HIDRASEC CHILDREN 30MG SACHET 16'S

HIDRASEC CHILDREN 30MG SACHET 16'S
 
 
Brand Name
HIDRASEC 30MG GRANULES FOR ORAL SUSPENSION
Generic Name
Racecadotril
Strength
30mg Racecadotril
Dosage Form
Granules for Oral Suspension
Class Name
Antidiarrheal
Indication/Usage
Complementary symptomatic treatment of acute diarrhea in infants (older than 3 months) and children together with oral rehydration (ORS).
If causal treatment of acute diarrhea is possible, racecadotril can be co-administered.
Dosage and Administration
The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals.
In infant less than 9 kg: one 10 mg sachet 3 times daily. In infant from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.
Treatment should be continued until two normal stools are recorded. Treatment duration should not exceed 7 days.
Long-term treatment with racecadotril is not recommended. There are no clinical trials in infants fewer than 3 months of age.
Warning and Precautions
- Rehydration is highly important in the management of acute diarrhea in infants.
- The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria
as a reason for diarrhea or the presence of other severe disease, warranting causal (e.g. antibiotic)
treatment or further investigation. Therefore, racecadotril should not be administered under these
conditions.
-In patients with diabetes, it should be taken into account that each sachet contains:
Racecadotril (Hidrasec) Infants: 0.966 g of sucrose
Racecadotril (Hidrasec) Children: 2.899 g of sucrose
- The product must not be administered to infants less than 3 months old, as there are no clinical
trials in this population.
- The product must not be administered to children with renal or liver impairment, whatever the
degree of severity, due to a lack of information on these patient populations.
- Occurrence of skin reactions has been reported with the use of the product
- Hypersensitivity/Angioedema have been reported in patients with racecadotril.
Contraindication
• 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.
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.
Requires prescription?
Yes
Storage Conditions
Store at temperatures not exceeding 30°C, away from direct heat and sunlight