Hot Flash Formulas

The Hot Flash Formula is a customized prescription blend that may include ingredients such as; estrogens, progesterone, testosterone and/or dehydroepiandrosterone (DHEA) that targets the main symptoms of menopause. It can be customized into an odorless gel typically applied once daily to a small area of the inner thigh or oral capsule that can be taken by mouth once daily before bedtime.

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What is the Hot Flash Formula?

The topical Hot Flash Formula combines prescription ingredients in a proprietary base developed specifically to deliver ingredients through the skin. It uses a unique delivery system designed to improve the solubility of hormones, and has been shown to increase the permeation of those molecules into and through the skin. The Hot Flash Formula is specifically made without fragrance, or gluten.

Topical vs. Oral

Topical applications are known to have a lower-side effect profile when compared with systemic administration. Because the drugs are being applied directly to the skin, there is no first-pass metabolism by the liver. As a result, lower doses of medicine may be used to get the intended response compared to the oral route. Research has shown topical estrogen formulations may be preferable to an oral estrogen for women who have a higher risk of blood clots (including those who smoke or are obese), are taking other medications, have borderline triglyceride levels, are at risk of gallstones, or have difficulty taking a pill. Topical application may also lower the incidence of nausea. However, you should always discuss the benefit to risk ratio with your healthcare prescriber.

Common Ingredients

DHEA

Dehydroepiandrosterone (DHEA) is a hormone that your body naturally produces in the adrenal gland. DHEA helps produce other hormones, including testosterone and estrogen. DHEA concentration decreases with age, therefore, DHEA has been considered a hormone that reduces the symptoms associated with aging.

Estrogen

Estrogens are female hormones naturally produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years. The ovaries begin to produce less estrogen after menopause (the change of life). Estrogen replacement medicine is often prescribed to make up for the lower amount of estrogen.

Progesterone

Progesterone is a female hormone naturally produced by the body and is necessary for the normal sexual development of females. Progesterone is commonly used to help prevent changes in the uterus in women who are taking estrogen replacement therapy after menopause. It is also used to properly regulate the menstrual cycle and treat unusual stopping of menstrual periods in women who are still menstruating.

Testosterone

Testosterone is naturally produced in the female body and declines with age. Research has shown topical testosterone replacement has significantly improved sexual desire, frequency of sex, receptivity, and initiation of sexual desire in menopausal women.

Frequently asked questions

What is a compounded medication?

One size doesn’t fit all and every patient is unique. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient by a pharmacist as the result of a practitioner’s prescription drug order. While compounded medications are not FDA-approved, they serve an important patient need—especially when FDA-approved medication is not available for treatment. Our formulations are made to order in small batches to ensure freshness. The specific ingredients in your compounded formula will depend on your specific concerns and goals. It should be understood that your personal healthcare practitioner will make the final decision.

Are compounded medications FSA & HSA eligible?

Yes! All of our compounded formulations, regardless of ingredients, are eligible for Flexible Spending Accounts (FSA) and Health Saving Accounts (HSA).

What is menopause?

Menopause is when your periods stop permanently and you can no longer get pregnant. You have reached menopause only after it has been a full year since your last period. This means you have not had any bleeding, including spotting, for 12 months in a row. After menopause, your ovaries make very low levels of the hormones estrogen and progesterone. These low hormone levels can raise your risk for certain health problems.


Menopause is a normal part of a woman's life. It is sometimes called "the change of life." Menopause does not happen all at once. As your body transitions to menopause over several years, you may have menopause symptoms and irregular periods. The average age for menopause in the United States is 52. The range for women is usually between 45 to 58. One way to tell when you might go through menopause is the age your mother went through it.

What are hot flashes?

Hot flashes are often described as the sudden feeling of warmth spreading through your upper body. They are triggered by small elevations in core body temperature. Hot flashes are most commonly felt over the face, neck, and chest, while your skin may become red, or blotchy. This is most commonly caused by lowering estrogen levels due to menopause.

How common are hot flashes?

About 75% of all women have these periodic fluctuations in their body temperature. Hot flashes usually last for 1 to 5 minutes, with some lasting as long as an hour. The average duration of symptoms is between 5 and 10 years, with some lasting as long as 20 years. In one U.S. study, 87% of the women reported daily hot flashes and about a third of those reported more than 10 per day. Hot flashes may begin several years before menopause. African-American women reported an average of 10 years of hot flashes, the longest of any ethnicity in the study.

What hormone levels do I need to get tested?

The only way to know if your hormones are in balance is to test them. You can either have your hormone levels tested at your next office visit or order an at-home test. We recommend having the following hormone levels tested:

  • Estradiol

  • Progesterone

  • Total Testosterone

  • Free Testosterone

  • DHEA-S

  • FSH

  • LH

  • TSH

  • Free T3

  • Free T4


Different Testing Methodologies


Serum Testing is a broadly accepted method for measuring hormones and other analytes that circulate in the bloodstream.

Suitable for:

  • · Assessing total circulating endogenous hormone levels (free plus protein-bound)

  • · Monitoring hormone replacement therapy (sublingual, patch, pellet)

  • · Assessing thyroid health

  • · Assessing analytes that cannot be determined in dried blood spot, e.g., ferritin

Not suitable for:

  • · Monitoring topical hormone replacement therapy (underestimates tissue uptake)


Dried Blood Spot Testing is ideal for measuring hormones and other analytes such as insulin, blood lipids, Vitamin D, thyroid hormones, and elements like lead and magnesium. Blood spot testing gives results equivalent to serum but with distinct advantages over serum testing for monitoring topical and vaginal hormone supplementation.

Suitable for:

  • · Assessing total circulating hormone levels (free plus protein-bound)

  • · Patients with dry mouth and/or children who may have difficulty collecting saliva

  • · Monitoring hormone replacement therapy (oral, sublingual, pellet)

  • · Assessing thyroid health, fertility parameters, and cardiometabolic risk factors

  • · Self-collection of sample at home at a time convenient to the patient and avoiding a trip to the phlebotomist


Saliva Testing identifies bioavailable hormone levels – the active quantity that's free to move into body tissue.

Suitable for:

  • · Assessing “free” (unbound to carrier proteins) hormone levels

  • · Monitoring hormone replacement given orally, topically, vaginally or via pellets

  • · Collecting multiple samples during a day, e.g., determining diurnal cortisol levels for adrenal stress assessment

Not suitable for:

  • · Monitoring sublingual/troche hormone replacement

  • · Patients with dry mouth, e.g., due to Sjögren’s Syndrome

Is the Hot Flash Formula a hormone replacement therapy (HRT)?

Yes, the Hot Flash Formula is a once daily topical gel that may contain a customized blend of estradiol, estriol, progesterone, testosterone and/or dehydroepiandrosterone (DHEA). The hormones used in the Hot Flash Formula are structurally identical to the hormones your body produces naturally. HRT is a regimen aimed at relieving the symptoms that some women experience during menopause. HRT works by replacing the hormones that your body stops producing when you go through menopause or when you have had surgery to remove your ovaries.


What is estrogen?

Estrogens are the primary female sex hormones. Estrogen has many important functions in the body such as; controlling cholesterol, maintaining bone structure, memory, heart health and skin. There are three major forms of estrogens in females: estrone, estradiol, and estriol. Each form of estrogen has its own unique characteristics. Estradiol is the most potent estrogen during the perimenopausal period in a woman’s life, whereas estrone plays a larger role after menopause. Research has shown high serum levels of estrone may be associated with an increased risk of causing certain breast cancers. Estriol is the least potent estrogen and plays a larger role during pregnancy. Considerable evidence exists to show that estriol may protect against breast cancer.


Symptoms of low estrogen

The most common reason for estrogen deficiency in women is due to natural or surgical menopause. Symptoms may include:

  • Periods that are less frequent or stop completely

  • Hot flashes and/or night sweats

  • Sleep disturbances

  • Vaginal dryness or painful intercourse

  • Decreased libido

  • Depression

  • Dry skin/hair

  • Memory lapse


What is progesterone?

Progesterone helps balance estrogen in the body and its main role is to protect the uterus from estrogen dominance. While progesterone is known mostly for its effect on the uterus, progesterone receptors are located in other parts of the body outside of the uterus as well, and have various effects on other tissues. Recent studies reveal additional effects of progesterone for bone health, hot flashes, and even sedation with implications for treatment of mood disorders.


Symptoms of low progesterone

The most common cause of low progesterone is menopause. Other causes may include thyroid conditions, chronic stress, obesity and PCOS. Decreased progesterone may lead to the following symptoms:

  • Anxiety

  • Depression

  • Irritability

  • Mood swings

  • Sleep disturbances

  • Pain and inflammation

  • Excessive menstruation


What is dehydroepiandrosterone (DHEA)?

DHEA is the most abundant circulating steroid hormone in humans. Low levels of DHEA may be associated with age-related changes. Researchers have shown DHEA to exert an immunomodulatory action, improve physical and psychological well-being, muscle strength and bone density. DHEA has also been reported to improve sexual satisfaction and insulin sensitivity. DHEA is converted by the body into testosterone and other sex hormones.

When should I see improvement in my symptoms?

Based on research and patient testimonials, it usually takes 4 to 6 weeks before you will feel the initial benefits and up to 3 months to feel the full effects; however, each patient is unique and time frames may differ. It may also take your body time to get used to it. When treatment begins you may experience side effects such as breast tenderness, nausea and leg cramps. Usually these side effects will dissipate within 6 to 8 weeks.

How should I use the Hot Flash Formula?

  • The Hot Flash Formula is for topical use only. If this medicine gets in your eyes or mouth, rinse with water. Do not apply this medication to your eyelids.

  • Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

  • Wash your hands with soap and water before and after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

  • Apply 1 dose to a small area of the inner thigh once daily before bedtime (rotating between the right and left thigh each day).

  • Let dry completely before dressing. Wait at least 1 hour before bathing or swimming.

  • Do not allow a child to come into contact with the skin where you have applied estrogens topically. Topical estrogen is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

  • Do not cover treated skin with a bandage. Bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.

  • Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estrogen therapy.

  • If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estrogens and progesterone.

Who should not use the Hot Flash Formula?

Do not start using the Hot Flash Formula if you:

  • Have unusual vaginal bleeding

    • Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Report any unusual vaginal bleeding right away.

  • Currently have or have had certain cancers

    • Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use the Hot Flash Formula.

  • Had a stroke or heart attack

    • Estrogens should not be used to prevent heart disease, stroke, or dementia.

  • Currently have or have had blood clots

  • Have been diagnosed with a bleeding disorder

  • Have a hypersensitivity to any of the ingredients prescribed

  • Think you may be pregnant

    • The Hot Flash Formula is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use the Hot Flash Formula if the test is positive and talk to your healthcare provider

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

How should I store this medication?

Store at room temperature away from moisture and heat between 68°F to 77°F (20°C to 25°C).

Safety Information

Research has shown, topically applied medications are less likely to cause the same systemic side effects or drug-to-drug interactions as oral medications; however, there is never an absolute zero chance that side effects or drug interactions will not occur. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What should I avoid while using the Hot Flash Formula?

  • Avoid getting this medicine in your eyes. If this does happen, rinse with water.

  • Wait at least 25 minutes after applying topical estrogen before you apply sunscreen to the same skin area.

  • Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estrogens and progesterone.

  • Grapefruit may interact with estrogen and lead to unwanted side effects. Avoid the use of grapefruit products.

  • Avoid using other products that may contain estradiol, estriol, progesterone, testosterone or dehydroepiandrosterone (DHEA) unless discussed with your doctor.


What are the common side effects of the Hot Flash Formula?

Less serious, but common side effects include:

  • Headache

  • Breast pain

  • Stomach or abdominal cramps, bloating

  • Nausea and vomiting

  • Hair loss

  • Fluid retention

  • Vaginal yeast infection


Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • New breast lumps

  • Unusual vaginal bleeding

  • Changes in vision or speech

  • Sudden new severe headaches

  • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue


Serious, but less common side effects include:

  • Heart attack

  • Stroke

  • Blood clots

  • Dementia

  • Breast cancer

  • Cancer of the lining of the uterus (womb)

  • Cancer of the ovary

  • High blood pressure

  • High blood glucose

  • Gallbladder disease

  • Liver problems

  • Changes in your thyroid hormone levels

  • Enlargement of benign tumors (“fibroids”)


These are not all of the possible side effects of the Hot Flash Formula. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.


What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose is unlikely; however, symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

References

  • FDA (2019, Aug 22). Menopause: Medicines to Help You. https://www.fda.gov/consumers/womens-health-topics/menopause

  • Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001. PMID: 26316239; PMCID: PMC4890704.

  • Freedman RR. Menopausal hot flashes: mechanisms, endocrinology, treatment. J Steroid Biochem Mol Biol. 2014 Jul;142:115-20. doi: 10.1016/j.jsbmb.2013.08.010. Epub 2013 Sep 4. PMID: 24012626; PMCID: PMC4612529.

  • Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, Hess R, Joffe H, Kravitz HM, Tepper PG, Thurston RC; Study of Women's Health Across the Nation. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9. doi: 10.1001/jamainternmed.2014.8063. PMID: 25686030; PMCID: PMC4433164.

  • Guy’s and St Thomas National Health Services Foundation Trust leaflet. (2019) Hormone replacement therapy: Available from: https://www.guysandstthomas.nhs.uk/resources/patient-information/gynaecology/hormone-replacement-therapy.pdf

  • Cobin RH, Goodman NF; AACE Reproductive Endocrinology Scientific Committee. American Association Of Clinical Endocrinologists And American College Of Endocrinology Position Statement On Menopause-2017 Update. Endocr Pract. 2017 Jul;23(7):869-880. doi: 10.4158/EP171828.PS. Erratum in: Endocr Pract. 2017 Dec;23 (12 ):1488. PMID: 28703650.

  • Ali ES, Mangold C, Peiris AN. Estriol: emerging clinical benefits. Menopause. 2017 Sep;24(9):1081-1085. doi: 10.1097/GME.0000000000000855. PMID: 28375935.

  • The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017 Jul;24(7):728-53

  • Asi N, Mohammed K, Haydour Q, Gionfriddo MR, Vargas OL, Prokop LJ, Faubion SS, Murad MH. Progesterone vs. synthetic progestins and the risk of breast cancer: a systematic review and meta-analysis. Syst Rev. 2016 Jul 26;5(1):121. doi: 10.1186/s13643-016-0294-5. PMID: 27456847; PMCID: PMC4960754.

  • von Mühlen D, Laughlin GA, Kritz-Silverstein D, Barrett-Connor E. The Dehydroepiandrosterone And WellNess (DAWN) study: research design and methods. Contemp Clin Trials. 2007 Feb;28(2):153-68. doi: 10.1016/j.cct.2006.04.009. Epub 2006 May 6. PMID: 16784898.

  • Miyoshi Y, Tanji Y, Taguchi T, Tamaki Y, Noguchi S. Association of serum estrone levels with estrogen receptor-positive breast cancer risk in postmenopausal Japanese women. Clin Cancer Res. 2003 Jun;9(6):2229-33. PMID: 12796390.

Disclaimer

All prescription medications require a valid and complete online consultation prior to approval and final pricing is determined. All compounded medications in the U.S. are considered off-label use. Licensed healthcare practitioners have the ability to prescribe compounds for off-label treatment, if they believe that it is an appropriate course of treatment.


The drug and medical information provided on this website is not meant to cover all adverse effects, drug interactions, warnings, medical uses, directions and precautions. The information provided is a medical resource and the judgment of your physician and/or healthcare practitioner should not be substituted. Premier Pharmacy has made every effort to ensure the information on the website is accurate and current based on present medical literature.


Premier Pharmacy does not make any guarantees regarding the drug and medical information, and does not assume responsibility regarding the content. The drug safety and drug information contained on the website may be time sensitive and should not be utilized as a medical reference beyond the date hereof. The deficiency of a warning for prescription medications and vitamins provided on this website in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient.


If you have questions or concerns about your medications, please do not hesitate to contact us and/or your medical practitioner, including your pharmacist. Compound prescription products have not been tested or approved by the FDA for their intended use. No claims are made as to the safety, efficacy or use of this compound.