Dosage & Administration

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Children Older than 12 Months and Younger than 4 Years

Administer PERTZYE during meals or snacks, with sufficient fluid.

Swallow PERTZYE capsules whole.

Do not crush or chew the capsules or the capsule contents.

For patients unable to swallow intact capsules, see the full prescribing information for instructions on opening the capsules and administering orally or via a gastrostomy tube.

Dosage

Administration

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

Infants (up to 12 months)

Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding.

Do not mix PERTZYE capsule contents directly into formula or breast milk prior to administration.

Limitations on Dosing

Dosage Forms & Strengths

Delayed-Release Capsules:

    - 4,000 USP units of lipase, 14,375 USP units of protease, 15,125 USP units of amylase

    - 8,000 USP units of lipase, 28,750 USP units of protease, 30,250 USP units of amylase

    - 16,000 USP units of lipase, 57,500 USP units of protease, 60,500 USP units of amylase

    - 24,000 USP units of lipase, 86,250 USP units of protease, 90,750 USP units of amylase

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