- Approval Id
- f36462ab47251f7f
- Drug Name
- HIDRASEC INFANTS GRANULES FOR ORAL SUSPENSION 10MG
- Product Name
- HIDRASEC INFANTS GRANULES FOR ORAL SUSPENSION 10MG
- Approval Number
- SIN14412P
- 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 MEDICINES
- Dosage Form
- GRANULE, FOR SUSPENSION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Hidrasec Infants 10mg and Hidrasec Children 30mg are administered via the oral route, together with oral rehydration (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Hidrasec Infants 10mg is intended for children < 13kg.<br>
Hidrasec Children 30mg is intended for children ≥ 13kg.</p>
<p>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.<br>
<u>In infants less than 9 kg:</u> one 10 mg sachet 3 times daily.<br>
<u>In infants from 9 kg to < 13 kg:</u> two 10 mg sachets 3 times daily.</p>
<p><u>In children from 13 kg to 27 kg:</u> one 30 mg sachet 3 times daily.<br>
<u>In children of more than 27 kg:</u> two 30 mg sachets 3 times daily.</p>
<p>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.</p>
<p>There are no clinical trials in infants under 3 months of age.</p>
<p><em><u>Special populations:</u></em><br>
There are no studies in infants or children with renal impairment or hepatic impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Caution is advised in patients with hepatic or renal impairment.</p>
<p>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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><u>Hidrasec Infants 10mg, Hidrasec Children 30mg:</u><br>
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.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li><p>Hypersensitivity to the active substance or to any of the excipients.</p></li>
<li><p>Patients who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) should not take racecadotril.</p></li>
</ul>
<p>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.</p>
- Atc Code
- A07XA04
- Atc Item Name
- racecadotril
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
