Each capsule contains: Proprietary Blend 650 mg: Amargo , Simarouba , Boldo , Fedegoso , Carqueja , Quinine , Erva Tostao , Epazote , Anamu , Graviola powder .
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 Amazon A P. 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
There is insufficient reliable information available about the effectiveness of carqueja.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of simaruba.
Below is general information about the safety of the known ingredients contained in the product Amazon A P. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Boldo has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. The volatile oil (2.5% in the leaf) contains the liver toxin ascaridole (4). Boldo has also been linked to a documented case of liver damage (13178). If boldo preparations are taken for medicinal purposes, only ascaridole-free preparations should be used. There is insufficient reliable information available about the safety of boldo when used topically.
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts.
In animals, boldo and the constituent boldine have abortive and teratogenic effects (100302). Also, the ascaridole constituent of boldo is a liver toxin (4).
There is insufficient reliable information available about the safety of carqueja.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally as a flavoring in tonic water and alcoholic beverages. The US Code of Federal Regulations allows not more than 83 parts per million (ppm) of total cinchona alkaloids in finished beverages (93229).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Cinchona derivatives marketed as over-the-counter (OTC) medicines are required to carry the warning, "Caution - discontinue use if ringing in the ears, deafness, skin rash, or visual disturbances occur" (93231). Cinchona contains the alkaloid quinine that was previously available OTC in the US for treatment and prevention of nocturnal leg muscle cramps. In 1994 the US Food and Drug Administration (FDA) determined that quinine was not generally recognized as safe and effective for this indication, citing serious adverse reactions and its narrow therapeutic index (93232,93233). A final ban on marketing of OTC quinine products was implemented by the FDA in 2007, and a Risk Evaluation and Mitigation Strategy (REMS) to reduce off-label use of prescription quinine products for night-time leg cramps was introduced in 2010 (93232).
LIKELY UNSAFE ...when excessive amounts are used orally. Cinchona contains the alkaloids quinine and quinidine, which are used as prescription medicines and have been associated with significant adverse effects at doses of 2 grams per day or more (505). The amount of these constituents in cinchona products is variable (13).
PREGNANCY: LIKELY UNSAFE
when used orally.
Cinchona is reported to have uterine stimulant and abortifacient activity, and to be fetotoxic and teratogenic, causing visual and auditory defects (12,19). Avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally.
The cinchona alkaloids quinine and quinidine are reported to be excreted in breast milk and may be toxic to infants (19).
POSSIBLY UNSAFE ...when used orally. Some research has found that consumption of large amounts of graviola fruit and/or tea made from graviola leaves (e.g., daily) is associated with an increased odds of having movement disorders that resemble Parkinson disease (7854).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally (7854).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Quassia has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used topically and appropriately. A 4% quassia gel has been safely used twice daily for up to 45 days (99995).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Quassia wood contains cardioactive glycosides (4), but toxicity is likely limited by emetic effects of large doses (4). There is insufficient reliable information available about the safety of rectal use of quassia.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally; avoid using.
Quassia has cytotoxic and emetic properties (4,18,19). There is insufficient reliable information available about the safety of rectal or topical use during pregnancy or lactation; avoid using.
There is insufficient reliable information available about the safety of simaruba.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally during pregnancy due to apparent abortifacient effects (18,4500); avoid using.
There is insufficient reliable information available about the safety of simaruba during lactation.
Below is general information about the interactions of the known ingredients contained in the product Amazon A P. 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, taking boldo with anticoagulant/antiplatelet drugs might increase the risk of bleeding.
Details
Animal and in vitro research shows that boldine, a constituent of boldo, has antiplatelet activity (5191,36789). In one case report, an adult taking a combination of boldo and fenugreek with warfarin experienced an increase in international normalized ratio (INR); however, it is unclear if this effect was due to boldo, fenugreek, the combination, or another factor (5191).
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Theoretically, taking boldo with hepatotoxic drugs might increase the risk of hepatic injury and disease.
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Theoretically, taking boldo with lithium might increase the levels and clinical effects of lithium.
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Boldo is believed to have diuretic effects (4). Theoretically, these diuretic effects might reduce the excretion of lithium. The dose of lithium might need to be decreased.
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Taking boldo with tacrolimus may decrease the levels and clinical effects of tacrolimus, potentially increasing the risk of transplant rejection.
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In one case report, a patient with a long-term history of stable tacrolimus levels developed subtherapeutic levels after taking boldo 300 mg twice daily orally for several weeks. Tacrolimus levels returned to normal after discontinuing boldo. However, the mechanism of this interaction is unclear (92601).
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Theoretically, carqueja might lower blood glucose levels (13585,13588) and might have additive effects when used with antidiabetes drugs. This might increase the risk of hypoglycemia in some patients. Monitor blood glucose levels closely. Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.
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Theoretically, concomitant use of chenopodium oil with other photosensitizing drugs can increase the risk of adverse effects.
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Chenopodium species are also associated with photosensitivity (19).
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Theoretically, taking cinchona might decrease the effectiveness of antacids. Theoretically, taking antacids might also increase the risk of adverse effects from cinchona.
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Some research shows that taking cinchona lowers stomach acid pH (19). In addition, some research shows that taking antacids might increase urinary pH. Theoretically, this may increase the amount of quinidine, a constituent of cinchona, reabsorbed in the renal tubules and increase the risk of quinidine toxicity (3046).
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Theoretically, taking cinchona might increase the drug effects and risk of bleeding with anticoagulant and antiplatelet drugs.
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Theoretically, taking cinchona might increase the adverse effects of carbamazepine.
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Clinical research shows that taking quinine, a constituent of cinchona, increases the peak plasma concentration and area under the curve of carbamazepine (11016).
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Theoretically, taking cinchona might inhibit cytochrome P450 2D6 (CYP2D6) and increase levels of drugs metabolized by this enzyme.
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Theoretically, taking cinchona might increase serum levels of digoxin.
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Quinine and quinidine, which are constituents of cinchona, decrease clearance of digoxin and increase serum digoxin levels in humans (3046).
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Theoretically, taking cinchona might decrease the effectiveness of H2-blockers.
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Some research shows that taking cinchona lowers stomach acid pH (19).
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Theoretically, taking cinchona might increase the adverse effects of phenobarbital.
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Theoretically, taking cinchona might decrease the effectiveness of PPIs.
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Some research shows that taking cinchona lowers stomach acid pH (19).
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Theoretically, taking cinchona with other QT interval-prolonging drugs might cause an additive effect and increase the risk of ventricular arrhythmias.
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Quinidine and quinine, which are constituents of cinchona, prolong the QT interval (3046).
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Theoretically, taking cinchona might increase plasma levels and adverse effects of quinidine.
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Cinchona contains quinidine (505).
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Theoretically, taking cinchona might increase plasma levels and adverse effects of quinine.
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Cinchona contains quinine (505).
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Theoretically, graviola might decrease concentrations of carbamazepine when used concomitantly.
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A study in rats shows that graviola extract reduces the area under the curve of carbamazepine by 46% and maximum concentration by 35% when compared with carbamazepine alone (112852).
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Theoretically, due to reports that quassia increases stomach acid, quassia might decrease the effectiveness of antacids (19).
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In animals, quassia extract reduced levels of fasting glucose (99998). Theoretically, quassia might have additive effects when used with antidiabetes drugs. This might increase the risk of hypoglycemia in some patients. Monitor blood glucose levels closely.
Details
Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.
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Quassin and neoquassin, constituents of quassia, have been shown to inhibit cytochrome P450 1A1 (CYP1A1) enzymes in vitro (99996). This effect has not been shown in humans. Theoretically, concomitant use of quassia with drugs metabolized by CYP1A1 may decrease the clearance of these drugs and increase their effects. Some of these drugs include chlorzoxazone, theophylline, and bufuralol.
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Theoretically, concomitant use with cardiac medications might increase the risk of therapeutic and adverse effects (4).
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Overuse of quassia might compound diuretic-induced potassium loss (13). There is some concern that people taking quassia along with potassium depleting diuretics might have an increased risk for hypokalemia. Initiation of potassium supplementation or an increase in potassium supplement dose may be necessary for some patients.
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Some diuretics that can deplete potassium include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), and hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), and others.
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Theoretically, due to reports that quassia increases stomach acid, quassia might decrease the effectiveness of H2-blockers (19). The H2 blockers include cimetidine (Tagamet), ranitidine (Zantac), nizatidine (Axid), and famotidine (Pepcid).
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Theoretically, due to reports that quassia increases stomach acid, quassia might decrease the effectiveness of PPIs (19). PPIs include omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esomeprazole (Nexium).
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Below is general information about the adverse effects of the known ingredients contained in the product Amazon A P. 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, boldo is generally well tolerated when used in amounts commonly found in foods.
However, when used in medicinal amounts, boldo can cause significant adverse effects such as hepatotoxicity. There is currently a limited amount of information on the adverse effects of topical boldo; however, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal pain, nausea, vomiting.
Topically: Dermatitis.
Severe Adverse Effects (Rare):
Orally: Hepatotoxicity, jaundice.
Cardiovascular ...In one report, a 39-year-old obese female developed palpitations and syncope after taking a weight loss supplement containing a combination of boldo, dandelion, and bladderwrack for 3 weeks. The patient was found to have prolonged QT-interval on ECG and frequent episodes of sustained polymorphic ventricular tachycardia (14321). It is not clear whether boldo, another ingredient, or the combination of ingredients is responsible for this adverse effect. The product was not analyzed to determine the presence of any potential toxic contaminants.
Dermatologic ...Topically, boldo can be irritating when applied to the skin (4). In one case report, a healthy 64-year-old patient experienced allergic contact dermatitis in an airborne pattern on the face, arms, and dorsum of both hands following airborne exposure to boldo. After exposure to boldo was avoided, the dermatitis resolved (106433).
Gastrointestinal ...In one case report, a manufacturer of an herbal laxative reformulated their product to contain boldo. Within 5 months of switching to this reformulated product, an 82-year-old male developed abdominal discomfort with gastrointestinal upset including heartburn (13178). In another case, a 72-year-old female reported nausea, vomiting, and anorexia, which were thought to be associated with hepatotoxic effects of a boldo infusion (100304).
Hepatic ...Orally, boldo is thought to potentially cause hepatotoxicity. The volatile oil from the boldo leaf contains the liver toxin, ascaridole. In one case report, a manufacturer of an herbal laxative reformulated their product to contain boldo. Within 5 months of switching to this reformulated product, an 82-year-old male with mild hepatic steatosis and very small gallbladder stones developed elevated liver transaminase levels. Levels normalized following discontinuation of the herbal product (13178). Several other cases of hepatotoxicity have been reported in elderly patients who received infusions of boldo leaves. These patients presented with elevated liver transaminase and bilirubin levels, sometimes up to 200 times the upper limit of normal, as well as nausea, vomiting, anorexia, asthenia, and jaundice. Lab tests and symptoms normalized a few days after stopping boldo (100304,106431).
Immunologic ...Boldo intake has been linked to one case of IgE-mediated anaphylactic allergic reaction (13185).
General ...No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, chenopodium oil is unsafe.
Most Common Adverse Effects:
Orally: Dizziness, headache, mucous membrane irritation, skin irritation, vertigo, vomiting.
Serious Adverse Effects (Rare):
Orally: Circulatory collapse, convulsions, deafness, death, kidney and liver damage, paralysis.
Dermatologic ...Orally, chenopodium oil can cause skin and mucous membrane irritation (11).
Gastrointestinal ...Orally, chenopodium oil can cause vomiting (11).
Hepatic ...Orally, chenopodium oil can cause liver damage (11).
Neurologic/CNS ...Orally, chenopodium oil affects the nervous system and can cause headache, vertigo/dizziness, temporary deafness, convulsions, circulatory collapse, paralysis, and death (11).
Renal ...Orally, chenopodium oil can cause kidney damage (11).
General
...Information on the adverse effects of cinchona is limited.
Orally, prolonged use of high doses of cinchona can cause severe adverse effects. Topically, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, nausea, ringing ears, vomiting.
Topically: Contact dermatitis, urticaria.
Serious Adverse Effects (Rare):
Orally: Arrhythmias, cinchonism syndrome, hemolytic uremic syndrome, QT prolongation, thrombotic thrombocytopenic purpura.
Cardiovascular ...Cinchona contains the alkaloids quinidine and quinine that can prolong the QT interval on the electrocardiogram, and cause potentially fatal cardiac arrhythmias such as torsades de pointes (3046,93232)
Dermatologic ...Topical use of cinchona bark extracts and occupational exposure to cinchona bark dust can cause contact dermatitis and other urticarial reactions (11,93234). A 31-year old man developed itching, erythema, and edema of the face and upper chest after occupational exposure to dust from cinchona bark. Skin testing produced reactions to ethanol and ether extracts of the bark, but not to the individual alkaloids quinine and quinidine (93234).
Gastrointestinal ...Cinchona stimulates secretion of stomach acid and has been associated with nausea, vomiting, and diarrhea (6,19).
Hematologic ...Quinine, which is present in cinchona, has been associated with serious, sometimes fatal, hematological disorders including thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and hemolytic uremic syndrome (hemolytic anemia, acute renal failure, and thrombocytopenia) (93232,93233). Initial symptoms may include bleeding from the gums, nose or gastrointestinal tract, easy bruising, and petechiae (93233). Bone marrow depression and thrombocytopenia have also been associated with quinidine (505).
Immunologic ...Oral use of quinine, an alkaloid present in cinchona, has been associated with severe allergic skin reactions, as well as anaphylaxis (19,93232).
Ocular/Otic ...Cinchona contains quinine that can cause dose-related adverse effects on hearing and vision, including tinnitus, deafness, vision changes, and blindness (6,8,12,93232).
Other ...Orally, prolonged use of high doses of cinchona or its alkaloids, or a single dose of 3 grams or more of the alkaloid quinine are associated with a toxicity syndrome known as cinchonism. Symptoms include headache, dizziness, nausea and vomiting, diarrhea, hemolysis, hypotension, cardiac arrhythmias, tinnitus, deafness, vision changes, blindness, abdominal pain, delirium, convulsions, paralysis, and collapse (6,12,19,505,93232). Doses of 10-15 grams of quinine may be fatal (18).
General
...Orally, regular consumption of graviola may be unsafe.
Most Common Adverse Effects:
Orally: Epigastrium pain, nausea.
Serious Adverse Effects (Rare):
Orally: Movement disorders, myeloneuropathy.
Gastrointestinal ...In one clinical study, some patients reported nausea and burning pain in the epigastrium after taking graviola leaf extract 300 mg daily (95045).
Neurologic/CNS ...Orally, regular consumption of graviola fruit may cause movement disorders and myeloneuropathy. The symptoms of these disorders are similar to Parkinson disease (7854). In addition, a large observational study in patients with Parkinson disease suggests that even low cumulative consumption of graviola fruit, juice, or any amount of herbal tea containing graviola is associated with worsened motor and cognitive symptoms (112854).
General
...Orally, quassia can cause mucous membrane irritation, nausea, and vomiting when used in medicinal amounts (4,18).
Long-term use can cause vision changes and blindness (18).
Topically, quassia seems to be well tolerated (99995). No adverse effects have been reported.
Gastrointestinal ...Orally, quassia has been reported to cause mucous membrane irritation, nausea, and vomiting when used in medicinal amounts (4,18).
Ocular/Otic ...Orally, long-term use of quassia can cause vision changes and blindness (18).