SUCRAID (sacrosidase)

CLINICAL STUDIES A two-phase (dose response preceded by a breath hydrogen phase) double-blind, multi-site, crossover trial was conducted in 28 pediatric patients (approximately 5 months to 12 years of age) with confirmed CSID. During the dose response phase, the patients were challenged with an ordinary sucrose-containing diet while receiving each of four doses of sacrosidase: full strength (9000 I.U./mL) and three dilutions (1:10 [900 I.U./mL], 1:100 [90 I.U./mL], and 1:1000 [9 I.U./mL]) in random order for a period of 10 days. Patients who weighed no more than 15 kg received 1 mL per meal; t...

ADVERSE REACTIONS The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid. The reported adverse reactions (number ...

CONTRAINDICATIONS Sucraid is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain (see WARNINGS).

Drug Interactions Fruit Juice The acidity in fruit juice may reduce the enzyme activity in Sucraid. Administration of Sucraid with liquids other than water, milk, or infant formula has not been studied and is not recommended (see DOSAGE AND ADMINISTRATION, Administration Instructions).