Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
lubiprostone (UNII: 7662KG2R6K) (lubiprostone - UNII:7662KG2R6K)
Avera McKennan Hospital
lubiprostone
lubiprostone 8 ug
PRESCRIPTION DRUG
New Drug Application
AMITIZA- LUBIPROSTONE CAPSULE, GELATIN COATED AVERA MCKENNAN HOSPITAL ---------- 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: • • • 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 • 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 • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS • 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 Lue koko asiakirja