Our Custom Rx Safety Information

Compound: Estradiol 0.02% (0.2 mg/g) Vaginal Cream - 30 g
Dosage Form: Vaginal cream (compounded - not FDA-approved)
Typical Use: Prescriber-directed hormone replacement therapy for treatment of vulvovaginal atrophy, dryness,
burning, itching, and dyspareunia associated with menopause or estrogen deficiency.
Usual Directions (example): Insert 1 applicatorful intravaginally at bedtime 2–3 times weekly or as directed by
prescriber.

Key Components & Risks
- Estradiol: Restores estrogen locally to vaginal tissues; improves lubrication, elasticity, and epithelial integrity.
- Risks: minimal systemic absorption compared to oral estrogens, but systemic risks remain possible
(thromboembolism, endometrial hyperplasia if unopposed, breast cancer).

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

Warnings & Precautions
- Although systemic absorption is lower with vaginal administration, systemic estrogenic effects may still occur.
- Women with intact uterus may require concomitant progestin therapy if prolonged use is anticipated to reduce
endometrial hyperplasia/cancer risk.
- Caution in women with cardiovascular disease, thrombotic history, migraines, or seizure disorders.
- Use lowest effective dose for shortest duration consistent with therapy goals.
Drug Interactions
- CYP3A4 inducers (rifampin, carbamazepine, phenytoin) may decrease estradiol levels.
- CYP3A4 inhibitors (ketoconazole, erythromycin, grapefruit) may increase estradiol levels.
- Concurrent systemic estrogen/progestin therapy may increase risks of adverse systemic effects.

Adverse Effects (Selected)
- Local: vaginal irritation, discharge, pruritus, burning, or discomfort.
- Systemic (less common): breast tenderness, headache, nausea, bloating, mood changes.
- Serious: thromboembolic events, endometrial cancer, breast cancer (rare at low-dose local therapy but risk not
excluded).
Monitoring (Per Prescriber)
- Baseline and periodic pelvic and breast exams.
- Mammography per clinical guidelines.
- Monitor for abnormal vaginal bleeding.
- Periodic reassessment of need for continued therapy.

Patient Counseling Points
- Use exactly as prescribed; apply intravaginally using applicator.
- Clean applicator thoroughly after each use if reusable.
- Do not use more frequently than directed; report abnormal bleeding or breast changes immediately.
- Therapy is local but systemic effects may still occur; report chest pain, leg swelling, severe headaches, or vision
changes promptly.
- Store medication at room temperature away from children and pets.

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

References (Selected)
- DailyMed: Estradiol vaginal cream labeling.
- ACOG and NAMS guidelines on local hormone therapy.
- FDA guidance on vaginal estrogen products.
- Women’s Health Initiative (WHI) trial data on systemic estrogen risks (contextual)

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.