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Amitiza

"Aug. 10, 2011 -- Two studies show that a new kind of experimental medication relieves the pain and bloating of persistent constipation better than a placebo.

The studies, which are published in the New England Journal of Medicine/"...

Amitiza

Amitiza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Amitiza (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. It is in a class of drugs known as chloride channel activators. Common side effects include nausea, diarrhea, gas, vomiting, dry mouth, runny nose, cough, fever, headache, dizziness, joint/back pain, or trouble sleeping.

To treat chronic idiopathic constipation, the recommended dose of Amitiza is 24 mcg twice daily orally with food and water. To treat irritable bowel syndrome with constipation, the recommended dose is 8 mcg twice daily orally with food and water. There may be other drugs that can affect Amitiza. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Amitiza is not recommended for use during pregnancy. Women should use birth control while taking this medication. 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.

Our Amitiza (lubiprostone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Amitiza in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Amitiza (Lubiprostone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Amitiza Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Amitiza (Lubiprostone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Amitiza FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in labeling:

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

During clinical development of Amitiza for CIC, OIC, and IBS-C, 1234 patients were treated with Amitiza for 6 months and 524 patients were treated for 1 year (not mutually exclusive).

Chronic Idiopathic Constipation

Adverse reactions in dose-finding, efficacy, and long-term clinical studies: The data described below reflect exposure to Amitiza 24 mcg twice daily in 1113 patients with chronic idiopathic constipation over 3-or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure ( ≤ 4 weeks). The placebo population (N = 316) had a mean age of 47.8 (range 21-81) years; was 87.3% female; 80.7% Caucasian, 10.1% African American, 7.3% Hispanic, 0.9% Asian; and 11.7% elderly ( ≥ 65 years of age). Of those patients treated with Amitiza 24 mcg twice daily (N=1113), the mean age was 50.3 (range 19-86) years; 86.9% were female; 86.1% Caucasian, 7.6% African American, 4.7% Hispanic, 1.0% Asian; and 16.7% elderly ( ≥ 65 years of age). Table 1 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo.

Table 1: Percent of Patients with Adverse Reactions (Chronic Idiopathic Constipation)

System/Adverse Reaction1 Placebo
N = 316 %
Amitiza 24 mcg Twice Daily
N = 1113 %
Gastrointestinal disorders
  Nausea 3 29
  Diarrhea 1 12
  Abdominal pain 3 8
  Abdominal distension 2 6
  Flatulence 2 6
  Vomiting 0 3
  Loose stools 0 3
  Abdominal discomfort2 1 3
  Dyspepsia < 1 2
  Dry mouth < 1 1
Nervous system disorders
  Headache 5 11
  Dizziness 1 3
General disorders and site administration conditions
  Edema < 1 3
  Fatigue 1 2
  Chest discomfort/pain 0 2
Respiratory, thoracic, and mediastinal disorders
  Dyspnea 0 2
1Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator).
2This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

The most common adverse reactions (incidence > 4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.

Nausea: Approximately 29% of patients who received Amitiza 24 mcg twice daily experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea. The rate of nausea associated with Amitiza 24 mcg twice daily was lower among male (8%) and elderly (19%) patients. No patients in the clinical studies were hospitalized due to nausea.

Diarrhea: Approximately 12% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 2% of patients discontinued treatment due to diarrhea.

Electrolytes: No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving Amitiza.

Less common adverse reactions: The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite.

Opioid-induced Constipation

Adverse reactions in efficacy and long-term clinical studies: The data described below reflect exposure to Amitiza 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks. The total population (N = 1492) had a mean age of 50.4 (range 20-89) years; was 62.7% female; 82.7% Caucasian, 14.2% African American, 0.8% American Indian/Alaska Native, 0.8% Asian; 5.2% were of Hispanic ethnicity; and 8.8% were elderly ( ≥ 65 years of age). Table 2 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo.

Table 2: Percent of Patients with Adverse Reactions (OIC Studies)

System/Adverse Reaction1 Placebo
N = 632 %
Amitiza 24 mcg Twice Daily
N = 860 %
Gastrointestinal disorders
  Nausea 5 11
  Diarrhea 2 8
  Abdominal pain 1 4
  Flatulence 3 4
  Abdominal distension 2 3
  Vomiting Abdominal discomfort2 2 1 3 1
Nervous system disorders
  Headache 1 2
General disorders and site administration conditions
  Peripheral edema < 1 1
1Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator).
2This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

The most common adverse reactions (incidence > 4%) in OIC were nausea and diarrhea.

Nausea: Approximately 11% of patients who received Amitiza 24 mcg twice daily experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea.

Diarrhea: Approximately 8% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea.

Less common adverse reactions: The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, blood potassium decreased.

Irritable Bowel Syndrome with Constipation

Adverse reactions in dose-finding, efficacy, and long-term clinical studies: The data described below reflect exposure to Amitiza 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks. The total population (N = 1267) had a mean age of 46.5 (range 18-85) years; was 91.6% female; 77.5% Caucasian, 12.9% African American, 8.6% Hispanic, 0.4% Asian; and 8.0% elderly ( ≥ 65 years of age). Table 3 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 8 mcg twice daily and that occurred more frequently with study drug than placebo.

Table 3: Percent of Patients with Adverse Reactions (IBS-C Studies)

System/Adverse Reaction1 Placebo
N = 435 %
Amitiza 8 mcg Twice Daily
N = 1011 %
Gastrointestinal disorders
  Nausea 4 8
  Diarrhea 4 7
  Abdominal pain 5 5
  Abdominal distension 2 3
1Includes only those events associated with treatment (possibly or probably related, as assessed by the investigator).

The most common adverse reactions (incidence > 4%) in IBS-C were nausea, diarrhea, and abdominal pain.

Nausea: Approximately 8% of patients who received Amitiza 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea.

Diarrhea: Approximately 7% of patients who received Amitiza 8 mcg twice daily experienced diarrhea; < 1% of patients had severe diarrhea and < 1% of patients discontinued treatment due to diarrhea.

Less common adverse reactions: The following adverse reactions (assessed by investigator as probably related to treatment) occurred in less than 1% of patients receiving Amitiza 8 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of Amitiza. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Voluntary reports of adverse reactions occurring with the use of Amitiza include the following: syncope, ischemic colitis, hypersensitivity/allergic-type reactions (including rash, swelling, and throat tightness), malaise, tachycardia, muscle cramps or muscle spasms, and asthenia.

Read the entire FDA prescribing information for Amitiza (Lubiprostone) »

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Amitiza - User Reviews

Amitiza User Reviews

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