Laxopride is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Dosage & Administration
Adults: 2 mg once daily with or without food, at any time of the day. Due to the specific mode of action of Prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.
Older people: Start with 1 mg once daily; if needed the dose can be increased to 2 mg once daily.
Children: Prucalopride should not be used in children and adolescents younger than 18 years.
Hepatic Impairment: Patients with severe hepatic impairment start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated. No dose adjustment is required for patients with mild to moderate hepatic impairment.
Route of Administration
Tablet should be taken orally.
Renal excretion is the main route for elimination of Prucalopride. A dose of 1 mg is recommended in Subjects with severe renal impairment. Caution should be exercised when prescribing Prucalopride to patients with severe hepatic impairment due to limited data in patients with severe hepatic impairment. In case of severe diarrhea, the efficacy of oral contraceptive method is recommended to prevent possible failure of oral contraception.
Use in Pregnancy and Lactation
Prucalopride is not recommended during pregnancy and women of childbearing potential should use effective contraception during treatment. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. In the absence of human data, it is not recommended to use Prucalopride during breast feeding.
Use in Children & Adolescents
The safety and effectiveness of Prucalopride have not been established in pediatric patients. No differences in safety and effectiveness were observed between elderly and younger patients.