| Ingredients | Amount Per Serving |
|---|---|
|
Digestive Blend
|
65 mg |
|
Amylase
(1560 SKB)
|
|
|
(390 HUT)
|
|
|
Cellulase
(13 CU)
|
|
|
(260 ALU)
|
|
|
(65 FIP)
|
|
|
(Papaya Enzyme (Form: Papain))
|
50 mg |
|
(Bromelain)
(70 GDU/g)
|
50 mg |
|
(aerial parts)
|
50 mg |
| 5 mg |
Dicalcium Phosphate, Silicon Dioxide (Alt. Name: SiO2), Stearic Acid (Alt. Name: C18:0), Croscarmellose Sodium, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose, Polyethylene Glycol
Below is general information about the effectiveness of the known ingredients contained in the product SuperDigest. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
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 SuperDigest. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when the leaves are used orally and appropriately, short-term (4,6,12).
LIKELY UNSAFE ...when large amounts are used long-term. Chronic ingestion of alfalfa has been associated with drug-induced lupus effects (381,14828,30602).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Alfalfa contains constituents with possible estrogenic activity (4,11,30592).
POSSIBLY SAFE ...when taken orally as a single dose of up to 1500 mg (93328,93329). There is insufficient reliable information available about the safety of betaine hydrochloride when used in multiple doses.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Doses up to 240 mg daily have been used safely for up to a year (6252,6253,10622,11457,18281,18284,91104,91105,91106,91111)(96449,103298). Higher doses up to 3200 mg daily have been used safely, short-term (18283,110546). ...when used topically and appropriately. Bromelain has been used safely as a debriding agent for up to 4 hours (18275,91113,103297,108148,108149).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately with lactose-containing foods. Lactase has Generally Recognized as Safe (GRAS) status in the US when prepared from Candida pseudotropicalis or Kluyveromyces lactis (104108,104109). Lactase has been used safely in doses up to 9900 international units (IU) and up to 13,500 food chemical codex (FCC) units (2371,2372,2373,106669).
CHILDREN: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
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.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Papain has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes, short-term. Papain has been used in combination with other proteolytic enzymes at a dose of up to 1200 mg daily for up to 9 weeks (964,965,968,67831,67834). ...when used topically as a diluted solution in appropriate doses for up to 20 minutes (67835,67843,67845).
POSSIBLY UNSAFE ...when used orally in large amounts. In excessive doses, papain can cause significant side effects including esophageal perforation (6). ...when raw papain is used topically. Raw papain or papaya latex is a severe irritant and vesicant (6).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
There is some concern that crude papain is teratogenic and embryotoxic (6).
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 SuperDigest. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, alfalfa might increase the risk of hypoglycemia when taken with antidiabetes drugs.
 Details
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Theoretically, alfalfa might interfere with the activity of contraceptive drugs.
Details
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Theoretically, alfalfa might interfere with hormone therapy.
Details
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Theoretically, alfalfa might decrease the efficacy of immunosuppressive therapy.
Details
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Theoretically, concomitant use of alfalfa with photosensitizing drugs might have additive effects.
Details
Animal research suggests that excessive doses of alfalfa may increase photosensitivity, possibly due to its chlorophyll content (106043). It is unclear if this effect would be clinically relevant in humans.
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Theoretically, alfalfa might reduce the anticoagulant activity of warfarin.
Details
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Betaine hydrochloride increases stomach acidity and could decrease the effects of antacids.
Details
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Betaine hydrochloride increases stomach acidity and could decrease the effects of H2-blockers.
Details
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Betaine hydrochloride increases stomach acidity and could decrease the effects of PPIs.
Details
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Bromelain may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
There is one case report of a patient experiencing minor bruising while taking bromelain with naproxen (14806). Bromelain is thought to have antiplatelet activity (10639,14806,18285,18286,37234). Whether this interaction is of concern with topical bromelain is unclear. Interference with coagulation of burn wounds has been reported in a patient receiving bromelain-based enzymatic debridement. However, observational research has found that topical bromelain debridement is not associated with increases or decreases in laboratory markers of coagulation when compared with surgical debridement (110547).
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Theoretically, bromelain might increase levels of tetracycline antibiotics.
Details
Laboratory research suggests that bromelain might increase the absorption of tetracycline antibiotics. However, a study in healthy adults reported no difference in tetracycline plasma levels when a 500 mg dose was taken with or without bromelain 80 mg (14296).
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Theoretically, papain might increase the effects and side effects of warfarin.
Details
In one case report, a patient previously stable on warfarin was found to have an international normalization ratio (INR) of 7.4, which was attributed to ingestion of a supplement containing papain from papaya extract (613).
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Below is general information about the adverse effects of the known ingredients contained in the product SuperDigest. 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
...Orally, alfalfa leaf seems to be well tolerated.
However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, and flatulence.
Serious Adverse Effects (Rare):
Orally: Lupus-like syndrome after chronic ingestion of alfalfa.
Dermatologic ...Dermatitis associated with alfalfa use has been reported. In a 1954 publication, dermatitis was noted in a 61-year-old female consuming 4-6 cups of tea made with two tablespoonfuls of alfalfa seeds for approximately two months prior to onset. Examination revealed diffuse, confluent edema and erythema on the face, eyelids, ears, hands, forearms, and distal humeral regions. The dermatitis improved with treatment; re-exposure to alfalfa resulted in a similar reaction (30609).
Endocrine
...Alfalfa contains constituents, including coumestrol, with reported estrogenic activity (30586,30592,4753).
Effects in humans are not known.
One case report documents hypokalemia in a female who had been drinking a "cleansing tea" containing alfalfa, licorice, and stinging nettle. The potassium level returned to normal after discontinuing the tea and initiating potassium supplementation. The specific cause of the hypokalemia is not clear. Notably, both stinging nettle and licorice have been associated with hypokalemia and may have been responsible for this effect (30562).
Gastrointestinal ...Orally, flatulence and bulkier feces were reported during the first week of a case series of three subjects ingesting alfalfa (30598). In a case series of 15 patients ingesting alfalfa, increased fecal volume and increased stool frequency was reported. Additional adverse effects included abdominal discomfort in two patients, diarrhea in two patients, loose stools in six patients, and intestinal gas in 13 patients (5816).
Hematologic ...Pancytopenia and splenomegaly were reported in a 59-year-old male who had been taking 80-160 grams of ground alfalfa seeds for up to six weeks at a time, for a five month period. Hematologic values and spleen size returned to normal when alfalfa was discontinued (381).
Other
...Alfalfa products, including sprouts, seeds, and tablets, have been found to be contaminated with Escherichia coli, Salmonella, and Listeria monocytogenes, which have caused documented infections (5600,30566,30568,30572,30569,30564,30604,30610,30563,30607) (30566,30564,30604,30610,30563,30607,30576).
Orally, alfalfa has been associated with the development of a lupus-like syndrome in animals and humans (30594,14828,14830,30602), as well as with possible exacerbations of lupus in patients with known systemic lupus erythematosus (SLE). These reactions may be associated with the amino acid L-canavanine (30594), which appears to be present in alfalfa seeds and sprouts, but not leaves, and therefore should not be present in alfalfa tablets manufactured from the leaves (30601). However, case reports have included individuals ingesting tablets. A lupus-like syndrome was described in four patients taking 12-24 alfalfa tablets per day. Symptoms included arthralgias, myalgias, and rash; positive antinuclear antibodies (ANA) arose anywhere from three weeks to seven months after initiating alfalfa therapy. Upon discontinuation of alfalfa tablets, all four patients became asymptomatic. In two patients, ANA levels normalized (14828). Two additional reports have documented possible exacerbation or induction of SLE associated with alfalfa use. One case involved a female with a 26-year history of SLE, who had been taking 15 tablets of alfalfa daily for nine months prior to an exacerbation. Because of the delay in onset of the exacerbation from the initiation of alfalfa therapy, causation cannot be clearly established (30575). In a different report, SLE and arthritis were found in multiple family members who had been taking a combination of vitamin E and alfalfa tablets for seven years (30602). It is not known what other environmental or genetic factors may have affected these individuals, and the association with alfalfa is unclear.
General ...Orally, betaine hydrochloride is generally well tolerated when taken as a single dose.
Gastrointestinal ...Theoretically, the hydrochloric acid produced from betaine hydrochloride might irritate gastric or duodenal ulcers or impede ulcer healing. It might also cause heartburn.
General
...Orally, bromelain seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, flatulence, gastric upset, headache.
Topically: Pruritus, urticaria.
Dermatologic
...Topically, bromelain may cause dermal allergic reactions including urticaria, pruritus, and skin swelling (9184).
Redness, swelling, burning, pain at the application site, and cellulitis have also been reported rarely (108148,113513). In one case, a fixed drug eruption with pruritis near the groin was reported in a 33-year-old male taking bromelain 50 mg orally daily for 10 days. After discontinuation of bromelain and treatment with topical corticosteroid, the lesion resolved. Upon re-challenge with bromelain, the lesion reappeared in the same area (103300).
In another case report, a 61-year-old male with a history of chronic lower leg ulceration secondary to chronic venous hypertension and recurrent deep vein thrombosis on rivaroxaban presented with a deep-dermal burn on his lower calf. Bromelain-based topical enzymatic debridement agent Nexobrid 2 grams was applied to the burn site. Thirty minutes later, the patient experienced two instances of hemorrhage at the site of debridement. The patient was stabilized and treated with fluids, packed red cells, and tranexamic acid, and then the Nexobrid was removed (111656). Caution should be used in patients with underlying coagulopathies.
Gastrointestinal ...Orally, bromelain may cause gastrointestinal disturbances, including diarrhea, nausea, vomiting, flatulence, and abdominal pain (9184,18274,18282,96216,113513).
Immunologic
...Immunoglobulin E (IgE)-mediated allergic reactions to bromelain may occur (9184).
If inhaled, bromelain may cause sensitization and allergic reactions such as asthma (37199,37215,37233). In case reports of occupational inhalation of bromelain, additional allergic symptoms included difficulty swallowing, throat itching, eye irritation, and rhinitis (37214).
General ...Orally, lactase is generally well tolerated.
Immunologic ...A case of lactase-induced contact dermatitis and immunoglobulin E (IgE)-mediated allergic rhinoconjunctivitis has been reported in a worker exposed to powdered lactase. Allergy to lactase was confirmed by prick test, open application test, and chamber challenge test (96348).
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 and topically, papain seems to be well tolerated when used short-term at appropriate doses.
Taking high oral doses may be unsafe.
Most Common Adverse Effects:
Orally: Allergic reactions in sensitive individuals.
Topically: Urticaria and pruritus in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Esophageal perforation and severe gastritis with high doses.
Dermatologic ...Topically, papain can cause itching (966). Urticarial reactions and itching have been reported in people occupationally exposed to papain, with papain confirmed as the causative agent by skin prick tests or radioallergosorbent tests (RAST) (95533,95534). In a randomized controlled trial assessing the effects of papain, trypsin, and chymotrypsin on adverse effects from radiotherapy, moderate to severe epitheliolysis was more frequent in the enzyme-treated group than the placebo group (67834). It is unclear if this adverse effect is due to papain, other enzymes, or the combination.
Gastrointestinal ...Orally, papain has been associated with diarrhea. In a randomized controlled trial assessing the effects of papain, trypsin, and chymotrypsin on adverse effects from radiotherapy, moderate to severe diarrhea was more frequent in the enzyme-treated group than the placebo group (67834). However, it is unclear if this adverse effect is due to papain, other enzymes, or the combination. Papain has also been associated with gastric ulcers and esophageal perforation in case reports of phytobezoars treated with papain (67848). In general, large amounts of papain can cause esophageal perforation (6). Ingestion of papaya latex (raw papain) can cause severe gastritis.
Genitourinary ...Orally, papain has been associated with hypernatremia in case reports of phytobezoars treated with papain (67848).
Immunologic ...Orally, papain may cause allergic reactions, including itchy watery eyes, runny nose, sneezing, abdominal cramps, sweating, and diarrhea, in individuals sensitive to papain (6,967). Occupational exposure to airborne papain dust may also cause respiratory allergic reactions (95532,95533,95534,95535,95536).
Pulmonary/Respiratory ...Occupational exposure to airborne papain dust may cause respiratory allergic reactions. Symptoms include rhinitis, sneezing, conjunctivitis, dyspnea, wheezing, cough, and asthma. In most cases, papain is confirmed as the causative agent by skin prick tests, radioallergosorbent tests (RAST), or detection of papain-specific immunoglobulin E (IgE) and IgG (95532,95533,95534,95535,95536).
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).
