Balsalazidedosage

Administration Instructions: Evaluate renal function before initiating therapy with balsalazide disodium capsules. Swallow capsules whole. Do not cut, break, crush or chew. For patients who cannot swallow intact capsules, the capsules may be opened and sprinkled on applesauce, then chewed and swallowed immediately. Teeth and/or tongue staining may occur when administered sprinkled on applesauce. Drink an adequate amount of fluids. Take balsalazide disodium capsules with or without food.

Dosage: Adults: The recommended dosage is 2.25 g (three 750 mg capsules) three times daily for 8 weeks. Some adult patients required treatment for up to 12 weeks in clinical trials. Pediatric Patients 5 Years to 17 Years of Age: The recommended dosage is either: 2.25 g (three 750 mg capsules) three times for up to 8 weeks.

OR: 750 mg (one capsule) three times daily for up to 8 weeks.

2.1 Important

Preparation and Administration Instructions Evaluate renal function before initiating therapy with balsalazide disodium capsules. Swallow balsalazide disodium capsules whole. Do not cut, break, crush or chew the capsules. For patients who cannot swallow intact capsules, balsalazide disodium capsules may also be administered by opening the capsule and sprinkling the capsule contents on applesauce. If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient. Place a small amount (approximately 10 mL) of applesauce into a clean container. Carefully open the capsules. Sprinkle the capsule contents on the applesauce. Mix the capsule contents with the applesauce. The contents may be chewed, if necessary. Consume the entire amount of applesauce mixture immediately. Do not store the applesauce mixture for future use. Teeth and/or tongue staining may occur in some patients when administered sprinkled on applesauce. Drink an adequate amount of fluids. Take balsalazide disodium capsules with or without food.

2.2 Recommended

Dosage in Adults and Pediatric Patients 5 Years to 17 Years of Age Adults: The recommended dosage in adults is 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks. Pediatric Patients 5 Years to 17 Years of Age: The recommended dosage in pediatric patients 5 years to 17 years of age is either: 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks;

OR: 750 mg (one capsule) three times daily for up to 8 weeks. Use of balsalazide disodium capsules in the pediatric population for more than 8 weeks has not been evaluated in clinical trials.