Dosage pediatric studies

Extemporaneous production of pediatric dosage forms is commonly undertaken in hospitals. Without the sophisticated formulation capabilities of pharmaceutical manufacturers, alcohol-based vehicles have been recommended for extemporaneous preparation of liquid dosage forms [73]. There is a critical need to conduct research studies to assist the pharmacist in replacing current formulations with stable, alcohol-free preparations [74]. 

Smell, taste, texture, and aftertaste, therefore, are important factors in the development of pediatric dosage forms. In a study of six brands of OTC chewable vitamins, flavor type and intensity, soft texture, and short aftertaste were critical factors in product preference. The flavor and texture attributes of the bestselling product were significantly different from the other brands [97]. 

Pediatric hypertensive patients 6 years of age and older - The usual recommended starting dosage is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or suspension. Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. 

Powder for oral suspension The recommended dosage in pediatric patients is 14 mg/kg, up to a maximum dose of 600 mg/day. Once daily dosing for 10 days is as effective as twice-daily dosing. Once-daily dosing has not been studied in skin infections therefore, administer oral suspension twice daily in this infection. Oral suspension may be administered without regard to meals. 

Didanosine EC (Videx EC) - Didanosine EC has not been studied in pediatric patients. Please consult the complete prescribing information for didanosine buffered formulation and pediatric powder for oral solution for dosage and administration of didanosine to pediatric patients. 

In summary, PK studies in the pediatric population should determine if the dosage regimen in the pediatric population is to be adjusted to achieve approximately the same level of systemic exposure that is safe and effective in adults. 

Since the recognition of the superior effectiveness of methotrexate and the publications of the Pediatric Rheumatology Collaborative Study Group, penicillamine has been used infrequently in juvenile rheumatoid arthritis. The maximum daily dose is about 10 mg/kg (750 mg/ day) (18). This dosage is reached in three equal steps, each of 6-8 weeks duration. Perhaps more than gold, penicillamine acts slowly, taking 9 months to 3 years for maximum effectiveness. 

Because the fiver is the main organ for drug metabofism, drug clearance usually is decreased in patients with hepatic disease however, most studies on the influence of liver disease on dosage requirements have been carried out in adults, and these data may not be extrapolated uniformly to pediatric patients. 

This equation, based on plasma creatinine, age, sex, and race, has been validated in the MDRD study sample, and is now recommended by the NKF for estimating GFR in patients with CKD and a GFR < 90 mL/min per 1.73 m in the updated NKF K/DOQI guidelines. The accuracy of these MDRD equations in estimating GFR in individuals with normal renal function those with diabetes pediatric, elderly, and obese patients and for drug dosage adjustment requires further evaluation. 

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