Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
linaclotide (UNII: N0TXR0XR5X) (linaclotide - UNII:N0TXR0XR5X)
Avera McKennan Hospital
linaclotide
linaclotide 145 ug
PRESCRIPTION DRUG
New Drug Application
LINZESS- LINACLOTIDE CAPSULE, GELATIN COATED AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LINZESS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LINZESS. LINZESS (LINACLOTIDE) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2012 WARNING: PEDIATRIC RISK _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ LINZESS IS CONTRAINDICATED IN PEDIATRIC PATIENTS UP TO 6 YEARS OF AGE; LINACLOTIDE CAUSED DEATHS DUE TO DEHYDRATION IN YOUNG JUVENILE MICE. AVOID USE OF LINZESS IN PEDIATRIC PATIENTS 6 THROUGH 17 YEARS OF AGE. THE SAFETY AND EFFICACY OF LINZESS HAS NOT BEEN ESTABLISHED IN PEDIATRIC PATIENTS UNDER 18 YEARS OF AGE (4, 5.1, 8.4, 13.2). RECENT MAJOR CHANGES DOSAGE AND ADMINISTRATION (2.3) 11/2015 INDICATIONS AND USAGE LINZESS is a guanylate cyclase-C agonist indicated in adults for treatment of: Irritable bowel syndrome with constipation (IBS-C) (1.1) Chronic idiopathic constipation (CIC) (1.2) DOSAGE AND ADMINISTRATION IBS-C: Take 290 mcg orally once daily (2.1) CIC: Take 145 mcg orally once daily (2.2) Take on empty stomach at least 30 minutes prior to first meal of the day (2.1, 2.2) For patients who have difficulty swallowing capsules or those with a nasogastric or gastrostomy tube, see full prescribing information for instructions for opening the capsule and administering with applesauce or water. DOSAGE FORMS AND STRENGTHS Capsules: 145 mcg and 290 mcg (3) CONTRAINDICATIONS Pediatric patients under 6 years of age (4) Patients with known or suspected mechanical gastrointestinal obstruction (4) WARNINGS AND PRECAUTIONS _Diarrhea:_ Patients may experience severe diarrhea. Hold or stop LINZESS (5.2) ADVERSE REACTIONS Most common adverse reactions (incidence of at least 2%) reported in IBS-C or CIC patients are diarrhea, abdominal pain, flatulence and abdominal distension. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOREST PHARMACEUTICALS, INC., AT 1- 800- 678-1605 OR FDA AT 1-800-FDA-1088 OR Leggi il documento completo