Samjin Pharmaceutical has removed the upper age limit for its pediatric diarrhea treatment, Hydrasec, and revised the dosage guidelines based on weight, thereby expanding its prescription range.
According to industry sources on October 13, the Ministry of Food and Drug Safety (MFDS) approved changes to the approval status of Hydrasec (active ingredient: Racecadotril) on September 23. Previously, it could only be administered to patients aged 3 months to under 12 years. With this change, prescriptions can now be made for children and adolescents aged 12 and older.
The dosage guidelines have also been categorized by weight. For children under 9 kg, the dosage is one 10 mg packet; for those between 9 kg and under 13 kg, it is two 10 mg packets; for those between 13 kg and under 27 kg, it is one 30 mg packet; and for those over 27 kg, it is two 30 mg packets, all taken three times a day at regular intervals.
Hydrasec is available in powder form and can be mixed with water, milk, or food. Samjin Pharmaceutical stated, "This approval change broadens the range of patients who can be prescribed the medication and simplifies the dosing instructions for caregivers."
This change aligns with shifts in the pediatric diarrhea treatment market. In July, the MFDS removed the indication for 'acute diarrhea in children aged 24 months and older' for a dioktahedral smectite-based product. Following this, demand for alternative treatments increased, leading to temporary supply issues for Hydrasec.
Samjin Pharmaceutical is currently supplying Hydrasec in 10 mg and 30 mg formulations. The company plans to ensure stable supply to prevent any gaps in pediatric diarrhea treatment following the approval changes.
Kim Sang-jin, CEO of Samjin Pharmaceutical, remarked, "This approval change has expanded the range of patients who can be prescribed the medication and improved dosing convenience. We will work to ensure a stable supply to prevent any gaps in pediatric diarrhea treatment."
Meanwhile, Samjin Pharmaceutical has recently been selected as a supported company under the '2026 World Class Plus Project,' organized by the Ministry of Trade, Industry and Energy and the Korea Institute for Advancement of Technology (KIAT).
The World Class Plus Project supports mid-sized companies with global growth potential and competitiveness by providing assistance in research and development, exports, finance, and consulting. Samjin Pharmaceutical will receive government R&D funding for up to four years.
According to industry sources on October 13, the Ministry of Food and Drug Safety (MFDS) approved changes to the approval status of Hydrasec (active ingredient: Racecadotril) on September 23. Previously, it could only be administered to patients aged 3 months to under 12 years. With this change, prescriptions can now be made for children and adolescents aged 12 and older.
The dosage guidelines have also been categorized by weight. For children under 9 kg, the dosage is one 10 mg packet; for those between 9 kg and under 13 kg, it is two 10 mg packets; for those between 13 kg and under 27 kg, it is one 30 mg packet; and for those over 27 kg, it is two 30 mg packets, all taken three times a day at regular intervals.
Hydrasec is available in powder form and can be mixed with water, milk, or food. Samjin Pharmaceutical stated, "This approval change broadens the range of patients who can be prescribed the medication and simplifies the dosing instructions for caregivers."
This change aligns with shifts in the pediatric diarrhea treatment market. In July, the MFDS removed the indication for 'acute diarrhea in children aged 24 months and older' for a dioktahedral smectite-based product. Following this, demand for alternative treatments increased, leading to temporary supply issues for Hydrasec.
Samjin Pharmaceutical is currently supplying Hydrasec in 10 mg and 30 mg formulations. The company plans to ensure stable supply to prevent any gaps in pediatric diarrhea treatment following the approval changes.
Kim Sang-jin, CEO of Samjin Pharmaceutical, remarked, "This approval change has expanded the range of patients who can be prescribed the medication and improved dosing convenience. We will work to ensure a stable supply to prevent any gaps in pediatric diarrhea treatment."
Meanwhile, Samjin Pharmaceutical has recently been selected as a supported company under the '2026 World Class Plus Project,' organized by the Ministry of Trade, Industry and Energy and the Korea Institute for Advancement of Technology (KIAT).
The World Class Plus Project supports mid-sized companies with global growth potential and competitiveness by providing assistance in research and development, exports, finance, and consulting. Samjin Pharmaceutical will receive government R&D funding for up to four years.
* This article has been translated by AI.
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