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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Horse Chestnut, Citrullus Colocynthis Fruit Pulp, Black Cohosh, Sodium Chloride, Strychnos Nux-vomica Seed, Phytolacca Americana Root, And Strontium Carbonate
Brand Name
D-50
Generic Name
Horse Chestnut, Citrullus Colocynthis Fruit Pulp, Black Cohosh, Sodium Chloride, Strychnos Nux-vomica Seed, Phytolacca Americana Root, And Strontium Carbonate
Active Ingredient
Black CohoshCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 4 [hp_X]/mL | SOLUTION | SUBLINGUAL | 58264-0050 |
Detailed information about D-50
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for D-50, you must consult a qualified healthcare professional.
Black Cohosh (Actaea racemosa) is a botanical extract primarily used for menopausal symptoms. It is categorized within several pharmacological classes including Estrogen [EPC] and Non-Standardized Plant Allergenic Extract [EPC] due to its complex physiological interactions.
Dosage for Black Cohosh can vary significantly based on the formulation and the specific condition being addressed. Because this is a botanical product, standardization is key to ensuring efficacy and safety.
Black Cohosh is not approved for use in pediatric populations. There is no clinical data establishing safety or efficacy in children or adolescents. Its hormonal effects could theoretically interfere with normal pubertal development. Always consult a pediatrician before giving any herbal supplement to a minor.
There are no specific guidelines for dosage adjustment in patients with renal impairment. However, because metabolites are partially cleared through the kidneys, patients with Stage 3 or higher Chronic Kidney Disease (CKD) should use Black Cohosh with extreme caution and under close monitoring of renal function.
Extreme caution is advised. Black Cohosh has been associated with rare but severe cases of hepatotoxicity (liver damage). Patients with pre-existing liver disease, such as hepatitis, cirrhosis, or non-alcoholic fatty liver disease (NAFLD), are generally advised to avoid Black Cohosh entirely. If use is deemed necessary by a specialist, frequent Liver Function Tests (LFTs) are mandatory.
In geriatric populations, dosing typically follows the adult range. However, clinicians should be mindful of the increased risk of polypharmacy (taking multiple medications) and the potential for drug-herb interactions. A lower starting dose (e.g., 20 mg once daily) may be considered to assess tolerability.
To maximize the benefit and minimize risks, follow these administration guidelines:
If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the dose to make up for a missed one, as this may increase the risk of side effects.
Signs of a Black Cohosh overdose may include severe dizziness, intense headache, nausea, vomiting, and a slowed heart rate (bradycardia). In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment is generally supportive and may include gastric lavage if the ingestion was recent.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or extend the duration of use without medical guidance, as the safety of long-term high-dose therapy has not been established.
While Black Cohosh is generally well-tolerated when used at recommended dosages for short durations, some patients may experience mild adverse effects. These typically occur during the first few weeks of therapy as the body adjusts:
> Warning: Stop taking Black Cohosh and call your doctor immediately if you experience any of the following symptoms, as they may indicate severe physiological distress or organ damage:
The safety of using Black Cohosh for longer than one year is not well-established. Potential long-term concerns include:
Currently, the U.S. FDA does not require a Black Box Warning for Black Cohosh, as it is regulated as a dietary supplement. However, several international regulatory bodies (such as the EMA in Europe and the TGA in Australia) require a warning label regarding the risk of liver injury.
Patients are advised that if they have a history of liver disease or are taking other medications that affect the liver, the risk-benefit ratio of Black Cohosh must be carefully weighed by a specialist. Report any unusual symptoms, especially those related to liver function or hormonal changes, to your healthcare provider immediately.
Black Cohosh is a potent botanical extract that can significantly affect various physiological systems. It should not be viewed as a 'simple herb' but as a pharmacologically active substance. Patients must inform all members of their healthcare team, including surgeons and anesthesiologists, if they are using Black Cohosh.
No FDA black box warnings for Black Cohosh. However, clinical consensus from the National Institutes of Health (NIH) and the American College of Obstetricians and Gynecologists (ACOG) emphasizes the need for caution regarding liver health.
There have been more than 80 worldwide reports of liver damage associated with Black Cohosh use. While a direct causal link is sometimes difficult to establish due to product contamination or pre-existing conditions, the association is strong enough to warrant extreme caution. Patients must have baseline liver function tests before starting therapy.
Because Black Cohosh may have estrogenic effects, patients with a history of breast cancer, uterine cancer, endometriosis, or uterine fibroids should avoid use unless specifically cleared by an oncologist or gynecologist. There is conflicting data on whether Black Cohosh stimulates or inhibits breast cancer cell growth in vitro.
Patients with a known allergy to plants in the Ranunculaceae (buttercup) family may experience cross-reactivity. Anaphylaxis, though rare, is a medical emergency.
Due to its potential effects on blood pressure and heart rate, Black Cohosh should be discontinued at least two weeks prior to elective surgery to avoid complications with anesthesia.
If your doctor approves the use of Black Cohosh, the following monitoring is typically recommended:
Black Cohosh may cause dizziness or lightheadedness in some individuals. Patients should assess their reaction to the supplement before driving or operating heavy machinery. If you experience vertigo or blurred vision, avoid these activities and contact your doctor.
Alcohol consumption should be strictly limited while taking Black Cohosh. Both alcohol and Black Cohosh are processed by the liver; combining them significantly increases the metabolic strain on hepatic tissues and may elevate the risk of hepatotoxicity.
There is no evidence of a withdrawal syndrome associated with Black Cohosh. However, symptoms of menopause (such as hot flashes) may return upon discontinuation. It is often recommended to taper the dose over 1 to 2 weeks rather than stopping abruptly to allow the body to readjust its thermoregulatory processes.
> Important: Discuss all your medical conditions, especially liver disease and hormone-sensitive cancers, with your healthcare provider before starting Black Cohosh.
For each major interaction, the mechanism typically involves competitive inhibition of hepatic enzymes or pharmacodynamic synergy. The clinical consequence is usually an increased risk of toxicity or a reduction in the therapeutic efficacy of the primary medication. Management strategies always involve a thorough medication reconciliation by a pharmacist or physician.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, as the list of potential interactions with Black Cohosh is extensive.
Black Cohosh must NEVER be used in the following circumstances:
Conditions requiring a careful risk-benefit analysis and close medical supervision include:
Patients who are allergic to aspirin or salicylates should use Black Cohosh with caution, as some species of Actaea contain small amounts of salicylic acid. Additionally, cross-reactivity with other 'buttercup' family plants like goldenseal or aconite is possible.
> Important: Your healthcare provider will evaluate your complete medical history, including your family history of cancer and liver health, before determining if Black Cohosh is a safe option for you.
Black Cohosh is classified by many herbalists as an emmenagogue (a substance that stimulates menstrual flow) and an oxytocic (a substance that stimulates uterine contractions). According to the FDA and various botanical safety handbooks, it is strictly contraindicated during pregnancy. Use during the first trimester may lead to spontaneous abortion, while use in the third trimester may trigger premature labor. There is no 'safe' dose for Black Cohosh during pregnancy.
The safety of Black Cohosh during lactation has not been established. It is unknown if the triterpene glycosides or other active metabolites pass into breast milk. Because of the potential for these compounds to affect the developing endocrine system of a nursing infant, healthcare providers generally recommend avoiding Black Cohosh while breastfeeding. If vasomotor symptoms are severe, non-pharmacological interventions or safer alternatives should be discussed.
There is no clinical justification for the use of Black Cohosh in children. It is not approved for any pediatric indication. The hormonal modulation associated with this supplement could potentially disrupt the delicate hypothalamic-pituitary-gonadal axis in developing children and adolescents. If a child accidentally ingests Black Cohosh, contact emergency services immediately.
Many women start Black Cohosh in their late 50s or 60s. In this population, the primary concerns are liver health and polypharmacy. Elderly patients are more likely to be taking statins, antihypertensives, or blood thinners, all of which can interact with Black Cohosh. Furthermore, age-related declines in hepatic blood flow may slow the metabolism of the supplement, increasing the risk of side effects. Clinicians should monitor for fall risks associated with dizziness.
Data regarding Black Cohosh in patients with impaired kidney function is limited. Since a portion of the metabolites are excreted renally, there is a risk of accumulation in patients with a GFR below 30 mL/min. Such patients should only use Black Cohosh under the direct supervision of a nephrologist.
Black Cohosh is contraindicated in patients with significant hepatic impairment (Child-Pugh Class B or C). For those with mild impairment (Class A), the risk of idiosyncratic liver injury is still considered high. If use is absolutely necessary, LFTs should be performed monthly for the duration of therapy.
> Important: Special populations, particularly pregnant women and those with liver disease, require individualized medical assessment. Never start an herbal regimen in these populations without specialist approval.
Black Cohosh acts through a complex, multi-modal mechanism. While it does not significantly increase circulating levels of estrogen (estradiol, LH, or FSH), it appears to act as a Selective Estrogen Receptor Modulator (SERM). It binds to estrogen receptors in specific tissues, potentially exerting an antagonistic effect in the breast while having an agonistic effect in the bone and brain.
Additionally, Black Cohosh interacts with the serotonergic system. Specifically, components like N-methylserotonin act as ligands for 5-HT1A, 5-HT1D, and 5-HT7 receptors. The interaction with 5-HT7 in the hypothalamus is believed to be the primary reason for its efficacy in treating hot flashes, as this receptor is a key player in the body's internal thermostat. It also shows activity as an Adrenergic alpha-Agonist and a Cholinesterase Inhibitor, which may contribute to its effects on mood and the autonomic nervous system.
The onset of action for Black Cohosh is relatively slow. Patients typically do not see a reduction in symptoms for 2 to 4 weeks, with maximum therapeutic effect occurring after 8 to 12 weeks of consistent use. The duration of effect after stopping the supplement is usually short, with symptoms often returning within 1 to 2 weeks. Tolerance does not appear to develop with short-term use (up to 6 months).
| Parameter | Value |
|---|---|
| Bioavailability | Variable (estimated 15-25%) |
| Protein Binding | Moderate (approx. 60-80%) |
| Half-life | 2 - 4 hours (active glycosides) |
| Tmax | 2 - 4 hours |
| Metabolism | Hepatic (Phase I and II) |
| Excretion | Renal (approx. 40%), Fecal (approx. 60%) |
The primary bioactive constituents of Black Cohosh are triterpene glycosides, including actein, 27-deoxyactein, and cimicifugoside. It also contains phenolic acids such as caffeic and fukinolic acids. The molecular formula for actein is C37H56O11, with a molecular weight of approximately 676.8 g/mol. These compounds are lipophilic and have limited solubility in water, which is why standardized ethanolic or isopropanolic extracts are preferred in clinical settings.
Black Cohosh belongs to the therapeutic class of Botanical Dietary Supplements and is pharmacologically categorized under Non-Standardized Plant Allergenic Extract [EPC]. Within the realm of women's health, it is considered a non-hormonal therapy for menopause, often grouped with other phytoestrogens like soy isoflavones and red clover, though its mechanism is distinct from these compounds.
Common questions about D-50
Black Cohosh is primarily used to manage symptoms of menopause, such as hot flashes, night sweats, and mood disturbances. It is also sometimes used for premenstrual syndrome (PMS) and painful menstruation, though the evidence for these uses is less robust. Many women choose Black Cohosh as a non-hormonal alternative to traditional hormone replacement therapy (HRT). It is important to note that while it helps with symptoms, it does not treat the underlying cause of menopause. Always consult a healthcare provider before using it for any of these conditions.
The most frequently reported side effects include mild gastrointestinal upset, such as bloating or stomach pain, and headaches. Some women also experience dizziness, nausea, or a feeling of heaviness in the legs. While these are usually mild and temporary, more serious side effects can occur. Specifically, any signs of liver trouble, such as yellowing of the skin or dark urine, should be reported to a doctor immediately. It is generally well-tolerated when taken at the recommended dosage for less than a year.
It is strongly recommended to avoid or strictly limit alcohol consumption while taking Black Cohosh. Both alcohol and Black Cohosh are processed by the liver, and taking them together can significantly increase the risk of liver strain or damage. Since Black Cohosh has been linked to rare cases of severe hepatotoxicity, adding alcohol to the mix increases this danger. If you have a history of heavy alcohol use, you should likely avoid Black Cohosh entirely. Discuss your alcohol intake with your doctor before starting this supplement.
No, Black Cohosh is considered unsafe for use during pregnancy. Historically, it has been used to stimulate uterine contractions and induce labor, which means taking it during pregnancy could lead to a miscarriage or premature birth. It is classified as an emmenagogue, a substance that promotes menstrual flow, which is dangerous for a developing fetus. If you are pregnant or planning to become pregnant, you should avoid all forms of Black Cohosh. Always inform your obstetrician about any herbal supplements you were taking prior to pregnancy.
Black Cohosh does not provide immediate relief from symptoms like hot flashes. Most clinical studies show that it takes between two to four weeks of consistent daily use before a noticeable improvement occurs. The full therapeutic benefits are typically reached after eight to twelve weeks of treatment. If you do not see any improvement after eight weeks, you should consult your healthcare provider to discuss other options. Consistency in dosing is key to achieving the best results.
Yes, you can generally stop taking Black Cohosh suddenly without experiencing physical withdrawal symptoms. However, because the supplement helps regulate your body's temperature control, stopping it abruptly may cause your menopausal symptoms to return quickly. To avoid a sudden surge in hot flashes or night sweats, some doctors recommend gradually reducing your dose over a week or two. This allows your body to adjust more slowly to the change in hormone-like signaling. Always let your doctor know when you plan to stop a supplement.
If you miss a dose of Black Cohosh, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue with your regular routine. You should never take two doses at once to make up for a missed one, as this can increase your risk of side effects like nausea or dizziness. Maintaining a regular schedule helps keep the active compounds at a steady level in your system. Setting a daily reminder on your phone can help you stay consistent.
Weight gain is not a commonly proven side effect of Black Cohosh, but some women do report it while taking the supplement. It is often difficult to determine if the weight gain is caused by the herb itself or by the natural metabolic changes that occur during menopause. Some studies suggest that by stabilizing hormones, Black Cohosh might actually help prevent some of the weight gain associated with menopausal transitions. If you notice rapid or unusual weight changes, discuss them with your healthcare provider to rule out other causes. Maintaining a healthy diet and exercise routine remains important.
Black Cohosh can interact with several types of medications, particularly those processed by the liver. It may interfere with the effectiveness of the breast cancer drug tamoxifen and can increase the risk of liver damage if taken with statins or high doses of acetaminophen. It might also lower blood pressure, which could cause problems if you are already taking blood pressure medication. Because of these potential interactions, it is vital to provide your doctor or pharmacist with a full list of all medications and supplements you are currently taking. Never start Black Cohosh without a professional medication review.
Black Cohosh is a botanical supplement, so it is not 'generic' in the way prescription drugs are, but it is available from many different manufacturers. You can find it as a store-brand supplement or as a specialized, branded extract like Remifemin. When choosing a product, look for one that is 'standardized' to contain a specific amount of active triterpene glycosides (usually 2.5%). It is also wise to look for third-party certifications, such as USP or NSF, which ensure the product contains what the label claims. Your pharmacist can help you select a high-quality version.
Other drugs with the same active ingredient (Black Cohosh)