Caulophyllum thalictroides 6 X. Other Ingredients: Lactose.
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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 Caulophyllum Thalictroides Tablets. 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 effectiveness of blue cohosh.
Below is general information about the safety of the known ingredients contained in the product Caulophyllum Thalictroides Tablets. 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 UNSAFE ...when used orally (4,12). Poisonings have occurred after ingestion of blue cohosh leaf or seeds (4).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Blue cohosh is a uterine stimulant and can induce labor (12047). Several blue cohosh constituents, such as anagyrine and N-methylcytisine, are potentially teratogenic and might cause congenital malformations in newborns (1122,7110,36718,94534). Use of blue cohosh near term can cause life-threatening toxicity in the infant (1207,9492,9493,12047,36725), as well as severe toxicity in the mother (36720). Many midwives still use blue cohosh to facilitate delivery. This dangerous practice should be avoided (1122,1207).
Below is general information about the interactions of the known ingredients contained in the product Caulophyllum Thalictroides Tablets. 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 some concern that blue cohosh might increase blood glucose levels (6002,36724). Theoretically, it might decrease the effectiveness of medicines used for diabetes. Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), chlorpropamide (Diabinese), glipizide (Glucotrol), tolbutamide (Orinase), and others.
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Constituents in blue cohosh might increase blood pressure by causing coronary vasoconstriction (6002). Theoretically, concomitant use might decrease the effectiveness of drugs used for angina and high blood pressure; use with caution. Some antihypertensive drugs include captopril (Capoten), enalapril (Vasotec), losartan (Cozaar), valsartan (Diovan), diltiazem (Cardizem), Amlodipine (Norvasc), hydrochlorothiazide (HydroDiuril), furosemide (Lasix), and many others.
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Blue cohosh can increase the effects of nicotine (6002).
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Below is general information about the adverse effects of the known ingredients contained in the product Caulophyllum Thalictroides Tablets. 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, blue cohosh can cause significant adverse effects including mucous membrane irritation, stomach upset including diarrhea and cramping, chest pain (angina), hypertension, and hyperglycemia (6002).
Neonatal acute myocardial infarction (MI), congestive heart failure (CHF), and shock has occurred following maternal use of a blue cohosh combination product one month before delivery (566,3383,94534). There is also a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94534). In another case, a mother was advised to drink a blue cohosh tea to induce labor. The infant experienced a seizure during delivery, and 2 days later it was discovered that the infant was experiencing an evolving ischemic stroke (12047,94534). In another case, nicotinic toxicity characterized by tachycardia, sweating, abdominal pain, vomiting, and muscle twitching and weakness was reported for a woman taking blue cohosh to induce abortion (36720,94534).
Due to these life-threatening side effects pregnant women should be advised not to ingest any blue cohosh product during pregnancy.
Cardiovascular ...Orally, blue cohosh can cause tachycardia, hypertension, and chest pain (angina) (36720,36724,94934). Neonatal acute myocardial infarction (MI), congestive heart failure (CHF), myocardial toxicity, and shock has occurred following maternal use of a blue cohosh combination product one month before delivery (566,3383,12047,36722,36725).
Gastrointestinal ...Orally, blue cohosh can cause mucous membrane irritation, stomach upset including diarrhea and cramping, nausea, vomiting, and abdominal pain (36720).
Musculoskeletal ...Orally, blue cohosh can cause muscle weakness and involuntary muscle contractions (36720).
Neurologic/CNS ...In one case, a mother was advised to drink a blue cohosh tea to induce labor. The infant experienced a seizure during delivery and 2 days later it was discovered that the infant was experiencing an evolving ischemic stroke (12047,94534). There is also another case report of severe complications, including seizures, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94934).
Renal ...There is a case report of severe complications, including renal failure, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94934).
