Adult Dosing

Irritable bowel syndrome with constipation (IBS-C)

• 290 mcg PO qd

Chronic idiopathic constipation (CIC)

• 145 mcg PO qd

Note:

• Dose should be taken on an empty stomach, administer 30 minutes before first meal

Pediatric Dosing

• Safety and effectiveness in pediatric patients has not been established
• Child ( 6 years): Contraindicated
• Child (6 - 17 years): Avoid use

• Irritable bowel syndrome with constipation (IBS-C)
• Chronic idiopathic constipation (CIC)

• Hypersensitivity to any of the ingredients of the product
• Children 6 years of age
• Known or suspected mechanical gastrointestinal obstruction

• Use of linaclotide is contraindicated in children 6 years of age
• Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Use of linaclotide is contraindicated in children 6 years of age [FDA Black Box Warning]
• Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice [FDA Black Box Warning]
• Severe diarrhea may occur in patients treated with linaclotide. Discontinue the medication if such reaction occurs and take medical advice

Pregnancy Category:C

Breastfeeding: Not known whether linaclotide is excreted in human milk, manufacturer advises caution

• CNS: Headache
• GI: Diarrhea, abdominal pain, flatulence, abdominal distension, dyspepsia, fecal incontinence, viral gastroenteritis
• RESP: Upper respiratory tract infection
• EENT: Sinusitis
• DERM: Urticaria

• Guanylate cyclase-C (GC-C) agonist; activates GC-C receptor in the intestine which results in increased cyclic guanosine monophosphate (cGMP), anion secretion, fluid secretion and intestinal transit
• Minimally absorbed in systemic circulation
• Metabolized in GI tract
• Excretion in feces 5% (fasted) and 3%(fed) and virtually 100% of active metabolite

US Trade Name(s)

• Linzess

US Availability

Linzess

• CAPS: 145, 290 mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Gastrointestinal

Functional Bowel Disorder Agents

Guanylate Cyclase-C Agonist