PRODUCT DESCRIPTION:

Hydroxyprogesterone Caproate Injection 500 MG is a long-acting progestin formulation widely used to reduce the risk of preterm birth in women with a history of spontaneous preterm delivery. Its high-dose, sustained-release profile ensures prolonged hormonal support during critical gestational windows.

It is also indicated in the treatment of threatened or habitual miscarriage, secondary amenorrhea, and other progesterone-responsive conditions. This formulation is available as a blister-packed ampoule or pre-filled syringe, designed for convenient administration in hospital and clinical settings.

Formulation & Presentation:

• Dosage Form: Injections
• Presentation: Blister Pack (Ampoules or Vials) Pre Filled Syringes also available
• Available Strengths: 500 MG Injections
• Route of Administration: IM (As per physician’s discretion or therapeutic indication)

Therapeutic Indications:

• Prevention of recurrent preterm birth in women with prior history
• Management of threatened and recurrent miscarriage
• Treatment of secondary amenorrhea
• Hormonal support in selected cases of infertility and assisted reproduction
• Management of certain endometrial disorders under clinical supervision

Side Effects:

• COMMON:  Local pain, swelling, or irritation at injection site, Headache, Nausea, Fatigue or drowsiness, Breast tenderness
• SERIOUS (RARE): Allergic reactions (rash, itching, anaphylaxis), Fluid retention or swelling, Cholestatic jaundice, Depression or mood changes, Thromboembolic events (extremely rare with proper screening)
• PRECAUTIONS: 

• Not indicated for use in early pregnancy without confirmed clinical need
• Contraindicated in patients with hormone-sensitive malignancies, active thromboembolic disorders, or liver disease
• Should be used cautiously in patients with a history of hypertension, diabetes, asthma, or migraine
• Periodic monitoring is recommended in long-term use
• Must be administered under the guidance of qualified healthcare professionals