Ethinyl Estradiol Norelgestromin

Ethinyl Estradiol Norelgestromin Brand Names- Ortho Evra | Xulane

What is Ethinyl Estradiol Norelgestromin

Ethinyl estradiol and norelgestromin are used together in a combined hormonal contraceptive transdermal patch system.

The patch is worn for 1 week and replaced on the same day of the week for 3 consecutive weeks, with the 4th week ‘patch-free’. Ethinyl estradiol is a potent, synthetic estrogen.

Norelgestromin, the primary active metabolite of norgestimate, is a third-generation progestin with lowered androgenic effects and relatively no estrogenic action compared to older progestins.

Thus norgestimate may have positive influences on acne, fluid retention, and lipid profiles. The overall exposure (i.e., AUC and steady-state concentrations) of ethinyl estradiol is higher for transdermal patch users vs. combined oral contraceptives (COC) users, and, in general, women are exposed to approximately 60% more estrogen when using the transdermal patch.

The increased estrogen exposure with this contraceptive transdermal patch is associated with an increased risk (RR 2.2, 95% CI 1.2 to 4) of venous thromboembolism; it is not known if the risk of other serious adverse events is also increased.

The transdermal system has the same other standard risks and benefits of combined hormonal contraceptives.

Combined hormonal contraceptives can be used in female patients from menarche to over the age of 40 years up until the time of menopause with proper selection of products.

The choice of a routine hormonal contraceptive for any given patient is based on the individual’s contraceptive needs, underlying medical conditions or risk factors for adverse effects, and individual preferences for use.

All combined hormonal contraceptives have risks related to venous and arterial thromboembolism, particularly in women who smoke and contain a boxed warning regarding tobacco smoking.

The Centers for Disease Control’s U.S. Medical Eligibility Criteria describe considerations for risk vs. benefits, including medical conditions or attributes that contraindicate use; these criteria can help prescribing practitioners in product selection for individual patients.

The FDA first approved the ethinyl estradiol/norelgestromin transdermal contraceptive patch in November 2001.

Indications

  1. acne vulgaris
  2. amenorrhea
  3. contraception
  4. dysfunctional uterine bleeding
  5. endometriosis
  6. hirsutism
  7. polycystic ovary syndrome

Side Effects

  1. abdominal pain
  2. acne vulgaris
  3. alopecia
  4. amenorrhea
  5. anorexia
  6. anxiety
  7. appetite stimulation
  8. breakthrough bleeding
  9. breast discharge
  10. breast enlargement
  11. candidiasis
  12. cervical dysplasia
  13. cholecystitis
  14. cholelithiasis
  15. cholestasis
  16. colitis
  17. contact dermatitis
  18. depression
  19. diarrhea
  20. diplopia
  21. dizziness
  22. dysgeusia
  23. dysmenorrhea
  24. edema
  25. elevated hepatic enzymes
  26. emotional lability
  27. erythema
  28. erythema multiforme
  29. erythema nodosum
  30. fatigue
  31. fluid retention
  32. galactorrhea
  33. gingivitis
  34. headache
  35. hepatitis
  36. hepatoma
  37. hirsutism
  38. hyperglycemia
  39. hypertension
  40. hypertensive crisis
  41. insomnia
  42. insulin resistance
  43. irritability
  44. jaundice
  45. keratoconus
  46. lactation suppression
  47. libido decrease
  48. libido increase
  49. maculopapular rash
  50. malaise
  51. mastalgia
  52. melasma
  53. menstrual irregularity
  54. migraine
  55. myocardial infarction
  56. nausea
  57. new primary malignancy
  58. optic neuritis
  59. pancreatitis
  60. peliosis hepatis
  61. photosensitivity
  62. pruritus
  63. pulmonary embolism
  64. rash
  65. retinal thrombosis
  66. skin irritation
  67. stroke
  68. thromboembolism
  69. thrombosis
  70. urticaria
  71. vaginal bleeding
  72. vaginal discharge
  73. vaginitis
  74. weight gain

Monitoring Parameters

  • pap smear
  • pelvic exam

Contraindications

  • acquired immunodeficiency syndrome (AIDS)
  • atrial fibrillation
  • breast cancer
  • breast-feeding
  • cerebrovascular disease
  • cervical cancer
  • children
  • chloasma
  • cholestasis
  • contact lenses
  • coronary artery disease
  • coronary thrombosis
  • depression
  • diabetes mellitus
  • endocarditis
  • endometrial cancer
  • gallbladder disease
  • geriatric
  • headache
  • hepatic disease
  • hepatitis
  • hepatocellular cancer
  • hereditary angioedema
  • history of angioedema
  • human immunodeficiency virus (HIV) infection
  • hypercalcemia
  • hypercholesterolemia
  • hyperlipidemia
  • hypertension
  • hypertriglyceridemia
  • hypothyroidism
  • jaundice
  • migraine
  • myocardial infarction
  • obesity
  • obstetric delivery
  • ocular disease
  • ovarian cancer
  • porphyria
  • postmenopausal females
  • pregnancy
  • protein C deficiency
  • protein S deficiency
  • renal disease
  • stroke
  • surgery
  • systemic lupus erythematosus (SLE)
  • thromboembolic disease
  • thrombophlebitis
  • thyroid disease
  • tobacco smoking
  • uterine cancer
  • vaginal bleeding
  • vaginal cancer
  • valvular heart disease

Interactions

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