Generic
Hydroxyprogesterone Caproate
8 brands available in the market
At a glance
Hydroxyprogesterone Caproate is used to prevent premature labor in pregnant women with a history of spontaneous preterm birth.
Description
Hydroxyprogesterone Caproate is a synthetic steroid hormone used to reduce the risk of preterm birth in pregnant women. It is a progestin (female hormone) that modulates the mother's immune response to prevent rejection of the embryo and allow its attachment to the uterus. This medication is administered only by or under the supervision of a doctor as an intramuscular injection.
Indications
- Reducing the risk of preterm birth (singleton pregnancy with history of spontaneous preterm birth)
- Prevention of preterm labor (patients aged 16 years or older with history of spontaneous preterm birth)
Therapeutic class
Hormone preparations for other uses
Pharmacological class
Progestin (Synthetic Steroid Hormone)
Pharmacology
Hydroxyprogesterone caproate is a synthetic steroid hormone similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone. Progesterone binds to progesterone receptors in the uterus, ovaries, breasts and central nervous system, leading to regulation of gene transcription. This results in an anti-inflammatory effect that blunts the proinflammatory state associated with labor initiation and maintains uterine quiescence by stabilizing progesterone action on the myometrium.
Mechanism of action
Binds to progesterone receptors to regulate gene transcription; maintains uterine quiescence through anti-inflammatory effects and prevents preterm birth.
Dosage
Adult Dose (Intramuscular):
- Preterm Birth Prevention: 250 mg weekly (initiate between 16-20 weeks, continue until 37 weeks or delivery)
- Recurrent Miscarriage: 250-500 mg weekly during first half of pregnancy
- Amenorrhea/Abnormal Uterine Bleeding: Single dose 375 mg; may repeat at 4-week intervals if needed
- Endometrial Carcinoma: Usual dose: 1 g weekly (1-7 g/week)
Child Dose: Safety and efficacy not established
Administration
Administered only under doctor's supervision as intramuscular injection; inject slowly into upper outer quadrant of gluteus maximus; applying pressure to injection site may minimize bruising and swelling.
Missed dose
If you miss a dose, please consult your doctor.
Side effects
Most Common:
- Injection site reactions (pain, swelling, pruritus, nodule)
- Hives
- Itching
- Nausea
- Diarrhea
Serious (Inform Doctor): Blood clot symptoms (leg swelling, redness, warmth, pain), allergic reactions (hives, itching, facial swelling)
Precautions & warnings
Precautions:
- Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs
- Allergic reactions: Consider discontinuing if allergic reactions occur
- Decreased glucose tolerance: Monitor pre-diabetic and diabetic women
- Fluid retention: Monitor women with pre-eclampsia, epilepsy, cardiac or renal dysfunction
- Depression: Monitor with history of clinical depression; discontinue if recurs
- Jaundice and hypertension: Carefully monitor
Contraindications
Contraindications:
- Current or history of thrombosis or thromboembolic disorders
- Known or suspected breast cancer or other hormone-sensitive cancer
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors (benign or malignant) or active liver disease
- Uncontrolled hypertension
- Undiagnosed vaginal bleeding, lactation
Drug interactions
Drug Interactions:
- Enzyme inducers (e.g., carbamazepine, phenytoin) increase clearance
- May inhibit metabolism of ciclosporin
Food interactions
Food Interactions: It is not known whether it is safe to consume alcohol with Hydroxyprogesterone Caproate; consult your doctor.
Use in pregnancy
Use in Pregnancy: Category B; generally considered safe; animal studies show low or no adverse effects; limited human studies.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Safe during breastfeeding; does not pass into breastmilk in significant amount; nonhormonal contraceptives preferred, especially during first 4 weeks postpartum.
Pediatric use
Safety and efficacy not established in pediatric patients <16 years; limited number of women <18 years studied.
Geriatric use
Not evaluated in women >65 years; not intended for postmenopausal women.
Renal / hepatic impairment
Renal Impairment: Effect on pharmacokinetics not evaluated; limited information available; consult your doctor.
Hepatic Impairment: Contraindicated in liver tumors or active liver disease; effect on pharmacokinetics not evaluated.
Overdose effects
No adverse events associated with overdosage have been reported.
Storage conditions
Store at controlled room temperature between 15°C to 30°C; protect from light; keep out of reach of children.
Chemical structure
Hydroxyprogesterone Caproate