Hydroxyprogesterone

Hydroxyprogesterone Brand Name– Makena

What is Hydroxyprogesterone

Hydroxyprogesterone caproate (also known as 17-alpha hydroxyprogesterone caproate) is an injectable progestin.

One product (Makena) is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth; the drug is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Studies have shown progestational agents to be ineffective in preventing preterm delivery in women carrying multiple fetuses (e.g., twins, triplets), in women at low-risk for preterm delivery (e.g., no history of preterm delivery in previous pregnancies), in the prevention of early pregnancy loss or threatened abortion, or in prolonging pregnancy once labor has started.

A meta-analysis of studies demonstrated that progestational agents reduce the risk of delivery before 37 weeks gestation (RR 0.57, 95% CI 0.36 to 0.9).

There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Hydroxyprogesterone caproate injections have long been used for other female hormonal conditions, including amenorrhea, dysfunctional uterine bleeding, and the palliation of advanced endometrial cancer.

The initial FDA approval of hydroxyprogesterone was in 1956.

Indications

  1. amenorrhea
  2. dysfunctional uterine bleeding
  3. endometrial cancer
  4. preterm delivery prophylaxis
  5. test for endogenous estrogen production

For preterm delivery prophylaxis in females with a singleton pregnancy who have a history of singleton spontaneous preterm birth

Side Effects

  1. anxiety
  2. breast discharge
  3. depression
  4. diabetes mellitus
  5. diarrhea
  6. dizziness
  7. dyspnea
  8. edema
  9. emotional lability
  10. erythema
  11. fatigue
  12. fetal death
  13. fever
  14. fluid retention
  15. galactorrhea
  16. headache
  17. hot flashes
  18. hyperglycemia
  19. hypertension
  20. infection
  21. injection site reaction
  22. irritability
  23. jaundice
  24. mastalgia
  25. nausea
  26. premature labor
  27. pruritus
  28. pulmonary embolism
  29. rash
  30. retinal thrombosis
  31. skin irritation
  32. spontaneous fetal abortion
  33. stroke
  34. thromboembolism
  35. urticaria
  36. vaginal bleeding
  37. vomiting

Monitoring Parameters

  • pelvic exam
  • pelvic ultrasound

Contraindications

  • asthma
  • benzyl alcohol hypersensitivity
  • breast cancer
  • breast-feeding
  • cardiac disease
  • cervical cancer
  • children
  • cholestasis
  • depression
  • diabetes mellitus
  • hepatic disease
  • hepatocellular cancer
  • hypertension
  • infants
  • intravenous administration
  • jaundice
  • labor
  • migraine
  • neonates
  • polyoxyethylated castor oil hypersensitivity
  • preeclampsia
  • pregnancy
  • renal disease
  • seizure disorder
  • thromboembolic disease
  • thromboembolism
  • thrombophlebitis
  • uterine cancer
  • vaginal bleeding
  • vaginal cancer

Interactions

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