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ALVIMOPAN is used to help the gut function after having gut surgery. Compare opioid antagonists.
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What is Entereg?

Commonly Used Brand Name(s)Entereg

Therapeutic ClassificationsGastrointestinal Agent

Pharmacologic ClassificationsOpioid Antagonist

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Blackbox WarningTOP

Oral route (Capsule)

Increased incidence of myocardial infarction was seen in alvimopan-treated patients compared with placebo-treated patients in a 12-month clinical trial. Alvimopan is available only for short-term (15 doses) use through a restricted program called the ENTEREG (R) Access Support and Education (E.A.S.E. (R)) Program .

OverviewTOP

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.

Proper UseTOP

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.

DosingTOP

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 DoseTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

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.

GeriatricTOP

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

PregnancyTOP

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast FeedingTOP

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 InteractionsTOP

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 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.

Other InteractionsTOP

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 ProblemsTOP

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.

PrecautionsTOP

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.

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