Estradiol Norethindrone

Estradiol Norethindrone Brand Names

Activella | Amabelz | CombiPatch | Lopreeza | Mimvey | Mimvey Lo

What is Estradiol Norethindrone

Estradiol and norethindrone are combined in oral and transdermal products.

Estradiol is the principal intracellular human estrogen and is substantially more active than its metabolites, estrone and estriol, at the cellular level.

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

The combination products are primarily used in women with an intact uterus to treat moderate to severe vasomotor and genitourinary symptoms associated with menopause; the oral product is additionally indicated for the prevention of osteoporosis in postmenopausal women.

The transdermal system is also used for hormone replacement in women with an intact uterus who have had an oophorectomy, or who have hypogonadism or primary ovarian failure.

The addition of a progestin to the estrogen replacement therapy substantially reduces, but does not eliminate, the risk for endometrial hyperplasia.

However, combination HRT may add additional health risks for some women, and hormone replacement regimens are recommended to be used for the shortest duration consistent with the treatment goals of the individual patients.

The transdermal patch is an adhesive-based matrix designed to release 17beta-estradiol and norethindrone acetate continuously upon application to the skin.

The oral tablet contains a daily combination regimen of 17beta-estradiol and norethindrone acetate.

The combination transdermal patch and the combination oral tablets were initially FDA-approved in 1998.

Indications

  1. atrophic vaginitis
  2. hot flashes
  3. hypogonadism
  4. menopause
  5. oophorectomy
  6. osteoporosis prophylaxis
  7. ovarian failure

For treatment of moderate to severe vasomotor symptoms (hot flashes) of menopause and/or related genitourinary symptoms including atrophic vaginitis, vulvar atrophy (kraurosis vulvae), whether menopause is natural or surgical (e.g., due to oophorectomy)

continuous combined regimen – for women who do not want to resume menses

Side Effects

  1. abdominal pain
  2. acne vulgaris
  3. alopecia
  4. amenorrhea
  5. anaphylactoid reactions
  6. angioedema
  7. anxiety
  8. arthralgia
  9. asthenia
  10. back pain
  11. biliary obstruction
  12. bowel ischemia
  13. breakthrough bleeding
  14. breast cancer
  15. breast discharge
  16. breast enlargement
  17. candidiasis
  18. cervical dysplasia
  19. cervicitis
  20. cholecystitis
  21. cholelithiasis
  22. cholestasis
  23. colitis
  24. dementia
  25. depression
  26. diarrhea
  27. diplopia
  28. dizziness
  29. dysmenorrhea
  30. edema
  31. elevated hepatic enzymes
  32. emotional lability
  33. endometrial cancer
  34. endometrial hyperplasia
  35. erythema
  36. erythema multiforme
  37. erythema nodosum
  38. fatigue
  39. fluid retention
  40. galactorrhea
  41. headache
  42. hepatitis
  43. hirsutism
  44. hypercalcemia
  45. hyperglycemia
  46. hypertension
  47. hypertriglyceridemia
  48. hypocalcemia
  49. hypothyroidism
  50. impaired cognition
  51. insomnia
  52. irritability
  53. jaundice
  54. libido decrease
  55. libido increase
  56. mastalgia
  57. melasma
  58. menorrhagia
  59. migraine
  60. muscle cramps
  61. myocardial infarction
  62. nausea
  63. new primary malignancy
  64. ovarian cancer
  65. pancreatitis
  66. papilledema
  67. peliosis hepatis
  68. peripheral edema
  69. pruritus
  70. pulmonary embolism
  71. rash
  72. retinal thrombosis
  73. skin irritation
  74. stroke
  75. teratogenesis
  76. thromboembolism
  77. thrombosis
  78. urinary incontinence
  79. urticaria
  80. vaginal bleeding
  81. vaginitis
  82. visual impairment
  83. vomiting
  84. weight gain

Monitoring Parameters

  • pap smear
  • pelvic exam

Contraindications

  • asthma
  • breast cancer
  • breast-feeding
  • cardiac disease
  • cerebrovascular disease
  • cervical cancer
  • children
  • contact lenses
  • coronary artery disease
  • dementia
  • depression
  • diabetes mellitus
  • endometrial cancer
  • endometrial hyperplasia
  • endometriosis
  • gallbladder disease
  • geriatric
  • hepatic disease
  • hepatocellular cancer
  • hereditary angioedema
  • history of angioedema
  • hypercalcemia
  • hypercholesterolemia
  • hypertension
  • hypertriglyceridemia
  • hypocalcemia
  • hypoparathyroidism
  • hypothyroidism
  • infants
  • jaundice
  • migraine
  • myocardial infarction
  • new primary malignancy
  • obesity
  • ovarian cancer
  • pancreatitis
  • porphyria
  • pregnancy
  • protein C deficiency
  • protein S deficiency
  • renal disease
  • seizure disorder
  • stroke
  • surgery
  • systemic lupus erythematosus (SLE)
  • thromboembolic disease
  • thromboembolism
  • thrombophlebitis
  • thyroid disease
  • tobacco smoking
  • uterine cancer
  • uterine leiomyomata
  • vaginal bleeding
  • vaginal cancer
  • visual disturbance

Interactions

  • Acarbose
  • Acetaminophen; Butalbital
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Propoxyphene
  • Acetohexamide
  • Acitretin
  • Albiglutide
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpha-glucosidase Inhibitors
  • Amikacin
  • Aminoglycosides
  • Amiodarone
  • Amobarbital
  • Amoxicillin
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Amoxicillin; Clavulanic Acid
  • Ampicillin
  • Ampicillin; Sulbactam
  • Amprenavir
  • Anastrozole
  • Apalutamide
  • Aprepitant, Fosaprepitant
  • Armodafinil
  • Artemether; Lumefantrine
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Azelastine; Fluticasone
  • Azithromycin
  • Aztreonam
  • Bacitracin
  • Barbiturates
  • Beclomethasone
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Betamethasone
  • Bexarotene
  • Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
  • Bismuth Subsalicylate; Metronidazole; Tetracycline
  • Boceprevir
  • Bosentan
  • Bromocriptine
  • Budesonide
  • Budesonide; Formoterol
  • Butabarbital
  • Calaspargase pegol
  • Calcium
  • Canagliflozin
  • Canagliflozin; Metformin
  • Carbamazepine
  • Carbapenems
  • Carbenicillin
  • 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
  • Charcoal
  • Chenodiol
  • Chloramphenicol
  • Chlorpropamide
  • Ciclesonide
  • Cimetidine
  • Ciprofloxacin
  • Clarithromycin
  • Clindamycin
  • Clobazam
  • Cobicistat
  • Colistimethate, Colistin, Polymyxin E
  • Conivaptan
  • Corticosteroids
  • Cortisone
  • Cosyntropin
  • Cyclosporine
  • Dabrafenib
  • Dalbavancin
  • Danazol
  • 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
  • Dicloxacillin
  • Diltiazem
  • Dipeptidyl Peptidase-4 Inhibitors
  • Doripenem
  • Doxycycline
  • Dulaglutide
  • Duloxetine
  • 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
  • Enasidenib
  • Encorafenib
  • Enzalutamide
  • Eravacycline
  • Ertapenem
  • Ertugliflozin
  • Ertugliflozin; Metformin
  • Ertugliflozin; Sitagliptin
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Eslicarbazepine
  • Ethotoin
  • Exemestane
  • Exenatide
  • Felbamate
  • Fidaxomicin
  • Flibanserin
  • Fluconazole
  • Fludrocortisone
  • Flunisolide
  • Fluoxetine
  • Fluoxetine; Olanzapine
  • Fluticasone
  • Fluticasone; Salmeterol
  • Fluticasone; Umeclidinium; Vilanterol
  • Fluticasone; Vilanterol
  • Formoterol; Mometasone
  • Fosamprenavir
  • Fosphenytoin
  • Gemifloxacin
  • Gentamicin
  • Glimepiride
  • Glimepiride; Pioglitazone
  • Glimepiride; Rosiglitazone
  • Glipizide
  • Glipizide; Metformin
  • Glyburide
  • Glyburide; Metformin
  • Glycylcyclines
  • grapefruit juice
  • Griseofulvin
  • Hemin
  • Hyaluronidase
  • Hyaluronidase, Recombinant; Immune Globulin
  • Hydantoins
  • Hydralazine
  • Hydralazine; Hydrochlorothiazide, HCTZ
  • Hydralazine; Isosorbide Dinitrate, ISDN
  • Hydrocortisone
  • Icosapent ethyl
  • Idelalisib
  • Imatinib
  • Imipenem; Cilastatin
  • Imipenem; Cilastatin; Relebactam
  • Incretin Mimetics
  • Indinavir
  • Insulin Degludec; Liraglutide
  • Insulin Glargine; Lixisenatide
  • Insulins
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Isotretinoin
  • Itraconazole
  • Ivosidenib
  • 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
  • Lopinavir; Ritonavir
  • Lorlatinib
  • Lumacaftor; Ivacaftor
  • Meglitinides
  • Melatonin
  • Mephobarbital
  • Meropenem
  • Meropenem; Vaborbactam
  • Metformin
  • Metformin; Pioglitazone
  • Metformin; Repaglinide
  • Metformin; Rosiglitazone
  • Metformin; Saxagliptin
  • Metformin; Sitagliptin
  • Methohexital
  • Methylprednisolone
  • Metreleptin
  • Metronidazole
  • Metyrapone
  • Midazolam
  • Mifepristone
  • Miglitol
  • Miltefosine
  • Mineral Oil
  • Minocycline
  • Minoxidil
  • Mivacurium
  • Modafinil
  • Mometasone
  • Morphine
  • Morphine; Naltrexone
  • Moxifloxacin
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Neomycin
  • Nevirapine
  • Nilotinib
  • Nitrofurantoin
  • Nitroprusside
  • Norfloxacin
  • Ofloxacin
  • Omadacycline
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole; Amoxicillin; Rifabutin
  • Oritavancin
  • Ospemifene
  • Oxacillin
  • Oxcarbazepine
  • Paromomycin
  • Pegaspargase
  • Penicillin G
  • Penicillin G Benzathine
  • Penicillin G Benzathine; Penicillin G Procaine
  • Penicillin G Procaine
  • Penicillin V
  • Pentobarbital
  • Pexidartinib
  • Phenobarbital
  • Phentermine; Topiramate
  • Phenytoin
  • Piperacillin
  • Piperacillin; Tazobactam
  • Pitolisant
  • Plazomicin
  • Polymyxin B
  • Polymyxins
  • Posaconazole
  • Pramlintide
  • Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements)
  • Prasterone, Dehydroepiandrosterone, DHEA (FDA-approved)
  • Prednisolone
  • Prednisone
  • Primidone
  • Propoxyphene
  • Pyrimethamine; Sulfadoxine
  • Raloxifene
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifampin
  • Rifamycins
  • Rifapentine
  • Riluzole
  • Ritonavir
  • Rituximab; Hyaluronidase
  • Roflumilast
  • Ropinirole
  • Rufinamide
  • Saquinavir
  • Sarilumab
  • Saxagliptin
  • Secobarbital
  • Semaglutide
  • SGLT2 Inhibitors
  • Siltuximab
  • Simvastatin; Sitagliptin
  • Sitagliptin
  • Somatropin, rh-GH
  • St. John’s Wort, Hypericum perforatum
  • Streptogramins
  • Streptomycin
  • Succinylcholine
  • Sugammadex
  • Sulfadiazine
  • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
  • Sulfasalazine
  • Sulfisoxazole
  • Sulfonamides
  • Sulfonylureas
  • Sunscreens
  • Tacrine
  • Tazemetostat
  • Tedizolid
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Teriflunomide
  • Testolactone
  • Tetracycline
  • Thalidomide
  • Thiazolidinediones
  • Thiopental
  • Thyroid hormones
  • Ticarcillin
  • Ticarcillin; Clavulanic Acid
  • Tigecycline
  • Tinidazole
  • Tipranavir
  • Tizanidine
  • Tobramycin
  • Tocilizumab
  • Tolazamide
  • Tolbutamide
  • Topiramate
  • Toremifene
  • Trandolapril; Verapamil
  • Tranexamic Acid
  • Trastuzumab; Hyaluronidase
  • Triamcinolone
  • Tricyclic antidepressants
  • Trimethoprim
  • Ulipristal
  • Ursodeoxycholic Acid, Ursodiol
  • Vancomycin
  • Verapamil
  • Voriconazole
  • Warfarin
  • Zafirlukast
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