Samjin Pharm's 'Hydrasec Granules' Approved for Patients Aged 12 and Older
Upper age limit of 12 years removed
New dosing instructions in sachet units
Samjin Pharm's pediatric antidiarrheal drug Hydrasec Granules (active ingredient: racecadotril) can now also be prescribed to adolescents aged 12 and older.
Samjin Pharm said on October 13 that the Ministry of Food and Drug Safety approved the change to Hydrasec Granules' product authorization on September 23. The upper age limit of under 12 years has been removed from the previous age range of children aged 3 months to under 12 years, expanding the eligible patients to children and adolescents aged 3 months and older.
The revised dosage and administration for Hydrasec Granules is based on the patient's weight: one 10 mg sachet per dose for patients weighing under 9 kg; two 10 mg sachets per dose for those weighing 9 kg or more but under 13 kg; one 30 mg sachet per dose for those weighing 13 kg or more and up to 27 kg; and two 30 mg sachets per dose for all children and adolescents weighing over 27 kg. Each dose should be taken three times a day at regular intervals.
In July, the Ministry of Food and Drug Safety removed the indication for "acute diarrhea in children aged 24 months and older" from products containing diosmectite, following safety concerns over lead content. As prescriptions for Hydrasec Granules increased as an alternative treatment, the product experienced a temporary supply disruption. Both the 10 mg and 30 mg strengths of Hydrasec Granules are now being supplied to the market normally.
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Kim Sangjin, CEO of Samjin Pharm, said, "The removal of the pediatric indication for smectite-based drugs has caused significant disruption in the medical field. We will do our utmost to ensure a stable supply of Hydrasec Granules so that there are no gaps in pediatric treatment."
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