Lubiprostone is used to treat chronic constipation, or constipation caused by opioid pain medicine.

Lubiprostone may also be used to treat irritable bowel syndrome in women with constipation as the main symptom.

Lubiprostone may also be used for purposes not listed in this medication guide.

Stop taking lubiprostone and call your doctor if you feel light-headed every time you take lubiprostone or if you have severe diarrhea.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food and water.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may have tightness in your chest or feel short of breath within 1 hour after taking lubiprostone. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Do not take lubiprostone if you have severe diarrhea. Call your doctor for instructions.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from heat and light.

Usual Adult Dose for Constipation -- Chronic:

24 mcg orally 2 times a day

Comments: The effectiveness of this drug in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

Use: Treatment of chronic idiopathic constipation and of opioid-induced constipation in adults with chronic non-cancer pain.

Usual Adult Dose for Irritable Bowel Syndrome:

8 mcg orally 2 times a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C) in women age 18 years and older.

You should not use lubiprostone if you have a blockage in your digestive tract, or if you have severe diarrhea.

Tell your doctor if you have ever had liver disease.

Tell your doctor if you are pregnant or breastfeeding.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Lubiprostone may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing nausea or diarrhea;

• trouble breathing; or

• a light-headed feeling, like you might pass out.

You may have low blood pressure and feel faint shortly after taking lubiprostone, especially if you've been sick with vomiting or diarrhea. Stop taking lubiprostone and call your doctor if you feel light-headed after every dose or if you have severe diarrhea.

Common side effects of lubiprostone may include:

• nausea, stomach pain;

• diarrhea, gas, bloating; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Make sure your doctor knows if you are using an opioid pain medicine.

Other drugs may affect lubiprostone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.