Our Custom Rx Safety Information

Compounds:
1) Progesterone 20% (200 mg/g) Cream - 30 g
2) Progesterone 15% (150 mg/g) Cream - 30 g
3) Progesterone 10% (100 mg/g) Cream - 30 g
Dosage Form: Topical cream (compounded - not FDA-approved)
Typical Use: Prescriber-directed hormone replacement therapy (HRT), often as adjunct to estrogen therapy in
women with intact uterus, or for luteal support in certain reproductive settings.
Usual Directions (example): Apply a thin layer to inner thigh, arm, or other site with less subcutaneous fat once daily
or as directed by prescriber.

Key Components & Risks
Progesterone: A natural progestin hormone used to oppose estrogen effects on the endometrium and regulate
menstrual/menopausal therapy. Risks include sedation, dizziness, breast tenderness, mood changes, and rare
thromboembolism.

Contraindications
- Known or suspected breast cancer or estrogen/progestin-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Active or history of thromboembolic disorders (DVT, PE, stroke, MI).
- Liver dysfunction or disease.
- Hypersensitivity to progesterone or formulation components.
- Pregnancy (unless prescribed for luteal support under supervision).

Warnings & Precautions
- Systemic absorption occurs with transdermal/topical progesterone; monitor for systemic side effects.
- May cause sedation, dizziness, or mood changes; use caution when driving or operating machinery.
- Increased risk of thromboembolism when used with estrogen therapy.
- Use lowest effective dose for shortest duration consistent with treatment goals.

Drug/Skincare Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine) may reduce progesterone levels.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, grapefruit juice) may increase progesterone levels.
- Alcohol or sedatives may enhance drowsiness/fatigue.
- Topical irritants may exacerbate local skin reactions.

Adverse Effects (Selected)
- Local: redness, itching, rash, skin irritation at site of application.
- Systemic: breast tenderness, bloating, fatigue, mood swings, headache, dizziness.
- Rare: thromboembolic events, depression, significant sedation.

Monitoring (Per Prescriber)
- Baseline and periodic physical examination including blood pressure and breast exam.
- Mammography per guidelines.
- Monitor for abnormal uterine bleeding and evaluate promptly.
- Consider hormone levels and liver function tests if indicated.

Patient Counseling Points
- Apply cream exactly as prescribed; rotate sites to reduce skin irritation.
- Do not exceed prescribed dose; report abnormal bleeding, breast changes, or severe mood changes.
- Avoid driving or operating machinery if drowsy or dizzy.
- Inform all healthcare providers of progesterone therapy.
- Store medication safely away from children and pets.

Storage & Handling
- Store at controlled room temperature (20–25 °C / 68–77 °F).
- Keep tightly closed; protect from heat, light, and moisture.
- For external use only.

References (Selected)
- DailyMed: Progesterone labeling (oral, vaginal, injectable).
- ACOG and NAMS guidelines on hormone replacement therapy.
- FDA guidance on compounded bioidentical hormone therapy.
- Women’s Health Initiative (WHI) trial: risks of hormone therapy including progestins.

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.