FDA Drug Safety Communication:
- As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
Oxycodone may be habit-forming. Take oxycodone exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking oxycodone, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. 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 has had an overdose, 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. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.
Oxycodone may cause serious or life-threatening breathing problems, especially during the first 24 to 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 a brain tumor, or any condition that increases the amount of pressure in your brain. 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, sedation, or coma. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: certain antibiotics such as clarithromycin (Biaxin, in PrevPac) and erythromycin (Erytab, Erythrocin); certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); medications for mental illness, nausea or pain; muscle relaxants; certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); 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. If you take oxycodone with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
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. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.
If you are taking the oxycodone extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. Do not presoak, lick or otherwise wet the tablet prior to placing in the mouth. 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.
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, extended-release capsules, 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 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.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment with oxycodone 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 (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 and extended-release capsules 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 and extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed. Oxycodone extended-release tablets, extended-release capsules, 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), 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.
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: antihistamines (found in cold and allergy medications); diuretics ('water pills'); buprenorphine (Butrans, in Suboxone, in Zubsolv, others); butorphanol; cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); medications for glaucoma, irritable bowel disease, and urinary problems; lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; naloxone (Evzio, Narcan, others); pentazocine (Talwin); 5-HT3 receptor antagonists such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); tramadol (Conzip, Ultram, in Ultracet), trazodone (Oleptro); or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with oxycodone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
- 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), problems urinating; or heart, kidney, liver, pancreas, thyroid, or gall bladder disease. If you will be taking the extended-release tablets or extended-release capsules, 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.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking oxycodone.
- 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 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 medication cause?
Oxycodone may cause side effects. Tell your doctor if any of these symptoms, are severe or do not go away:
- dry mouth
- stomach pain
- 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:
- 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, nausea, vomiting, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- chest pain
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- 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 (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). 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
In case of emergency/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.
While taking oxycodone, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a caregiver or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
Symptoms of overdose may include the following:
- difficulty breathing
- slowed or stopped breathing
- excessive sleepiness
- limp or weak muscles
- narrowing or widening of the pupils (dark circle in the eye)
- cold, clammy skin
- unable to respond or wake up
What other information should I know?
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.
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)¶
- 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)¶
¶ This branded product is no longer on the market. Generic alternatives may be available.