Crotalus Horridus 800.0 C • Ignatia amara 21.0 D • Matricaria chamomilla 18.0 LM • Phosphorus 16.0 LM • Pituitarum Posterium 21.0 D. Other Ingredients: Ethanol.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Emvita 24. 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 Ignatius bean.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Emvita 24. 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. German chamomile has Generally Recognized as Safe (GRAS) status in the US (4912,110318).
POSSIBLY SAFE ...when used orally, for medicinal purposes, short-term. German chamomile has been used with apparent safety at doses of up to 1500 mg daily for up to 26 weeks (6655,12724,12729,13089,19377,19716,104806,111380). ...when applied topically. A lotion containing 0.2% microencapsulated German chamomile extract has been applied to the skin with apparent safety for up to 35 days (108993). ...when used topically as an oral rinse (99853).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Preliminary clinical research suggests that several multi-ingredient products containing German chamomile are safe in infants when used for up to 4 weeks (16735,19705,19715,96278). ...when used topically and appropriately, short-term. Six drops of oil infused with German chamomile flower has been applied nightly with apparent safety for up to 6 weeks in children 6-18 years old (98621).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately short-term (15). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term (104471). Long-term use or high doses used orally or rectally require monitoring of serum electrolytes (2494,2495,2496,2497,2498,3092,112922). ...when used intravenously. Potassium phosphate is an FDA-approved prescription drug (15).
POSSIBLY UNSAFE ...when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 4 grams daily for adults under 70 years and 3 grams daily for adults older than 70. Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when used rectally more frequently than once every 24 hours, in excessive doses, with longer retention enema time, or in older patients with comorbidity or renal impairment (112922). The US Food and Drug Administration (FDA) warns that this may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).
CHILDREN: LIKELY SAFE
when used orally and appropriately at recommended dietary allowances (RDAs).
The daily RDAs are: children 1-3 years, 460 mg; children 4-8 years, 500 mg; males and females 9-18 years, 1250 mg (7555). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term in children 2 years and older (104471). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).
CHILDREN: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 3 grams daily for children 1-8 years of age and 4 grams daily for children 9 years and older.
Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when sodium phosphate is used rectally more frequently than once every 24 hours, or in children under 2 years of age or with Hirchsprung disease (112922). The US Food and Drug Administration (FDA) warns that these uses may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately at the recommended dietary allowance (RDA) of 1250 mg daily for individuals 14-18 years of age and 700 mg daily for those over 18 years of age (7555).
...when sodium phosphate is used rectally and appropriately short-term (15). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL).
Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur. The UL during pregnancy is 3.5 grams daily. During lactation, the UL is 4 grams daily (7555).
Below is general information about the interactions of the known ingredients contained in the product Emvita 24. 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, German chamomile might have additive effects when used with CNS depressants.
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Theoretically, large amounts of German chamomile might reduce the effectiveness of oral contraceptives.
In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, concomitant use of large amounts of German chamomile might interfere with contraceptive drugs through competition for estrogen receptors.
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Theoretically, German chamomile might inhibit CYP1A2 and increase levels of drugs metabolized by these enzymes.
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Theoretically, German chamomile might inhibit CYP2C9 and increase levels of drugs metabolized by these enzymes.
In vitro evidence shows that German chamomile might inhibit CYP2C9 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2C9 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP2D6 and increase levels of drugs metabolized by these enzymes.
In vitro evidence shows that German chamomile might inhibit CYP2D6 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2D6 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP3A4 and increase levels of drugs metabolized by these enzymes.
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Theoretically, large amounts of German chamomile might reduce the effectiveness of estrogens.
In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, large amounts of German chamomile might interfere with hormone replacement therapy through competition for estrogen receptors.
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Theoretically, large amounts of German chamomile might interfere with the activity of tamoxifen.
In vitro, German chamomile has demonstrated antiestrogenic activity (12728).
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German chamomile might increase the effects of warfarin and increase the risk of bleeding.
In one case, a 70-year-old female taking warfarin developed retroperitoneal hematoma and bilateral recti muscle bleeding along with an INR of 7.9 following ingestion of German chamomile tea 4-5 cups daily and use of a topical chamomile-based lotion applied 4-5 times daily (14309).
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Theoretically, taking phosphate salts with bisphosphonates might increase the risk of hypocalcemia.
Combining bisphosphonates and phosphate can cause hypocalcemia. In one report, hypocalcemic tetany developed in a patient taking alendronate (Fosamax) who received a large dose of phosphate salts as a pre-operative laxative (14589).
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Taking erdafitinib with phosphate salts increases the risk of hyperphosphatemia.
Erdafitinib increases phosphate levels. It is recommended that patients taking erdafitinib restrict phosphate intake to no more than 600-800 mg daily (104470).
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Taking futibatinib with phosphate salts increases the risk of hyperphosphatemia.
Futibatinib can cause hyperphosphatemia, as reported in 88% of patients in clinical studies. In addition, 77% of patients in clinical studies required use of a phosphate binder to manage hyperphosphatemia. Phosphate salts should generally be avoided by people taking this medication (112912).
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Below is general information about the adverse effects of the known ingredients contained in the product Emvita 24. 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 and topically, German chamomile is well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions and irritation.
Dermatologic ...Topically, German chamomile may cause allergic dermatitis and eczema (9766,9768,10377,110318).
Gastrointestinal ...When used topically as an oral rinse, German chamomile has been reported to cause nausea and burning in the mouth in some patients (99853).
Immunologic ...Orally, German chamomile tea can cause allergic reactions including severe hypersensitivity reactions and anaphylaxis in some patients (567). In one case report, a 47-year-old female who tolerated drinking chamomile tea, reported sneezing, nasal and ocular itching, red and watery eyes, and severe rhinorrhea after 10 years of occupational exposure to German chamomile dust (90542).
Ocular/Otic ...If used near the eyes, German chamomile can cause irritation (10377).
General
...Orally, Ignatius bean is generally regarded as unsafe for use.
Any benefits of therapy may not outweigh the risk of toxicity. Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, can cause restlessness, anxiety, heightened sense perception, enhanced reflexes, equilibrium disorders, painful back and neck stiffness, twitching, spasms of jaw and neck muscles, myoglobinuric renal failure, rhabdomyolysis, extreme muscle tension, and agitation and difficulty breathing after respiratory spasms (55854). Seizures have been reported to occur within 15 minutes of Ignatius bean ingestion (17). Taking Ignatius bean at a dose of 1-2 grams can be fatal (18). Most deaths occur within 3-6 hours of ingestion and are due to respiratory and subsequent cardiac arrest, anoxic brain damage, or multiple organ failure secondary to hyperthermia (18,505).
Long-term consumption of Ignatius bean can cause strychnine accumulation, particularly in individuals with liver damage. Chronic use can cause death after a period of weeks (18).
By inhalation, Ignatius bean has been reported to cause seizures (17).
Cardiovascular ...Orally, Ignatius bean 1-2 grams has been reported to cause fatal cardiac arrest within 3-6 hours of ingestion (55853,55855).
Endocrine ...Orally, Ignatius bean 1-2 grams has been reported to cause hyperthermia resulting in multiple organ failure within 3-6 hours of ingestion (18,505).
Musculoskeletal ...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause rhabdomyolysis, painful back and neck stiffness, spasms of jaw and neck muscles, and extreme muscle tension (55854).
Neurologic/CNS
...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause restlessness, anxiety, heightened sense perception, enhanced reflexes, and twitching.
It has also been reported to cause seizures within 15 minutes of ingestion (55854). Taking 1-2 grams of Ignatius bean has been reported to cause death due to anoxic brain damage (18,505).
By inhalation, Ignatius bean has been reported to cause seizures within 5 minutes (17).
Pulmonary/Respiratory ...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause respiratory acidosis and difficulty breathing due to respiratory spasms (55854).
Renal ...Orally, Ignatius bean has been associated with myoglobinuric renal failure (55854).
Other ...Orally, Ignatius bean 1-2 grams can be fatal. Most deaths occur 3-6 hours after exposure and occur from respiratory and cardiac arrest, anoxic brain damage, or multiple organ failure due to hyperthermia (55853). Chronic use of lower doses of Ignatius bean has been reported to cause death after a period of weeks (55853).
General
...Orally, intravenously, and rectally, phosphate salts are generally well tolerated when used appropriately and/or as prescribed.
Most Common Adverse Effects:
Orally: Abdominal pain, anal irritation, bloating, diarrhea, headache, gastrointestinal irritation, hyperphosphatemia, hypocalcemia, malaise, nausea, sleep disturbance, and vomiting.
Rectally: Hyperphosphatemia and hypocalcemia.
Serious Adverse Effects (Rare):
Orally: Extraskeletal calcification.
Cardiovascular ...Orally, a case of allergic acute coronary syndrome e., Kounis syndrome) is reported in a 43-year-old female after ingesting a specific sodium phosphate laxative product (Travad oral). She presented with maculopapular rash that progressed to anaphylaxis and a non-ST elevation acute coronary syndrome. The patient recovered after hospitalization for 3 days with medical management (112894).
Gastrointestinal ...Orally, phosphate salts can cause gastrointestinal irritation, nausea, abdominal pain, bloating, anal irritation, and vomiting (15,2494,2495,2496,2497,93846,93848,93850,93851,93853,107008). Sodium and potassium phosphates can cause diarrhea (15). Aluminum phosphate can cause constipation (15). A large comparative study shows that, when taken orally as a bowel preparation for colonoscopy, sodium phosphate is associated with gastric mucosal lesions in about 4% of patients (93868).
Neurologic/CNS ...Orally, phosphate salts can commonly cause malaise (93846). Headaches and sleep disturbance may also occur (93848,93851).
Renal ...Orally, use of sodium phosphate for bowel cleansing has been associated with an increased risk of acute kidney injury in some patients (93863). However, a pooled analysis of clinical research suggests that results are not consistent for all patients (93864). Some evidence suggests that female gender, probably due to lower body weight, iron-deficiency anemia, dehydration, and chronic kidney disease are all associated with an increased risk of sodium phosphate-induced kidney dysfunction (93865).
Other
...Orally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia, and extraskeletal calcification.
Potassium phosphates can cause hyperkalemia. Sodium phosphates can cause hypernatremia and hypokalemia (15,2494,2495,2496,2497,107008).
Rectally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia (15,112922).
Deaths related to intake of oral or rectal phosphate salts are rare and most have occurred in infants and are related to overdose (93866). However, death has also been reported in elderly patients using sodium phosphate enemas, mainly at standard doses of 250 mL (93867).