Our Custom Rx Safety Information

Compounds:
1) Progesterone SR (E4M) 200 mg Capsule
2) Progesterone SR (E4M) 150 mg Capsule
3) Progesterone SR (E4M) 100 mg Capsule
Dosage Form: Sustained-Release Oral Capsule (compounded - not FDA-approved)
Typical Use: Prescriber-directed hormone replacement therapy (HRT), luteal phase support in fertility treatment, or
management of certain gynecological conditions.
Usual Directions (example): Take one capsule orally at bedtime or as directed by prescriber. Sustained-release
formulation intended for prolonged effect.

Key Components & Risks
- Progesterone SR (E4M base): Bioidentical progesterone in a sustained-release matrix to provide stable serum
concentrations.
- Risks: sedation, dizziness, breast tenderness, mood changes, rare thromboembolism, potential liver enzyme
changes.

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

Warnings & Precautions
- May cause drowsiness; administer at bedtime to minimize daytime sedation.
- Increased risk of thromboembolic events when combined with estrogen therapy.
- Use lowest effective dose for shortest duration consistent with treatment goals.
- Monitor closely in patients with depression, migraines, or seizure disorders.

Drug Interactions
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine) may decrease progesterone levels.
- CYP3A4 inhibitors (ketoconazole, clarithromycin, grapefruit juice) may increase progesterone exposure.
- Alcohol and sedatives may enhance CNS depressant effects.
- Concurrent estrogen therapy increases thromboembolic risks.

Adverse Effects (Selected)
- Common: drowsiness, dizziness, breast tenderness, bloating, mood swings, headache, nausea.
- Serious: thromboembolic events, depression, liver dysfunction (rare).
- Sustained-release forms may prolong sedative and systemic effects.

Monitoring (Per Prescriber)
- Baseline and periodic blood pressure, breast exam, and pelvic exam.
- Mammography per clinical guidelines.
- Monitor for abnormal uterine bleeding; evaluate promptly if persistent.
- Consider hormone levels and liver function tests as clinically indicated.

Patient Counseling Points
- Take at bedtime to minimize daytime drowsiness.
- Do not drive or operate machinery until drug effects are known.
- Report abnormal bleeding, breast changes, severe mood swings, or signs of blood clot (leg swelling, chest pain,
sudden headache/vision change).
- Do not consume alcohol excessively while taking this medication.
- Take only as prescribed; do not double doses if missed.

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

References (Selected)
- DailyMed: Progesterone capsule labeling (Prometrium and generics).
- ACOG & NAMS guidelines on hormone replacement therapy.
- FDA guidance on compounded bioidentical hormone therapy.
- Women’s Health Initiative (WHI) trial data on hormone 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.