Falessa

What is Falessa

Ethinyl estradiol and levonorgestrel are used together as a combination oral contraceptive (COC).

Ethinyl estradiol is a potent, synthetic estrogen. Levonorgestrel is a second-generation progestin with moderate to high androgenic activity and minimal estrogenic activity.

The levomefolate in these products provides daily folate supplementation. 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 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.

Levonorgestrel containing combination products can be used off-label in the U.S. as a postcoital ’emergency’ contraceptive; the FDA has explicitly declared all levonorgestrel containing combination products to be safe and effective for emergency post-coital contraception under the ‘Yutzpe method’; however, levonorgestrel-only emergency contraceptive regimens are more effective and cause a lower incidence of side effects (e.g., vomiting).

Ethinyl estradiol levonorgestrel levomefolate COC products were first approved by the FDA in 2014.

Indications

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

For routine contraception

Side Effects

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

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
  • glaucoma
  • 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
  • ovarian cancer
  • pernicious anemia
  • porphyria
  • pregnancy
  • protein C deficiency
  • protein S deficiency
  • renal disease
  • stroke
  • surgery
  • systemic lupus erythematosus (SLE)
  • thromboembolic disease
  • thromboembolism
  • thrombophlebitis
  • thyroid disease
  • tobacco smoking
  • uterine cancer
  • vaginal bleeding
  • vaginal cancer
  • valvular heart disease
  • visual disturbance
  • vitamin B12 deficiency

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
  • Capecitabine
  • Carbamazepine
  • Carbapenems
  • Carbenicillin
  • Carvedilol
  • Cefaclor
  • Cefadroxil
  • Cefazolin
  • Cefdinir
  • Cefditoren
  • Cefepime
  • Cefiderocol
  • Cefixime
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  • Cefotetan
  • Cefoxitin
  • Cefpodoxime
  • Cefprozil
  • Ceftaroline
  • Ceftazidime
  • Ceftazidime; Avibactam
  • Ceftibuten
  • Ceftizoxime
  • Ceftolozane; Tazobactam
  • Ceftriaxone
  • Cefuroxime
  • Cenobamate
  • Cephalexin
  • Ceritinib
  • Charcoal
  • Chenodiol
  • Chloramphenicol
  • Chlordiazepoxide
  • Chlordiazepoxide; Clidinium
  • Chlorpropamide
  • Cholestyramine
  • Ciclesonide
  • Cimetidine
  • Ciprofloxacin
  • Clarithromycin
  • Clevidipine
  • Clindamycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Cobimetinib
  • Colchicine
  • Colchicine; Probenecid
  • Colesevelam
  • Colestipol
  • 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
  • Diphenhydramine; Ibuprofen
  • Diphenhydramine; Naproxen
  • 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
  • Esomeprazole; Naproxen
  • Estazolam
  • Ethanol
  • Exemestane
  • Exenatide
  • Famotidine; Ibuprofen
  • Felbamate
  • Felodipine
  • Fidaxomicin
  • Flibanserin
  • Floxuridine
  • Fluconazole
  • Fludrocortisone
  • Flunisolide
  • Fluorouracil, 5-FU
  • Fluoxetine
  • Fluoxetine; Olanzapine
  • Flurazepam
  • Fluticasone
  • Fluticasone; Salmeterol
  • Fluticasone; Umeclidinium; Vilanterol
  • Fluticasone; Vilanterol
  • food
  • Formoterol; Mometasone
  • Fosamprenavir
  • Fosphenytoin
  • 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
  • Hydrochlorothiazide, HCTZ; Triamterene
  • Hydrocodone; Ibuprofen
  • Hydrocortisone
  • Ibuprofen
  • Ibuprofen; Oxycodone
  • Ibuprofen; Pseudoephedrine
  • Icosapent ethyl
  • Idelalisib
  • Imipenem; Cilastatin
  • Imipenem; Cilastatin; Relebactam
  • Incretin Mimetics
  • Indinavir
  • Indomethacin
  • Insulin Degludec; Liraglutide
  • Insulin Glargine; Lixisenatide
  • Insulins
  • Isavuconazonium
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Isotretinoin
  • Isradipine
  • Itraconazole
  • Ivosidenib
  • Ixabepilone
  • Kanamycin
  • Ketoconazole
  • Lamotrigine
  • Lansoprazole; Naproxen
  • 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
  • Methotrexate
  • 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
  • Naproxen
  • Naproxen; Pseudoephedrine
  • Naproxen; Sumatriptan
  • 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
  • Pentamidine
  • Pentobarbital
  • Perampanel
  • Perindopril; Amlodipine
  • Pexidartinib
  • Phenobarbital
  • Phenothiazines
  • Phenoxybenzamine
  • Phentermine; Topiramate
  • Phenytoin
  • 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
  • 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
  • Sulindac
  • 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
  • Triamterene
  • Triazolam
  • Tricyclic antidepressants
  • Trimethoprim
  • Tucatinib
  • Ulipristal
  • Ursodeoxycholic Acid, Ursodiol
  • Valdecoxib
  • Valproic Acid, Divalproex Sodium
  • Vancomycin
  • Verapamil
  • Vincristine
  • Vincristine Liposomal
  • Vorapaxar
  • Voriconazole
  • Warfarin
  • Zolmitriptan
  • Zonisamide
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