Sacrosidase

Pregnancy Category C.

Animal reproduction studies have not been conducted with sacrosidase. Sacrosidase is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sacrosidase should be given to a pregnant woman only if clearly needed.

The sacrosidase enzyme is broken down in the stomach and intestines, and the component amino acids and peptides are then absorbed as nutrients.

Long-term studies in animals with sacrosidase have not been performed to evaluate the carcinogenic potential. Studies to evaluate the effect of sacrosidase on fertility or its mutagenic potential have not been performed.

Adverse experiences with sacrosidase in clinical trials were generally minor and were frequently associated with the underlying disease.

In clinical studies of up to 54 months duration, physicians treated a total of 52 patients with sacrosidase. The adverse experiences and respective number of patients reporting each event (in parenthesis) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1).

Note: diarrhea and abdominal pain can be a part of the clinical presentation of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

One asthmatic child experienced a serious hypersensitivity reaction (wheezing) probably related to sacrosidase (seeWarnings). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.