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What to Know About VitalCore Balance
VitalCore Balance is the name Voshell's Pharmacy uses for a compounded preparation that may include estradiol and micronized progesterone. Learn about ingredients, prescription status, and usage.
Not medical advice. Speak with a healthcare professional before using any medication.
Reviewed by:
D. Goren
Head of Content
Updated Nov, 30
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Contact UsWhat Is VitalCore Balance
DISCLOSURE: Voshell's Pharmacy is a licensed compounding pharmacy that prepares and sells compounded medications by prescription. As a provider of competing products, our perspective may be influenced by our professional and commercial interests.
VitalCore Balance is the name Voshell's Pharmacy uses for compounded preparations that may include estradiol and micronized progesterone in a transdermal gel or cream base, prepared in response to a valid prescription from a qualified prescriber. Compounded medications are not reviewed by FDA for safety or effectiveness before dispensing and are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient.
Formulation and Key Ingredients
- Estradiol: According to the estradiol prescribing information, estradiol is a human-identical estrogen used in low, physiologic doses and may be used to address vasomotor and other symptoms associated with declining estrogen levels.
- Micronized progesterone: According to ACOG, micronized progesterone is processed for improved absorption and may be used alongside estrogen therapy to support uterine health in women with an intact uterus.
- Transdermal vehicle: According to the estradiol prescribing information, transdermal delivery may provide steadier absorption compared with some oral formulations.
- Compounded formulation: A qualified prescriber may determine whether a compounded preparation is appropriate for an individual patient's clinical needs.
- FDA boxed warnings: According to the FDA-approved prescribing information for systemic estrogens, products in this class carry boxed warnings regarding endometrial cancer (in unopposed-estrogen use), cardiovascular events (stroke, deep vein thrombosis, pulmonary embolism), breast cancer, and probable dementia in postmenopausal women age 65 and older. Compounded preparations are not reviewed by FDA, but the same labeled risks for the underlying hormones apply.
How It Works and Practical Points
- Mechanism: According to NAMS, declining estrogen levels during perimenopause and menopause are associated with vasomotor symptoms such as hot flashes and night sweats; hormone therapy may address these symptoms under prescriber supervision.
- Individualized dosing: Dose and strength are determined by a qualified prescriber based on individual patient evaluation and follow-up.
- Storage and use: Store per label directions; apply to clean, dry skin and follow all prescription instructions from your prescriber and pharmacist.
Key Product Features
Estrogens and Progestogens
- According to the NIH Office of Dietary Supplements and NAMS, estrogens and progestogens are involved in the regulation of the female reproductive system and play a role in physiological processes that may change during perimenopause and menopause. Inclusion of these hormones in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.
Transdermal Delivery Systems
- According to the estradiol prescribing information, transdermal formulations are involved in delivering hormones through the skin and have been studied for their absorption characteristics compared with oral administration routes. Inclusion of a transdermal vehicle in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.
Micronized Progesterone
- According to ACOG, micronized progesterone has been studied for its role in uterine health when used alongside estrogen therapy, and the micronization process is involved in improving oral and topical absorption compared with non-micronized forms. Inclusion of micronized progesterone in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.
Compounding Excipients and Bases
- According to the Natural Medicines database, pharmaceutical excipients and cream or gel bases used in compounded preparations play a role in drug stability, consistency of delivery, and patient tolerability. Inclusion of these excipients in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.
Contact Us for a Personalized Care Plan
Have questions about compounding? Contact Voshell's Pharmacy — we prepare patient-specific medications pursuant to valid prescriptions from your licensed prescriber.
Do You Need Prescription for VitalCore Balance
Do You Need a Prescription for VitalCore Balance?
Whether VitalCore Balance requires a prescription depends on the active ingredients and how the product is labeled. If the label reads "Dietary Supplement," it is typically available without a prescription. If the product contains prescription hormones such as estradiol, progesterone, or testosterone in a compounded preparation, a valid prescription from a licensed prescriber is required.
- Check the label: Look for "Rx Only" and review the listed active ingredients to determine the product's regulatory classification.
- Speak with your prescriber or pharmacist: A licensed prescriber or pharmacist may review the product with you, clarify its prescription status, and discuss whether it is appropriate for your individual health needs.
- Compounded preparations: Compounded medications are not FDA-reviewed for safety or efficacy prior to dispensing; they are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient, and dose and formulation are determined by a qualified prescriber.
- Consult your prescriber before use: Any preparation containing hormones warrants evaluation by a qualified prescriber for appropriate dosing, monitoring, and follow-up care.
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These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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