Ethinyl Estradiol Norethindrone Acetate

Ethinyl Estradiol Norethindrone Acetate Brand Names

Aurovela | femhrt 1/5 | Fravolv | Fyavolv | Gildess | Hailey 1.5/30 | Jevantique | Jinteli 1/5 | Junel 1.5/30 | Junel 1/20 | LARIN | Loestrin 1.5/30 | Loestrin 1/20 | Microgestin 1.5/30 | Microgestin 1/20

What is Ethinyl Estradiol Norethindrone Acetate

Ethinyl estradiol and norethindrone acetate are an estrogen and progestin, respectively, that are found in combination products for oral contraception or for hormone replacement therapy (HRT) for women’s health.

Ethinyl estradiol is a potent, synthetic estrogen.

Norethindrone acetate is a first generation oral progestin with moderate androgenic and slight estrogenic activity relative to newer progestins.

Norethindrone acetate is known as norethisterone acetate outside of the United States. Many ethinyl estradiol; norethindrone acetate products are used as routine oral contraceptives. Combined hormonal contraceptives can be used in female patients from menarche to over the age of 40 years and up until the time of menopause with the 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 oral contraceptives (COCs) have risks related to venous and arterial thromboembolism, particularly in women who smoke; all combined hormonal contraceptive labels contain a boxed warning about 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.

Certain combination products with ethinyl estradiol; norethindrone acetate are exclusively used for hormonal replacement therapy (HRT) for osteoporosis prophylaxis and/or to treat vasomotor and genitourinary symptoms associated with menopause in women with an intact uterus; a progestin, when added to estrogen replacement therapy, reduces, but does not completely eliminate, the risk for endometrial hyperplasia.

However, the addition of a progestin to an estrogen regimen may present additional risks for individual women.

Patients should be prescribed HRT products with the indication of use and individual risk:benefit in mind, and for the shortest duration consistent with the treatment goals of the individual.

Boxed warnings for HRT relate to cardiovascular, dementia and cancer risks in the menopausal/post-menopausal population.

Ethinyl estradiol/norethindrone acetate oral contraceptive products were first approved by the FDA prior to 1982.

Products for menopausal symptoms and post-menopausal osteoporosis prophylaxis were first FDA-approved in October 1999.

Indications

1. acne vulgaris
2. amenorrhea
3. atrophic vaginitis
4. contraception
5. dysfunctional uterine bleeding
6. endometriosis
7. hirsutism
8. hot flashes
9. menopause
10. osteoporosis prophylaxis
11. polycystic ovary syndrome

NOTE: OC Products containing 50 mcg estrogen should be used only when medically indicated. Examples of potential medical indications for products containing 50 mcg of estrogen include a history of known contraceptive failure on the 50 mcg products, or increased hepatic metabolism of OCs, such as occurs with some anticonvulsant medications.

Side Effects

1. abdominal pain
2. acne vulgaris
3. alopecia
4. amenorrhea
5. anaphylactoid reactions
6. angioedema
7. anorexia
8. anxiety
9. arthralgia
10. asthenia
11. back pain
12. bowel ischemia
13. breakthrough bleeding
14. breast cancer
15. breast discharge
16. breast enlargement
17. candidiasis
18. cataracts
19. cervical dysplasia
20. cholecystitis
21. cholelithiasis
22. cholestasis
23. colitis
24. cystitis
25. dementia
26. depression
27. diplopia
28. dysmenorrhea
29. edema
30. elevated hepatic enzymes
31. emotional lability
32. endometrial cancer
33. endometrial hyperplasia
34. erythema multiforme
35. erythema nodosum
36. fatigue
37. fluid retention
38. galactorrhea
39. gingivitis
40. headache
41. hepatitis
42. hepatoma
43. hirsutism
44. hyperlipidemia
45. hypertension
46. hypertriglyceridemia
47. impaired cognition
48. intracranial bleeding
49. irritability
50. jaundice
51. lactation suppression
52. leukorrhea
53. libido decrease
54. libido increase
55. lupus-like symptoms
56. maculopapular rash
57. mastalgia
58. melasma
59. menorrhagia
60. menstrual irregularity
61. migraine
62. muscle cramps
63. musculoskeletal pain
64. myalgia
65. myocardial infarction
66. nausea
67. new primary malignancy
68. optic neuritis
69. ovarian cancer
70. pancreatitis
71. papilledema
72. peliosis hepatis
73. pelvic pain
74. photosensitivity
75. porphyria
76. pruritus
77. pulmonary embolism
78. rash
79. retinal thrombosis
80. rhinitis
81. sinusitis
82. stroke
83. thromboembolism
84. thrombosis
85. urinary incontinence
86. urticaria
87. vaginal discharge
88. vaginal irritation
89. vaginitis
90. visual impairment
91. vomiting
92. weight gain
93. weight loss

Monitoring Parameters

• pap smear
• pelvic exam

Contraindications

• acquired immunodeficiency syndrome (AIDS)
• asthma
• atrial fibrillation
• breast cancer
• breast-feeding
• cardiac disease
• cerebrovascular disease
• cervical cancer
• children
• chloasma
• contact lenses
• coronary artery disease
• coronary thrombosis
• dementia
• depression
• diabetes mellitus
• endocarditis
• endometrial cancer
• endometrial hyperplasia
• endometriosis
• gallbladder disease
• geriatric
• glaucoma
• headache
• hepatic disease
• hepatitis
• hepatocellular cancer
• hereditary angioedema
• history of angioedema
• human immunodeficiency virus (HIV) infection
• hypercalcemia
• hypercholesterolemia
• hypertension
• hypertriglyceridemia
• hypocalcemia
• hypoparathyroidism
• hypothyroidism
• infants
• jaundice
• migraine
• myocardial infarction
• new primary malignancy
• obesity
• obstetric delivery
• ovarian cancer
• pancreatitis
• porphyria
• pregnancy
• protein C deficiency
• protein S deficiency
• renal disease
• seizure disorder
• sexually transmitted disease
• stroke
• surgery
• systemic lupus erythematosus (SLE)
• thromboembolic disease
• thromboembolism
• thrombophlebitis
• thyroid disease
• tobacco smoking
• uterine cancer
• uterine leiomyomata
• vaginal bleeding
• vaginal cancer
• valvular heart disease
• visual disturbance

Interactions

• Acarbose
• Acetaminophen
• Acetaminophen; Aspirin, ASA; Caffeine
• Acetaminophen; Butalbital
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Caffeine
• Acetaminophen; Caffeine; Dihydrocodeine
• Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
• Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
• Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
• Acetaminophen; Codeine
• Acetaminophen; Dextromethorphan
• Acetaminophen; Dextromethorphan; Doxylamine
• Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
• Acetaminophen; Dextromethorphan; Phenylephrine
• Acetaminophen; Dextromethorphan; Pseudoephedrine
• Acetaminophen; Dichloralphenazone; Isometheptene
• Acetaminophen; Diphenhydramine
• Acetaminophen; Guaifenesin; Phenylephrine
• Acetaminophen; Hydrocodone
• Acetaminophen; Oxycodone
• Acetaminophen; Pentazocine
• Acetaminophen; Propoxyphene
• Acetaminophen; Pseudoephedrine
• Acetaminophen; Tramadol
• Acetohexamide
• Acitretin
• Albiglutide
• Aliskiren; Amlodipine
• Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
• Alogliptin
• Alogliptin; Metformin
• Alogliptin; Pioglitazone
• Alpha-glucosidase Inhibitors
• Alprazolam
• Amikacin
• Aminoglycosides
• Amiodarone
• Amitriptyline; Chlordiazepoxide
• Amlodipine
• Amlodipine; Atorvastatin
• Amlodipine; Benazepril
• Amlodipine; Celecoxib
• Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
• Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
• Amlodipine; Olmesartan
• Amlodipine; Telmisartan
• Amlodipine; Valsartan
• Amobarbital
• Amoxicillin
• Amoxicillin; Clarithromycin; Lansoprazole
• Amoxicillin; Clarithromycin; Omeprazole
• Amoxicillin; Clavulanic Acid
• Ampicillin
• Ampicillin; Sulbactam
• Amprenavir
• Anastrozole
• Apalutamide
• Aprepitant, Fosaprepitant
• Armodafinil
• Artemether; Lumefantrine
• Ascorbic Acid, Vitamin C
• Aspirin, ASA; Butalbital; Caffeine
• Aspirin, ASA; Butalbital; Caffeine; Codeine
• Aspirin, ASA; Caffeine; Dihydrocodeine
• Aspirin, ASA; Caffeine; Orphenadrine
• Atazanavir
• Atazanavir; Cobicistat
• Atorvastatin
• Atorvastatin; Ezetimibe
• Atropine; Hyoscyamine; Phenobarbital; Scopolamine
• Azelastine; Fluticasone
• Azithromycin
• Aztreonam
• Bacitracin
• Barbiturates
• Beclomethasone
• Belladonna Alkaloids; Ergotamine; Phenobarbital
• Bendamustine
• Benzhydrocodone; Acetaminophen
• Betamethasone
• Bexarotene
• Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
• Bismuth Subsalicylate; Metronidazole; Tetracycline
• Blinatumomab
• Boceprevir
• Bosentan
• Brigatinib
• Bromocriptine
• Budesonide
• Budesonide; Formoterol
• Butabarbital
• Cabozantinib
• Caffeine
• Caffeine; Ergotamine
• Calaspargase pegol
• Calcium
• Calcium-channel blockers
• Canagliflozin
• Canagliflozin; Metformin
• Carbamazepine
• Carbapenems
• Carbenicillin
• Carvedilol
• Cefaclor
• Cefadroxil
• Cefazolin
• Cefdinir
• Cefditoren
• Cefepime
• Cefiderocol
• Cefixime
• Cefotaxime
• Cefotetan
• Cefoxitin
• Cefpodoxime
• Cefprozil
• Ceftaroline
• Ceftazidime
• Ceftazidime; Avibactam
• Ceftibuten
• Ceftizoxime
• Ceftolozane; Tazobactam
• Ceftriaxone
• Cefuroxime
• Cenobamate
• Cephalexin
• Ceritinib
• Charcoal
• Chenodiol
• Chloramphenicol
• Chlordiazepoxide
• Chlordiazepoxide; Clidinium
• Chlorpropamide
• Ciclesonide
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Clevidipine
• Clindamycin
• Clobazam
• Clonazepam
• Clorazepate
• Cobicistat
• Cobimetinib
• Colesevelam
• Colistimethate, Colistin, Polymyxin E
• Conivaptan
• Corticosteroids
• Cortisone
• Cosyntropin
• Cyclosporine
• Dabrafenib
• Dalbavancin
• Dantrolene
• Dapagliflozin
• Dapagliflozin; Metformin
• Dapagliflozin; Saxagliptin
• Daptomycin
• Daratumumab; Hyaluronidase
• Darunavir
• Darunavir; Cobicistat
• Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Deferasirox
• Deflazacort
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dexamethasone
• Diazepam
• Dicloxacillin
• Diltiazem
• Dipeptidyl Peptidase-4 Inhibitors
• Dirithromycin
• Doripenem
• Doxazosin
• Doxercalciferol
• Doxorubicin
• Doxycycline
• Dronabinol
• Dronedarone
• Dulaglutide
• Duloxetine
• Dutasteride; Tamsulosin
• Efavirenz
• Efavirenz; Emtricitabine; Tenofovir
• Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
• Elagolix
• Elagolix; Estradiol; Norethindrone acetate
• Elvitegravir
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
• Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
• Empagliflozin
• Empagliflozin; Linagliptin
• Empagliflozin; Linagliptin; Metformin
• Empagliflozin; Metformin
• Enalapril; Felodipine
• Enasidenib
• Encorafenib
• Enzalutamide
• Eravacycline
• Ertapenem
• Ertugliflozin
• Ertugliflozin; Metformin
• Ertugliflozin; Sitagliptin
• Erythromycin
• Erythromycin; Sulfisoxazole
• Eslicarbazepine
• Estazolam
• Exemestane
• Exenatide
• Felbamate
• Felodipine
• Fidaxomicin
• Flibanserin
• Fluconazole
• Fludrocortisone
• Flunisolide
• Flurazepam
• Fluticasone
• Fluticasone; Salmeterol
• Fluticasone; Umeclidinium; Vilanterol
• Fluticasone; Vilanterol
• food
• Formoterol; Mometasone
• Fosamprenavir
• Fostemsavir
• Frovatriptan
• Gemifloxacin
• Gentamicin
• Glecaprevir; Pibrentasvir
• Glimepiride
• Glimepiride; Pioglitazone
• Glimepiride; Rosiglitazone
• Glipizide
• Glipizide; Metformin
• Glyburide
• Glyburide; Metformin
• Glycylcyclines
• grapefruit juice
• Green Tea
• Griseofulvin
• Hemin
• Hyaluronidase
• Hyaluronidase, Recombinant; Immune Globulin
• Hydantoins
• Hydralazine
• Hydralazine; Hydrochlorothiazide, HCTZ
• Hydralazine; Isosorbide Dinitrate, ISDN
• Hydrocortisone
• Icosapent ethyl
• Idelalisib
• Imipenem; Cilastatin
• Imipenem; Cilastatin; Relebactam
• Incretin Mimetics
• Indinavir
• Insulin Degludec; Liraglutide
• Insulin Glargine; Lixisenatide
• Insulins
• Isavuconazonium
• Isoniazid, INH; Pyrazinamide, PZA; Rifampin
• Isoniazid, INH; Rifampin
• Isotretinoin
• Isradipine
• Itraconazole
• Ivosidenib
• Ixabepilone
• Kanamycin
• Ketoconazole
• Lamotrigine
• Lefamulin
• Leflunomide
• Lenalidomide
• Lesinurad
• Lesinurad; Allopurinol
• Letrozole
• Levofloxacin
• Levothyroxine
• Levothyroxine; Liothyronine (Porcine)
• Levothyroxine; Liothyronine (Synthetic)
• Linagliptin
• Linagliptin; Metformin
• Lincomycin
• Lincosamides
• Linezolid
• Liothyronine
• Liraglutide
• Lixisenatide
• Lomitapide
• Loperamide
• Loperamide; Simethicone
• Lopinavir; Ritonavir
• Lorazepam
• Lorlatinib
• Lumacaftor; Ivacaftor
• Mecamylamine
• Meglitinides
• Melatonin
• Mephobarbital
• Meropenem
• Meropenem; Vaborbactam
• Metformin
• Metformin; Pioglitazone
• Metformin; Repaglinide
• Metformin; Rosiglitazone
• Metformin; Saxagliptin
• Metformin; Sitagliptin
• Methohexital
• Methylprednisolone
• Metreleptin
• Metronidazole
• Metyrapone
• Miconazole
• Miconazole; Petrolatum; Zinc Oxide
• Midazolam
• Mifepristone
• Miglitol
• Miltefosine
• Mineral Oil
• Minocycline
• Minoxidil
• Mitotane
• Mivacurium
• Modafinil
• Mometasone
• Morphine
• Morphine; Naltrexone
• Moxifloxacin
• Mycophenolate
• Nafcillin
• Naratriptan
• Nefazodone
• Nelfinavir
• Neomycin
• Nevirapine
• Nicardipine
• Nifedipine
• Nimodipine
• Nisoldipine
• Nitrofurantoin
• Nitroprusside
• Norfloxacin
• Ofloxacin
• Omadacycline
• Ombitasvir; Paritaprevir; Ritonavir
• Omeprazole; Amoxicillin; Rifabutin
• Oritavancin
• Ospemifene
• Oxacillin
• Oxazepam
• Oxcarbazepine
• Paromomycin
• Pazopanib
• Pegaspargase
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Benzathine; Penicillin G Procaine
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Perindopril; Amlodipine
• Pexidartinib
• Phenobarbital
• Phenothiazines
• Phenoxybenzamine
• Phentermine; Topiramate
• Piperacillin
• Piperacillin; Tazobactam
• Pitolisant
• Plazomicin
• Polymyxin B
• Polymyxins
• Posaconazole
• Pramlintide
• Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements)
• Prasterone, Dehydroepiandrosterone, DHEA (FDA-approved)
• Prazosin
• Prednisolone
• Prednisone
• Primidone
• Propafenone
• Propoxyphene
• Pyrimethamine; Sulfadoxine
• Quazepam
• Raloxifene
• Ramelteon
• Ranolazine
• Rasagiline
• Reserpine
• Ribociclib
• Ribociclib; Letrozole
• Rifabutin
• Rifampin
• Rifamycins
• Rifapentine
• Riluzole
• Ritonavir
• Rituximab; Hyaluronidase
• Rivaroxaban
• Roflumilast
• Romidepsin
• Ropinirole
• Rosuvastatin
• Rufinamide
• Ruxolitinib
• Sapropterin
• Saquinavir
• Sarilumab
• Saxagliptin
• Secobarbital
• Selegiline
• Semaglutide
• SGLT2 Inhibitors
• Siltuximab
• Simvastatin; Sitagliptin
• Sincalide
• Sitagliptin
• Sofosbuvir; Velpatasvir
• Sofosbuvir; Velpatasvir; Voxilaprevir
• Somatropin, rh-GH
• St. John’s Wort, Hypericum perforatum
• Streptogramins
• Streptomycin
• Succinylcholine
• Sugammadex
• Sulfadiazine
• Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
• Sulfasalazine
• Sulfisoxazole
• Sulfonamides
• Sulfonylureas
• Tacrine
• Tacrolimus
• Tamsulosin
• Tazemetostat
• Tedizolid
• Telaprevir
• Telavancin
• Telithromycin
• Telotristat Ethyl
• Temazepam
• Temsirolimus
• Terazosin
• Terbinafine
• Teriflunomide
• Testolactone
• Tetracycline
• Thalidomide
• Theophylline, Aminophylline
• Thiazolidinediones
• Thiopental
• Thyroid hormones
• Ticarcillin
• Ticarcillin; Clavulanic Acid
• Tigecycline
• Tinidazole
• Tipranavir
• Tizanidine
• tobacco
• Tobramycin
• Tocilizumab
• Tolazamide
• Tolbutamide
• Tolvaptan
• Topiramate
• Toremifene
• Trandolapril; Verapamil
• Tranexamic Acid
• Trastuzumab; Hyaluronidase
• Triamcinolone
• Triazolam
• Tricyclic antidepressants
• Trimethoprim
• Tucatinib
• Ulipristal
• Ursodeoxycholic Acid, Ursodiol
• Valdecoxib
• Valproic Acid, Divalproex Sodium
• Vancomycin
• Verapamil
• Vincristine
• Vincristine Liposomal
• Vorapaxar
• Voriconazole
• Warfarin
• Zolmitriptan
• Zonisamide