sacrosidase

FDA Drug Profile — Sucraid

Drug Details

Generic Name
sacrosidase
Brand Names
Sucraid
Application Number
BLA020772
Sponsor
QOL Medical, LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
SACROSIDASE

Indications and Usage

INDICATIONS AND USAGE Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.

Warnings

WARNINGS Severe Hypersensitivity Reactions Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid. Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION). A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization. Postmarketing cases of cutaneous hypersensitivity reactions have also been reported. Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur. Sucraid is contraindicated in patients who have had a known hypersensitivity reaction (see CONTRAINDICATIONS).