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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA.
AMITIZA (lubiprostone) capsule, gelatin coated for oral use
Initial U.S. Approval: 2006
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RECENT MAJOR CHANGES
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Dosage and Administration (2) |
2/2011 |
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INDICATIONS AND USAGE
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Amitiza is a chloride channel activator indicated for:
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Treatment of chronic idiopathic constipation in adults (1.1)
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Treatment of irritable bowel syndrome with constipation in women ≥ 18 years old (1.2)
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DOSAGE AND ADMINISTRATION
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Chronic idiopathic constipation
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24 mcg taken twice daily orally with food and water (2.1)
Reduce the dosage in patients with moderate and severe hepatic impairment (2.1)
Irritable bowel syndrome with constipation
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8 mcg taken twice daily orally with food and water (2.2)
Reduce the dosage in patients with severe hepatic impairment (2.2)
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DOSAGE FORMS AND STRENGTHS
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Gelatin capsules: 8 mcg and 24 mcg (3)
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CONTRAINDICATIONS
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Patients with known or suspected mechanical gastrointestinal obstruction should not receive Amitiza (4)
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WARNINGS AND PRECAUTIONS
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Women who could become pregnant should have a negative pregnancy test prior to beginning therapy and should be capable of complying with effective contraceptive measures (8.1)
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Use during pregnancy only if the potential benefit justifies the potential risk to the fetus (5.1)
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Patients may experience nausea; concomitant administration of food may reduce this symptom (5.2)
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Do not prescribe for patients that have severe diarrhea (5.3)
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Patients taking Amitiza may experience dyspnea within an hour of first dose. This symptom generally resolves within 3 hours, but may recur with repeat dosing (5.4)
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eva luate patients with symptoms suggestive of mechanical gastrointestinal obstruction prior to initiating treatment with Amitiza (5.5)
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ADVERSE REACTIONS
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Most common adverse reactions (incidence > 4%) in chronic idiopathic constipation are nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence (6.1)
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Most common adverse reactions (incidence > 4%) in irritable bowel syndrome with constipation are nausea, diarrhea, and abdominal pain (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 02/2011 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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1 INDICATIONS AND USAGE
1.1 Chronic Idiopathic Constipation
1.2 Irritable Bowel Syndrome with Constipation
2 DOSAGE AND ADMINISTRATION
2.1Chronic Idiopathic Constipation
2.2Irritable Bowel Syndrome with Constipation
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy
5.2 Nausea
5.3 Diarrhea
5.4 Dyspnea
5.5 Bowel Obstruction
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Chronic Idiopathic Constipation
14.2 Irritable Bowel Syndrome with Constipation
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Dosing Instructions
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Chronic Idiopathic Constipation
Amitiza® is indicated for the treatment of chronic idiopathic constipation in adults.
1.2 Irritable Bowel Syndrome with Constipation
Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old.
2 DOSAGE AND ADMINISTRATION
Amitiza should be taken orally with food and water. Physicians and patients should periodically assess the need for continued therapy.
2.1Chronic Idiopathic Constipation
The recommended dose is 24 mcg twice daily orally with food and water.
Reduced dosage in patients with hepatic impairment
For patients with moderately impaired hepatic function (Child-Pugh Class B), the recommended dose is 16 mcg twice daily. For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended dose is 8 mcg twice 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.
2.2Irritable Bowel Syndrome with Constipation
The recommended dose is 8 mcg twice daily orally with food and water.
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).
3 DOSAGE FORMS AND STRENGTHS
Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone.
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8-mcg capsules are pink and are printed with "SPI" on one side
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24-mcg capsules are orange and are printed with "SPI" on one side
4 CONTRAINDICATIONS
Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy
The safety of Amitiza in pregnancy has not been eva luated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. Amitiza should be used during pregnancy only if the potential 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 [see Use in Specific Populations (8.1)].
5.2 Nausea
Patients taking Amitiza may experience nausea. If this occurs, concomitant administration of food with Amitiza may reduce symptoms of nausea [see Adverse Reactions (6.1)].
5.3 Diarrhea
Amitiza should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients sh
