Brand Name(s):

    
  • Dazidox®¶
  • Endocodone®¶
  • ETH-Oxydose®¶
  • Oxecta®
  • Oxycontin®
  • Oxyfast®¶
  • OxyIR®¶
  • Percolone®¶
  • Roxicodone®
  • Combunox®(as a combination product containing Ibuprofen, Oxycodone)¶
  • Endocet®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Endodan®(as a combination product containing Aspirin, Oxycodone)¶
  • Lynox®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Magnacet®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Narvox®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Oxycet®(as a combination product containing Acetaminophen, Oxycodone)
  • Percocet®(as a combination product containing Acetaminophen, Oxycodone)
  • Percodan®(as a combination product containing Aspirin, Oxycodone)
  • Perloxx®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Primlev®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Roxicet®(as a combination product containing Acetaminophen, Oxycodone)
  • Roxiprin®(as a combination product containing Aspirin, Oxycodone)¶
  • Taxadone®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Tylox®(as a combination product containing Acetaminophen, Oxycodone)¶
  • Xartemis XR®(as a combination product containing Acetaminophen, Oxycodone)
  • Xolox®(as a combination product containing Acetaminophen, Oxycodone)¶
  • IMPORTANT WARNING

    Oxycodone may cause serious or life-threatening breathing problems, especially during the first 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take oxycodone. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury any condition that increases the amount of pressure in your brain, or kyphoscoliosis (curving of the spine that may cause breathing problems). The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

    Taking certain other medications with oxycodone may increase the risk of serious or life-threatening breathing problems. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: certain antibiotics such as clarithromycin (Biaxin) and erythromycin (E-Mycin, Erythrocin);antidepressants; certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole (Nizoral) and voriconazole (Vfend); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); medications for anxiety, mental illness or nausea; muscle relaxants;certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan) nelfinavir (Viracept),and ritonavir (Norvir, in Kaletra); other narcotic pain medications; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin).rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; or tranquilizers.Your doctor may need to change the doses of your medication and will monitor you carefully.

    Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with oxycodone increases the risk that you will experience serious, life-threatening side effects. Talk to your doctor about the risks of drinking alcohol during your treatment.

    If you are taking the oxycodone extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. Swallow each tablet right after you put it in your mouth. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much oxycodone at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

    Oxycodone comes as a regular solution (liquid) and as a concentrated solution that contains more oxycodone in each milliliter of solution. Be sure that you know whether your doctor has prescribed the regular or concentrated solution and the dose in milliliters that your doctor has prescribed. Use the dosing cup, oral syringe, or dropper provided with your medication to carefully measure the number of milliliters of solution that your doctor prescribed. Read the directions that come with your medication carefully and ask your doctor or pharmacist if you have any questions about how to measure your dose or how much medication you should take. You may experience serious or life threatening side effects if you take an oxycodone solution with a different concentration or if you take a different amount of medication than prescribed by your doctor.

    Oxycodone may be habit-forming. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse oxycodone if you have or have ever had any of these conditions.

    Do not allow anyone else to take your medication. Oxycodone may harm or cause death to other people who take your medication, especially children.

    Store oxycodone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep oxycodone out of the reach of children. Keep track of how many tablets or capsules, or how much liquid is left so you will know if any medication is missing. Dispose of unwanted capsules, tablets, extended-release tablets, and liquid properly according to instructions. (See STORAGE and DISPOSAL).

    Tell your doctor if you are pregnant or plan to become pregnant. If you take oxycodone extended-release tablets regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

    Talk to your doctor about the risks of taking oxycodone.

    If you are taking oxycodone extended-release tablets or solution, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

    WHY is this medicine prescribed?

    Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Oxycodone extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Oxycodone extended-release tablets and concentrated solution should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week. 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.

    Oxycodone is also available in combination with acetaminophen (Oxycet, Percocet, Roxicet, Xartemis XR, others); aspirin (Percodan); and ibuprofen. This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    Oxycodone comes as a solution (liquid), concentrated solution, tablet, capsule, and extended-release (long-acting) tablet to take by mouth. The solution, concentrated solution, tablet, and capsule are usually taken with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablets are taken every 12 hours. 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 the extended-release tablets or Oxecta brand tablets, swallow the tablets one at a time with plenty of water. Swallow the tablet or extended-release tablet right after putting it in your mouth. Do not presoak, wet, or lick the tablets or extended-release tablets before you put them in your mouth. Do not chew or crush Oxecta 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 are taking the concentrated solution, your doctor may tell you to mix the medication in a small amount of juice or semi-solid 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.

    Are there OTHER USES for this medicine?

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

    What SPECIAL PRECAUTIONS should I follow?

    Before taking oxycodone,

        
  • tell your doctor and pharmacist if you are allergic to oxycodone, any other medications, or any of the ingredients in the oxycodone product you plan to take. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants; antihistamines (found in cold and allergy medications); diuretics ('water pills'); buprenorphine (Buprenex, Butrans, in Suboxone, in Zubsolv); butorphanol; ipratropium (Atrovent); medications for glaucoma, irritable bowel disease, and urinary problems; nalbuphine; naloxone (Evzio); and pentazocine (Talwin); Also tell your doctor or pharmacist if you are taking the following medications or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take oxycodone.
  • Also tell your doctor if you have or have ever had a blockage in your stomach or intestine; low blood pressure; seizures; Addison's disease (condition in which the adrenal gland does not produce enough hormone), seizures; urethral stricture (blockage of the tube that allows urine to leave the body), enlarged prostate (a male reproductive gland), or heart, kidney, liver, pancreas, thyroid, or gall bladder disease. If you will be taking the extended-release tablets, 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 breastfeeding.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are 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 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 in 12 hours.

    What SIDE EFFECTS can this medicine cause?

    Oxycodone may cause side effects. Tell your doctor if any of these symptoms, are severe or do not go away:

        
  • nausea
  • vomiting
  • loss of appetite
  • dry mouth
  • dizziness
  • stomach pain
  • drowsiness
  • flushing
  • sweating
  • weakness
  • headache
  • mood changes
  • 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:

        
  • fast or slow heartbeat
  • chest pain
  • hives
  • itching
  • rash
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty breathing or swallowing
  • seizures
  • extreme drowsiness
  • lightheadedness when changing positions
  • 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 [at Web Site] 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. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). 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.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include the following:

        
  • difficulty breathing
  • slowed or stopped breathing
  • excessive sleepiness
  • dizziness
  • fainting
  • limp or weak muscles
  • narrowing or widening of the pupils (dark circle in the eye)
  • cold, clammy skin
  • slow or stopped heartbeat
  • blue color of skin, fingernails, lips, or area around the mouth
  • loss of consciousness or coma
  • What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.

    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.

    ¶This branded product is no longer on the market. Generic alternatives may be available.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: August 15, 2014.