Our Custom Rx Safety Information

Compounds:
1) Progesterone IR 200 mg Capsule
2) Progesterone IR 150 mg Capsule
3) Progesterone IR 100 mg Capsule
Dosage Form: Immediate-Release Oral Capsule (compounded - not FDA-approved)
Typical Use: Prescriber-directed hormone replacement therapy (HRT), luteal phase support in fertility treatment, or
management of gynecologic/endocrine conditions.
Usual Directions (example): Take one capsule orally once or twice daily as directed by prescriber.
Immediate-release formulation intended for rapid absorption.

Key Components & Risks
- Progesterone IR: Bioidentical hormone, immediate release; provides more rapid systemic absorption compared to
sustained-release formulations.
- Risks: sedation, dizziness, breast tenderness, mood changes, thromboembolism, and 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 excipients.
- Pregnancy (unless prescribed specifically for luteal phase support).

Warnings & Precautions
- May cause significant drowsiness; avoid driving or operating heavy machinery after dosing.
- Increased risk of thromboembolic events, especially when combined with estrogen therapy.
- Monitor closely in patients with seizure disorders, migraines, depression, or cardiovascular disease.
- Use lowest effective dose for shortest duration consistent with therapy goals.

Drug Interactions
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine) may lower progesterone levels.
- CYP3A4 inhibitors (ketoconazole, erythromycin, grapefruit juice) may increase progesterone exposure.
- Alcohol and sedatives may potentiate CNS depressant effects.
- Estrogen co-administration increases thromboembolic risk.

Adverse Effects (Selected)
- Common: drowsiness, dizziness, fatigue, headache, breast tenderness, bloating, mood swings, nausea.
- Serious: thromboembolic events, depression, severe sedation, hepatic dysfunction (rare).
- Immediate-release may cause more acute sedation compared to sustained-release.

Monitoring (Per Prescriber)
- Baseline and follow-up breast exams, pelvic exams, and blood pressure.
- Mammography as recommended by clinical guidelines.
- Monitor abnormal uterine bleeding for possible malignancy or endometrial pathology.
- Consider hormone levels and liver function tests where indicated.

Patient Counseling Points
- Take at bedtime or when rest is possible due to sedative effects.
- Report abnormal vaginal bleeding, breast changes, severe headaches, vision changes, or leg pain/swelling
immediately.
- Do not consume alcohol excessively while on therapy.
- Take only as prescribed; do not double doses if missed.
- Inform healthcare providers of progesterone therapy before procedures or new prescriptions.

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

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