Dosage / Direction for Use
Cap Initially 1 cap anytime of the day, then, 1 cap tid before main meals. Continued until 2 normal stools are recorded. Treatment duration: 7 days. Granules for susp Childn >27 kg Two 30 mg sachet tid; 13-27 kg One 30 mg sachet tid; infant from 9 to <13 kg Two 10 mg sachet tid; <9 kg One 10 mg sachet tid. Continued until 2 normal stools are recorded. Treatment duration: 7 days.
Administration
May be taken with or without food: Cap: Take preferably before main meals. Granules for susp: Granules may be added to food or dispersed in a small amount of water. Mix well & administer immediately.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) should not take racecadotril.
Granules for Oral Suspension: Due to the presence of sucrose, Racecadotril (Hidrasec) Infants/Children is contraindicated in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency.
Interactions
Increased risk of angioedema w/ ACE inhibitors eg, captopril, enalapril, lisinopril, fosinopril, perindopril, ramipril.
Special Precautions
Should not be administered in patients w/ diarrhea caused by invasive bacteria (bloody or purulent stools; fever). Not recommended for antibiotic-associated & chronic diarrhea; long-term treatment. Renal, hepatic & liver impairment. Pregnancy & lactation. Cap: Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Granules for susp: Rehydration. Regular feeding (including breastfeeding) should not be interrupted. Monitor fluid intake. Should not be administered in infants w/ prolonged or uncontrolled vomiting. Contains sucrose. Infant <3 mth.