Norethindrone

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Norethindrone Brand Names

Aygestin | Camila | Deblitane 28-Day | Errin | Heather | Jencycla | Jolivette | Lyza | Nora-BE | Norlyroc | Nor-QD | Ortho Micronor | Sharobel 28-Day

What is Norethindrone

Norethindrone is a synthetic oral progestin.

Norethindrone acetate is a prodrug that is rapidly converted to norethindrone in the body; on a weight basis, norethindrone acetate is twice as potent as norethindrone.

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

Norethindrone is known as norethisterone outside of the United States.

Norethindrone is used for routine contraception and is available as either a progestin-only contraceptive or in combination hormonal contraceptive products with an estrogen.

Progestin-only formulations or “mini-pills” of norethindrone are not widely used due to the higher risk of contraceptive failure and certain side effects such as spotting and breakthrough bleeding compared to combination hormonal contraceptives.

However, progesin-only oral contraceptives may be appropriate choices when women have relative or absolute contraindications to the use of estrogen-based hormonal contraception.

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.

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.

Norethindrone acetate is found in some combination oral contraceptives. Single-agent norethindrone acetate products are primarily used to treat such conditions as secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

For endometriosis, norethindrone acetate is commonly used in combination with leuprolide.

While norethindrone acetate is effective at preventing endometrial hyperplasia due to unopposed estrogen therapy in postmenopausal women, single-agent norethindrone products are not available for this indication in the U.S.

Norethindrone was initially approved by the FDA in 1961.

Indications

  • amenorrhea
  • contraception
  • dysfunctional uterine bleeding
  • endometriosis
  • estrogen replacement therapy

For the treatment of secondary amenorrhea or dysfunctional uterine bleeding due to hormonal imbalance in the absence of organic pathology such as submucous fibroids or uterine cancer

Side Effects

  1. abdominal pain
  2. acne vulgaris
  3. alopecia
  4. anaphylactic shock
  5. anaphylactoid reactions
  6. anorexia
  7. anxiety
  8. appetite stimulation
  9. biliary obstruction
  10. breakthrough bleeding
  11. cervicitis
  12. depression
  13. dizziness
  14. edema
  15. elevated hepatic enzymes
  16. emotional lability
  17. fatigue
  18. fluid retention
  19. galactorrhea
  20. headache
  21. hepatitis
  22. hepatoma
  23. hirsutism
  24. hypercholesterolemia
  25. hyperglycemia
  26. hypertension
  27. insomnia
  28. jaundice
  29. lactation suppression
  30. leukorrhea
  31. libido decrease
  32. libido increase
  33. mastalgia
  34. melasma
  35. menorrhagia
  36. menstrual irregularity
  37. musculoskeletal pain
  38. nausea
  39. optic neuritis
  40. pruritus
  41. pulmonary embolism
  42. rash
  43. retinal thrombosis
  44. thromboembolism
  45. thrombosis
  46. urticaria
  47. vaginitis
  48. vomiting
  49. weight gain
  50. weight loss

Monitoring Parameters

  • pap smear

Contraindications

  • asthma
  • breast cancer
  • breast-feeding
  • cerebrovascular disease
  • children
  • depression
  • diabetes mellitus
  • ectopic pregnancy
  • hepatic disease
  • human immunodeficiency virus (HIV) infection
  • hyperlipidemia
  • incomplete abortion
  • migraine
  • myocardial infarction
  • ovarian cyst
  • pregnancy
  • renal disease
  • seizure disorder
  • stroke
  • thromboembolic disease
  • thrombophlebitis
  • tobacco smoking
  • vaginal bleeding

Interactions

  • Acetaminophen; Butalbital
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetohexamide
  • Acitretin
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpha-glucosidase Inhibitors
  • Amikacin
  • Aminoglycosides
  • Amobarbital
  • Amoxicillin
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Amoxicillin; Clavulanic Acid
  • Ampicillin
  • Ampicillin; Sulbactam
  • Amprenavir
  • Apalutamide
  • Aprepitant, Fosaprepitant
  • Armodafinil
  • Artemether; Lumefantrine
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Azithromycin
  • Aztreonam
  • Bacitracin
  • Barbiturates
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Bexarotene
  • Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
  • Bismuth Subsalicylate; Metronidazole; Tetracycline
  • Boceprevir
  • Bosentan
  • Bromocriptine
  • Butabarbital
  • Calaspargase pegol
  • 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
  • Ciprofloxacin
  • Clarithromycin
  • Clindamycin
  • Clobazam
  • Cobicistat
  • Colistimethate, Colistin, Polymyxin E
  • Dabrafenib
  • Dalbavancin
  • Dapagliflozin
  • Dapagliflozin; Metformin
  • Dapagliflozin; Saxagliptin
  • Daptomycin
  • Darunavir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Deferasirox
  • Delafloxacin
  • Demeclocycline
  • Dicloxacillin
  • Doripenem
  • Doxycycline
  • 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; Metformin
  • Ertugliflozin; Sitagliptin
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Eslicarbazepine
  • Felbamate
  • Fidaxomicin
  • Flibanserin
  • Fosamprenavir
  • Gemifloxacin
  • Gentamicin
  • Glimepiride
  • Glimepiride; Pioglitazone
  • Glimepiride; Rosiglitazone
  • Glipizide
  • Glipizide; Metformin
  • Glyburide
  • Glyburide; Metformin
  • Glycylcyclines
  • Griseofulvin
  • Hydantoins
  • Idelalisib
  • Imipenem; Cilastatin
  • Imipenem; Cilastatin; Relebactam
  • Incretin Mimetics
  • Indinavir
  • Insulins
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Isotretinoin
  • Ivosidenib
  • Kanamycin
  • Lamotrigine
  • Lefamulin
  • Leflunomide
  • Lesinurad
  • Lesinurad; Allopurinol
  • Levofloxacin
  • Linagliptin
  • Linagliptin; Metformin
  • Lincomycin
  • Lincosamides
  • Linezolid
  • Lomitapide
  • Lopinavir; Ritonavir
  • Lorlatinib
  • Lumacaftor; Ivacaftor
  • Meglitinides
  • Mephobarbital
  • Meropenem
  • Meropenem; Vaborbactam
  • Metformin
  • Metformin; Pioglitazone
  • Metformin; Repaglinide
  • Metformin; Rosiglitazone
  • Metformin; Saxagliptin
  • Metformin; Sitagliptin
  • Methohexital
  • Metronidazole
  • Mifepristone
  • Miltefosine
  • Minocycline
  • Mivacurium
  • Modafinil
  • Morphine
  • Morphine; Naltrexone
  • Moxifloxacin
  • Nafcillin
  • Nelfinavir
  • Neomycin
  • Nevirapine
  • Nitrofurantoin
  • Norfloxacin
  • Ofloxacin
  • Omadacycline
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole; Amoxicillin; Rifabutin
  • Oritavancin
  • 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
  • Piperacillin
  • Piperacillin; Tazobactam
  • Pitolisant
  • Plazomicin
  • Polymyxin B
  • Polymyxins
  • Pramlintide
  • Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements)
  • Prasterone, Dehydroepiandrosterone, DHEA (FDA-approved)
  • Primidone
  • Pyrimethamine; Sulfadoxine
  • Rifabutin
  • Rifampin
  • Rifamycins
  • Rifapentine
  • Riluzole
  • Ritonavir
  • Roflumilast
  • Rufinamide
  • Sarilumab
  • Saxagliptin
  • Secobarbital
  • Siltuximab
  • Simvastatin; Sitagliptin
  • Sitagliptin
  • St. John’s Wort, Hypericum perforatum
  • Streptogramins
  • Streptomycin
  • Succinylcholine
  • Sugammadex
  • Sulfadiazine
  • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
  • Sulfasalazine
  • Sulfisoxazole
  • Sulfonamides
  • Sulfonylureas
  • Tazemetostat
  • Tedizolid
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Teriflunomide
  • Tetracycline
  • Thalidomide
  • Thiopental
  • Ticarcillin
  • Ticarcillin; Clavulanic Acid
  • Tigecycline
  • Tinidazole
  • Tipranavir
  • Tizanidine
  • Tobramycin
  • Tocilizumab
  • Tolazamide
  • Tolbutamide
  • Topiramate
  • Trimethoprim
  • Ulipristal
  • Vancomycin
  • Voriconazole

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