Pronunciation:

loo-bi-PROST-one

Brand Names:

• Amitiza

Dosage Forms:

• Capsule, Liquid Filled

Classifications:

Therapeutic—

Laxative

Uses of This Medicine:

Lubiprostone is used to treat long-lasting constipation in adults. It is also used to treat constipation caused by opioids (narcotic pain medicines) in adults with long-lasting pain that is not caused by cancer, or in patients with long-lasting pain caused by a previous cancer or its treatment who do not need weekly increases in opioid dosage. This medicine works by increasing the fluid secretion of the bowels, 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.

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, known or suspected 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 to lessen the chances of having nausea.

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:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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

Black, tarry stools

blood in the stools

chest discomfort or pain

chills

colds

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

stomach discomfort

sweating

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

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

stomach tenderness

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

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

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.