• menu btn
  • AMITIZA (lubiprostone)

  • menu btn
Members get exclusive access to special content like eLearning programs

For HCPs | Visit patient website

Indications:  AMITIZA is for Chronic Idiopathic Constipation (CIC) in adults, Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, and Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years. Effectiveness in patients taking diphenylheptane opioids has not been established.

Indications

AMITIZA is for Chronic Idiopathic Constipation (CIC) in adults, Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, and Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years. Effectiveness in patients taking diphenylheptane opioids has not been established.

Patient FAQs

Frequently asked questions from patients

Here are some commonly asked questions from patients about AMITIZA, as well as questions they may have about their condition.

IBS-C

Q: What is AMITIZA?
View Answer
A: AMITIZA (8 mcg) twice daily is a prescription medicine for women 18 years and older used to treat Irritable Bowel Syndrome with Constipation (see definition below). It is a soft, pink, oval gelatin capsule.
Q: What is Irritable Bowel Syndrome with Constipation (IBS-C)?
View Answer
A: Irritable Bowel Syndrome with Constipation (IBS-C) is just one form of Irritable Bowel Syndrome (IBS) in which the predominant symptom is abdominal pain, associated with constipation. You may be living with IBS-C if you have experienced the following symptoms in the last 3 months, starting at least 6 months ago:
  • Re-occurring abdominal pain or discomfort at least 3 days a month in the past 3 months associated with 2 or more of the following:
    • Improvement with a bowel movement
    • Changes in the number of bowel movements
    • Changes in stool appearance
  • Hard or lumpy stools at least 25% of the time and loose or watery stools in less than 25% of bowel movements (without the use of anti-diarrhea medications or laxatives)
Q: What should I tell my healthcare provider before starting AMITIZA?
View Answer
A: Before you take AMITIZA, tell your healthcare professional if you:
  • Are taking any medications to lower blood pressure.
  • Are taking a diphenylheptane opioid (e.g., methadone).
  • Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus.
  • Are breastfeeding or planning to breastfeed. If breastfeeding while taking AMITIZA, you should monitor the breastfed infant for diarrhea.
  • Have liver problems.
  • Cannot swallow a capsule.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

You and your healthcare provider should regularly assess the need for continued therapy.

Q: Who should not take AMITIZA?
View Answer
A: Do not take AMITIZA if:
  • You know or suspect you have a bowel blockage. If you are unsure, your healthcare professional should check your condition before starting AMITIZA.
  • You have severe diarrhea.
  • You are pregnant or become pregnant, unless you have discussed this with your healthcare professional. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used in pregnancy if the potential benefit justifies the potential risks to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus. Tell your healthcare professional if you are breastfeeding, and monitor infants for diarrhea.
  • You are allergic to AMITIZA or any of its ingredients. See the final FAQ for a complete list of ingredients.
Q: What other important information should I know about AMITIZA?
View Answer
A: Some patients taking AMITIZA may experience nausea or diarrhea. Take AMITIZA with food and water to reduce the occurrence of nausea. If your diarrhea becomes severe, stop taking AMITIZA and tell your healthcare provider.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.

Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus. Tell your healthcare provider if you are nursing and monitor infants for diarrhea.

Tell your healthcare provider if you have liver problems.

Q: What are the possible side effects of AMITIZA (8 mcg) twice daily?
View Answer
A: The most common side effects of taking AMITIZA (8 mcg) twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

Q: How should I take AMITIZA?
View Answer
A: AMITIZA is to be taken twice a day or as prescribed by your healthcare professional with food and water. Swallow the gelatin capsule whole. Capsules should not be broken apart or chewed.
Q: What should I do if I miss a dose?
View Answer
A: If you miss a dose of AMITIZA, just skip that dose. Do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.
Q: Will AMITIZA interfere with other medications?
View Answer
A: AMITIZA may affect how other medicines work and other medicines may affect how AMITIZA works. Only your healthcare provider can decide whether AMITIZA may be right for you. Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).
Q: How do I store AMITIZA?
View Answer
A: Store AMITIZA at room temperature and protect from light and extreme temperatures. AMITIZA should be stored in a tightly closed, child-proof container and kept out of the reach of children. Do not use AMITIZA past the expiration date shown on the package.
General information about AMITIZA
View Answer

Do not use AMITIZA for a disease or condition for which it was not prescribed.

Do not give AMITIZA to others, even if they have the same symptoms you have. It may harm them.

Q: Where can I find more information about AMITIZA?
View Answer
A: If you would like more information, talk with your healthcare professional. If you would like more information about AMITIZA, you may access the complete Prescribing Information by clicking here or call toll-free at 1-877-825-3327.
Q: What are the ingredients in AMITIZA?
View Answer
A: Active ingredient: lubiprostone, 24 mcg or 8 mcg

Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol and purified water. The 24 mcg (orange) capsules also contain the dyes FD&C Red #40 and D&C Yellow #10. The 8 mcg (pink) capsules also contain the dyes ferric oxide and titanium dioxide.

CIC

Q: What is AMITIZA?
View Answer
A: AMITIZA (24 mcg) twice daily is a prescription drug for adults used to treat Chronic Idiopathic Constipation (see definition below). It is a soft, orange, oval gelatin capsule.
Q: What is Chronic Idiopathic Constipation (CIC)?
View Answer
A:  “Chronic” Constipation means that for 3 months or more, you have had infrequent bowel movements or difficulty passing stools through the bowels. "Idiopathic" means that the cause of the constipation is unknown and not due to an underlying illness or medication. The signs and symptoms associated with Chronic Constipation may include straining, hard or lumpy stools, abdominal bloating and discomfort, feeling like your bowel is never completely empty, and generally fewer than 3 bowel movements a week.
Q: What should I tell my healthcare provider before starting AMITIZA?
View Answer
A: Before you take AMITIZA, tell your healthcare professional if you:
  • Are taking any medications to lower blood pressure.
  • Are taking a diphenylheptane opioid (e.g., methadone).
  • Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus.
  • Are breastfeeding or planning to breastfeed. If breastfeeding while taking AMITIZA, you should monitor the breastfed infant for diarrhea.
  • Have liver problems.
  • Cannot swallow a capsule.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

You and your healthcare provider should regularly assess the need for continued therapy.

Q: Who should not take AMITIZA?
View Answer
A: Do not take AMITIZA if:
  • You know or suspect you have a bowel blockage. If you are unsure, your healthcare professional should check your condition before starting AMITIZA.
  • You have severe diarrhea.
  • You are pregnant or become pregnant, unless you have discussed this with your healthcare professional. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used in pregnancy if the potential benefit justifies the potential risks to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus. Tell your healthcare professional if you are breastfeeding, and monitor infants for diarrhea.
  • You are allergic to AMITIZA or any of its ingredients. See the final FAQ for a complete list of ingredients.
Q: What other important information should I know about AMITIZA?
View Answer
A: Some patients taking AMITIZA may experience nausea or diarrhea. Take AMITIZA with food and water to reduce the occurrence of nausea. If your diarrhea becomes severe, stop taking AMITIZA and tell your healthcare provider.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.

Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus. Tell your healthcare provider if you are nursing and monitor infants for diarrhea.

Tell your healthcare provider if you have liver problems.

Q: What are the possible side effects of AMITIZA (24 mcg) twice daily for Chronic Idiopathic Constipation?
View Answer
A: The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas for patients treated for CIC. These are not all the side effects associated with AMITIZA.

Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

Q: How should I take AMITIZA?
View Answer
A: AMITIZA is to be taken twice a day or as prescribed by your healthcare professional with food and water. Swallow the gelatin capsule whole. Capsules should not be broken apart or chewed.
Q: What should I do if I miss a dose?
View Answer
A: If you miss a dose of AMITIZA, just skip that dose. Do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.
Q: How soon will AMITIZA begin to work for CIC?
View Answer
A: In two 4-week clinical studies, 57% and 63% of patients who received AMITIZA experienced a bowel movement within 24 hours after taking AMITIZA compared to 37% and 32% of patients who received a placebo, respectively. Individual results may vary.
Q: Will AMITIZA interfere with other medications?
View Answer
A: AMITIZA may affect how other medicines work and other medicines may affect how AMITIZA works. Only your healthcare provider can decide whether AMITIZA may be right for you. Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).
Q: How do I store AMITIZA?
View Answer
A: Store AMITIZA at room temperature and protect from light and extreme temperatures. AMITIZA should be stored in a tightly closed, child-proof container and kept out of the reach of children. Do not use AMITIZA past the expiration date shown on the package.
General information about AMITIZA
View Answer

Do not use AMITIZA for a disease or condition for which it was not prescribed.

Do not give AMITIZA to others, even if they have the same symptoms you have. It may harm them.

Q: Where can I find more information about AMITIZA?
View Answer
A: If you would like more information, talk with your healthcare professional. If you would like more information about AMITIZA, you may access the complete Prescribing Information by clicking here or call toll-free at 1-877-825-3327.
Q: What are the ingredients in AMITIZA?
View Answer
A: Active ingredient: lubiprostone, 24 mcg or 8 mcg

Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol and purified water. The 24 mcg (orange) capsules also contain the dyes FD&C Red #40 and D&C Yellow #10. The 8 mcg (pink) capsules also contain the dyes ferric oxide and titanium dioxide.

OIC

Q: What is AMITIZA?
View Answer
A: AMITIZA (24 mcg) twice daily is approved to treat Opioid-Induced Constipation in adults with chronic, non-cancer pain (see definition below). It is a soft, orange, oval gelatin capsule. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone).
Q: What is Opioid-Induced Constipation (OIC)?
View Answer
A: Opioids are commonly prescribed to help alleviate pain. However, people taking opioids may develop constipation as a side effect. Your doctor may call this Opioid-Induced Constipation (OIC). OIC occurs due to the way opioids work in your body.

Talk to your doctor if you’re experiencing the following symptoms while taking an opioid medication for chronic, non-cancer pain:

  • Less than 3 bowel movements per week with at least 25% of bowel movements associated with one or more of the following conditions:
    • Moderate to very severe straining
    • Hard to very hard stools
    • Feeling like your bowel is never completely empty
Q: What should I tell my healthcare provider before starting AMITIZA?
View Answer
A: Before you take AMITIZA, tell your healthcare professional if you:
  • Are taking any medications to lower blood pressure.
  • Are taking a diphenylheptane opioid (e.g., methadone).
  • Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus.
  • Are breastfeeding or planning to breastfeed. If breastfeeding while taking AMITIZA, you should monitor the breastfed infant for diarrhea.
  • Have liver problems.
  • Cannot swallow a capsule.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

You and your healthcare provider should regularly assess the need for continued therapy.

Q: Who should not take AMITIZA?
View Answer
A: Do not take AMITIZA if:
  • You know or suspect you have a bowel blockage. If you are unsure, your healthcare professional should check your condition before starting AMITIZA.
  • You have severe diarrhea.
  • You are pregnant or become pregnant, unless you have discussed this with your healthcare professional. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used in pregnancy if the potential benefit justifies the potential risks to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare professional to evaluate the risks to the fetus. Tell your healthcare professional if you are breastfeeding, and monitor infants for diarrhea.
  • You are allergic to AMITIZA or any of its ingredients. See the final FAQ for a complete list of ingredients.
Q: What other important information should I know about AMITIZA?
View Answer
A: Some patients taking AMITIZA may experience nausea or diarrhea. Take AMITIZA with food and water to reduce the occurrence of nausea. If your diarrhea becomes severe, stop taking AMITIZA and tell your healthcare provider.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.

Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus. Tell your healthcare provider if you are nursing and monitor infants for diarrhea.

Tell your healthcare provider if you have liver problems.

Q: What are the possible side effects of AMITIZA (24 mcg) twice daily for Opioid-Induced Constipation?
View Answer
A: The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea and diarrhea for patients treated for OIC. These are not all the side effects associated with AMITIZA.

Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

Q: How should I take AMITIZA?
View Answer
A: AMITIZA is to be taken twice a day or as prescribed by your healthcare professional with food and water. Swallow the gelatin capsule whole. Capsules should not be broken apart or chewed.
Q: What should I do if I miss a dose?
View Answer
A: If you miss a dose of AMITIZA, just skip that dose. Do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.
Q: Will AMITIZA interfere with other medications?
View Answer
A: AMITIZA may affect how other medicines work and other medicines may affect how AMITIZA works. Only your healthcare provider can decide whether AMITIZA may be right for you. Tell your healthcare provider if you are taking a diphenylheptane opioid (e.g., methadone).
Q: How do I store AMITIZA?
View Answer
A: Store AMITIZA at room temperature and protect from light and extreme temperatures. AMITIZA should be stored in a tightly closed, child-proof container and kept out of the reach of children. Do not use AMITIZA past the expiration date shown on the package.
General information about AMITIZA
View Answer

Do not use AMITIZA for a disease or condition for which it was not prescribed.

Do not give AMITIZA to others, even if they have the same symptoms you have. It may harm them.

Q: Where can I find more information about AMITIZA?
View Answer
A: If you would like more information, talk with your healthcare professional. If you would like more information about AMITIZA, you may access the complete Prescribing Information by clicking here or call toll-free at 1-877-825-3327.
Q: What are the ingredients in AMITIZA?
View Answer
A: Active ingredient: lubiprostone, 24 mcg or 8 mcg

Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol and purified water. The 24 mcg (orange) capsules also contain FD&C Red #40 and D&C Yellow #10. The 8 mcg (pink) capsules also contain ferric oxide and titanium dioxide.

 

Important Safety Information

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.

Hide references

  1. Data on file. Takeda Pharmaceuticals.
  2. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al; American College of Gastroenterology Task Force on Irritable Bowel Syndrome. Am J Gastroenterol. 2009;104(suppl 1):S1-S35.
  3. AMITIZA (lubiprostone) Prescribing Information. Sucampo Pharma Americas, LLC.
  4. Brandt LJ, Prather CM, Quigley EM, Schiller LR, Schoenfeld P, Talley NJ. Am J Gastroenterol. 2005;100(suppl 1):S5-S21.
  5. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Gastroenterology. 2006;130:1480-1491.
  6. Drossman DA, Chey WD, Johanson JF, et al. Aliment Pharmacol Ther. 2009;29:329-341.
  7. Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
  8. Barish CF, Drossman D, Johanson JF, Ueno R. Dig Dis Sci. 2010;55:1090-1097.
  9. Lipecka J, Bali M, Thomas A, et al. Am J Physiol Cell Physiol. 2002;282:C805-C816.
  10. Jentsch TJ, Stein V, Weinreich F, Zdebik AA. Physiol Rev. 2002;82:503-568.
  11. Hall JE. Textbook of Medical Physiology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:773-788.
  12. Keely SJ, Montrose MH, Barrett KE. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. West Sussex, England: John Wiley & Sons Ltd; 2009:330-367.
  13. Data on file. Sucampo Pharma Americas, LLC.
  14. Chey WD, Drossman DA, Johanson JF, Scott C, Panas RM, Ueno R. Aliment Pharmacol Ther. 2012;35:587-599.
  15. Patierno S, Anselmi L, Jaramillo I, Scott D, Garcia R, Sternini C. Gastroenterology. 2011;140:618-626.
  16. Hungin APS, Chang L, Locke GR, et al. Aliment Pharmacol Ther. 2005;21:1365-1375.
  17. Moeser AJ, Nighot PK, Engelke KJ, Ueno R, Blikslager AT. Am J Physiol Gastrointest Liver Physiol. 2007;292:G647-G656.
  18. Cuppoletti J, Malinowska DH, Tewari KP, et al. Am J Physiol Cell Physiol. 2004;287:C1173-C1183.
  19. Camilleri M, Gorman H. Neurogastroenterol Motil. 2007;19:545-552.
  20. Higgins PDR, Johanson JF. Am J Gastroenterol. 2004;99:750-759.
  21. National Digestive Diseases Information Clearinghouse (NDDIC). Constipation (2007).
  22. Furness JB, Nguyen TV, Nurgali K, Shimizu Y. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. Hoboken, NJ: Wiley Blackwell; 2009:15-36.
  23. Sternini C. Am J Physiol Gastrointest Liver Physiol. 2001;281:G8-G15.
  24. Pappagallo M. Am J Surg. 2001;182:11S-18S.
  25. Brock C, Olesen SS, Olesen AE, Frøkjaer JB, Andresen T, Drewes AM. Drugs. 2012;72:1847-1865.

Important Safety Information

AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.