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Methylnaltrexone bromide (Oral route)

Pronunciation:

meth-il-nal-TREX-one BROE-mide

Brand Names:

  • Relistor

Dosage Forms:

  • Tablet

Classifications:

Therapeutic

Gastrointestinal Agent

Pharmacologic

Methylnaltrexone

Uses of This Medicine:

Methylnaltrexone bromide is used to treat constipation caused by opioids (narcotic pain medicines), in adults with long-lasting pain that is not caused by cancer. This medicine is used when other medicines for constipation (laxatives) have not worked well.

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

Before Using This Medicine:

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.

Children

Appropriate studies have not been performed on the relationship of age to the effects of methylnaltrexone in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methylnaltrexone in the elderly. However, elderly patients are more likely to have diarrhea and have kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 taking this medication while breastfeeding.

Other medicines

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.

  • Buprenorphine
  • Morphine
  • Morphine Sulfate Liposome
  • Naloxegol
  • Oxycodone
  • Oxymorphone

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:

  • Crohn's disease or
  • Diverticulitis or
  • Ogilvie's syndrome (decreased movement of food in the intestines) or
  • Peptic ulcer or
  • Stomach or bowel cancer May increase risk for more serious side effects.
  • Kidney disease, moderate and severe or
  • Liver disease, moderate and severe Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or bowel blockage Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly 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. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with water on an empty stomach at least 30 minutes before the first meal of the day.

Stop taking other laxatives before starting treatment with methylnaltrexone. Also, stop using this medicine if you have stopped taking narcotic pain medicines.

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 (tablets):
    • For constipation caused by opioids in patients with chronic non-cancer pain:
      • Adults 450 milligrams (mg) once a day, in the morning.
      • 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.

Keep out of the reach of children.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have a severe stomach pain that does not go away.

If severe or persistent (non-stop) diarrhea occurs while using this medicine, check with your doctor right away.

Do not suddenly stop using this medicine without checking first with your doctor. Doing so may cause symptoms, such as anxiety, chills, diarrhea, irritability, stomach pain, sweating, and yawning.

Side Effects of This Medicine:

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:

Incidence not known
Chills
diarrhea
fear or nervousness
increased sweating
severe abdominal or stomach pain
severe or persistent diarrhea
yawning

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
Full or bloated feeling
headache
muscle spasms
pressure in the stomach
runny nose
swelling of abdominal or stomach area
vomiting

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.


Last Updated: 9/15/2016
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