17-Alpha-Hydroxyprogesterone
17-Alpha-Hydroxyprogesterone is a synthetic progestin hormone used primarily to reduce the risk of recurrent preterm birth in pregnant women with a history of spontaneous preterm delivery. It belongs to the sex hormones and modulators of the genital system drug class (ATC-G03).
A synthetic progestin used to help prevent preterm birth in high-risk pregnancies.
Key facts at a glance
- ATC
- G03DA03
- RxNorm
- 5542
- Generic
- 17-Alpha-Hydroxyprogesterone
- Class
- atc-g03
- Brands
- Makena
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, solution
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid unless clearly needed
avoid use during first trimester unless benefits significantly outweigh potential risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second third trimesterstandard dosing as indicated
indicated for prevention of preterm birth in women with history of spontaneous preterm birth
regular fetal monitoring and uterine assessment
lactation
breastfeedingmonitor infant
small amounts of 17-alpha-hydroxyprogesterone may be excreted in breast milk; use with caution
monitor infant for any adverse effects
Use with caution and monitor for adverse effects.
pediatric_age
neonates infantsnot applicable
not indicated for use in pediatric populations; safety and efficacy not established
not applicable
geriatric
elderlynot applicable
not indicated for geriatric population; drug is specifically for pregnant women
not applicable
renal_impairment
mild moderateuse with caution
renal impairment may affect drug elimination; use with caution and monitor renal function
monitor renal function parameters
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severedo not use
contraindicated in patients with significant hepatic impairment or liver disease
liver function monitoring if used inadvertently
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA Approval Year
FDA approval for prevention of preterm birth
Drug class
Synthetic progesterone analog
Primary indication
Therapeutic indication
Route of administration
Dosage form information
Primarily used to reduce the risk of recurrent spontaneous preterm birth in singleton pregnancies. Has also been used historically for treatment of menstrual disorders, amenorrhea, and endometriosis, though these uses have become less common.
Acts as a synthetic progestogen that binds to progesterone receptors, exerting progestational effects on the uterus. Helps maintain uterine quiescence and supports pregnancy continuation by supplementing natural progesterone levels.
Contraindicated in patients with known or suspected breast cancer, other hormone-sensitive cancers, liver disease, thromboembolic disorders, or undiagnosed vaginal bleeding. Administered by intramuscular injection. Regular prenatal monitoring is recommended during use. Not intended for use as a contraceptive.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy