Prucalopride (Vegaprat) 2 mg – [30 tablets]

Description

Vegaprat Pharmacodynamics
Prucaloprid is a dihydrobenzofurancarboxamide that enhances intestinal motility. Prucaloprid is a selective, high-affinity 5NT4-serotonin receptor agonist, which most likely explains its action on intestinal motility. Binding to other receptor types in vitro was observed only at concentrations of the substance that exceeded its affinity for 5NT4 receptors by at least 150-fold.

Indications
Prucalopride is intended for symptomatic treatment of chronic constipation in women for whom laxatives do not provide a sufficient effect in the elimination of symptoms.

Contraindications
– Hypersensitivity to the active component or any excipient.
– Renal dysfunction requiring dialysis.
– Intestinal perforation or obstruction due to anatomical or functional abnormalities of the intestinal wall, mechanical intestinal obstruction, severe inflammation of the intestine, such as Crohn’s disease, ulcerative colitis and toxic megalon/megarectum.
Caution.
The use of the drug in patients with severe and clinically unstable comorbidities (kidney disease, lung disease, cardiovascular disease, neurological disease, endocrine disease, psychiatric disorders, cancer, AIDS) has not been studied. Caution should be exercised when prescribing the drug Prucalopride in patients with cardiac arrhythmia or coronary heart disease in the anamnesis.
Use in pregnancy and during breast-feeding
Experience with the use of prucalopride during pregnancy is limited. Cases of miscarriage have been reported in clinical trials, although, given the presence of other risk factors, the association of these events with the use of prócalopride remains unproven. Animal studies have shown no direct or indirect adverse effects on pregnancy, embryo/fetal development, labor and postnatal development of the offspring. The drug is not recommended for use during pregnancy. During treatment with Prócalopride, women who are capable of childbearing should use adequate contraceptive methods.
Pruncalopride is excreted with breast milk; however, when used in therapeutic doses, the drug is unlikely to affect newborns/infants. Because of the lack of data on use in breastfeeding mothers, the drug is not recommended for use during breastfeeding.
Animal studies have not revealed any other effects of the drug on the fertility of males and females.

Directions for use and dosages

• The drug is taken orally, regardless of meals at any time of the day.
• Adults: 2 mg once a day.
• Elderly (over 65 years of age): start with 1 mg once a day, if necessary, increase the dose to 2 mg once a day.
• Children and adolescents: Pruncaloprid is not recommended for use in children and adolescents under 18 years of age.
• Patients with impaired renal function: In severe renal function impairment (glomerular filtration rate less than 30 ml/min/1.73 m2) the dose is 1 mg once daily.
• No dose adjustment is required for patients with mild to moderately severe renal dysfunction.
• Patients with hepatic impairment: In severe hepatic impairment (class C according to Child-Pugh) the dose is 1 mg once daily. No dose adjustment is required for patients with mild to moderately expressed hepatic impairment.
• Because of the specific mechanism of action of prucalopride (stimulation of intestinal motility), an increased daily dose of more than 2 mg is unlikely to increase the effect. If prucalopride once daily for 4 weeks has no effect, the patient should be reevaluated to determine whether to continue treatment.