Our Custom Rx Safety Information

Compounds:
1) Estradiol 0.7% (7 mg/g) / Progesterone 20% (200 mg/g) Cream - 30 g
2) Estradiol 0.5% (5 mg/g) / Progesterone 20% (200 mg/g) Cream - 30 g
3) Estradiol 0.3% (3 mg/g) / Progesterone 15% (150 mg/g) Cream - 30 g
Dosage Form: Topical cream (compounded - not FDA-approved)
Typical Use: Prescriber-directed therapy for hormone replacement (HRT), usually for menopausal symptom
management or other endocrinological conditions.
Usual Directions (example): Apply thin layer to skin areas with less subcutaneous fat (e.g., inner thigh, forearm)
once daily or as directed by prescriber.

Key Components & Risks
- Estradiol: Estrogen replacement; systemic absorption possible. Risks include thromboembolic events, endometrial
hyperplasia/cancer (unopposed estrogen), breast cancer, stroke, cardiovascular disease.
- Progesterone: Used to counteract unopposed estrogen and protect endometrium. Risks include sedation,
dizziness, breast tenderness, mood changes; rare risk of thromboembolism.

Contraindications
- Known/suspected breast cancer or estrogen-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Active/history of DVT, PE, arterial thromboembolic disease (MI, stroke).
- Liver dysfunction/disease.
- Hypersensitivity to estrogens or progesterone.
- Pregnancy and breastfeeding.

Warnings & Precautions
- Systemic absorption occurs; monitor for systemic estrogen/progestin adverse effects.
- Increased risk of breast cancer, stroke, myocardial infarction, and thromboembolic events with estrogen/progestin
therapy.
- Use lowest effective dose for shortest duration consistent with treatment goals.
- Endometrial safety: Progesterone required for women with intact uterus receiving estrogen.
- May cause dizziness, fatigue, or mood changes; caution in activities requiring alertness.

Drug/Skincare Interactions
- Inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin) may reduce hormone levels.
- Inhibitors of CYP3A4 (e.g., ketoconazole, erythromycin, grapefruit) may increase hormone levels.
- Other topical irritants may exacerbate local reactions.
- Alcohol and smoking may increase thrombotic/cardiovascular risks.

Adverse Effects (Selected)
- Local: application site irritation, rash, itching.
- Systemic: breast tenderness, headache, bloating, mood swings, nausea.
- Serious: thromboembolism, stroke, myocardial infarction, endometrial hyperplasia/cancer (if unopposed estrogen).
- Progesterone-specific: sedation, dizziness, fatigue.

Monitoring (Per Prescriber)
- Baseline and periodic blood pressure, breast exam, and pelvic exam.
- Mammography per guidelines.
- Endometrial evaluation in women with persistent/recurring abnormal bleeding.
- Consider baseline and follow-up lipids, liver function, and hormone levels as clinically indicated.

Patient Counseling Points
- Apply exactly as prescribed; do not exceed recommended dose.
- Rotate application sites to avoid skin irritation.
- Report abnormal vaginal bleeding, breast changes, leg swelling/pain, chest pain, or sudden headache/vision
changes immediately.
- Use lowest effective dose for shortest duration consistent with treatment goals.
- Inform all healthcare providers of hormone therapy use.

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

References (Selected)
- DailyMed: Estradiol transdermal/oral labeling (estrogen risks).
- DailyMed: Progesterone labeling (endometrial protection, adverse effects).
- Women’s Health Initiative (WHI) trial results on estrogen/progestin risks.
- ACOG/NAMS guidelines on hormone therapy for menopausal symptoms.
- FDA guidance on compounded hormone replacement therapy.

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.