Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Dazidox
  2. Eth-Oxydose
  3. Oxecta
  4. Oxycontin
  5. Oxycontin CR
  6. Oxydose
  7. Oxyfast
  8. Oxy IR
  9. Roxicodone
  10. Roxicodone Intensol

Canadian Brand Name

  1. APO-Oxycodone CR
  2. CO Oxycodone CR
  3. Oxycodone
  4. Oxy-IR
  5. OxyNEO
  6. pms-Oxycodone

Descriptions


Oxycodone is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.

Oxycodone controlled-release tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet, Extended Release
  • Tablet
  • Capsule
  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone in the elderly. However, elderly patients are more likely to have age-related lung, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone.

Pregnancy

Information about this oxycodone-oral-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetophenazine
  • Adinazolam
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Atazanavir
  • Brofaromine
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Codeine
  • Crizotinib
  • Dabrafenib
  • Dantrolene
  • Desflurane
  • Dexmedetomidine
  • Dezocine
  • Diazepam
  • Diphenhydramine
  • Doxylamine
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Fentanyl
  • Flumazenil
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluvoxamine
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Halothane
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ketamine
  • Ketazolam
  • Ketoconazole
  • Lazabemide
  • Levorphanol
  • Linezolid
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nitrazepam
  • Nitrous Oxide
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pargyline
  • Pentazocine
  • Pentobarbital
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Piperaquine
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Ritonavir
  • Saquinavir
  • Secobarbital
  • Selegiline
  • Sertraline
  • Sevoflurane
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Triflupromazine
  • Trimeprazine
  • Zaleplon
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Miconazole
  • Perampanel
  • Rifampin
  • St John's Wort
  • Voriconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, hypoxia) or
  • Cancer of the esophagus or colon or
  • Central nervous system (CNS) depression or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Drug dependence, especially with narcotics, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Problems with passing urine or
  • Psychosis (a mental disease) or
  • Trouble swallowing or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, severe or
  • Hypercarbia (high carbon dioxide in the blood) or
  • Paralytic ileus (intestine stops working and may be blocked) or
  • Respiratory depression (very slow breathing) or
  • Stomach or bowel blockage—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation or swelling of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a Medication Guide and a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Oxycodone extended-release tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxecta® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes.

Oxycodone extended-release tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • Patients switching from regular oxycodone forms:
        • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (immediate-release tablets):
    • For moderate to severe pain:
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from fixed-ratio oral narcotic/non-narcotic combinations:
        • Adults—Your doctor will determine whether or not to continue the non-narcotic pain medicine. Also, the total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (liquid concentrate, solution, or tablets):
    • For moderate to severe pain:
      • Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Oxycodone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused extended-release tablets and immediate-release tablets down the toilet.

Precautions

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Chills
  2. cold sweats
  3. confusion
  4. difficult or labored breathing
  5. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  6. fever
  7. tightness in the chest
  8. twitching

Rare

  1. Abdominal or stomach pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blood in the urine
  4. burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. chest pain
  6. convulsions
  7. cough
  8. decrease in the frequency of urination
  9. decrease in urine volume
  10. decreased urine output
  11. difficult or painful urination
  12. difficulty in passing urine (dribbling)
  13. difficulty with swallowing
  14. dizziness
  15. dry mouth
  16. fainting
  17. fast, irregular, pounding, or racing heartbeat or pulse
  18. feeling of warmth or heat
  19. flushing or redness of the skin, especially on the face and neck
  20. frequent urination
  21. headache
  22. hives
  23. increase in heart rate
  24. increased thirst
  25. increased volume of pale, dilute urine
  26. itching
  27. lightheadedness
  28. muscle pain or cramps
  29. nausea or vomiting
  30. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  31. rapid breathing
  32. rapid weight gain
  33. severe constipation
  34. severe vomiting
  35. shakiness in the legs, arms, hands, or feet
  36. skin rash
  37. sunken eyes
  38. sweating
  39. swelling or puffiness of the face
  40. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  41. thirst
  42. tingling of the hands or feet
  43. trembling or shaking of the hands or feet
  44. unusual tiredness or weakness
  45. unusual weight gain or loss
  46. wrinkled skin

Incidence not known

  1. Blurred vision
  2. choking
  3. clay-colored stools
  4. cold, clammy skin
  5. dark urine
  6. diarrhea
  7. fast, weak pulse
  8. gagging
  9. irregular, fast, slow, or shallow breathing
  10. loss of appetite
  11. low blood pressure or pulse
  12. pale or blue lips, fingernails, or skin
  13. unconsciousness
  14. unpleasant breath odor
  15. very slow breathing
  16. very slow heartbeat
  17. yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Change in consciousness
  2. chest pain or discomfort
  3. constricted, pinpoint, or small pupils (black part of the eye)
  4. decreased awareness or responsiveness
  5. extreme drowsiness
  6. loss of consciousness
  7. no muscle tone or movement
  8. severe sleepiness
  9. slow or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Difficulty having a bowel movement (stool)
  2. drowsiness
  3. lack or loss of strength
  4. relaxed and calm feeling
  5. sleepiness or unusual drowsiness

Less common

  1. Abnormal dreams
  2. acid or sour stomach
  3. anxiety
  4. belching
  5. burning feeling in the chest or stomach
  6. false or unusual sense of well-being
  7. heartburn
  8. hiccups
  9. indigestion
  10. stomach discomfort, upset, or pain
  11. tenderness in the stomach area
  12. trouble sleeping
  13. weight loss

Rare

  1. Absent, missed, or irregular menstrual periods
  2. bad, unusual or unpleasant (after) taste
  3. bloated or full feeling
  4. body aches or pain
  5. change in taste
  6. change in walking and balance
  7. changes in vision
  8. clumsiness or unsteadiness
  9. congestion
  10. continuing ringing or buzzing or other unexplained noise in the ears
  11. cracks in the skin
  12. crying
  13. decreased interest in sexual intercourse
  14. dental caries or tooth decay
  15. depersonalization
  16. depression
  17. difficulty with speaking
  18. dry skin
  19. dryness or soreness of the throat
  20. dysphoria
  21. excess air or gas in the stomach or intestines
  22. excessive muscle tone
  23. feeling of constant movement of self or surroundings
  24. feeling of unreality
  25. general feeling of discomfort or illness
  26. headache, severe and throbbing
  27. hearing loss
  28. hives or welts
  29. hoarseness
  30. hyperventilation
  31. inability to have or keep an erection
  32. increase in body movements
  33. increased appetite
  34. increased cough
  35. irritability
  36. loss in sexual ability, desire, drive, or performance
  37. loss of heat from the body
  38. loss of memory
  39. loss of strength or energy
  40. mental depression
  41. muscle pain or weakness
  42. muscle stiffness
  43. muscle tension or tightness
  44. neck pain
  45. paranoia
  46. passing of gas
  47. problems with memory
  48. quick to react or overreact emotionally
  49. rapidly changing moods
  50. red, swollen skin
  51. restlessness
  52. runny nose
  53. scaly skin
  54. sensation of spinning
  55. sense of detachment from self or body
  56. severe sleepiness
  57. stomach pain, fullness, or discomfort
  58. stopping of menstrual bleeding
  59. swelling or inflammation of the mouth
  60. tender, swollen glands in the neck
  61. unusual weak feeling
  62. voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.