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FDA approves hydrocortisone oral granules for adrenocortical insufficiency in kids
The US Food and Drug Administration (FDA) has approved hydrocortisone (ALKINDI SPRINKLE) oral granules as a replacement therapy for adrenocortical insufficiency (AI) in pediatric patients.
Pediatric adrenocortical Insufficiency (AI) is a rare disease characterized by an inability to synthesize and release cortisol, and sometimes aldosterone. This causes excessive androgens (abnormal sexual development in females, premature puberty, premature growth termination and short stature). To survive, patients with AI must replace the missing cortisol daily
ALKINDI SPRINKLE is an immediate-release oral hydrocortisone granule preparation that has been specifically designed to meet the dosing needs of pediatric patients with adrenocortical insufficiency.
Prior to ALKINDI SPRINKLE's approval, parent caregivers had to cut or split higher strength hydrocortisone tablets to achieve the lower doses required for small children, which could result in inaccurate dosing. ALKINDI SPRINKLE is manufactured using commercially proven technology in four strengths: 0.5mg, 1mg, 2mg and 5mg, to give greater dosing flexibility to clinicians. Taste-masking excipients that are acceptable for pediatric use eliminate the bitter taste of hydrocortisone. ALKINDI SPRINKLE has a shelf life of three years at ambient temperature and does not require refrigeration.
With the approval Eton Pharmaceuticals now has the only FDA-approved granular hydrocortisone formulation for the disease specifically designed for the use in children.
Prior to the approval of ALKINDI SPRINKLE, oral hydrocortisone was only FDA-approved in tablet formulations of 5mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precision titration. ALKINDI SPRINKLE will now be available in 0.5mg, 1mg, 2mg, and 5mg strengths, allowing clinicians greater flexibility to individualize dosing based on each patient's needs in accordance with the instructions for dosage and administration.
Dr Satabdi Saha (BDS, MDS) is a practicing pediatric dentist with a keen interest in new medical researches and updates. She has completed her BDS from North Bengal Dental College ,Darjeeling. Then she went on to secure an ALL INDIA NEET PG rank and completed her MDS from the first dental college in the country – Dr R. Ahmed Dental College and Hospital. She is currently attached to The Marwari Relief Society Hospital as a consultant along with private practice of 2 years. She has published scientific papers in national and international journals. Her strong passion of sharing knowledge with the medical fraternity has motivated her to be a part of Medical Dialogues.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751