FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year-old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive.
Other serious events have not been linked to Sucraid.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sucraid® (sacrosidase) Oral Solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
History
There is currently no drug history available for this drug.
Other Information
Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
Sucraid is a pale yellow to colorless, clear solution with a pleasant sweet taste. Each milliliter (mL) of Sucraid contains 8,500 International Units (I.U.) of the enzyme sacrosidase, the active ingredient. The chemical name of this enzyme is ß,D-fructofuranoside fructohydrolase. The enzyme is derived from baker’s yeast (Saccharomyces cerevisiae).
It has been reported that the primary amino acid structure of this protein consists of 513 amino acids with an apparent molecular weight of 100,000 g/mole for the glycosylated monomer (range 66,000-116,000 g/mole). Reports also suggest that the protein exists in solution as a monomer, dimer, tetramer, and octomer ranging from 100,000 g/mole to 800,000 g/mole. It has an isoelectric point (pI) of 4.5.
Sucraid may contain small amounts of papain. Papain is known to cause allergic reactions in some people. Papain is a protein-cleaving enzyme that is introduced in the manufacturing process to digest the cell wall of the yeast and may not be completely removed during subsequent process steps.
Sucraid contains sacrosidase in a vehicle comprised of glycerol (50% wt/wt), water, and citric acid to maintain the pH at 4.0 to 4.7. Glycerol (glycerin) in the amount consumed in the recommended doses of Sucraid has no expected toxicity.
This enzyme preparation is fully soluble with water, milk, and infant formula (DO NOT HEAT SOLUTIONS CONTAINING SUCRAID). Do not put Sucraid in warm or hot liquids.
Sources
Sucraid Manufacturers
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Qol Medical, Llc
Sucraid | Qol Medical, Llc
The recommended dosage is 1 or 2 mL (8,500 to 17,000 I.U.) or 1 or 2 full measuring scoops (each full measuring scoop equals 1 mL; 28 drops from the Sucraid container tip equals 1 mL) taken orally with each meal or snack diluted with 2 to 4 ounces (60 to 120 mL) of water, milk, or infant formula. The beverage or infant formula should be served cold or at room temperature. The beverage or infant formula should not be warmed or heated before or after addition of Sucraid because heating is likely to decrease potency. Sucraid should not be reconstituted or consumed with fruit juice since its acidity may reduce the enzyme activity.
It is recommended that approximately half of the dosage be taken at the beginning of the meal or snack and the remainder be taken during the meal or snack.
The recommended dosage is as follows:
1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight.
2 mL (17,000 I.U.) (two full measuring scoops or 56 drops) per meal or snack for patients over 15 kg in body weight.
Dosage may be measured with the 1 mL measuring scoop (provided) or by drop count method (1 mL equals 28 drops from the Sucraid container tip).
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