will probably tell you not to take oxycodone.

• tell your doctor if you have or have ever had a head injury, a brain tumor, or any condition that increases pressure in the brain;seizures;difficulty urinating; or heart, kidney,liver,pancreas, thyroid, or gall bladder disease. If you will be taking the extended-release products, also tell your doctor if you have or have ever had difficulty swallowing,diverticulitis (condition in which small pouches form in the intestines and become swollen and infected), colon cancer (cancer that begins in the large intestine), or esophageal cancer (cancer that begins in the tube that connects the mouth and stomach).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If youbecome pregnant while taking oxycodone call your doctor immediately.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking oxycodone.

• you should know that this medication may make you drowsy.Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.

• you should know to not drink alcoholic beverages while you are taking oxycodone products. Alcohol can make the side effects from oxycodone worse.

• you should know that oxycodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position.To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that oxycodone may cause constipation.Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are taking oxycodone.

What special dietary instructions should I follow?

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

What should I do if I forget to take a dose?

If you are taking oxycodone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of the extended-release tablets or capsules in 12 hours.

What side effects can this medicine cause?

Oxycodone may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section, are severe or do not go away:

• nausea, vomiting
• difficulty falling asleep or staying asleep
• headache
• weakness, tiredness
• decreased sexual desire, inability to get or keep an erection

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help:

• chest pain, changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• rash; itching; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue, lips, or throat
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• seizures
• extreme drowsiness
• unusual snoring or long pauses during breaths during sleep

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Oxycodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

Store oxycodone products in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or solution is left so you will know if any are missing.

Dispose of any oxycodone 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 oxycodone medication down the toilet so that others will not take it.Talk to your pharmacist about the proper disposal of your medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• difficulty breathing, slow or shallow breathing, unusual snoring
• excessive sleepiness, unable to respond or wake up
• limp or weak muscles
• narrowing or widening of the pupils (dark circle in the eye)
• cold, clammy skin
• slowed heartbeat

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Oxaydo^®¶
• Oxycontin^®
• Roxicodone^®
• Roxybond^®
• Xtampza^® ER
• also available generically