Brand Name
US Brand Name
Dazidox
Eth-Oxydose
Oxaydo
OxyCONTIN
OxyCONTIN CR
Oxydose
Oxyfast
Oxy IR
Roxicodone
Roxicodone Intensol
Roxybond
Xtampza ER
Description
Oxycodone is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called opioid analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.
Oxycodone extended-release capsules or 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, or in situations when non-opioid medication is effective. 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, under the close supervision of healthcare providers, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Capsule, Extended Release
- Tablet, Extended Release
- Tablet
- Solution
- Capsule
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 Oxaydo®, Roxicodone®, Roxybond™, and Xtampza® ER in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oxycontin® in children. However, safety and efficacy have not been established in children younger than 11 years of age.
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 liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxycodone in order to avoid potentially serious side effects.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Isocarboxazid
- Levoketoconazole
- Mavorixafor
- Naltrexone
- Safinamide
- Samidorphan
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asciminib
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
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.
- Desflurane
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
- Grapefruit Juice
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 disease (adrenal gland problem) or
- Alcohol use disorder, or history of or
- Brain tumor, history of or
- Breathing or lung problems (eg, hypoxia, COPD, sleep apnea) or
- Cancer of the esophagus or colon or
- CNS depression or
- Cor pulmonale (serious heart condition) or
- Drug dependence, especially with opioids, or history of or
- Enlarged prostate (eg, BPH, prostatic hypertrophy) or
- Gallbladder disease or gallstones or
- Head injuries, history of or
- Hypothyroidism (an underactive thyroid) or
- Hypovolemia (low blood volume) or
- Increased pressure in the head or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Problems with passing urine or
- Psychosis (mental disease) or
- Stomach or bowel problems (eg, esophageal or colon cancer with a small gastrointestinal lumen) or
- Trouble swallowing or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Respiratory depression (serious breathing problem) or
- Stomach or bowel blockage (including paralytic ileus)—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (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).
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. This medicine should also come with a Medication Guide and a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
Close follow-up with healthcare providers and creation of a pain management plan is an effective way to manage chronic pain. This plan may include limiting opioid medicines to the lowest effective dose for a limited period of time. The plan may also include non-medicine treatments such as relaxation techniques, massage therapy, or transcutaneous electrical stimulation (TENS).
Oxycodone extended-release capsules or tablets should only be used by patients who have already been taking opioid pain medicines. 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 Oxaydo® 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.
If you are using the extended-release capsules:
- Take this medicine with food and with about the same amount of food each time.
- If you have trouble swallowing, you may open the capsule and sprinkle the contents on soft foods (eg, applesauce, pudding, yogurt, ice cream, or jam) or into a cup and swallow immediately. Drink a glass of water to make sure all the medicine has been taken.
- This medicine may also be given through a nasogastric or gastrostomy tube.
Oxycodone extended-release capsules or 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.
While taking the Roxybond™ tablet, part of it may pass into your stool. This is normal and nothing to worry about.
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 capsules):
- For severe pain:
- Patients who are not taking opioid medicines or are not opioid tolerant:
- Adults—At first, 9 milligrams (mg) every 12 hours with food. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines or are not opioid tolerant:
- For severe pain:
- For oral dosage form (capsules):
- For moderate to severe pain:
- Patients who are not taking opioid medicines:
- Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines:
- For moderate to severe pain:
- For oral dosage form (extended-release tablets):
- For moderate to severe pain:
- Patients switching from regular oxycodone forms:
- Adults—One tablet 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 given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
- Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
- Children younger than 11 years of age—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—One tablet every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
- Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
- Children younger than 11 years of age—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines:
- Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
- Older adults—At first, 3 to 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from regular oxycodone forms:
- For moderate to severe pain:
- For oral dosage form (immediate-release tablets):
- For moderate to severe pain:
- Patients who are not taking opioid medicines:
- Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines:
- For moderate to severe pain:
- For oral dosage forms (liquid concentrate or solution):
- For moderate to severe pain:
- Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe pain:
- For oral dosage forms (solution):
- For moderate to severe pain:
- Adults—5 to15 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe pain:
- For oral dosage form (tablets):
- For moderate to severe pain:
- Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe pain:
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.
If you miss a dose of OxyContin®, Roxicodone®, Roxybond™, or Xtampza® ER, skip the missed dose and go back to your regular dosing schedule.
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 opioid pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that sometimes produces a pink frothy sputum, decreased awareness or responsiveness, extreme dizziness or weakness, increased sweating, irregular, fast, or slow, or shallow breathing, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, slow heartbeat, seizures, swelling in legs and ankles, or trouble breathing. Call your doctor right away if you notice these symptoms.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine will add to the effects of alcohol and other CNS depressants. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. 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 dizziness or lightheadedness.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using opioids 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 stomach cramps, anxiety, fever, nausea, restlessness, runny nose, sweating, tremors, or trouble sleeping.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome 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.
For nursing mothers:
- Talk to your doctor if you have any questions about taking oxycodone or about how this medicine may affect your baby. This medicine may be present in your breast milk and passed to your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
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
- Chest tightness
- chills
- cold sweats
- confusion
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- twitching
Rare
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- cough
- decrease in the frequency of urination
- decreased urine output
- difficult or painful urination
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dizziness
- dry mouth
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- frequent urination
- headache
- hives, itching, or skin rash
- increase in heart rate
- increased thirst
- increased volume of pale, dilute urine
- lightheadedness
- muscle pain or cramps
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid breathing
- rapid weight gain
- seizures
- severe constipation
- severe vomiting
- stomach pain
- sunken eyes
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thirst
- trembling or shaking of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- wrinkled skin
Incidence not known
- Blurred vision
- choking
- clay-colored stools
- cold, clammy skin
- dark urine
- darkening of the skin
- diarrhea
- fast, weak pulse
- gagging
- increased sensitivity to pain
- irregular, fast, slow, or shallow breathing
- loss of appetite
- loss of consciousness
- pale or blue lips, fingernails, or skin
- unpleasant breath odor
- very slow heartbeat
- worsening of pain
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- chest pain or discomfort
- cold, clammy skin
- constricted, pinpoint, or small pupils (black part of the eye)
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- increased sweating
- irregular, fast, or slow, or shallow breathing
- loss of consciousness
- no muscle tone or movement
- pale or blue lips, fingernails, or skin
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- swelling in the legs and ankles,
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
- Difficulty having a bowel movement
- drowsiness
- lack or loss of strength
- relaxed and calm feeling
Less common
- Abnormal dreams
- anxiety
- belching
- burning feeling in the chest or stomach
- false or unusual sense of well-being
- heartburn
- hiccups
- indigestion
- stomach discomfort or upset
- tenderness in the stomach area
- trouble sleeping
- weight loss
Rare
- Absent, missed, or irregular menstrual periods
- bad, unusual or unpleasant (after) taste
- bloated or full feeling
- body aches or pain
- change in taste
- change in walking and balance
- changes in vision
- clumsiness or unsteadiness
- continuous ringing or buzzing or other unexplained noise in the ears
- crying
- decreased interest in sexual intercourse
- deep or fast breathing with dizziness
- delusions of persecution, mistrust, suspiciousness, or combativeness
- dental caries or tooth decay
- depression
- difficulty with speaking
- dry skin
- dryness or soreness of the throat
- excess air or gas in the stomach or bowels
- excessive muscle tone
- feeling of constant movement of self or surroundings
- feeling of unreality
- general feeling of discomfort or illness
- headache, severe and throbbing
- hearing loss
- hoarseness
- inability to have or keep an erection
- increase in body movements
- increased appetite
- increased cough
- irritability
- loss in sexual ability, desire, drive, or performance
- loss of heat from the body
- loss of memory
- loss of strength or energy
- muscle stiffness, tension, tightness, pain, or weakness
- neck pain
- numbness of the feet, hands, and around the mouth
- passing of gas
- problems with memory
- quick to react or overreact emotionally
- rapidly changing moods
- red, swollen skin
- restlessness
- runny nose
- scaly skin
- sensation of spinning
- sense of detachment from self or body
- swelling or inflammation of the mouth
- 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.
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