Our Custom Rx Safety Information

Compounds:
1) Estradiol 1% (10 mg/g) Cream - 30 g
2) Estradiol 0.7% (7 mg/g) Cream - 30 g
3) Estradiol 0.5% (5 mg/g) Cream - 30 g
4) Estradiol 0.1% (1 mg/g) Cream - 30 g
Dosage Form: Topical cream (compounded - not FDA-approved)
Typical Use: Prescriber-directed hormone replacement therapy (HRT) for menopausal symptoms, urogenital
atrophy, or other estrogen deficiency states.
Usual Directions (example): Apply a thin layer to clean, dry skin (inner thigh, forearm, or as directed by prescriber)
once daily.

Key Components & Risks
- Estradiol: Bioidentical estrogen; restores estrogen levels to alleviate vasomotor symptoms, urogenital atrophy, and
prevent osteoporosis.
- Risks: thromboembolic events, myocardial infarction, stroke, endometrial hyperplasia/cancer (when unopposed),
breast cancer, gallbladder disease.

Contraindications
- Known or suspected breast cancer or estrogen-dependent neoplasia.
- Undiagnosed abnormal vaginal bleeding.
- Active/history of thromboembolic disease (DVT, PE, MI, stroke).
- Severe liver dysfunction/disease.
- Hypersensitivity to estradiol or cream excipients.

Warnings & Precautions
- Systemic absorption occurs; monitor for systemic estrogen-related adverse effects.
- Women with intact uterus require concomitant progestin therapy to reduce risk of endometrial hyperplasia/cancer.
- Use lowest effective dose for shortest duration consistent with treatment goals.
- Caution in patients with history of hypertension, migraines, seizure disorder, or cardiovascular disease.

Drug Interactions
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine) may reduce estradiol efficacy.
- CYP3A4 inhibitors (ketoconazole, erythromycin, grapefruit juice) may increase estradiol levels.
- Corticosteroids: potential additive systemic effects.
- Alcohol and tobacco: increased risk of thrombotic and cardiovascular complications.

Adverse Effects (Selected)
- Local: skin irritation, itching, redness at application site.
- Systemic: breast tenderness, headache, nausea, bloating, mood changes.
- Serious: thromboembolic events, myocardial infarction, stroke, breast cancer, endometrial cancer, gallbladder
disease.

Monitoring (Per Prescriber)
- Baseline and periodic blood pressure, breast exams, and pelvic exams.
- Mammography per clinical guidelines.
- Monitor for abnormal vaginal bleeding.
- Consider lipid profile, liver function, and hormone levels as clinically appropriate.

Patient Counseling Points
- Apply cream exactly as prescribed; rotate application sites to avoid irritation.
- Do not apply to breasts, broken skin, or mucous membranes.
- Report abnormal bleeding, breast changes, severe headaches, chest pain, or leg swelling immediately.
- Inform all healthcare providers of estradiol therapy before new treatments or surgeries.

Storage & Handling
- Store at controlled room temperature (20–25 °C / 68–77 °F).
- Protect from heat, light, and moisture.
- Keep tightly closed and out of reach of children and pets.

References (Selected)
- DailyMed: Estradiol topical and systemic labeling.
- ACOG and NAMS guidelines on hormone therapy.
- FDA guidance on compounded hormone replacement therapy.
- Women’s Health Initiative (WHI) data on estrogen therapy risks. 

Disclaimer: This document is for clinical reference by licensed healthcare professionals. It does not replace
prescriber judgment, patient-specific recommendations, or official labeling of individual drug products.