Oxycodone (patient information)

IMPORTANT WARNING:

• 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. Keep 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 how much liquid is left so you will know if any medication is missing.
• Oxycodone may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. 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 kyphoscoliosis (curving of the spine that may cause breathing problems) or lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). The risk that you will develop breathing problems may be higher if you are an older adult or are weakened 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.
• Drinking alcohol, taking prescription or non-prescription 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.
• Taking certain other medications during your treatment with oxycodone may increase the risk that you will experience breathing problems or other serious, life-threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: other narcotic pain medications; medications for anxiety, seizures, mental illness, or nausea; muscle relaxants; sedatives; sleeping pills;or tranquilizers.
• Swallow oxycodone extended-release tablets whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, or crushed 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.
• Talk to your doctor about the risks of taking oxycodone.
• If you are taking oxycodone extended release tablets, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment and each time you refill 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Why is this medication prescribed?

• Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets are only used to treat people who are expected to need medication to relieve moderate to severe pain around the clock. 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 (Endocet, Percocet, Roxicet, Tylox, others); aspirin (Endodan, Percodan, Roxiprin, others); and ibuprofen (Combunox). 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 oxycodone concentrated solution, be sure to carefully measure and double check the dose before taking the medication. Use the measuring dropper that comes with the medication to measure your dose. Mix the medication with at least 1 ounce (30 milliliters) of juice or other liquid, or with a semi-solid food such as applesauce or pudding. If you are taking oxycodone concentrated solution from an ampule (small pre-packaged tube containing oxycodone liquid), be sure to follow your doctor's instructions for taking a dose. Ask your pharmacist or doctor if you have any questions about measuring your dose or taking your medication.
• 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.
• 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. 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.
• Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

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 oxycodone liquid, tablets, extended-release tablets, or capsules. 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 any of the following: antidepressants;certain antibiotics including clarithromycin (Biaxin, in Prevpac) and erythromycin (E.E.S., Ery-C); certain antifungal medications including itraconazole (Sporanox) and ketoconazole (Nizoral); antihistamines (found in cold and allergy medications); diuretics ('water pills'); buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Equetro, Tegretol); certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept) and ritonavir (Norvir, in Kaletra); ipratropium (Atrovent); medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems;nalbuphine (Nubain); naloxone (Narcan); phenobarbital; phenytoin (Dilantin); pentazocine (Talwin); rifabutin (Mycobutin) and rifampin (Rifadin, in Rifamate, in Rifater). 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, a blockage in your stomach or intestines, 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 head injury,a tumor in your brain or nervous system, any condition causing increased pressure in your brain; hypothyroidism (condition in which the thyroid gland produces less hormone than normal), low blood pressure;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, or pancreas, or biliary tract disease. If you will be taking the extended-release tablets, also tell your doctor if you have or have ever had 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 breast-feeding. If you become pregnant while taking oxycodone, call your doctor.
• 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. ask your doctor about the safe use of alcoholic beverages while you are taking oxycodone. When alcohol is taken with this medication, dangerous side effects can occur.

• 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.

What special dietary instructions should I follow?

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

What should I do if I forget 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 medication 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
• Constipation
• Dry mouth
• Dizziness or lightheadedness
• Drowsiness
• Flushing
• Sweating
• Itching
• Weakness
• Headache
• Mood changes
• Narrowing of the pupil (dark circle in eye)
• Red eyes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• Fast or slow heartbeat
• Difficulty breathing
• Slowed breathing
• Hives
• Rash
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Difficulty swallowing
• Seizures

• 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 http://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. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Throw away oxycodone concentrate solution 90 days after you open the product. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/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:

• Difficulty breathing or slowed or stopped breathing
• Excessive sleepiness
• Dizziness
• Fainting
• Limp or weak muscles
• Narrowing or widening of the pupils (dark circle in the eye) size
• 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.
• 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.

Brand names

• Dazidox®¶
• Endocodone®¶
• ETH-Oxydose®¶
• Oxecta®
• Oxycontin®
• Oxyfast®¶
• OxyIR®¶
• Percolone®¶
• Roxicodone®

Brand names of combination products

• Combunox® (containing Ibuprofen, Oxycodone)
• Endocet® (containing Acetaminophen, Oxycodone)
• Endodan® (containing Aspirin, Oxycodone)
• Lynox® (containing Acetaminophen, Oxycodone)¶
• Magnacet® (containing Acetaminophen, Oxycodone)
• Narvox® (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)