Leuprolide Norethindrone

Leuprolide Norethindrone Brand Name– Lupaneta

What is Leuprolide Norethindrone

Leuprolide acetate for depot suspension injection and norethindrone tablets are combined in a “pack” (Lupaneta Pack) for the treatment of endometriosis in adult females.

Leuprolide is a gonadotropin-releasing hormone agonist (GnRH or LH-RH agonist) and norethindrone is a synthetic oral progestin.

Efficacy for the combination was determined based on reduction in the signs and symptoms of endometriosis (dysmenorrhea, pelvic pain, deep dyspareunia, pelvic tenderness and pelvic induration).

Supression of menses was maintained in 84% of patients in the controlled clinical trials during active treatment.

The combined product was FDA approved in December 2012.

Indications

  • endometriosis

For the initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms

Side Effects

  1. acne vulgaris
  2. alopecia
  3. amenorrhea
  4. anaphylactoid reactions
  5. anxiety
  6. arthralgia
  7. asthenia
  8. bone fractures
  9. constipation
  10. depression
  11. diarrhea
  12. dizziness
  13. dyspepsia
  14. edema
  15. elevated hepatic enzymes
  16. emotional lability
  17. flatulence
  18. fluid retention
  19. headache
  20. hepatitis
  21. hepatomegaly
  22. hot flashes
  23. hyperlipidemia
  24. hypertension
  25. hypotension
  26. infection
  27. injection site reaction
  28. insomnia
  29. leukopenia
  30. libido decrease
  31. mastalgia
  32. memory impairment
  33. migraine
  34. muscle cramps
  35. muscle paralysis
  36. myalgia
  37. myocardial infarction
  38. nausea
  39. nephrolithiasis
  40. osteopenia
  41. osteoporosis
  42. paresthesias
  43. peripheral neuropathy
  44. photosensitivity
  45. pituitary apoplexy
  46. pulmonary embolism
  47. rash
  48. seizures
  49. stroke
  50. suicidal ideation
  51. synovitis
  52. thrombosis
  53. urticaria
  54. vaginitis
  55. vertigo
  56. vomiting
  57. weight gain

Monitoring Parameters

  • blood pressure
  • pelvic exam

Contraindications

  • asthma
  • breast cancer
  • breast-feeding
  • cardiac disease
  • cervical cancer
  • children
  • coronary artery disease
  • depression
  • diabetes mellitus
  • Gonadotropin-Releasing Hormone (GnRH) analogs hypersensitivity
  • heart failure
  • hepatic disease
  • hyperlipidemia
  • hypertension
  • infants
  • migraine
  • neonates
  • obesity
  • osteoporosis
  • pregnancy
  • renal disease
  • seizure disorder
  • stroke
  • systemic lupus erythematosus (SLE)
  • thromboembolic disease
  • thrombophlebitis
  • tobacco smoking
  • uterine cancer
  • vaginal bleeding
  • vaginal cancer
  • visual disturbance

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