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naldemedine (Oral route)

nal-DEM-e-deen

Commonly used brand name(s)

In the U.S.

  • Symproic

Available Dosage Forms:

  • Tablet

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Opioid Antagonist

Uses For naldemedine

Naldemedine is used to treat constipation that is caused by opioids (narcotic pain medicines), in adults with long-lasting pain that is not caused by cancer.

naldemedine is available only with your doctor's prescription.

Before Using naldemedine

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 naldemedine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to naldemedine 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 naldemedine in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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.

Interactions with 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 naldemedine, 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 naldemedine 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.

  • Alvimopan
  • Methylnaltrexone
  • Nalorphine
  • Naloxone
  • Naltrexone
  • Samidorphan

Interactions with Food/Tobacco/Alcohol

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 naldemedine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Crohn's disease or
  • Diverticulitis or
  • Ogilvie syndrome or
  • Peptic ulcer or
  • Stomach or bowel cancer—May increase risk for more serious side effects.
  • Patients at increased risk of stomach blockage or
  • Stomach or bowel blockage, known or suspected—Should not be used in patients with these conditions.

Proper Use of naldemedine

Take naldemedine 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.

naldemedine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take it with or without food.

Dosing

The dose of naldemedine 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 naldemedine. 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:
      • Adults—0.2 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of naldemedine, 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.

Precautions While Using naldemedine

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 take it.

naldemedine 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.

Tell your doctor right away if you have an increased sweating, chills, increased tearing, redness on the face, neck, arms, and upper chest, feeling cold, abdominal or stomach pain, diarrhea, nausea, and vomiting.

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 (eg, St. John's wort) or vitamin supplements.

naldemedine Side Effects

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
  • Abdominal or stomach pain
  • diarrhea
  • nausea
Less common
  • Fast heartbeat
  • fever
  • hives, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • loss of appetite
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • vomiting
  • weakness
Incidence not known
  • Bloody, black, or tarry stools
  • chills
  • feeling cold
  • heartburn
  • increased sweating
  • indigestion
  • redness on the face, neck, arms, and upper chest
  • severe abdominal or stomach pain, cramping, or burning
  • vomiting of material that looks like coffee grounds, severe and continuing

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:

Incidence not known
  • Fast, pounding, or irregular heartbeat or pulse
  • increased tearing

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.

See also: Side effects (in more detail)

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