Maximum Recommended Dose of Prometrium (Progesterone)
The maximum recommended dose of Prometrium (progesterone) is 400 mg per day for most indications, though doses up to 1200 mg per day have been used in specific clinical scenarios such as preterm labor. 1
Dosing by Indication
Hormone Replacement Therapy
- For postmenopausal women on estrogen therapy, Prometrium is typically administered at 200 mg daily for 12 days per 28-day cycle 1
- For continuous combined regimens, doses of 100-200 mg daily are commonly used 2
Secondary Amenorrhea
- 300-400 mg daily for 10 days has been shown to effectively induce withdrawal bleeding 1
- In clinical studies, both 300 mg and 400 mg daily doses resulted in similar rates of withdrawal bleeding (73.8% and 76.8%, respectively) 1
Preterm Birth Prevention
- For threatened preterm labor, higher doses have been used: 400 mg orally every 6 hours for 24 hours, then 400 mg every 8 hours for 24 hours, followed by 300 mg every 8 hours (total of 1200 mg/day initially) 2
- For vaginal administration in women with short cervical length, 90-mg gel or 200-mg suppository daily is recommended 2
Administration Considerations
- Oral micronized progesterone has improved bioavailability compared to older formulations 3
- Taking progesterone at bedtime can minimize the side effect of drowsiness 3, 4
- For menopausal symptoms, 300 mg at bedtime has been shown effective for vasomotor symptoms in a 3-month randomized controlled trial 4
Safety Considerations
- Prometrium has a more favorable safety profile compared to synthetic progestins, particularly regarding cardiovascular effects 3, 4
- No significant alterations in circulating androgen levels have been observed with oral micronized progesterone at doses of 300 mg daily (100 mg morning, 200 mg bedtime) 5
- Higher doses (>400 mg/day) should be monitored for side effects such as sedation 3
Clinical Monitoring
- When using higher doses (>400 mg/day), monitor for excessive sedation 3
- For long-term therapy, endometrial protection should be assessed periodically 1
- No special monitoring of androgen levels is required when using standard doses 5
Common Pitfalls to Avoid
- Confusing oral micronized progesterone (Prometrium) with injectable 17-alpha-hydroxyprogesterone caproate (17P), which has different dosing and indications 2
- Failing to recognize that drowsiness is a common side effect, which can be minimized by bedtime administration 3
- Not distinguishing between vaginal and oral administration routes, which have different bioavailability and dosing requirements 2
While higher doses have been used in specific clinical scenarios such as preterm labor prevention, the standard maximum recommended dose for most indications is 400 mg daily, with the most common regimens being 200-300 mg daily for hormone replacement therapy and treatment of secondary amenorrhea.