Rauwolfia serpentina 6 X. Other Ingredients: Lactose, Sucrose.
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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 Rauwolfia Serpentina (Globule). 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
Below is general information about the safety of the known ingredients contained in the product Rauwolfia Serpentina (Globule). 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 UNSAFE ...when used orally. Indian snakeroot contains small amounts of the drugs reserpine and yohimbine. Although most adverse effects to Indian snakeroot appear to be mild, higher doses can cause cardiovascular side effects including bradycardia and hypotension. Prolonged use can cause depression in some people (94330,94331,94332,94438,94440).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
The reserpine alkaloid constituents appear to cross the placenta and are excreted in breast milk (4260).
Below is general information about the interactions of the known ingredients contained in the product Rauwolfia Serpentina (Globule). 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 Indian snakeroot might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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Theoretically, concomitant use of Indian snakeroot with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, concomitant use of Indian snakeroot and antihypertensive drugs might increase the risk of hypotension.
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Theoretically, concomitant use might increase the risk of adverse effects.
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Theoretically, taking Indian snakeroot with beta-blockers might increase the risk of bradycardia and/or hypotension.
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Indian snakeroot contains small amounts of reserpine. Reserpine causes catecholamine-depletion (15). Concomitant use of Indian snakeroot and beta-blockers might increase the risk or bradycardia and/or hypotension.
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Theoretically, taking Indian snakeroot might cause additive sedative effects.
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Theoretically, Indian snakeroot might inhibit CYP2D6 enzymes and reduce the metabolism of CYP2D6 substrates.
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Indian snakeroot contains small amounts of the drug yohimbine. In vitro research shows that yohimbine inhibits CYP2D6 enzyme activity (23117).
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Theoretically, taking Indian snakeroot with digoxin might increase the risk of bradycardia.
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Theoretically, taking Indian snakeroot with ephedrine might alter the effects and side effects of ephedrine.
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Theoretically, taking Indian snakeroot with levodopa may reduce the effectiveness of levodopa.
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Theoretically, taking Indian snakeroot with MAOIs might cause additive effects.
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Theoretically, concomitant use might cause additive effects.
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Theoretically, concomitant use might alter the effects of Indian snakeroot and increase the risk of adverse effects.
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A small clinical study in patients taking TCAs for at least 4 weeks shows that receiving doses of intravenous yohimbine, a constituent of Indian snakeroot, 2.5-20 mg daily for up to 7 days precipitates severe anxiety, agitation, and tremor (105881). Also, concomitant use of TCAs with Indian snakeroot may decrease the effects of other rauwolfia alkaloids (15).
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Below is general information about the adverse effects of the known ingredients contained in the product Rauwolfia Serpentina (Globule). 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, Indian snakeroot may be unsafe, particularly at high doses.
Most adverse effects are thought to be from the constituents reserpine and yohimbine.
Most Common Adverse Effects:
Orally: Abdominal pain, bradycardia, congestion, diarrhea, hypotension, increased appetite, nightmares, sedation, weight gain.
Serious Adverse Effects (Rare):
Orally: Atrial fibrillation, convulsions, depression, myocardial infarction.
Cardiovascular ...Orally, Indian snakeroot has been associated with reports of bradycardia and mild hypotension. These adverse effects are thought to be related to the constituent reserpine (94331,94440). Adverse reactions to reserpine also include angina-like symptoms (94328). At high doses, adverse effects related to yohimbine, another constituent of Indian snakeroot, include hypertension, tachycardia, palpitations, myocardial infarction, and atrial fibrillation (3312,17465,86801,91521). A supplement containing Indian snakeroot and several other ingredients (Carditone, Ayush Herbs) has been associated with reduction in blood pressure and increase in serum potassium levels (102838).
Dermatologic ...Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. Orally, reserpine can cause facial flushing, skin rash, and itching (94328). Yohimbine may cause rash, erythrodermic skin eruption, and exanthema (3312,3971,86878,86896).
Endocrine ...Indian snakeroot contains small amounts of reserpine and may theoretically cause some of the adverse effects associated with this constituent. Orally, reserpine can cause galactorrhea and breast enlargement (275,94328).
Gastrointestinal ...Orally, Indian snakeroot has been associated with increased or decreased appetite, diarrhea, nausea, vomiting, and abdominal pain (94332,94438,94440). Yohimbine, a constituent of Indian snakeroot, has been associated with nausea, vomiting, increased salivation, diarrhea, and gastrointestinal distress (3970,17465,86780,86786,86804,86827,86896). Reserpine, another constituent of Indian snakeroot, may cause gastrointestinal irritation and activation of peptic ulcers (15,19).
Genitourinary ...Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. Yohimbine may cause dartos contraction or decreased libido in some patients (86786,86882).
Hematologic ...Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. A case of drug-induced agranulocytosis has been reported following prolonged use of oral yohimbine (86877). Reserpine may cause thrombocytopenia (275).
Immunologic ...There is one report of a hypersensitivity reaction to yohimbine, a constituent of Indian snakeroot. Symptoms included fever, chills, malaise, itchy, scaly skin, progressive kidney failure, and a lupus-like syndrome (6169).
Musculoskeletal ...Orally, Indian snakeroot has been associated with muscle aches and cramps (94438).
Neurologic/CNS ...Orally, Indian snakeroot may cause headaches, feeling cold, dizziness, drowsiness, nightmares, and mild sedation (94331,94332,94438,94440). Indian snakeroot contains small amounts of reserpine and yohimbine and may theoretically cause some of the adverse effects associated with these constituents. Doses of reserpine of greater than 0.5 mg daily can increase the risk of side effects. In extremely large amounts, Parkinson-like symptoms, extrapyramidal reactions, and convulsions may occur (15,94328,94332). Orally, yohimbine has been associated with reports of tremulousness, head twitching, seizures, loss of consciousness, decreased energy, dizziness, vertigo, headache, feeling cold, flushing, diaphoresis, and paralysis (11,18,3312,3971,17465,86786,86801,86804,86827,86896).
Oncologic ...Indian snakeroot contains small amounts of reserpine and may theoretically cause some of the adverse effects associated with this constituent. Some preliminary research suggests a link between reserpine and an increased risk of breast cancer; but this has not been confirmed in further research (94328).
Psychiatric
...Orally, Indian snakeroot can cause emotional upset or depression, especially in people with prior episodes.
This appears to be related to the constituent reserpine (94332,94438). One study shows the rate of depressive episodes is similar for patients taking Indian snakeroot and those taking reserpine (94438). Some research suggests that the risk of depression might increase with dose or the length of use. When taken for less than 40 days, depression did not occur in patients taking Indian snakeroot or reserpine (94330).
Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. Orally, yohimbine may increase anxiety and impulsivity (17465,86784,86810).
Pulmonary/Respiratory ...Orally, Indian snakeroot can cause nasal stuffiness or congestion and shortness of breath (94330,94332,94438,94440). One study shows that Indian snakeroot may increase the risk for nasal congestion more than the constituent reserpine. (94438). Reserpine is also associated with rare reports of allergic reactions that can precipitate asthma (15,94328). Another constituent of Indian snakeroot, yohimbine, may cause bronchospasm, tachypnea, cough, sinusitis, and rhinorrhea (17465,86825,86850,94112). Excessive doses of yohimbine can cause respiratory depression (1118).
Renal
...Orally, Indian snakeroot may cause increased urination (94332).
Indian snakeroot contains small amounts of yohimbine and may theoretically cause some of the adverse effects associated with this constituent. A case of acute kidney failure related to yohimbine-induced systemic lupus erythematosus has been reported (6169).
Other ...Orally, Indian snakeroot has been associated with reports of weight gain (94438).
