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Linzess (Linaclotide) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

No drug-drug interaction studies have been conducted with LINZESS. Linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses; hence, no systemic drug-drug interactions or drug interactions mediated by plasma protein binding of linaclotide or its metabolite are anticipated [see Clinical Pharmacology].

Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide is neither a substrate nor an inhibitor of the efflux transporter P-glycoprotein (P-gp).

OVERDOSAGE

There is limited experience with overdose of LINZESS. During the clinical development program of LINZESS, single doses of 2897 mcg were administered to 22 healthy volunteers; the safety profile in these subjects was consistent with that in the overall LINZESS-treated population, with diarrhea being the most commonly reported adverse reaction.

CONTRAINDICATIONS

LINZESS is contraindicated in:

  • Pediatric patients up to 6 years of age [see Warnings and Precautions Use in Specific Populations and Nonclinical Toxicology]
  • Patients with known or suspected mechanical gastrointestinal obstruction

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