Roxicodone Intensol

Name: Roxicodone Intensol

How to use

Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).Use the provided medicine dropper to carefully measure the dose. Do not use a household spoon because you may not get the correct dose. Do not confuse the dose in milligrams (mg) with the dose in milliliters (mL). You may mix the dose with a small amount of juice, water, applesauce or pudding. Take all of the mixed dose immediately. Ask your pharmacist or doctor if you are not sure how to check, measure, or mix the dose.The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting narcotic medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other non-narcotic pain relievers (such as acetaminophen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using oxycodone safely with other drugs.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.Tell your doctor if your pain persists or worsens.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain pain medications (mixed narcotic agonists/antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone).The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.Other medications can affect the removal of oxycodone from your body, which may affect how oxycodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Storage

Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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Reviewed on 4/16/2014 References

Commonly used brand name(s)

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
  • Capsule
  • Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Roxicodone Intensol

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 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-narcotic 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, 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.

Proper Use of oxycodone

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Roxicodone Intensol. Please read with care.

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 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 approximately 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, ice cream, or jam) or into a cup and then give it directly into the mouth and swallow immediately. Drink a glass of water to make sure all medicine has been taken.
  • This medicine may also be given through a feeding 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.

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 if 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 if 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—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 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 consecutive days 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—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 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 consecutive days 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 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 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.

Precautions While Using Roxicodone Intensol

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.

Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.

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. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you 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 (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 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.

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.

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.

For Healthcare Professionals

Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release

General

The most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation.[Ref]

Nervous system

Very common (10% or more): Headache (14%, pediatrics)
Common (1% to 10%): Dizziness (pediatrics)
Frequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine
Postmarketing reports: Serotonin syndrome[Ref]

Respiratory

Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.[Ref]

Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (23% to 27%), constipation (23% to 26%), vomiting (12% to 14%)
Frequency not reported: Abdominal pain, anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis[Ref]

In pediatric studies with the oral extended release product, gastrointestinal adverse events were reported in 40% of patients 11 to 16 years of age (56 of 140); vomiting, nausea, constipation, and diarrhea were experienced by 21%, 15%, 9%, and 6%, respectively. Abdominal pain and gastroesophageal reflux disease were reported in 1% to less than 5% of patients.[Ref]

Psychiatric

Frequency not reported: Paranoia, psychosis, hallucinations, agitation, anxiety[Ref]

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, rash
Frequency not reported: Herpes simplex, rash, sweating, urticaria[Ref]

Hepatic

Frequency not reported: Increased hepatic enzymes

Cardiovascular

Frequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapse[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary retention
Frequency not reported: Urinary tract infection[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylaxis[Ref]

Immunologic

Frequency not reported: Flu syndrome, infection, sepsis[Ref]

Metabolic

Common (1% to 10%): Decreased appetite (pediatrics)
Frequency not reported: Gout, hyperglycemia, iron deficiency anemia[Ref]

Musculoskeletal

Frequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fracture[Ref]

Ocular

Frequency not reported: Photosensitivity reaction, amblyopia[Ref]

Other

Very common (10% or more): Pyrexia (11%, pediatrics)
Frequency not reported: Chills and fever, accidental injury[Ref]

Endocrine

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Some side effects of Roxicodone Intensol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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