Each tablet contains: Aceticum Acidum 4X • Pulsatilla 4X • Caulophyllum Thalictroides 6X • Hydrastis canadensis 6X • Lilium Tigrinum 6X • Kreosotum 8X • Asterias rubens 10X • Mercurius Iodatus Flavus 10X • Thuja occidentalis 12X.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
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 BHI Menstrual. 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 pulsatilla.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product BHI Menstrual. 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 used orally and appropriately as a single dose (260,261). There is insufficient reliable information available about the safety of goldenseal when used as more than a single dose.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of goldenseal can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
PREGNANCY: LIKELY UNSAFE
when used orally.
Berberine is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to goldenseal (2589).
LACTATION:
LIKELY UNSAFE when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589). Use during lactation can cause kernicterus in the newborn and several resulting fatalities have been reported (2589).
LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.
PREGNANCY: LIKELY UNSAFE
when used orally.
The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.
LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19).
There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Thuja that is thujone-free has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Large doses of thuja have been reported to cause seizures, severe vomiting, organ toxicity, and death in some cases (6002,40888). There is insufficient reliable information available about the safety of thuja when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally due to abortifacient activity (12); avoid using.
LACTATION: LIKELY UNSAFE
when used orally due to toxicity (11); avoid using.
Below is general information about the interactions of the known ingredients contained in the product BHI Menstrual. 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, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
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Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.
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Theoretically, goldenseal might increase the risk of hypotension when taken with antihypertensive drugs.
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Goldenseal contains berberine. Animal research shows that berberine can have hypotensive effects (33692,34308). Also, an analysis of clinical research shows that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase the sedative effects of CNS depressants.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2C9.
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In vitro research shows that goldenseal root extract can modestly inhibit CYP2C9. This effect may be due to its alkaloid constituents, hydrastine and berberine (21117). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP2D6.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2E1.
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In vitro research shows that goldenseal root extract can inhibit the activity of CYP2E1 (94140). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP3A4.
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Most clinical and in vitro research shows that goldenseal inhibits CYP3A4 enzyme activity and increases serum levels of CYP3A4 substrates, such as midazolam (6450,13536,21117,91740,111725). However, in one small clinical study, goldenseal did not affect the levels of indinavir, a CYP3A4 substrate, in healthy volunteers (10690,93578). This is likely due to the fact that indinavir has a high oral bioavailability, making it an inadequate probe for CYP3A4 interactions (13536,91740) and/or that it is primarily metabolized by hepatic CYP3A, while goldenseal has more potential to inhibit intestinal CYP3A enzyme activity (111725). Both goldenseal extract and its isolated constituents berberine and hydrastine inhibit CYP3A, with hydrastine possibly having more inhibitory potential than berberine (111725).
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Theoretically, goldenseal might increase serum levels of dextromethorphan.
Details
Goldenseal contains berberine. A small clinical study shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).
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Goldenseal might increase serum levels of digoxin, although this effect is unlikely to be clinically significant.
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Clinical research shows that goldenseal modestly increases digoxin peak levels by about 14% in healthy volunteers. However, goldenseal does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal does not cause a clinically significant interaction with digoxin. Digoxin is a P-glycoprotein substrate. Some evidence suggests that goldenseal constituents might affect P-glycoprotein; however, it is unclear whether these constituents inhibit or induce P-glycoprotein.
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Theoretically, goldenseal might decrease the conversion of losartan to its active form.
Details
Goldenseal contains berberine. A small clinical study shows that berberine inhibits cytochrome P450 2C9 (CYP2C9) activity and reduces the metabolism of losartan (34279). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might reduce blood levels of metformin.
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In vitro research shows that goldenseal extract decreases the bioavailability of metformin, likely by interfering with transport, intestinal permeability, or other processes involved in metformin absorption. It is unclear which, if any, of metformin's transporters are inhibited by goldenseal. Goldenseal does not appear to alter the clearance or half-life of metformin (105764).
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Theoretically, goldenseal might reduce the therapeutic effects of oseltamivir by decreasing its conversion to its active form.
Details
In vitro evidence suggests that goldenseal reduces the formation of the active compound from the prodrug oseltamivir (105765). The mechanism of action and clinical relevance is unclear.
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Theoretically, goldenseal might increase or decrease serum levels of P-glycoprotein (P-gp) substrates.
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There is conflicting evidence about the effect of goldenseal on P-gp. In vitro research suggests that berberine, a constituent of goldenseal, modestly inhibits P-gp efflux. Other evidence suggests that berberine induces P-gp. In healthy volunteers, goldenseal modestly increases peak levels of the P-gp substrate digoxin by about 14%. However, it does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal is not a potent inhibitor of P-gp-mediated drug efflux. Until more is known, goldenseal should be used cautiously with P-gp substrates.
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Theoretically, goldenseal might increase the sedative effects of pentobarbital.
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Animal research shows that berberine, a constituent of goldenseal, can prolong pentobarbital-induced sleeping time (13519). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase serum levels of tacrolimus.
Details
Goldenseal contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of tacrolimus dosing to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).
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Thuja products can contain thujone, which might lower the seizure threshold (1304). Theoretically, this could decrease the effectiveness of anticonvulsants drugs.
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Thuja might stimulate immune function (1305). Theoretically, taking thuja might decrease the effects of immunosuppressive therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), and other corticosteroids (glucocorticoids).
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Thuja products can contains significant amounts of thujone, a neurotoxin (1304). Theoretically, patients taking drugs that lower the seizure threshold might be at greater risk of seizure if they also take thuja. Advise patients taking these drugs to avoid thuja products. Some drugs that lower the seizure threshold include anesthetics (propofol, others), antiarrhythmics (mexiletine), antibiotics (amphotericin, penicillin, cephalosporins, imipenem), antidepressants (bupropion, others), antihistamines (cyproheptadine, others), immunosuppressants (cyclosporine), narcotics (fentanyl, others), stimulants (methylphenidate), theophylline, and others.
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Below is general information about the adverse effects of the known ingredients contained in the product BHI Menstrual. 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
...There is limited reliable information available about the safety of goldenseal when used in more than a single dose.
Berberine, a constituent of goldenseal, is generally well tolerated when used orally.
Most Common Adverse Effects:
Orally: Berberine, a constituent of goldenseal, can cause abdominal distension, abdominal pain, bitter taste, constipation, diarrhea, flatulence, headache, nausea, and vomiting.
Dermatologic ...Orally, berberine, a constituent of goldenseal, may cause rash. However, this appears to be rare (34285). A case of photosensitivity characterized by pruritic, erythematous rash on sun-exposed skin has been reported in a 32-year-old female taking a combination product containing goldenseal, ginseng, bee pollen, and other ingredients. The rash resolved following discontinuation of the supplement and treatment with corticosteroids (33954). It is not clear if this adverse effect is due to goldenseal, other ingredients, or the combination.
Endocrine ...A case of severe, reversible hypernatremia has been reported in an 11-year-old female with new-onset type 1 diabetes and diabetic ketoacidosis who took a goldenseal supplement (52592).
Gastrointestinal ...Orally, berberine, a constituent of goldenseal, may cause diarrhea, constipation, flatulence, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953). Theoretically, these effects may occur in patients taking goldenseal. However, this hasn't been reported in clinical research or case reports.
Neurologic/CNS ...Orally, berberine, a constituent of goldenseal, may cause headache when taken in a dose of 5 mg/kg daily (33648). Theoretically, this may occur with goldenseal, but this hasn't been reported in clinical research or case reports.
General
...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).
Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).
Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).
Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).
Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).
Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).
Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).
General ...Orally, large doses of thuja have been reported to cause toxicity involving headache, nervous agitation, seizures, gastric irritation, vomiting, abdominal pain, and diarrhea. Thuja toxicity has also been reported to cause liver damage, renal toxicity, and death in some cases (6002,40888).
Dermatologic
...Contact dermatitis, presenting as an itchy papular squamous eruption on the hands, developed in a 46-year-old female who handled thuja plants while gardening.
It resolved when contact with thuja was avoided. The causative ingredient of thuja was identified as limonene (113415).
In one case report, a 5-year-old female presented with a papillary eccrine adenoma. In an effort to avoid excisional biopsy, an ointment containing thuja was applied to the lesion for 6 months, resulting in peripheral extension and central necrosis of the lesion, eventually necessitating complete excision (106048).
Gastrointestinal ...Orally, large doses of thuja have been reported to cause toxicity involving gastric irritation, vomiting, abdominal pain, and diarrhea (6002,40888).
Hepatic ...Orally, large doses of thuja have been reported to cause toxicity involving liver damage and death (6002,40888). In one case report, a healthy 40-year-old female taking thuja and black cohosh for 1 month presented with 3 days of severe abdominal pain and AST and ALT levels exceeding 5 times the upper limit of normal. Symptoms improved within 5 days of supplement discontinuation and levels normalized within 2 weeks (106047). It is unclear if this reaction was due to thuja, black cohosh, or other factors.
Neurologic/CNS ...Orally, large doses of thuja have been reported to cause toxicity involving nervous agitation, seizures, and death (6002,40888).
Renal ...Orally, large doses of thuja have been reported to cause toxicity involving renal toxicity and death (6002,40888).
