- Approval Id
- 4683f9a91335fff4
- Drug Name
- Hidrasec Children Granules for Oral Suspension 30mg
- Product Name
- Hidrasec Children Granules for Oral Suspension 30mg
- Approval Number
- SIN14413P
- Approval Date
- 2013-09-30
- Registrant
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Licence Holder
- ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- GRANULE, FOR SUSPENSION
- Dosage
- **4.2 Posology and method of administration**
Hidrasec Infants 10mg and Hidrasec Children 30mg are administered via the oral route, together with oral rehydration (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Hidrasec Infants 10mg is intended for children < 13kg.
Hidrasec Children 30mg is intended for children ≥ 13kg.
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 infants less than 9 kg: one 10 mg sachet 3 times daily.
In infants 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.
The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days. Long term treatment with racecadotril is not recommended.
There are no clinical trials in infants under 3 months of age.
_Special populations:_
There are no studies in infants or children with renal impairment or hepatic impairment (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Caution is advised in patients with hepatic or renal impairment.
The granules can be added to food, dispersed in a glass of water or in the feeding-bottle, mixing well and followed by immediate administration.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Hidrasec Infants 10mg, Hidrasec Children 30mg:
Complementary, symptomatic treatment of acute diarrhoea in infants (older than 3 months) and children, when oral rehydration and usual support measures are insufficient to control the clinical condition.
- Contraindications
- **4.3 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.
Due to the presence of sucrose, Hidrasec Infants/Children is contraindicated in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency.
- Atc Code
- A07XA04
- Atc Item Name
- racecadotril
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Company Detail Path
- /organization/abbott-laboratories-singapore-private-limited
