Progesterone
endogenous
Pronunciation: proe-JES-ter-oen
What it isProgesterone-receptor agonist; endometrial protection with estrogen and luteal support.
Why this oneIt is the endogenous hormone rather than a synthetic progestin, with less adverse lipid effect than medroxyprogesterone.
What limits itSedation favors bedtime use. Oral absorption is variable, and the capsule's peanut oil matters in severe allergy.
FDA-approved for
- hormone therapy/luteal support (~1998)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Prevention of endometrial hyperplasia (postmenopausal, on estrogen) | Adult | 200 mg QHS x12 sequential days per 28-day cycle | ||
| Secondary amenorrhea | Adult | 400 mg QHS x10 days |
Renal Undefined
Hepatic Undefined
Instructions
- Take as a single dose at bedtime
- If difficulty swallowing, take with a glass of water while standing
- Contains peanut oil
Available strengths
- cap 100, 200 mg
- oil 6.4 g/30 g
- oil 12.8 g/60 g
- cream 20 mg/58 g
- cream 25 mg/85 g
- cream 1 mg/mg
- gel 8 %
- insert 100 mg
- + 2 other marketed forms not shown
Contraindications
- Undiagnosed abnormal genital bleeding
- Known, suspected, or history of breast cancer
- Active or prior deep vein thrombosis / pulmonary embolism
- Active or prior arterial thromboembolic disease (stroke, MI)
- Known liver dysfunction or disease
- Known or suspected pregnancy
- Peanut allergy (contains peanut oil)
Cautions
- Cardiovascular and thromboembolic risk (boxed)
- Breast cancer risk (boxed)
- Probable dementia in women ≥65 (boxed)
- May cause depression, fluid retention
Adverse reactions
- Headache, breast tenderness
- Dizziness, abdominal bloating
- Depression, joint pain
- Hot flashes, vaginal discharge
- Amenorrhea use: dizziness, headache, abdominal cramping
Pregnancy Should not be used during pregnancy (contraindicated); Category B
Lactation Undefined
Cost
Generic entry2001
⚠ BOXED WARNINGS
- Cardiovascular disorders with estrogen plus progestin therapy
- Breast cancer
- Probable dementia
Principal riskSedation; it is a peanut oil formulation
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityVenous thromboembolism and hormone-related adverse effects; estrogen also lowers lamotrigine exposure.