General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Hydroxyprogesterone Caproate
HYDROXYPROGESTERONE CAPROATE
INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
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Brand names:Hydroxyprogesterone Caproate
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- HYDROXYPROGESTERONE CAPROATE
- Medicine class
- General Medicine
- Brand names
- Hydroxyprogesterone Caproate
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
What Is Hydroxyprogesterone Caproate?
INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
Hydroxyprogesterone Caproate (HYDROXYPROGESTERONE CAPROATE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Hydroxyprogesterone Caproate. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Hydroxyprogesterone Caproate with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Hydroxyprogesterone Caproate is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV);
in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer;
as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
DOSAGE AND ADMINISTRATION Suggested dosages are presented in the therapy guide. Because of the low viscosity of the vehicle, Hydroxyprogesterone Caproate Injection, USP may be administered with a small gauge needle. Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection. Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose. Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Protect from light. Store vial in its box. Store upright. Discard any unused product within 5 weeks after first use. THERAPY GUIDE CYCLIC THERAPY SCHEDULE: (28-day cycle; repeated ev
Available Forms
Available Strengths
Side Effects
Common
- ADVERSE REACTIONS A.
- Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins.
- neuroocular lesions (e.g., retinal thrombosis and optic neuritis);
- gastrointestinal symptoms (such as abdominal cramps or bloating);
- breakthrough bleeding, spotting, or withdrawal bleeding;
- breast tenderness;
- changes in body weight (increase or decrease);
Serious
- WARNINGS Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine.
- Medication should be stopped if examination reveals papilledema or retinal vascular lesions.
- Allergic reactions Hypersensitivity reaction to progestins have been reported.
- Hydroxyprogesterone caproate is contraindicated in women with a history of hypersensitivity to a progestin.
- Glucose tolerance Progestins may decrease glucose tolerance and the blood glucose concentration should be monitored in diabetic users.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
WARNINGS Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Medication should be stopped if examination reveals papilledema or retinal vascular lesions. Allergic reactions Hypersensitivity reaction to progestins have been reported. Hydroxyproge
How Hydroxyprogesterone Caproate Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Hydroxyprogesterone Caproatewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Hydroxyprogesterone Caproate dosage guide
Adult, pediatric, renal, and hepatic dosing for Hydroxyprogesterone Caproate
- Detail
Hydroxyprogesterone Caproate side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Hydroxyprogesterone Caproate
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.