Roxicodone Intensol (Oral)

Oxycodone is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medications have not worked well or cannot be tolerated. It is part of a group of medicines called narcotic analgesics (pain medicines). Oxycodone works 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 a short time, like after surgery. Do not use this medicine for mild pain or when non-narcotic medications are effective. This medicine should not be used for pain that occurs only occasionally or "as needed."

If oxycodone is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to happen when narcotics are used for this purpose. Physical dependence may result in withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

This medicine is available only through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your progress while you are using this medicine, especially in the first 24 to 72 hours of treatment. This will help your doctor determine if the medicine is effective and if you should keep taking it. Blood and urine tests may be required to check for side effects.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) in the past 14 days.

This medicine may cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor immediately if you experience a rash, itching, hoarseness, difficulty breathing or swallowing, or any swelling of your hands, face, or mouth while using this medicine.

It is illegal and dangerous for anyone else to use your medicine. Keep any unused medicine in a safe and secure location. People who are addicted to drugs may try to steal this medicine.

If you suspect that you or someone else has taken an overdose of this medicine, seek emergency assistance immediately. Your doctor may also provide naloxone to treat an overdose. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that may produce pink frothy sputum, decreased awareness or responsiveness, extreme dizziness or weakness, increased sweating, irregular, fast, 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 any of these symptoms.

This medicine may lead to sleep-related breathing issues (for example, sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you experience sleep apnea while using this medicine.

This medicine will enhance the effects of alcohol and other CNS depressants. Examples of CNS depressants include antihistamines or medications for allergies or colds, sedatives, tranquilizers, or sleeping pills, other prescription pain medications or narcotics, medications for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medications), including some dental anesthetics. These effects may persist for a few days after you stop using this medicine. Consult your doctor before taking any of these medications while using this medicine.

This medicine may be habit-forming. If you feel the medicine is not working as well, do not exceed your prescribed dose. Contact your doctor for guidance.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help reduce these effects. Lying down for a while may also ease dizziness or lightheadedness.

This medicine may cause dizziness, drowsiness, or lightheadedness. Avoid driving or engaging in any activities that could be dangerous until you know how this medicine affects you.

Long-term use of this medicine can lead to severe constipation. To prevent this, your doctor may recommend laxatives, increased fluid intake, or a higher fiber diet. Follow the instructions carefully, as ongoing constipation can lead to more serious issues.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or stop using it suddenly without consulting your doctor. Your doctor may suggest gradually reducing your dosage before stopping completely. This can help prevent worsening of your condition and lessen the chance of withdrawal symptoms, which may include stomach cramps, anxiety, fever, nausea, restlessness, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine during pregnancy may lead to serious unwanted effects, including neonatal withdrawal syndrome in your newborn. Inform your doctor immediately if you suspect you are pregnant or plan to become pregnant while using this medicine.

For nursing mothers taking this medicine:

• Discuss with your doctor if you have any questions about taking oxycodone or its effects on your baby.
• Contact your doctor if you become extremely tired and struggle to care 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.
• Seek immediate help from your doctor or hospital emergency room if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, trouble breathing, or limpness. These may indicate an overdose and require urgent medical attention.

Taking too much of this medicine may cause infertility (inability to have children). Speak with your doctor before using this medicine if you plan to have children.

This medicine may lead to issues with your adrenal glands. Contact your doctor immediately if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Notify your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or perceive things that are not there. These may be signs of a serious condition known as serotonin syndrome. Your risk may increase if you are also taking certain other medications that affect serotonin levels in your body.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of some medical tests.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. As well inform 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 issues 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 issues that would limit the usefulness of oxycodone in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, heart, or lung issues, which may require caution and an adjustment in the dose for patients receiving oxycodone in order to avoid potentially serious side effects.

Breast Feeding

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 using this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially essential 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 medications is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other drugs you take.

• Levoketoconazole
• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

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

• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Adagrasib
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Alvimopan
• 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
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopentolate
• Cyclosporine
• Cyproheptadine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Ipratropium
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lanreotide
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylnaltrexone
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Mobocertinib
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Nalorphine
• Naloxone
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Octreotide
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Sotorasib
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Trofinetide
• Tropicamide
• Trospium
• Tryptophan
• Tucatinib
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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

• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drugs may as well 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 drug with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you inform your clinician if you have any other medical issues, especially:

• Addison disease (adrenal gland issue) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing or lung issues (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 narcotics, 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 issues) or
• Problems with passing urine or
• Psychosis (mental disease) or
• Stomach or bowel issues (eg, esophageal or colon cancer with a small gastrointestinal lumen) or
• Trouble swallowing or
• Weakened physical condition—Use with caution. May raise chance for more serious adverse effects.

• Asthma, acute or serious or
• Respiratory depression (serious breathing problem) or
• Stomach or bowel blockage (such as 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 since of slower removal of the medication from the body.

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

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

Less common

• Chills
• cold sweats
• confusion
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• tightness in the chest
• twitching

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning while urinating, 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
• 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
• 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, 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.

In the U.S.

• Dazidox
• Eth-Oxydose
• Oxaydo
• OxyCONTIN
• OxyCONTIN CR
• Oxydose
• Oxyfast
• Oxy IR
• Roxicodone
• Roxicodone Intensol
• Roxybond
• Xtampza ER

Available Dosage Forms:

• Capsule, Extended Release
• Tablet, Extended Release
• Tablet
• Solution
• Capsule

Therapeutic Class: Analgesic

Chemical Class: Opioid

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.

Oxycodone extended-release capsules or 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 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 narcotic 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. However, the dose is usually not more than 288 mg per day. 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 as needed. Children—Use and dose must be determined by your doctor.
• For oral dosage form (capsules):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 as 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 as needed. Children—Use and dose must be determined by your doctor.
• 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 narcotic 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 narcotic 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 narcotic 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.
• 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 as 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 as needed. Children—Use and dose must be determined by your doctor.
• 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 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 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.

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 narcotic 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 narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic 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

• Oxycodone vs Hydrocodone vs OTC Pain Relievers
• What drugs cause pinpoint pupils?
• Tramadol vs. Oxycodone: What are the key differences?
• How long does oxycodone stay in your system?
• Which drugs cause opioid-induced constipation?
• How long does Percocet stay in your system?
• Oxycodone vs OxyContin - What's the difference?
• How long does oxycodone take to work?
• How long does opioid withdrawal last?

View more FAQ