Amitiza

DRUG DESCRIPTION

Amitiza (lubiprostone) is chemically designated as ()-7-[(2R,4aR,5R,7aR)-2-(1,1difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 and a chemical structure as follows:

Amitiza (lubiprostone)  Structural Formula Illustration

Lubiprostone drug substance occurs as white, odorless crystals or crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. Amitiza (lubiprostone) is available as an imprinted, oval, soft gelatin capsule in two strengths. Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, ferric oxide, titanium dioxide, and purified water. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, FD&C Red #40, D&C Yellow #10, and purified water.

What are the possible side effects of lubiprostone (Amitiza)?

Stop using lubiprostone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe vomiting or diarrhea.

Less serious side effects are more likely to occur. Continue using lubiprostone and talk with your doctor if you have any of these less serious side effects:

  • nausea, vomiting, mild diarrhea, loss of appetite;
  • stomach pain, bloating, gas,
  • sore...

Read All Potential Side Effects and See Pictures of Amitiza

What are the precautions when taking lubiprostone (Amitiza)?

Before taking lubiprostone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a severe stomach condition (mechanical bowel obstruction).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe diarrhea.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic...

Read All Potential Precautions of Amitiza


Amitiza Consumer (continued)

SIDE EFFECTS: Nausea, diarrhea, gas, vomiting, dry mouth, runny nose, cough, fever, headache, dizziness, joint/back pain, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe diarrhea, swelling of arms/legs, mental/mood changes.

Lubiprostone may infrequently cause trouble breathing and chest tightness within 30 to 60 minutes after the first dose. This reaction is usually not serious and generally goes away within 3 hours. It may happen again with other doses. However, you may not be able to tell this reaction apart from a rare, severe reaction that also causes trouble breathing and/or chest pain. Therefore, seek immediate medical attention if you develop any trouble breathing or chest tightness/discomfort/pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lubiprostone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a severe stomach condition (mechanical bowel obstruction).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe diarrhea.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is not recommended for use during pregnancy. Women of childbearing age should have a negative pregnancy test before starting this medication. Also, women should use an effective form of birth control while taking this medication. Consult your doctor for more details.

It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Amitiza Patient Information Including Side Effects

Brand Names: Amitiza

Generic Name: lubiprostone (Pronunciation: loo bee PROS tone)

  • What is lubiprostone (Amitiza)?
  • What are the possible side effects of lubiprostone (Amitiza)?
  • What is the most important information I should know about lubiprostone (Amitiza)?
  • What should I discuss with my health care provider before taking lubiprostone (Amitiza)?
  • How should I take lubiprostone (Amitiza)?
  • What happens if I miss a dose (Amitiza)?
  • What happens if I overdose (Amitiza)?
  • What should I avoid while taking lubiprostone (Amitiza)?
  • What other drugs will affect lubiprostone (Amitiza)?
  • Where can I get more information?

What is lubiprostone (Amitiza)?

Lubiprostone increases the secretion of fluid in your intestines to help make it easier to pass stools (bowel movements).

Lubiprostone is used to treat chronic constipation in adults. It is also used to treat irritable bowel syndrome in women with constipation as the main symptom.

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

What are the possible side effects of lubiprostone (Amitiza)?

Stop using lubiprostone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe vomiting or diarrhea.

Less serious side effects are more likely to occur. Continue using lubiprostone and talk with your doctor if you have any of these less serious side effects:

  • nausea, vomiting, mild diarrhea, loss of appetite;
  • stomach pain, bloating, gas,
  • sore throat, cough;
  • headache, dizziness;
  • swelling in your hands, ankles, or feet;
  • joint or muscle pain; or
  • anxiety, cold sweats.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lubiprostone (Amitiza)?

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

Before using this medication, tell your doctor if you have a history of hernia, gallstones, Crohn's disease, Hirschsprung's disease, impacted bowel movement, diverticulitis, polyps, or any other cause for obstruction in your gastrointestinal (digestive) system.

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.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

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