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Hydroxyprogesterone Caproate: Brands, Price & Uses in Bangladesh
Approved Indication Hydroxyprogesterone Caproate injection is indicated to reduce the risk of preterm birth in women pregnant with a single baby (singleton gestation) who have a documented history…
About Hydroxyprogesterone Caproate
Indications of Hydroxyprogesterone Caproate
Approved Indication
Hydroxyprogesterone Caproate injection is indicated to reduce the risk of preterm birth in women pregnant with a single baby (singleton gestation) who have a documented history of at least one prior spontaneous preterm birth. Its use is limited to this specific obstetric risk-reduction setting and must be initiated and supervised by a qualified physician.
Regulatory note: The approval of the branded intramuscular product for this indication was originally granted under an accelerated-approval pathway. A required confirmatory trial did not verify the expected clinical benefit, and regulatory status of branded Hydroxyprogesterone Caproate products has been reconsidered in some markets, including voluntary market withdrawal of the branded U.S. injection in 2023. Where still available, Hydroxyprogesterone Caproate should be used only under specialist obstetric guidance, and patients should discuss current local approval status and evidence with their physician.
Historical / Other Progestin-Responsive Uses
Hydroxyprogesterone Caproate has historically also been used, less commonly and with weaker evidence, for other progestin-responsive gynecological indications. Such uses are not well-established by current major guidelines and should be considered only on individualized specialist advice; Hydroxyprogesterone Caproate is not indicated for general use during pregnancy outside the specific preterm-birth-risk-reduction population described above.
Dosage & Administration of Hydroxyprogesterone Caproate
Approved Obstetric Indication — Preterm Birth Risk Reduction
| Population | Dose | Schedule |
|---|---|---|
| Pregnant women, singleton gestation, prior spontaneous preterm birth | 250 mg (1 mL) by intramuscular injection | Once weekly, starting between 16 weeks 0 days and 20 weeks 6 days of gestation, and continuing weekly until 37 weeks 0 days of gestation or delivery, whichever occurs first |
If a scheduled dose is missed, the next dose should be administered as soon as possible, per physician instruction; a missed-dose window of more than 7 days should be discussed with the treating obstetrician before resuming.
Hydroxyprogesterone Caproate must be initiated and monitored by an obstetric specialist; it is not intended for self-initiation or use outside this specific clinical protocol. See Contraindications and Precautions and Warnings before use.
Side Effects of Hydroxyprogesterone Caproate
Common
- Injection-site reactions: pain, swelling, itching, bruising, or nodule/lump formation at the injection site (most frequently reported)
- Urticaria (hives) and pruritus (itching)
- Nausea
- Headache
Less Common / Serious
- Hypersensitivity reactions, including rare anaphylaxis (related to castor oil vehicle in the intramuscular formulation)
- Thromboembolic events (see Contraindications and Precautions and Warnings)
- Mood changes, including depression
- Fluid retention
- Reduced glucose tolerance
Patients should seek prompt medical attention for signs of a blood clot (leg pain/swelling, chest pain, shortness of breath), severe allergic reaction, or new/worsening mood changes while receiving Hydroxyprogesterone Caproate.
Contraindications of Hydroxyprogesterone Caproate
Hydroxyprogesterone Caproate is contraindicated in patients with any of the following:
- Current or past history of thrombotic or thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism, stroke)
- Known or suspected breast cancer or other known or suspected hormone-sensitive (progestin-sensitive) cancer, currently or in the past
- Undiagnosed abnormal vaginal bleeding not related to the current pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- Uncontrolled hypertension
- Known hypersensitivity to Hydroxyprogesterone Caproate or any component of the formulation (including castor oil in the intramuscular vehicle)
- Missed abortion
Frequently Asked Questions about Hydroxyprogesterone Caproate
What is Hydroxyprogesterone Caproate used for?
Hydroxyprogesterone Caproate is used to reduce the risk of preterm (early) birth in women who are pregnant with one baby and who have previously had a spontaneous preterm birth. It is given as a weekly injection starting in the second trimester and continuing until around 37 weeks of pregnancy or delivery, whichever comes first, under the supervision of an obstetrician.
How is Hydroxyprogesterone Caproate given?
Hydroxyprogesterone Caproate is given as a deep intramuscular (into the muscle) injection, usually in the buttock, once a week, by a trained healthcare professional. It is not a tablet or a self-administered oral medicine in its standard obstetric formulation.
Is Hydroxyprogesterone Caproate safe to use during pregnancy?
Hydroxyprogesterone Caproate is specifically used during pregnancy for one approved indication — reducing the risk of recurrent preterm birth. It should be used only under close medical supervision and only if your physician judges that the potential benefit outweighs the potential risk for your specific situation. It is not intended for general or elective use in pregnancy, and it is contraindicated in a missed abortion. Always follow your physician's guidance regarding continuing or stopping Hydroxyprogesterone Caproate.
Who should not use Hydroxyprogesterone Caproate?
Hydroxyprogesterone Caproate should not be used by anyone with a current or past history of blood clots, known or suspected breast cancer or other hormone-sensitive cancer, undiagnosed vaginal bleeding unrelated to the pregnancy, cholestatic jaundice of pregnancy, liver tumors or active liver disease, uncontrolled high blood pressure, a missed abortion, or a known allergy to Hydroxyprogesterone Caproate or its ingredients (including castor oil in the injectable form). Tell your doctor about your full medical history before starting Hydroxyprogesterone Caproate.
What are the common side effects of Hydroxyprogesterone Caproate?
The most common side effects of Hydroxyprogesterone Caproate are reactions at the injection site, such as pain, swelling, itching, bruising, or a small lump. Hives, itching, nausea, and headache have also been reported. Seek urgent medical care for signs of a blood clot (leg swelling or pain, chest pain, shortness of breath), a severe allergic reaction, or worsening mood or depression while using Hydroxyprogesterone Caproate.
What should I do if I miss a dose of Hydroxyprogesterone Caproate?
If you miss a scheduled dose of Hydroxyprogesterone Caproate, contact your obstetric care provider as soon as possible for guidance on when to receive the next dose; do not double a dose or restart on your own without medical advice.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.