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Irritable Bowel Syndrome Glossary > Amitiza

Amitiza ~ For Irritable Bowel Syndrome Constipation

Are there safer alternatives to Amitiza? Amitiza is a medication meant for the treatment of Irritable Bowel Syndrome constipation in women 18 years of age and older. As Amitiza was just approved by the FDA for IBS constipation in April 2008, the medication has not been on the market long enough to determine safety or effectiveness for lifelong use.

Amitiza is not to be prescribed to women with diarrhea-predominant Irritable Bowel Syndrome. Amitiza is not to be prescribed to men with Irritable Bowel Syndrome. Amitiza is not to be prescribed to pregnant women.

What is Amitiza?
Amitiza (generic name lubiprostone) is a drug marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals, and available by prescription only. Amitiza is classified as a chloride channel activator.

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Amitiza promotes fluid secretion into the intestinal lumen with no clinically significant changes in serum electrolyte levels, though the methoc of action of Amitiza in IBS constipation is not fully understood. However, some studies suggest that Amitiza stimulates recovery of mucosal barrier function by restoring intestinal tight junctions (the role of tight junctions in IBS constipation is unclear). In plain English, Amitiza increases fluid secretion in your intestines, which increases intestinal muscle movement, which helps make it easier to have a bowel movements.

Amitiza - How well does it work?
Amitiza is a prescription drug for IBS constipation, abdominal discomfort, abdominal pain, and bowel habits in women. In the clinical trials for this medication, IBS patients fared only a little better -- 6 percent to 7 percent better -- when taking Amitiza than when taking dummy pills (placebos). (The percentage of patients in one Amitiza clinincal study qualifying as an "overall responder" was 13.8% in the group receiving Amitiza 8 mcg twice daily compared to 7.8% of patients receiving placebo twice daily. In a second Amitiza clinical study, 12.1% of patients in the Amitiza 8 mcg group were "overall responders" versus 5.7% of patients in the placebo group.)

The recommended Amitiza dosage for Irritable Bowel Syndrome constipation is a single 8 mcg capsule of Amitiza twice daily with food and water. Amitiza is not meant to be taken only as needed; it is a twice-daily maintenance drug. Amitiza is meant to increase the movement of stools through the bowels, which relieves the IBS symptom of constipation, but Amitiza does not cure IBS (nothing does). For those who are helped by Amitiza, the drug can reduce abdominal pain and discomfort, and constipation.

Once you stop taking Amitiza your IBS constipation and other symptoms will likely return very shortly. For safe lifelong management and prevention of constipation and bloating due to Irritable Bowel Syndrome, the IBS diet and a soluble fiber supplement such as organic Tummy Fiber Acacia are healthy alternatives. Fennel is a safe herbal tea that can be extremely beneficial for bloating associated with IBS.

Who should NOT take Amitiza?
Amitiza is not recommended for use by pregnant or breast-feeding women. (If you are a woman of childbearing potential, you should use birth control to avoid getting pregnant while you are using Amitiza. If you have become pregnant while taking Amitiza, tell your doctor immediately.)

Amitiza is not to be used by women with IBS diarrhea. Amitiza is not established as safe for children, and its use in children is not recommended. The drug should also not be used by women who have a bowel obstruction (intestinal blockage). Amitiza should not be used by patients who are allergic to any of its active or inactive ingredients.

Amitiza Side Effects

Side Effects Quick List
Most Frequent Side Effects:
Abdominal Pain with Cramps, Diarrhea, Dizziness, Headache Disorder, Nausea

Less Frequent Side Effects:
Abdominal Swelling, Anxiety, Arthralgia, Cough, Depression, Dyspepsia, Dyspnea, Fatigue, Flatulence, Gastroesophageal Reflux, Influenza, Loose Stools, Urinary Tract Infections, Vomiting

Rare Side Effects:
Allergic Reactions, Anorexia, Chest Pain, Chest Tightness, Constipation, Cramps, Dysgeusia, Edema, Eructation, Fainting, Fecal Incontinence, General Weakness, Hyperhidrosis, Malaise, Palpitations, Skin Rash, Tremors, Weight Gain, Xerostomia

Amitiza Side Effects ~ Detailed Information

In clinical trials of Amitiza in patients with Irritable Bowel Syndrome with constipation, the most common side effects were nausea, diarrhea, abdominal pain, and abdominal distension.

Amitiza may also cause trouble with breathing. If your symptoms and condition do not improve within a few days of taking Amitiza, or if they become worse, check with your doctor. If you will be taking Amitiza for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this drug. This will also allow your doctor to see if Amitiza is working properly and to decide if you should continue to take it.

Amitiza 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 to confirm the absence of such an obstruction prior to taking Amitiza.

The safety of Amitiza in pregnancy has not been evaluated in humans. Amitiza should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with Amitiza and should be capable of complying with effective contraceptive measures.

Patients taking Amitiza may experience nausea. If this occurs, taking food with Amitiza may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.

Amitiza should not be prescribed to patients that have diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.

Patients taking Amitiza may experience tightness in their chest and shortness of breath within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience shortness of breath should inform their healthcare provider. Some patients have discontinued therapy because of this side effect.

The following side effects occurred in less than 1% of patients receiving Amitiza for IBS constipation in clinical studies:

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

Side effects of Amitiza reported post-FDA approval:
syncope
allergic-type reactions (including rash, swelling, and throat tightness)
malaise
increased heart rate
muscle cramps or muscle spasms
rash
asthenia

Amitiza Prices
As of 2010, Amitiza capsules from Takeda Pharmaceuticals sell for about $4 each. Some industry estimates are that Amitiza has the potential to net sales revenues of $450 million by 2012.

Alternatives to Amitiza
For safe and effective non-drug approaches to managing IBS symptoms, learn how the organic soluble fiber Tummy Fiber Acacia can help relieve constipation without risks or side effects, why high volatile oil fennel tea can be extremely beneficial for bloating, how peppermint oil capsules can relieve and prevent abdominal pain, and how gut-directed hypnotherapy addresses the underlying pathology of bowel dysfunctions and relieves all IBS symptoms.

If you feel confident that your constipation and bloating are symptoms of Irritable Bowel Syndrome, information is key. Learn all you need to know about this disorder with The First Year: IBS, an essential guide to successfully managing Irritable Bowel Syndrome.

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Amitiza clinical information supplied by Amitiza Patient & Healthcare Provider Prescribing Information drug inserts.
   


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