Linzess

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders
  • Constipation and bowel cleansers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Linzess Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Linaclotide 72mcg, 145mcg, 290mcg; caps.

    Pharmacological Class

    Guanylate cyclase-C agonist.

    How Supplied

    Caps—30

    Manufacturer

    AbbVie

    Generic Availability

    NO

    Mechanism of Action

    Both linaclotide and its active metabolite bind to GCC and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit.

    Linzess Indications

    Indications

    Irritable bowel syndrome with constipation (IBS-C).

    Linzess Dosage and Administration

    Adult

    Swallow whole. Take on empty stomach, at least 30mins before first meal of the day. May open caps and mix contents in applesauce or with water if unable to swallow; or, may give with water via NG or gastrostomy tube. 290mcg once daily.

    Children

    <2yrs: contraindicated. 2–<18yrs: not established.

    Administration

    Swallow whole. Take on an empty stomach, at least 30mins prior to first meal of the day.

    Nursing Considerations

    Swallow whole. Take on an empty stomach, at least 30mins prior to first meal of the day (looser stools and higher stool frequency when taken with high fat meal). Advise patients to report severe abdominal pain and/or severe diarrhea.

    Linzess Contraindications

    Contraindications

    Children <2yrs old. Known or suspected mechanical GI obstruction.

    Linzess Boxed Warnings

    Boxed Warning

    Risk of serious dehydration in pediatric patients <2yrs of age.

    Linzess Warnings/Precautions

    Warnings/Precautions

    Consider dose suspension and rehydration if severe diarrhea occurs. Pregnancy. Nursing mothers.

    Linzess Pharmacokinetics

    Metabolism

    GI.

    Elimination

    Fecal.

    Linzess Interactions

    Not Applicable

    Linzess Adverse Reactions

    Adverse Reactions

    Diarrhea, abdominal pain, flatulence, abdominal distention.

    Linzess Clinical Trials

    See Literature

    Linzess Note

    Not Applicable

    Linzess Patient Counseling

    See Literature

    Linzess Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Linaclotide 72mcg, 145mcg, 290mcg; caps.

    Pharmacological Class

    Guanylate cyclase-C agonist.

    How Supplied

    Caps—30

    Manufacturer

    AbbVie

    Generic Availability

    NO

    Mechanism of Action

    Both linaclotide and its active metabolite bind to GCC and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit.

    Linzess Indications

    Indications

    Chronic idiopathic constipation (CIC) in adults. Functional constipation (FC) in pediatric patients.

     

    Linzess Dosage and Administration

    Adult

    FC (≥18yrs): not established. Swallow whole. Take on empty stomach, at least 30mins before first meal of the day. May open caps and mix contents in applesauce or with water if unable to swallow; or, may give with water via NG or gastrostomy tube. CIC (≥18yrs): 145mcg once daily. A dosage of 72mcg once daily may be used based on individual presentation or tolerability.

    Children

    <2yrs: contraindicated. CIC (<18yrs): not established. FC (<6yrs): not established. Swallow whole. Take on empty stomach, at least 30mins before first meal of the day. May open caps and mix contents in applesauce or with water if unable to swallow; or, may give with water via NG or gastrostomy tube. FC (6–17yrs): 72mcg once daily.

    Administration

    Swallow whole. Take on an empty stomach, at least 30mins prior to first meal of the day.

    Nursing Considerations

    Swallow whole. Take on an empty stomach, at least 30mins prior to first meal of the day (looser stools and higher stool frequency when taken with high fat meal). Advise patients to report severe abdominal pain and/or severe diarrhea.

    Linzess Contraindications

    Contraindications

    Children <2yrs old. Known or suspected mechanical GI obstruction.

    Linzess Boxed Warnings

    Boxed Warning

    Risk of serious dehydration in pediatric patients <2yrs of age.

    Linzess Warnings/Precautions

    Warnings/Precautions

    Consider dose suspension and rehydration if severe diarrhea occurs. Pregnancy. Nursing mothers.

    Linzess Pharmacokinetics

    Absorption

    • Minimally absorbed with negligible systemic availability following oral administration. 

    Metabolism

    • Linaclotide is metabolized within the gastrointestinal tract to its principal, active metabolite by loss of the terminal tyrosine moiety. Both linaclotide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids.

    Elimination

    Fecal.

    Linzess Interactions

    Not Applicable

    Linzess Adverse Reactions

    Adverse Reactions

    Diarrhea, abdominal pain, flatulence, abdominal distention.

    Linzess Clinical Trials

    See Literature

    Linzess Note

    Not Applicable

    Linzess Patient Counseling

    See Literature

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