Amitiza

1. Constipation Myths and Facts Slideshow
2. Hemorrhoids Slideshow Pictures
3. Constipation: Foods to Eat, Foods to Avoid

Amitiza (lubiprostone) is a chloride channel activator used to treat chronic constipation in adults. Amitiza is also used to treat irritable bowel syndrome in women with constipation as the main symptom. Common side effects of Amitiza include:

• nausea,
• stomach pain,
• diarrhea,
• gas,
• bloating,
• vomiting,
• dry mouth,
• runny nose,
• cough,
• fever,
• headache,
• dizziness,
• joint/back pain, or
• trouble sleeping.

Tell your doctor if you have unlikely but serious side effects of Amitiza including:

• severe diarrhea,
• swelling of arms or legs, and
• mental/mood changes.

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 breastfeeding.

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.

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

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

Common side effects may include:

• mild nausea, stomach pain;
• mild 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.

Read the entire detailed patient monograph for Amitiza (Lubiprostone)

SIDE EFFECTS

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

• Nausea [see WARNINGS AND PRECAUTIONS]
• Diarrhea [see WARNINGS AND PRECAUTIONS]
• Dyspnea [see WARNINGS AND PRECAUTIONS]

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)

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)

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)

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)

Read the Amitiza User Reviews »

© Amitiza Patient Information is supplied by Cerner Multum, Inc. and Amitiza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.