Indication
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.
Contraindication
Sucraid® is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.
Warnings, Precautions, and Additional Important Safety Information
- Severe Hypersensitivity Reactions
Severe hypersensitivity reactions, including wheezing, difficulty breathing, rash, pruritis, and swelling of the face, lips, mouth, or tongue have been reported with administration of Sucraid®. Sucraid® contains papain, which is associated with hypersensitivity reactions.
- Increased Blood Glucose Concentration in Patients With Diabetes Mellitus
Sucraid® enables the products of sucrose hydrolysis, glucose and fructose, to be absorbed and may increase blood glucose concentrations. Monitor blood glucose concentrations and adjust the diet accordingly for patients with diabetes mellitus.
- Dietary Starch Restriction
Sucraid® does not replace isomaltase. Therefore, patients may still experience symptoms of CSID while taking Sucraid®. Consider dietary starch restriction in addition to Sucraid®, especially in patients in whom symptoms are not adequately controlled by Sucraid®.
- Adverse reactions as a result of taking Sucraid® may include worse abdominal pain, vomiting, nausea, diarrhea, constipation, difficulty sleeping, headache, nervousness, and dehydration.
- The effects of Sucraid® have not been evaluated in patients with secondary (acquired) disaccharidase deficiency.
- DO NOT HEAT SOLUTIONS CONTAINING SUCRAID®. Do not put Sucraid® in warm or hot fluids. Do not reconstitute or consume Sucraid® with fruit juice since the acidity of the juice may reduce the enzyme activity of Sucraid®. Half of the reconstituted Sucraid® should be taken at the beginning of the meal or snack and the other half during the meal or snack.
- Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light; single-use containers can be removed from refrigeration and stored at 59°F-77°F (15°C-25°C) for up to 3 days (72 hours). Refer to Instructions for Use for full information on how to take Sucraid®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.