Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Amitiza

Descriptions


Lubiprostone is used to treat chronic constipation in adults. It is also used to treat constipation caused by opioid (narcotic) medicines in adults with chronic, non-cancer pain. This medicine works by increasing intestinal fluid secretion, which helps ease the passage of stool and helps relieve the symptoms associated with constipation.

Lubiprostone is also used to treat irritable bowel syndrome (IBS) in women who have constipation as the main symptom.

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

This product is available in the following dosage forms:

  • Capsule, Liquid Filled
  • Capsule

Before Using

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 lubiprostone 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 lubiprostone in the elderly.

Pregnancy

Information about this lubiprostone-oral-route
Pregnancy Category Explanation
All Trimesters C Animal 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.

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:

  • Bowel or stomach blockage, or history of or
  • Diarrhea, severe—Should not be used in patients with these conditions.
  • Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

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.

Swallow the soft gelatin capsule whole. Do not crush, break, or chew it. It is best to take this medicine with food and water.

Drink at least 6 to 8 glasses (8 ounces each) of liquid each day. This will help make the stool softer.

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 (soft gelatin capsules):
    • For chronic constipation:
      • Adults—24 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
      • Children—Use and dose must be determined by your doctor.
    • For constipation caused by opioid medicines:
      • Adults—24 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
      • Children—Use and dose must be determined by your doctor.
    • For irritable bowel syndrome (IBS):
      • Adults—8 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
      • 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.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. This will also allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Lubiprostone may cause difficulty with breathing, nausea, or severe diarrhea. If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.

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

  1. Diarrhea
  2. full or bloated feeling or pressure in the stomach
  3. nausea
  4. stomach pain
  5. swelling of abdominal or stomach area

Less common

  1. Abdominal or stomach discomfort
  2. black, tarry stools
  3. blood in the stools
  4. chest discomfort or pain
  5. chills
  6. cold or flu-like symptoms
  7. cough
  8. difficult or labored breathing
  9. fever
  10. general feeling of discomfort or illness
  11. headache
  12. increased sweating
  13. joint pain
  14. loss of appetite
  15. loss of bowel control
  16. muscle aches and pains
  17. runny nose
  18. shivering
  19. shortness of breath
  20. sore throat
  21. sweating
  22. tightness in the chest
  23. trouble sleeping
  24. unusual tiredness or weakness
  25. vomiting

Incidence not known

  1. Abdominal or stomach tenderness
  2. difficulty with swallowing
  3. fainting
  4. fast, pounding, or irregular heartbeat or pulse
  5. hives
  6. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  7. skin rash
  8. swelling

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Dry heaves
  2. dry mouth
  3. feeling of warmth
  4. lack or loss of strength
  5. paleness of the skin
  6. redness of the face, neck, arms, and occasionally, upper chest
  7. severe, unusual tiredness or weakness
  8. weight loss

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:

More common

  1. Excess air or gas in the stomach or intestines
  2. passing gas

Less common

  1. Acid or sour stomach
  2. belching
  3. bladder pain
  4. bloody or cloudy urine
  5. change in taste
  6. cold sweats
  7. difficult, burning, or painful urination
  8. difficulty with moving
  9. discouragement
  10. dizziness
  11. fear or nervousness
  12. feeling sad or empty
  13. frequent urge to urinate
  14. heartburn
  15. increased weight
  16. indigestion
  17. irritability
  18. loss of interest or pleasure
  19. loss of taste
  20. lower back or side pain
  21. muscle cramps
  22. muscle stiffness
  23. sore throat
  24. stomach upset
  25. swollen joints
  26. tingling of the hands or feet
  27. unusual drowsiness, dullness, tiredness, or feeling of sluggishness

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.