ALINIA - nitazoxanide powder, for suspension 
Linzess(linaclotide)
LINZESS (linaclotide) capsule, gelatin coated
[Forest Laboratories, Inc.]
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. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide caused deaths in young juvenile mice (4, 5.1, 8.4, 13.2).
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)
DOSAGE FORMS AND STRENGTHS
Capsules: 145 mcg and 290 mcg (3)
CONTRAINDICATIONS
•Pediatric patients up to 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 www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 08/2012
 
 
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: PEDIATRIC RISK

1 INDICATIONS AND USAGE

1.1 Irritable Bowel Syndrome with Constipation (IBS-C)

1.2 Chronic Idiopathic Constipation (CIC)

2 DOSAGE AND ADMINISTRATION

2.1 Irritable Bowel Syndrome with Constipation (IBS-C)

2.2 Chronic Idiopathic Constipation (CIC)

2.3 Important Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Pediatric Risk

5.2 Diarrhea

6 ADVERSE REACTIONS

6.1 Clinical Trials 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 Hepatic or Renal 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, and Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Irritable Bowel Syndrome with Constipation (IBS-C)

14.2 Chronic Idiopathic Constipation (CIC)

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT CO