AMITIZA lubiprostone capsule gelatin coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

lubiprostone (UNII: 7662KG2R6K) (lubiprostone - UNII:7662KG2R6K)

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

lubiprostone

Composizione:

lubiprostone 8 ug

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

AMITIZA- LUBIPROSTONE CAPSULE, GELATIN COATED
AVERA MCKENNAN HOSPITAL
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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) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Indications and Usage (1.2)
04/2013
Dosage and Administration (2.1)
04/2013
Warnings and Precautions, Pregnancy (5.1)
removed 11/2012
INDICATIONS AND USAGE
Amitiza is a chloride channel activator indicated for:
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Limitations of Use:
DOSAGE AND ADMINISTRATION
Capsules should be swallowed whole and should not be broken apart or
chewed (2)
CHRONIC IDIOPATHIC CONSTIPATION AND OPIOID-INDUCED CONSTIPATION
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Reduce the dosage in patients with moderate and severe hepatic
impairment (2.1)
IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
•
Reduce the dosage in patients with severe hepatic impairment (2.2)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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Treatment of chronic idiopathic constipation in adults (1.1)
Treatment of opioid-induced constipation in adults with chronic,
non-cancer pain (1.2)
Treatment of irritable bowel syndrome with constipation in women ≥
18 years old (1.3)
Effectiveness of Amitiza in the treatment of opioid-induced
constipation in patients taking diphenylheptane opioids
(e.g., methadone) has not been established (1) (14.2)
24 mcg taken twice daily orally with food and water (2.1)
8 mcg taken twice daily orally with food and water (2.2)
Capsules: 8 mcg and 24 mcg (3)
Amitiza is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction. (4)
Patients may experience nausea; concomitant administration of food may
reduce this symptom (5.1)
Do not prescribe for patients that have severe diarrhea (5.2)
Patients taking Amitiza may experience dyspnea within an hour of first
dose. This symptom generally resolves within
3 hours, but may recur with