This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Hydroxyprogesterone is a synthetic hormone that mimics the effects of natural progesterone, a key hormone responsible for supporting pregnancy. It is primarily used to reduce the risk of preterm birth in women who have previously experienced spontaneous preterm deliveries. By supplementing the body's progesterone levels, it helps maintain a stable uterine environment, supporting fetal development and delaying early labor. Hydroxyprogesterone does not act as a labor suppressant but rather as a preventive measure in high-risk pregnancies.

Hydroxyprogesterone was first approved by the U.S. FDA in 1956 for various gynecological uses. In 2011, it received FDA approval under the trade name Makena specifically for the prevention of recurrent preterm birth. It is administered as a long-acting intramuscular injection, typically once weekly from the 16th to the 36th week of pregnancy. In India, Hydroxyprogesterone is widely used in obstetric care and is included in several public and private antenatal protocols. It is contraindicated in women with multiple gestations, uncontrolled hypertension, or a history of hormone-sensitive cancers.

Mechanism of Action of undefined

Hydroxyprogesterone works by binding to progesterone receptors in the body and reinforcing the hormonal signals that help maintain pregnancy. It supports the uterine lining, reduces uterine irritability, and helps delay cervical shortening factors that contribute to a lower risk of early labor. This helps create a more stable environment for the growing fetus.

The drug’s long-acting formulation allows it to be given once weekly as an injection, maintaining steady hormone levels over time. It does not induce labor or affect existing contractions but plays a preventive role by sustaining the pregnancy in women already at risk of premature birth. Its mechanism is hormonal, not muscle-based, and it does not cause dependency or withdrawal effects.

Uses of undefined

Hydroxyprogesterone is FDA-approved for:

  • Preventing recurrent preterm birth in women with a history of spontaneous preterm delivery (singleton pregnancy)

It may also be prescribed off-label for:

  • Hormone replacement in certain gynecologic conditions
  • Support during assisted reproductive techniques (as decided by the doctor)

undefined Drug administaration and Dosage available

Hydroxyprogesterone is typically given as a 250 mg intramuscular injection once weekly, starting between 16 and 20 weeks of pregnancy and continuing until 36 weeks or delivery whichever comes first. The injection is administered into the upper outer quadrant of the buttock by a healthcare provider under sterile conditions.

Patients should follow their antenatal schedule closely and report any signs of uterine contractions, vaginal bleeding, or allergic reactions during treatment.

Warnings, Precautions and Side Effects of undefined

Warnings

  • Do not use in patients with a current or history of hormone-sensitive cancers (e.g., breast cancer).
  • Avoid if the patient has active or history of thrombosis, stroke, or severe liver disease.
  • Not indicated for use in women carrying multiple babies (twins, triplets).
  • Use with caution in patients with uncontrolled hypertension or diabetes.
  • Injection site reactions and allergic responses may occur and should be reported immediately.

Precautions

Before starting treatment with Hydroxyprogesterone, it is essential to inform your doctor about any personal or family history of blood clots, stroke, liver problems, uncontrolled hypertension, or hormone-sensitive cancers such as breast cancer. Patients should also disclose any current use of hormonal therapies, including oral contraceptives or estrogen supplements, as these may interact with the medication. Although Hydroxyprogesterone is generally well-tolerated, it must be used strictly under medical supervision and should never be self-administered. Routine antenatal monitoring, including ultrasounds and blood pressure checks, is vital throughout the course of treatment. Patients are advised to immediately report any unusual symptoms such as persistent headaches, swelling of the limbs, pain or discolouration at the injection site, sudden shortness of breath, or signs of jaundice (yellowing of the skin or eyes), as these may require urgent medical evaluation.

Side Effects

Common Side Effects

  • Injection site pain or swelling
  • Headache
  • Nausea
  • Fatigue
  • Mild fluid retention

Serious Side Effects

  • Signs of blood clots (leg pain, chest pain, difficulty breathing)
  • Jaundice or liver dysfunction
  • Severe allergic reaction (rash, itching, swelling)
  • Vision changes or severe headache
     

Word Of Advice

Hydroxyprogesterone should be used under regular medical supervision. Always attend scheduled visits for monitoring and injection. Do not stop the treatment without consulting your doctor, even if you feel fine. Avoid using any hormonal products, herbal remedies, or supplements without prior approval. Inform any new doctor about your ongoing therapy, especially before surgeries or new prescriptions. Keep a record of doses taken for your and your doctor’s reference.

Frequently Asked Question

References

  1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021945s005lbl.pdf
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s012lbl.pdf
  3. https://www.ema.europa.eu/en/medicines/human/referrals/hydroxyprogesterone-caproate-containing-medicinal-products
  4. https://pubchem.ncbi.nlm.nih.gov/compound/Hydroxyprogesterone#section=3D-Conformer

Disclaimer

The content provided here is for informational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of your physician or another qualified healthcare provider with any questions you may have regarding a medical condition.