Constella (Linaclotide) 145mcg

Description: Anticholinergic Agent

“ALERT: US Boxed Warning

Risk of serious dehydration in pediatric patients:
Linaclotide is contraindicated in pediatric patients less than 6 years; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Avoid use of linaclotide in patients 6 years to less than 18 years. The safety and effectiveness of linaclotide has not been established in patients less than 18 years.”

Brand Name Canada: Constella
US Equivalent: Linzess

CSA NA – FDA Approved – REMS (N) – Can Ship 

Linaclotide and its active metabolite bind and agonize guanylate cyclase-C on the luminal surface of intestinal epithelium. Intracellular and extracellular cyclic guanosine monophosphate (cGMP) concentrations are raised resulting in the secretion of chloride and bicarbonate into the intestinal lumen. Intestinal fluid increases and GI transit is accelerated. Increased extracellular cGMP may decrease visceral pain by reducing pain-sensing nerve activity.

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

Before starting Linaclotide, Constella/Linzess make sure your physician is aware of any allergies or medications you currently take.  May cause severe diarrhea associated with dizziness, syncope, hypotension, and electrolyte abnormalities (hypokalemia and hyponatremia) requiring hospitalization or IV fluids.  Consider discontinuation of therapy and rehydration if severe diarrhea occurs. Administration with a high-fat meal may worsen diarrhea.

CIC: Oral: 145 mcg once daily; 72 mcg once daily may be used based on patient presentation or tolerability.

IBS-C: Oral: 290 mcg once daily.

Administer at least 30 minutes before the first meal of the day on an empty stomach; loose stools and greater stool frequency may occur after administration with a high-fat breakfast. Swallow capsule whole; do not break, crush, or chew capsules or capsule contents.

Diarrhea, abdominal pain, flatulence, 

Note this is not a complete list of side effects for Linaclotide, Constella/Linzess only common ones.

1. What do I do if side effects are intolerable?
   If side effects are causing a lot of distress speak to your physician as soon as possible to discuss options.