Our Custom Rx Safety Information

Compound: Estradiol Transdermal Patches (24-hour, generic version of Climara)
Available Strengths: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.06 mg/day, 0.075 mg/day, 0.1 mg/day
Dosage Form: Transdermal patch, applied once weekly
Typical Use: Hormone replacement therapy (HRT) for menopausal symptoms (vasomotor symptoms, vulvar/vaginal
atrophy) and prevention of postmenopausal osteoporosis.
Usual Directions (example): Apply one patch to clean, dry skin of lower abdomen or buttock twice weekly. Rotate
sites; avoid breasts or waistline.

Key Components & Risks
- Estradiol: Bioidentical estrogen, restores estrogen levels to reduce menopausal symptoms and prevent bone loss.
- Risks: thromboembolic events, stroke, myocardial infarction, endometrial cancer (if unopposed), breast cancer,
gallbladder disease.

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

Warnings & Precautions
- Systemic absorption occurs; monitor for systemic estrogen-related effects.
- Increased risks of stroke, MI, DVT/PE, and breast cancer with prolonged estrogen therapy.
- Women with intact uterus require progestin co-therapy to prevent endometrial hyperplasia/cancer.
- Monitor patients with history of hypertension, diabetes, migraines, or liver disease.
- Use lowest effective dose for shortest duration consistent with treatment goals.

Drug Interactions
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine) may reduce estradiol effectiveness.
- CYP3A4 inhibitors (ketoconazole, erythromycin, grapefruit) may increase estradiol exposure.
- Corticosteroids: may increase systemic steroid effects.
- Alcohol and smoking: increase cardiovascular and thrombotic risks.

Adverse Effects (Selected)
- Local: application site reactions (redness, itching, irritation).
- Systemic: headache, breast tenderness, nausea, bloating, mood swings.
- Serious: thromboembolism, MI, stroke, breast or endometrial cancer, gallbladder disease.

Monitoring (Per Prescriber)
- Baseline and periodic blood pressure, breast and pelvic exams.
- Mammography as clinically indicated.
- Endometrial evaluation for persistent abnormal bleeding.
- Periodic lipid and liver function monitoring as clinically appropriate.

Patient Counseling Points
- Apply patch to clean, dry skin on lower abdomen or buttocks; rotate sites with each application.
- Avoid applying to breasts or irritated/damaged skin.
- Press firmly for 10 seconds to ensure adhesion; replace if patch falls off (do not reuse).
- Report leg pain/swelling, chest pain, severe headache, or vision changes immediately.
- Inform all healthcare providers of estradiol patch use.

Storage & Handling
- Store at controlled room temperature (20–25 °C / 68–77 °F).
- Protect from moisture and excessive heat.
- Dispose of used patches safely (fold adhesive sides together).
- Keep away from children and pets.

References (Selected)
- DailyMed: Estradiol transdermal system labeling (generic Climara).
- ACOG and NAMS guidelines on hormone therapy for menopausal symptoms.
- Women’s Health Initiative (WHI) trial data on estrogen therapy risks.
- FDA guidance on transdermal estrogen therapies.

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.