Alvimopan (Oral Route)

    Alvimopan (Oral Route)

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    Description and Brand Names of Alvimopan (Oral Route)

    US Brand Name

    1. Entereg

    Descriptions

    Alvimopan is used to help restore normal bowel function in patients who have just had bowel resection surgery. This medicine works by blocking the effects of certain substances (e.g., hormones, opioids) on bowel movement and secretion, thus, helping prevent a condition called post-operative ileus.

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

    This product is available in the following dosage forms:

    • Capsule

    Before Using Alvimopan (Oral Route)

    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 alvimopan in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of alvimopan in the elderly.

    Pregnancy

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    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:

    • Blocked bowels or
    • Kidney disease, severe or
    • Liver disease, severe – Not recommended for use in patients with these conditions.

    Proper Use of Alvimopan (Oral Route)

    This medicine is used only as part of a special program called Entereg® Access Support and Education (E.A.S.E.) in hospitalized patients. It is intended for short-term use only.

    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 (capsules):

      • For restoring normal bowel function after bowel surgery:

        • Adults – 12 milligrams (mg) 30 minutes to 5 hours before the surgery, then 12 mg two times a day starting from the day after surgery up to a maximum of 7 days or until discharge.
        • 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.

    Precautions

    It is very important that your doctor check your progress at regular visits to check for any problems or unwanted effects that may be caused by this medicine.

    Taking this medicine for more than 15 doses may increase the risk for a heart attack. Patients should not receive more than 15 doses of this medicine.

    Make sure your doctor knows if you have been using narcotic pain relievers (e.g., codeine, morphine, or Dolophine®) in the past 7 days before you start taking this medicine. Using this medicine together with narcotic pain relievers may increase the chance of unwanted effects.

    Side Effects of Alvimopan (Oral Route)

    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:

    More common

    1. Acid or sour stomach
    2. belching
    3. bloated
    4. convulsions
    5. decreased urine
    6. difficulty having a bowel movement (stool)
    7. dry mouth
    8. excess air or gas in stomach or intestines
    9. full feeling
    10. heartburn
    11. increased thirst
    12. indigestion
    13. irregular heartbeat
    14. loss of appetite
    15. mood changes
    16. muscle pain or cramps
    17. nausea or vomiting
    18. numbness or tingling in hands, feet, or lips
    19. pale skin
    20. passing gas
    21. shortness of breath
    22. stomach discomfort, upset, or pain
    23. troubled breathing with exertion
    24. unusual bleeding or bruising
    25. unusual tiredness or weakness

    Less common

    1. Decrease in frequency of urination
    2. decrease in urine volume
    3. difficulty in passing urine (dribbling)
    4. painful urination

    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:

    Less common

    1. Back pain

    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.