BHRT

Progesterone E4M Oral Capsule

A compounded micronized progesterone capsule, chemically identical to the progesterone produced by the human ovary, prepared to your prescriber's specified dose.

Off-Label / Compounding Note

This capsule is compounded to an individual prescriber's order and is not independently reviewed by the FDA for safety, effectiveness, or manufacturing quality. When used for indications, cyclic schedules, or continuous daily dosing outside the FDA-approved regimens for oral micronized progesterone (prevention of endometrial hyperplasia in women on estrogen therapy, or treatment of secondary amenorrhea), this also represents off-label use. Follow your prescriber's specific dosing instructions.

Boxed Warning

Estrogen plus progestin therapy should not be used to prevent cardiovascular disease or dementia. In a large clinical trial (the Women's Health Initiative), postmenopausal women taking daily oral estrogen combined with a progestin had higher rates of stroke, deep vein thrombosis (DVT), pulmonary embolism, heart attack, and invasive breast cancer compared with women taking placebo. A related study also found a higher rate of probable dementia in women 65 and older taking combined estrogen/progestin therapy.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have known, suspected, or a history of breast cancer
• Have active or a history of deep vein thrombosis, pulmonary embolism, stroke, or heart attack
• Have liver dysfunction or disease
• Are pregnant or think you may be pregnant

Other Warnings

• May cause fluid retention; use caution with heart or kidney conditions
• May cause dizziness or drowsiness — take at bedtime and use caution driving or operating machinery
• Report any unusual or persistent vaginal bleeding to your provider promptly
• Sudden vision changes, severe headache, or migraine with aura should be evaluated immediately

Common Side Effects

• Headache, dizziness, breast tenderness or pain
• Bloating, abdominal cramping, nausea
• Mood changes, irritability, or low mood
• Joint pain, fatigue

Serious Side Effects — Seek Care Right Away

• Chest pain, shortness of breath, or coughing up blood
• Sudden severe headache, vision changes, slurred speech, weakness or numbness
• Leg pain or swelling
• Yellowing of skin or eyes
• New breast lumps or unusual vaginal bleeding

Special Populations

• Pregnancy: not to be used during pregnancy
• Breastfeeding: small amounts pass into breast milk; use with caution and discuss with your provider

Overdose

No formal human overdose data exist. In case of suspected overdose, stop the medication and contact your healthcare provider or Poison Control (1-800-222-1222) for guidance.

Storage

Store at controlled room temperature (about 68–77°F / 20–25°C). Protect from excessive moisture and light. Keep out of reach of children.

Estradiol Oral Capsule

A compounded micronized 17β-estradiol capsule, chemically identical to the primary estrogen produced by the human ovary, prepared to your prescriber's specified dose.

Off-Label / Compounding Note

This capsule is compounded to an individual prescriber's order and is not independently reviewed by the FDA for safety, effectiveness, or manufacturing quality. Use for indications, cycling schedules, or in combination with other compounded hormones not reflected in FDA-approved labeling is off-label; follow your prescriber's instructions.

Boxed Warning

Estrogens increase the risk of endometrial cancer in women with a uterus who take estrogen without a progestogen; close clinical surveillance and evaluation of any abnormal bleeding is important. Estrogen (with or without a progestin) should not be used to prevent cardiovascular disease. In the Women's Health Initiative study, women taking oral estrogen combined with a progestin had higher rates of heart attack, stroke, invasive breast cancer, pulmonary embolism, and DVT than women on placebo; a related memory study also found a higher rate of probable dementia in women 65 and older on combined therapy.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have known, suspected, or a history of breast cancer (except in select cases of metastatic disease under oncology care)
• Have a known or suspected estrogen-dependent tumor
• Have active or a history of DVT, pulmonary embolism, stroke, or heart attack
• Have liver dysfunction or disease
• Are pregnant or think you may be pregnant

Other Warnings

• Increases risk of gallbladder disease
• May raise blood pressure or triglycerides in susceptible individuals
• May worsen fluid retention, migraine, asthma, epilepsy, or systemic lupus erythematosus
• Sudden vision loss, migraine with aura, or eye changes should be evaluated immediately and may require stopping the medication
• May affect thyroid-binding proteins; patients on thyroid hormone replacement may need dose adjustment

Common Side Effects

• Headache, breast tenderness or enlargement
• Nausea, abdominal cramping or bloating
• Irregular vaginal bleeding or spotting
• Hair loss, fluid retention

Serious Side Effects — Seek Care Right Away

• Chest pain, sudden shortness of breath
• Sudden severe headache, vision or speech changes, weakness or numbness
• Leg pain, swelling, or warmth
• New breast lumps or unusual vaginal bleeding
• Yellowing of skin or eyes, severe abdominal pain

Special Populations

• Pregnancy: not to be used; no indication for use during pregnancy
• Breastfeeding: may reduce milk supply; hormone passes into breast milk
• Geriatric use: start at the lowest effective dose; women 65 and older had a higher relative risk of stroke, breast cancer, and dementia in clinical trials of combined therapy

Overdose

Serious effects from acute overdose are uncommon; nausea, vomiting, and withdrawal bleeding may occur. Contact your healthcare provider or Poison Control (1-800-222-1222) if overdose is suspected.

Storage

Store at controlled room temperature (59–86°F / 15–30°C) in a tight, light-resistant container. Keep out of reach of children.

Estradiol Transdermal Patch

A retail, FDA-approved transdermal system that delivers estradiol continuously through the skin, bypassing first-pass liver metabolism. Applied to a clean, dry area of the lower abdomen or upper buttock and changed on the schedule provided by your prescriber.

Product & Usage Note

This is a manufactured, FDA-approved product rather than a compounded preparation. Follow your prescriber's application and replacement schedule exactly, as patch delivery rates are not interchangeable between manufacturers.

Boxed Warning

Unopposed estrogen (without a progestogen) increases the risk of endometrial cancer in women with a uterus. Estrogen-alone therapy has been associated with an increased risk of stroke and DVT; combined estrogen-progestin therapy has been associated with an increased risk of stroke, DVT, pulmonary embolism, heart attack, and invasive breast cancer. Estrogen therapy, alone or combined, should not be used to prevent cardiovascular disease or dementia; a related memory study found increased rates of probable dementia in women 65 and older.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have breast cancer or a history of breast cancer
• Have a known or suspected estrogen-dependent tumor
• Have active or a history of DVT, pulmonary embolism, stroke, or heart attack
• Have a known clotting disorder (protein C, protein S, or antithrombin deficiency)
• Have liver impairment or disease
• Have a known allergy to the patch adhesive or its components

Other Warnings

• Increases risk of gallbladder disease requiring surgery
• May worsen high triglycerides, fluid retention, migraine, epilepsy, asthma, or lupus
• Sudden vision changes should be evaluated immediately
• May affect thyroid-binding proteins; those on thyroid replacement may need dose adjustment
• Do not apply to or near the breasts; rotate application sites

Common Side Effects

• Application-site redness or irritation
• Headache, breast pain or tenderness
• Abdominal pain, bloating, nausea
• Fluid retention, mild swelling

Serious Side Effects — Seek Care Right Away

• Chest pain, shortness of breath, coughing blood
• Sudden severe headache, vision or speech changes, weakness or numbness
• Leg pain, swelling, or warmth
• New breast lumps or unusual vaginal bleeding

Special Populations

• Pregnancy: not indicated for use during pregnancy
• Breastfeeding: hormone passes into breast milk; may decrease milk supply
• Geriatric use: use caution; increased relative risk of stroke, breast cancer, and dementia observed in women 65 and older in clinical trials of oral estrogen products

Overdose

Overdose may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and withdrawal bleeding. Remove the patch and contact your healthcare provider or Poison Control (1-800-222-1222).

Storage & Disposal

Store unopened patches at controlled room temperature (68–77°F / 20–25°C) in their sealed pouch; apply immediately after opening. Used patches still contain active hormone — fold the sticky side onto itself and discard in the household trash out of reach of children and pets. Do not flush.

Biest 80/20 Cream (Estradiol/Estriol)

A compounded topical estrogen combination cream containing estriol and estradiol in an 80:20 ratio, applied to the skin. Because it combines two estrogen types and is compounded to an individualized strength, it is not an FDA-approved drug product.

Off-Label / Compounding Note

Biest creams are compounded preparations not evaluated by the FDA for safety, effectiveness, dosing accuracy, or absorption. Estriol in particular is not an FDA-approved ingredient for any drug product marketed in the United States. Use exactly as directed by your prescriber, including the application site and amount, since absorption can vary by location and skin condition.

Boxed Warning (Estrogen Class)

Estrogens increase the risk of endometrial cancer in women with a uterus who use estrogen without an opposing progestogen. Systemic absorption can occur with topical estrogen use, and the warnings, precautions, and adverse reactions associated with oral estrogen should be considered, including increased risk of stroke, DVT, pulmonary embolism, heart attack, invasive breast cancer, and probable dementia in women 65 and older, based on data from oral estrogen and estrogen-progestin studies.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have known, suspected, or a history of breast cancer
• Have a known or suspected estrogen-dependent tumor
• Have active or a history of DVT, pulmonary embolism, stroke, or heart attack
• Have liver dysfunction or disease
• Have a known clotting disorder
• Are pregnant or think you may be pregnant

Other Warnings

• Systemic absorption is possible with topical/transdermal application, particularly with larger doses or broken skin
• Increases risk of gallbladder disease
• May worsen fluid retention, migraine, epilepsy, asthma, or lupus
• Sudden vision changes should be evaluated immediately
• Avoid transferring cream to others through skin-to-skin contact; wash hands after application and cover the area once dry if others may have contact with the site

Common Side Effects

• Application-site irritation
• Breast tenderness, headache
• Irregular vaginal bleeding or spotting
• Bloating, mild fluid retention

Serious Side Effects — Seek Care Right Away

• Chest pain, shortness of breath
• Sudden severe headache, vision or speech changes, weakness or numbness
• Leg pain, swelling, or warmth
• New breast lumps or unusual vaginal bleeding

Special Populations

• Pregnancy: not indicated for use during pregnancy
• Breastfeeding: use with caution; estrogens pass into breast milk and may reduce supply

Overdose

Excess topical use may increase the likelihood of estrogen-related side effects such as nausea, breast tenderness, or bloating. Contact your healthcare provider or Poison Control (1-800-222-1222) with questions about accidental over-application or ingestion.

Storage

Store at room temperature away from heat and direct light, as directed on the pharmacy label. Keep tightly capped and out of reach of children and pets.

Estriol Vaginal Cream

A compounded low-potency estrogen cream applied vaginally, most often used for localized symptoms of vaginal atrophy such as dryness, irritation, or discomfort with intercourse.

Off-Label / Compounding Note

Estriol is not an FDA-approved drug ingredient in the United States; no FDA prescribing information exists for estriol products. This cream is a compounded preparation not evaluated by the FDA for safety, effectiveness, or dosing accuracy. The safety information below is adapted from FDA-approved labeling for other vaginal estrogen products, since estriol is a weaker, shorter-acting estrogen in the same hormone class.

Boxed Warning (Estrogen Class)

Systemic absorption can occur with vaginal estrogen use, particularly at higher doses or with prolonged use, and the warnings, precautions, and adverse reactions associated with oral estrogen should be considered. These include an increased risk of endometrial cancer in women with a uterus using unopposed estrogen, and increased risks of stroke, DVT, pulmonary embolism, heart attack, invasive breast cancer, and probable dementia (in women 65 and older) reported with systemic estrogen therapy.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have known, suspected, or a history of breast cancer
• Have a known or suspected estrogen-dependent tumor
• Have active or a history of DVT, pulmonary embolism, stroke, or heart attack
• Have liver dysfunction or disease
• Are pregnant or think you may be pregnant

Other Warnings

• Systemic absorption is lower than with oral or transdermal estrogen but is not zero, especially with higher doses
• Report any unusual vaginal bleeding or spotting to your provider
• Vaginal irritation, itching, or discharge can occur at the application site
• Use of a vaginal applicator as directed helps ensure consistent, accurate dosing

Common Side Effects

• Vaginal discharge, irritation, or itching
• Breast tenderness
• Headache
• Mild spotting

Serious Side Effects — Seek Care Right Away

• Chest pain, shortness of breath
• Sudden severe headache, vision or speech changes, weakness or numbness
• Leg pain, swelling, or warmth
• New breast lumps or persistent unusual vaginal bleeding

Special Populations

• Pregnancy: not indicated for use during pregnancy
• Breastfeeding: use with caution; discuss with your provider

Overdose

Excess use may increase the chance of estrogen-related side effects. Contact your healthcare provider or Poison Control (1-800-222-1222) with questions about accidental over-application or ingestion.

Storage

Store at room temperature away from heat and direct light, as directed on the pharmacy label. Keep out of reach of children and pets.

Progesterone Cream

A compounded topical progesterone preparation applied to the skin. No FDA-approved topical progesterone product exists in the United States (FDA-approved micronized progesterone is available only as an oral capsule); the safety information below is adapted from FDA-approved oral progesterone labeling, the closest available reference for this hormone.

Off-Label / Compounding Note

Topical progesterone is a compounded preparation not evaluated by the FDA for safety, effectiveness, or absorption, and its use is inherently off-label since no topical progesterone product carries FDA approval. Absorption through the skin can vary by application site, amount used, and individual factors; use exactly the amount and site directed by your prescriber.

Boxed Warning (Progestin Class, Oral Reference)

This warning applies to oral micronized progesterone combined with estrogen and is included as the closest available reference, since topical progesterone has not been studied in comparable trials. Estrogen plus progestin therapy should not be used to prevent cardiovascular disease or dementia. Postmenopausal women taking daily oral estrogen combined with a progestin had higher rates of stroke, DVT, pulmonary embolism, heart attack, and invasive breast cancer in clinical trials, along with a higher rate of probable dementia in women 65 and older.

Do Not Use If You

• Have undiagnosed abnormal vaginal bleeding
• Have known, suspected, or a history of breast cancer
• Have active or a history of DVT, pulmonary embolism, stroke, or heart attack
• Have liver dysfunction or disease
• Are pregnant or think you may be pregnant

Other Warnings

• May cause fluid retention; use caution with heart or kidney conditions
• May cause drowsiness or dizziness in some individuals, though less common than with oral progesterone
• Report any unusual or persistent vaginal bleeding to your provider promptly
• Avoid skin-to-skin transfer to others; wash hands after application

Common Side Effects

• Application-site irritation
• Breast tenderness, bloating
• Headache, mood changes
• Fatigue

Serious Side Effects — Seek Care Right Away

• Chest pain, shortness of breath
• Sudden severe headache, vision or speech changes, weakness or numbness
• Leg pain, swelling, or warmth
• Yellowing of skin or eyes
• New breast lumps or unusual vaginal bleeding

Special Populations

• Pregnancy: not to be used during pregnancy
• Breastfeeding: hormone may pass into breast milk; use with caution and discuss with your provider

Overdose

No formal overdose data exist for topical progesterone. Contact your healthcare provider or Poison Control (1-800-222-1222) if overdose or accidental ingestion is suspected.

Storage

Store at room temperature away from heat and direct light, as directed on the pharmacy label. Keep tightly capped and out of reach of children and pets.

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