Each capsule contains: Amylase (from aspergillus oryzae) 3000 DU • Protease Protease Note: 250,000 HUT/G (from A. oryzae) 20,200 HUT • Glucoamylase (from A. oryzae) 10 AGU • Protease Protease Note: 250,000 HUT/G (from A. niger) 10.1 SAPU • Invertase (from saccharomyces cerevisiae) 400 SU • Lipase (from candida rugosa) 480 FIP • Lipase (from A. niger) 10 FIP • Lipase (from rhizopus oryzae) 10 FIP. Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Capsule (hypromellose, sorbitol, silicon dioxide, water).
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Digestase. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.
Below is general information about the safety of the known ingredients contained in the product Digestase. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the safety of lipase.
CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants.
Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Digestase. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product Digestase. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...No adverse effects have been reported in adults.
However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.
Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).
General
...Orally, proteolytic enzymes are generally well tolerated.
See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.
Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).
Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).
