Resolor

Resolor

prucalopride

Manufacturer:

Janssen Cilag

Distributor:

Integrated Market Services
Concise Prescribing Info
Contents
Prucalopride
Indications/Uses
Symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Dosage/Direction for Use
Adult 2 mg once daily. Elderly >65 yr Initially 1 mg once daily, may be increased to 2 mg once daily. Patient w/ severe renal impairment (GFR <30 mL/min/1.73 m2) 1 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract eg, Crohn's disease, ulcerative colitis & toxic megacolon/megarectum. Renal impairment requiring dialysis.
Special Precautions
Limited information in patients w/ severe & clinically unstable concomitant disease (eg, liver, CV or lung disease, neurological or psychiatric disorders, cancer or AIDS & other endocrine disorders). Efficacy of OCs may be reduced in case of severe diarrhea & use of additional contraception is recommended. Monitor all patients for persistent worsening of depression or emergence of suicidal thoughts & behavior. Patients w/ renal impairment. Women of childbearing potential should use effective contraception during treatment. Not recommended during pregnancy & breast-feeding. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Headache; nausea, diarrhea, abdominal pain. Decreased appetite; dizziness; vomiting, dyspepsia, flatulence, abnormal GI sounds; fatigue.
Drug Interactions
Increased Cmax & AUC24h of erythromycin. Increased systemic exposure w/ ketoconazole & other potent P-gp inhibitors eg, verapamil, cyclosporine A, & quinidine.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A06AX05 - prucalopride ; Belongs to the class of other laxatives.
Presentation/Packing
Form
Resolor FC tab 1 mg
Packing/Price
28's
Form
Resolor FC tab 2 mg
Packing/Price
28's