OVERVIEW
- AMITIZA (8 mcg twice daily) for the treatment of Irritable Bowel Syndrome with Constipation
(IBS-C) in women 18 years and older1 - AMITIZA should be taken twice daily orally with food and water1
- Reduce the dosage in IBS-C patients with severe hepatic impairment1
- No restriction on duration of use*
- Need for continued therapy should be periodically assessed1
DOSAGE AND ADMINISTRATION
AMITIZA FOR THE TREATMENT OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C) IN WOMEN 18 YEARS AND OLDER1
- The recommended dose is 8 mcg twice daily1
- AMITIZA should be taken twice daily orally with food and water1
- Reduced dosage in patients with severe hepatic impairment
- For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended dose is 8 mcg once daily. If this dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response. Dosage adjustment is not required for patients with moderately impaired hepatic function (Child-Pugh Class B)1
- There are no restrictions on the duration of use of AMITIZA*
- You should periodically assess your patients' needs for continued therapy1
- AMITIZA for Irritable Bowel Syndrome with Constipation is an oval, gelatin capsule containing 8 mcg of lubiprostone1
- AMITIZA 8 mcg capsules are pink and are printed with "SPI" on one side1
*Based on safety studies up to 52 weeks: 12- to 16-week, double-blind studies and a 36-week, open-label, safety study.
IN DEPTH
DOSING INSTRUCTIONS1
AMITIZA should be taken twice daily with food and water to reduce potential symptoms of nausea. The capsule should be taken once in the morning and once in the evening daily as prescribed. The capsule should be swallowed whole and should not be broken apart or chewed. Physicians and patients should periodically assess the need for continued therapy.1
Patients on treatment who experience severe nausea, severe diarrhea, or dyspnea should inform their physician. Patients taking AMITIZA may experience dyspnea within an hour of the first dose. This symptom generally resolves within 3 hours, but may recur with repeat dosing.1
REFERENCE
- AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
Indication
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥ 18 years old.
Important Safety Information
- 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 initiating AMITIZA treatment.
- 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, concomitant administration of 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 severe 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 dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
- In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316) in patients with Chronic Idiopathic Constipation (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 (8 mcg twice daily vs placebo; N=1011 vs N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
- Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.
Please click here for complete Prescribing Information.
This site is intended for use by U.S. residents only. This site is intended for healthcare professionals.
AMITIZA is a trademark of Sucampo Pharmaceuticals, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
©2011 Takeda Pharmaceuticals North America, Inc.
LUB-03057
