Motelity®

Prucalopride Succinate INN equivalent to Prucalopride 1 mg

Dosage Form: Tablet
Pack Size: 2 X 10's
Composition:

Motelity® 1 Tablet: Each film coated tablet contains Prucalopride Succinate

INN equivalent to Prucalopride 1 mg.

Motelity® 2 Tablet: Each film coated tablet contains Prucalopride Succinate

INN equivalent to Prucalopride 2 mg.

Description:

Motelity® (Prucalopride) is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies.

 

Indications:

Motelity® is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Dosage & Administration:

Chronic Constipation

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 ( 65 Years)

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.

Patients with renal Impairment

The dose for patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) is 1 mg once daily. No dose adjustment is required for patients with mild to moderate renal impairment

Patients with hepatic Impairment

Patients with severe hepatic impairment (Child-Pugh class C) 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 wel tolerated. No dose adjustment is required for patients with mild to moderate hepatic impaltment.

Contraindications:

Prucalopnde iS contraindicated in those people ino are hypersensitive to the active substance or to any of the excipients, people with renal impairment requinng dialysis Intestinal perforation or obstruction due to structural or functional disorder of gut wall obstructive leus, severe inflammatory conditions of the intestinal tract (eg, Grohn disease, ulcerative colitis, toxic megacolon megarectum)

Warning & Precautions:

Renal excretion is the main route of elimmation of Fl I-alopride. A dose of 1 mg is recommended in subjects with severe renal impalment. Caution should be exercised when prescribing Prucalopride (Motelity") to patients with severe hepatic impairment. (Child-Pugh class C) due to limited data in patients with severe hepatic impairment. In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible tallure of oral contraception. The tablets contain lactose. Patients with rare hereditary prablems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorp-fion should not take this medicinal product.

Overdose:

Treatment with prucalopride was wel tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose). 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 Resolor 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

Storage Conditions:

Store below 30°C. & dry place. Keep away from light and out of the reach of children.

Commercial Pack:

Motelity® 1 tablet: Each box contains in 2 X 10's tablets in alu-alu blister pack.

Motelity* 2 tablet: Each box contains in 2 X 10's tablets in alu-alu blister pack.