Progeshield

Hydroxyprogesterone Caproate Injection USP is a sterile, long-acting preparation of the caproate ester of the naturally occurring progestational hormone, hydroxyprogesterone, in an oil solution for intramuscular use^5,6. The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy]. It has an empirical formula of C₂₇H₄₀O₄ and a molecular weight of 428.60. Hydroxyprogesterone caproate exists as white to creamy white crystalline powder.

Indications

• Hydroxyprogesterone caproate is indicated for the prevention of spontaneous preterm births in women with a singleton gestation who have previously had a spontaneous preterm birth.^5,7
• The US Food and Drug Administration has approved the use of this agent during pregnancy to reduce the risk of recurrent preterm birth in women with a history of at least 1 prior spontaneous preterm delivery.⁴
• In non-pregnant women, hydroxyprogesterone caproate is indicated for:⁶
  
  • Treatment of advanced adenocarcinoma of the uterine corpus (stage III or IV)
  • Management of amenorrhea (primary and secondary)
  • 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
  • Production of secretory endometrium and desquamation.⁶

Dosage and Administration

• Due to low viscosity of the vehicle, hydroxyprogesterone caproate may be administered with a small gauge needle.⁶
• Care should be taken to inject it deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection.⁶
• As 250 mg potency provides a high concentration in a small volume, special care should be taken to administer the full dose.⁶
• Use of a wet needle or syringe may make the solution cloudy, however, this does not affect the potency of the material.⁶
• Visual inspection of parenteral drug products should be done for particulate matter and discoloration prior to administration, whenever solution and container permit.⁶
• Protect it from light.⁶
• Store vial in its box.⁶
• Store upright.⁶

Contraindications

• Hydroxyprogesterone caproate is contraindicated in patients with:
  
  • Known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions
  • Undiagnosed abnormal vaginal bleeding
  • Liver dysfunction or disease
  • Missed abortion
  • History of hypersensitivity to the drug
  • Current or history of thrombotic or thromboembolic disorders.
• It is also contraindicated as a diagnostic test for pregnancy.⁶