Laxpru

Indicated for the treatment of chronic idiopathic constipation in adult female patientsin whom laxatives failed to provide adequate relief.

Dihydrobenzofurancarboxamide derivative

Prucalopride acts as a selective stimulator of the 5-HT4 receptors while having no interaction with hERG channel or 5-HT1 receptors which reduces significantly the cardiovascular risk found in other similar drugs. 5-HT4 receptors can be found throughout the gastrointestinal tract primarily in smooth muscle cells, enterochromaffin cells, and myenteric plexus. Its activation produces the release of acetylcholine which is the major excitatory neurotransmitter in the GI tract. Hence, prucalopride stimulates motility by interacting specifically with 5-HT4 receptors in the GI tract which causes a release of acetylcholine and further contraction of the muscle layer of the colon and relaxation of the circular muscle layer leading to the propulsion of luminal content.

Take this medication by mouth with or without food as directed by your doctor, usually once a day. The dosage is based on your age, medical condition, and response to treatment. The usual dose is 2 milligrams per day.

In-vitro data indicate that, Prucalopride has a low interaction potential and therapeutic concentrations of Prucalopride are not expected to affect the CYP-mediated metabolism of co medicated medicinal products. Although Prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations. Ketoconazole (200 mg b.i.d.), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%. This effect is too small to be clinically relevant. Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine. Studies in healthy subjects showed that, there were no clinically relevant effects of Prucalopride on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives. In-vitro data indicate that, Prucalopride has a low interaction potential and therapeutic concentrations of Prucalopride are not expected to affect the CYP-mediated metabolism of co medicated medicinal products. Although Prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations. Ketoconazole (200 mg b.i.d.), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%. This effect is too small to be clinically relevant. Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine. Studies in healthy subjects showed that, there were no clinically relevant effects of Prucalopride on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.Patients with renal impairment requiring dialysis.Patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn?s disease, ulcerative colitis, and toxic megacolon/megarectum.

Nausea, abdominal pain, diarrhea, or headache commonly occur during the first 1 to 2 days of treatment. Dizziness or tiredness may also occur.

Prucalopride should not be taken during pregnancy. In addition, all women of child-bearing age should use effective contraception while taking prucalopride. In practice, prucalopride should be avoided.

An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea. Specific treatment is not available for Prucalopride overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Store at room temperature, below 30°C. Do not remove desiccant. Dispense in original bottle.