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Lubiprostone (Oral route)

Pronunciation:

loo-bi-PROST-one

Brand Names:

  • Amitiza

Dosage Forms:

  • Capsule, Liquid Filled
  • Capsule

Classifications:

Therapeutic—

Laxative

Uses of This Medicine:

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.

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 lubiprostone 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 lubiprostone in the elderly.

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. 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
  • 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 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.

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 While Using This Medicine:

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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine or if you become dehydrated. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

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 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:

More common
Diarrhea
full or bloated feeling or pressure in the stomach
nausea
stomach pain
swelling of the abdominal or stomach area
Less common
Abdominal or stomach discomfort
black, tarry stools
blood in the stools
chest discomfort or pain
chills
cold or flu-like symptoms
cough
difficult or labored breathing
fever
general feeling of discomfort or illness
headache
increased sweating
joint pain
loss of appetite
loss of bowel control
muscle aches and pains
runny nose
shivering
sore throat
sweating
tightness in the chest
trouble sleeping
unusual tiredness or weakness
vomiting
Incidence not known
Abdominal or stomach tenderness
blurred vision
confusion
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
fast, pounding, or irregular heartbeat or pulse
hives or skin rash
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
swelling

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

Symptoms of overdose
Dry heaves
dry mouth
feeling of warmth
lack or loss of strength
paleness of the skin
redness of the face, neck, arms, and occasionally, upper chest
severe, unusual tiredness or weakness
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
Excess air or gas in the stomach or intestines
passing gas
Less common
Acid or sour stomach
belching
bladder pain
bloody or cloudy urine
change in taste
cold sweats
difficult, burning, or painful urination
difficulty with moving
discouragement
dizziness
fear or nervousness
feeling sad or empty
frequent urge to urinate
heartburn
increased weight
indigestion
irritability
loss of interest or pleasure
loss of taste
lower back or side pain
muscle cramps
muscle stiffness
sore throat
stomach upset
swollen joints
tingling of the hands or feet
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.


Last Updated: 8/4/2017
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