Indications & Uses
Hydroxyprogesterone Caproate is used for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. It is also used for the prevention of preterm labor in a singleton pregnancy, for patients aged 16 years or older who have a history of spontaneous preterm birth.
Pharmacology
Hydroxyprogesterone caproate is a synthetic steroid hormone, similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17a-hydroxyprogesterone, formed from caproic acid (hexanoic acid). How progesterone prevents preterm birth is not well understood, but many pathways are likely involved. Progesterone helps regulate the female reproductive system, and it is important for successful implantation of the embryo and for maintaining pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Once progesterone binds to them, the end result is regulation of gene transcription. This produces an anti-inflammatory effect, which blunts the proinflammatory state that occurs when labor begins, and it maintains uterine quiescence by stabilizing progesterone acting on the myometrium.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Hydroxyprogesterone Caproate is given as an intramuscular injection, at a dose of 500 mg or 250 mg once a week. Treatment starts between 16 weeks, 0 days and 20 weeks, 6 days of pregnancy. The weekly injections continue until week 37 (through 36 weeks, 6 days) or until delivery, whichever comes first.
Administration
Clean the top of the ampoule with an alcohol swab before use. Draw up 1 ml of the medicine into a 2 ml syringe. Once the skin has been prepared, inject into the upper outer quadrant of the gluteus maximus. The solution is viscous and oily, so a slow injection, over one minute or longer, is recommended. Applying pressure to the injection site may minimize bruising and swelling.
Side Effects
The most common side effects of Hydroxyprogesterone Caproate are reactions at the injection site, such as pain, swelling, pruritus and a nodule. Hives, itching, nausea and diarrhea can also happen. Call your doctor if you get any of the symptoms below. Blood clots show up as swelling in your leg, redness in your leg, a spot on your leg that is warm to touch, or leg pain that gets worse when you bend your foot. An allergic reaction shows up as hives, itching or swelling of the face.
Cautions & Contraindications
Warnings & Precautions
Thromboembolic disorders: stop Hydroxyprogesterone Caproate if thrombosis or thromboembolism occurs. Allergic reactions: think about stopping the medicine if an allergic reaction occurs. Decreased glucose tolerance: women who are pre-diabetic or diabetic and are receiving Hydroxyprogesterone Caproate should be monitored. Fluid retention: women with conditions that fluid retention may affect, such as pre-eclampsia, epilepsy, cardiac or renal dysfunction, should be monitored. Depression: women with a history of clinical depression should be monitored, and Hydroxyprogesterone Caproate should be stopped if the depression recurs. Jaundice: if a woman develops jaundice while receiving Hydroxyprogesterone Caproate, monitor her carefully and consider whether the benefit of use warrants continuation. Hypertension: if a woman develops hypertension while receiving Hydroxyprogesterone Caproate, monitor her carefully and consider whether the benefit of use warrants continuation.
Contraindications
Don't use Hydroxyprogesterone Caproate if you have a current or past history of thrombosis or thromboembolic disorders. It is also not for anyone with known or suspected breast cancer, another hormone-sensitive cancer, or a history of these conditions. Other contraindications are undiagnosed abnormal vaginal bleeding unrelated to pregnancy, cholestatic jaundice of pregnancy, liver tumors (benign or malignant), active liver disease, and uncontrolled hypertension.
Pregnancy & Breastfeeding
Pregnancy: Category B. There are no adequate and well-controlled studies of Hydroxyprogesterone Caproate in women during the first trimester of pregnancy. In a study of pregnant women who received the drug in their second and third trimesters, no teratogenic risk was shown for the infants exposed in utero. A follow-up safety study of those infants also showed none. The drug is not intended to stop active preterm labour, and its effect for that use is unknown.
Lactation: Detectable amounts of progestins have been found in the breast milk of women receiving progestins. No adverse effects of progestins have been seen on breastfeeding performance, or on the health, growth or development of infants. Discontinue the drug at 37 weeks of gestation or upon delivery.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Hydroxyprogesterone Caproate is not indicated for use in pediatric patients. Its safety and efficacy have not been established in patients under 16 years of age. Only a limited number of women under 18 years of age were studied, but safety and efficacy are expected to be the same in women over 16 years of age as in those over 18.
Geriatric use: The medicine has not been evaluated in women over 65 years of age. It is not intended for use in postmenopausal women, and its safety and efficacy have not been established in postmenopausal women.
Hepatic impairment: Hydroxyprogesterone Caproate is contraindicated in patients with liver tumors (benign or malignant) or active liver disease. The effect of hepatic impairment on the pharmacokinetics of the drug has not been evaluated.
Renal impairment: The effect of renal impairment on the pharmacokinetics of the drug has not been evaluated.
Overdose
No adverse events have been reported with an overdose of Hydroxyprogesterone Caproate.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Hydroxyprogesterone Caproate at room temperature, between 15°C and 30°C. Protect it from light, and keep it out of the reach of children.
Common questions about HPC Injection 250 mg/ml
What is HPC Injection 250 mg/ml Injection?
HPC Injection 250 mg/ml Injection is a medicine that contains Hydroxyprogesterone Caproate. It is made by Popular Pharmaceuticals PLC. It belongs to the Hormone preparations for other uses group of medicines.
What is HPC Injection used for?
Hydroxyprogesterone Caproate is used for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. It is also used for the prevention of preterm labor in a singleton pregnancy, for patients aged 16 years or older who have a history of spontaneous preterm birth.
What are the side effects of HPC Injection?
The most common side effects of Hydroxyprogesterone Caproate are reactions at the injection site, such as pain, swelling, pruritus and a nodule. Hives, itching, nausea and diarrhea can also happen.
Can I take HPC Injection during pregnancy or while breastfeeding?
Pregnancy: Category B. There are no adequate and well-controlled studies of Hydroxyprogesterone Caproate in women during the first trimester of pregnancy. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much HPC Injection?
No adverse events have been reported with an overdose of Hydroxyprogesterone Caproate. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store HPC Injection?
Keep Hydroxyprogesterone Caproate at room temperature, between 15°C and 30°C. Protect it from light, and keep it out of the reach of children.
Do I need a prescription for HPC Injection?
HPC Injection is a prescription (Rx) medicine. Take it as your doctor advises.