Important Preparation and Administration Instructions

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Evaluate renal function before initiating therapy with COLAZAL [see Warnings and Precaution (5.1)].

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Swallow COLAZAL capsules whole. Do not cut, break, crush or chew the capsules.

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For patients who cannot swallow intact capsules, COLAZAL 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.

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Place a small amount (approximately 10 mL) of applesauce into a clean container.

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Carefully open the capsules.

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Sprinkle the capsule contents on the applesauce.

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Mix the capsule contents with the applesauce. The contents may be chewed, if necessary.

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Consume the entire amount of applesauce mixture immediately. Do not store the applesauce mixture for future use.

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Teeth and/or tongue staining may occur in some patients when administered sprinkled on applesauce.

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Drink an adequate amount of fluids [see Warnings and Precautions (5.8)].

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Take COLAZAL with or without food [see Clinical Pharmacology (12.3)].

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:

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2.25 g (three 750 mg capsules) three times daily for up to 8 weeks;

OR:

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

Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials [see Clinical Studies (14)].