The recommended dose is one capsule (290 micrograms) once daily.
Physicians should periodically assess the need for continued treatment. The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months. If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
Special populations: Patients with renal or hepatic impairment: No dose adjustments are required for patients with hepatic or renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly patients: For elderly patients, although no dose adjustment is required the treatment should be carefully monitored and periodically re-assessed (see Precautions).
Paediatric population: The safety and efficacy of linaclotide in children aged 0 to18 years have not yet been established. No data are available.
LINZESS should not be used in children and adolescents (see Pharmacology: Pharmacodynamics under Actions and Precautions).
Method of administration: Oral use. The capsule should be taken at least 30 minutes before a meal (see Interactions).