Linzess Special Precautions

LINZESS should be used after organic diseases have been ruled out and a diagnosis of moderate to severe IBS-C (see Pharmacology: Pharmacodynamics under Actions) is established.
Patients should be aware of the possible occurrence of diarrhoea during treatment. They should be instructed to inform their physician if severe or prolonged diarrhoea occurs (see Adverse Reactions).
Should prolonged (e.g. more than 1 week) or severe diarrhoea occur, medical advice should be sought and temporary discontinuation of linaclotide until diarrhoea episode is resolved may be considered. Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with CV diseases, diabetes, hypertension), and electrolyte control should be considered.
Linaclotide has not been studied in patients with chronic inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis; therefore it is not recommended to use LINZESS in these patients.
Effects on ability to drive and use machines: LINZESS has no or negligible influence on the ability to drive and use machines.
Use in children: LINZESS should not be used in children and adolescents as it has not been studied in this population. As GC-C receptor is known to be overexpressed at early ages, children younger than 2 years may be particularly sensitive to linaclotide effects.
Use in elderly: There are limited data in elderly patients (see Pharmacology: Pharmacodynamics under Actions). Because of the higher risk of diarrhoea seen in the clinical trials (see Adverse Reactions), special attention should be given to these patients and the treatment benefit-risk ratio should be carefully and periodically assessed.