Resolor Special Precautions

Patients with Renal Impairment: Renal excretion is the main route of elimination of prucalopride (see Pharmacokinetics). A dose of 1 mg is recommended in subjects with severe renal impairment (see Dosage & Administration).
Concomitant Disease: There is limited information in patients with severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders). Therefore, caution should be exercised when prescribing Prucalopride succinate (Resolor) to patients with these conditions.
Oral Contraceptives: In case of severe diarrhea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Suicidal Ideation and Behavior: In clinical trials and postmarketing experience, cases of suicide, suicide attempts and suicidal ideation have been reported. A causal association between the treatment with Prucalopride succinate (Resolor) and an increased risk of suicidal ideation and behavior has not been established.
Monitor all patients treated with Prucalopride succinate (Resolor) for persistent worsening of depression or the emergence of suicidal thoughts and behaviors. Counsel patients, their caregivers, and family members of patients to be aware of any unusual changes in mood or behavior and alert the healthcare provider immediately.
Special Populations: Hepatic Impairment: Non-renal elimination contributes up to about 35% of total elimination. After a single oral dose of 2 mg, C_max and AUC of prucalopride were on average 10-20% higher in subjects with moderate and severe hepatic impairment than in subjects with normal hepatic function.
Renal Impairment: Compared to subjects with normal renal function, plasma concentrations of prucalopride after a single 2 mg dose were on average 25% and 51% higher in subjects with mild (Cl_CR 50-≤79 mL/min/1.73 m²) and moderate (Cl_CR 25-≤49 mL/min/1.73 m²) renal impairment, respectively. In subjects with severe renal impairment (Cl_CR ≤24 mL/min/1.73 m²), plasma concentrations were 2.3 times the levels in healthy subjects. (see Dosage & Administration and Precautions).
Use in Children: After a single oral dose of 0.03 mg/kg in pediatric patients aged 4-12 years, C_max of prucalopride was comparable to the C_max in adults after a single 2 mg dose. Unbound AUC was 30-40% lower than after 2 mg in adults. Unbound exposure was similar over the whole age-range (4-12 years). The average terminal half-life in pediatric patients was about 19 hours (range 11.6-26.8 hours). Safety and efficacy of prucalopride in pediatric patients was evaluated in a double-blind, placebo controlled study. Efficacy results do not support the use of Prucalopride succinate (Resolor) in pediatric patients and therefore Prucalopride succinate (Resolor) is not recommended in this patient population (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Use in the Elderly: After once daily dosing of 1 mg, peak plasma concentrations and AUC of prucalopride in geriatric patients were 26%-28% higher than in young adults. This effect can be attributed to a diminished renal function in elderly.