From the Guidelines
Linzess (linaclotide) is a prescription medication used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults, with a recommended dose of 290 mcg once daily for IBS-C and 145 mcg once daily for CIC, taken on an empty stomach at least 30 minutes before the first meal of the day 1. The medication works by increasing intestinal fluid secretion and accelerating transit through the gut, which helps relieve constipation and associated symptoms like abdominal pain and bloating. Some key points to consider when prescribing Linzess include:
- Common side effects include diarrhea, abdominal pain, gas, and bloating
- Severe diarrhea can occur, particularly when starting treatment
- Linzess is contraindicated in patients under 18 years of age and in those with known or suspected mechanical gastrointestinal obstruction
- It should be stored at room temperature and kept in its original container with the desiccant to protect from moisture
- Patients should not double-dose if they miss a dose but simply take the next dose at the regular time the following day According to the most recent guidelines, the use of linaclotide is recommended for the treatment of CIC and IBS-C in adults, with a strong recommendation based on high certainty in the evidence of effects 1. In terms of specific dosing, the recommended dose of linaclotide for CIC is 72μg or 145μg daily, while the 290μg daily dose is approved for IBS-C 1. It's also important to note that linaclotide has been demonstrated to improve abdominal symptoms of bloating, discomfort, and pain in IBS-C trials, making it a useful option for individuals with these coexisting symptoms 1.
From the FDA Drug Label
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration 1 INDICATIONS AND USAGE LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 6 to 17 years of age 2 DOSAGE AND ADMINISTRATION 2. 1 Recommended Dosage Irritable Bowel Syndrome with Constipation (IBS-C) in adults The recommended dosage of LINZESS is 290 mcg orally once daily. Chronic Idiopathic Constipation (CIC) in adults The recommended dosage of LINZESS is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability Functional Constipation (FC) in pediatric patients 6 to 17 years of age The recommended dosage of LINZESS is 72 mcg orally once daily.
The prescribing information for Linzess (Linaclotide) includes:
- Indications:
- Irritable bowel syndrome with constipation (IBS-C) in adults
- Chronic idiopathic constipation (CIC) in adults
- Functional constipation (FC) in pediatric patients 6 to 17 years of age
- Dosage:
- IBS-C in adults: 290 mcg orally once daily
- CIC in adults: 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability
- FC in pediatric patients 6 to 17 years: 72 mcg orally once daily
- Administration Instructions: Take on an empty stomach at least 30 minutes prior to a meal at approximately the same time each day. Do not crush or chew LINZESS capsule or capsule contents. 2 2
From the Research
Prescribing Information for Linzess (Linaclotide)
- Linaclotide (Linzess) is indicated for the treatment of adults with chronic idiopathic constipation (CC) and irritable bowel syndrome with constipation (IBS-C) 3, 4, 5.
- The recommended dosage for CC is 145 μg or 72 μg once daily, and for IBS-C is 290 μg once daily 4, 6.
- Linaclotide acts on guanylate cyclase-C receptors to increase chloride and bicarbonate secretions into the intestine, inhibit the absorption of sodium ions, and increase the secretion of water into the lumen, improving defecation 4.
- The most common adverse effect of linaclotide is diarrhea, which was reported in 16-20% of clinical trial participants 4, 6, 7.
- Linaclotide has been shown to be effective in increasing weekly spontaneous bowel movements and complete spontaneous bowel movements, and reducing abdominal pain in patients with CC and IBS-C 4, 7.
- The safety and tolerability of linaclotide have been evaluated in several clinical trials, with the majority of adverse events being mild and confined to the gastrointestinal tract 4, 6, 7.