HYDROXYPROGESTERONE

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 patients with a history of spontaneous preterm deliveries. By supplementing the body's progesterone levels, it helps maintain a stable uterine environment, supporting fetal development and delaying early labour. Hydroxyprogesterone does not act as a labour suppressant but rather as a preventive measure in high-risk pregnancies. Hydroxyprogesterone was first approved by the U.S. FDA in 1956 for various gynaecological 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 patients with multiple gestations, uncontrolled hypertension, or a history of hormone-sensitive cancers.

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)

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.

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

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.

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.

Hydroxyprogesterone requires ongoing medical supervision. Attend all scheduled monitoring visits and injections as planned. Do not discontinue treatment without consulting your doctor, regardless of how you feel. Avoid other hormonal products, herbal remedies, or supplements unless your doctor approves them first. Inform any healthcare provider about your current therapy before undergoing surgery or starting new medications. Maintain a record of all doses for your reference and your doctor's records.

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