Ethinyl Estradiol Levonorgestrel Ferrous bisglycinate Brand Name– Balcoltra
What is Ethinyl Estradiol Levonorgestrel Ferrous bisglycinate
Ethinyl estradiol and levonorgestrel are used together as combined oral contraceptive (COC); the ferrous bisglycinate component does not serve any therapeutic purpose other than to add a small amount of iron replacement during menses.
Ethinyl estradiol is a potent, synthetic estrogen. Levonorgestrel is a second-generation progestin with moderate to high androgenic activity and minimal estrogenic activity. 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 COCs 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 ferrous bisglycinate COC products were FDA approved in January 2018.
Indications
- acne vulgaris
- amenorrhea
- contraception
- dysfunctional uterine bleeding
- endometriosis
- hirsutism
- polycystic ovary syndrome
For routine contraception
Side Effects
- abdominal pain
- acne vulgaris
- alopecia
- amenorrhea
- angioedema
- anorexia
- anxiety
- appetite stimulation
- arthralgia
- asthenia
- back pain
- bowel ischemia
- breakthrough bleeding
- breast discharge
- breast enlargement
- candidiasis
- cataracts
- cervical dysplasia
- chest pain (unspecified)
- cholecystitis
- cholelithiasis
- cholestasis
- colitis
- cough
- cystitis
- depression
- diarrhea
- diplopia
- dizziness
- dysmenorrhea
- dyspepsia
- dyspnea
- edema
- elevated hepatic enzymes
- emotional lability
- erythema multiforme
- erythema nodosum
- fatigue
- fluid retention
- galactorrhea
- gingivitis
- headache
- hepatitis
- hepatoma
- hirsutism
- hot flashes
- hyperlipidemia
- hypertension
- hypertriglyceridemia
- hypoesthesia
- insomnia
- intracranial bleeding
- irritability
- jaundice
- lactation suppression
- leukorrhea
- libido decrease
- libido increase
- lupus-like symptoms
- maculopapular rash
- malaise
- mastalgia
- melasma
- menorrhagia
- menstrual irregularity
- migraine
- musculoskeletal pain
- myalgia
- myocardial infarction
- nausea
- new primary malignancy
- oligomenorrhea
- optic neuritis
- palpitations
- pancreatitis
- papilledema
- paresthesias
- peliosis hepatis
- pelvic pain
- pharyngitis
- photosensitivity
- porphyria
- pruritus
- pulmonary embolism
- rash
- retinal thrombosis
- rhinitis
- sinusitis
- stroke
- thromboembolism
- thrombosis
- urticaria
- vaginal discharge
- vaginal irritation
- vaginitis
- visual impairment
- vomiting
- weight gain
- 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
- 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
- hypercholesterolemia
- hyperlipidemia
- hypertension
- hypertriglyceridemia
- hypothyroidism
- infants
- jaundice
- migraine
- myocardial infarction
- neonates
- obesity
- obstetric delivery
- ovarian cancer
- pancreatitis
- porphyria
- pregnancy
- protein C deficiency
- protein S deficiency
- renal disease
- salicylate hypersensitivity
- seizure disorder
- sexually transmitted disease
- stroke
- surgery
- systemic lupus erythematosus (SLE)
- tartrazine dye hypersensitivity
- thromboembolic disease
- thromboembolism
- thrombophlebitis
- thyroid disease
- tobacco smoking
- uterine cancer
- 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
- enteral feedings
- 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
- Perampanel
- 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
- Trientine
- Trimethoprim
- Tucatinib
- Ulipristal
- Ursodeoxycholic Acid, Ursodiol
- Valdecoxib
- Valproic Acid, Divalproex Sodium
- Vancomycin
- Verapamil
- Vincristine
- Vincristine Liposomal
- Vorapaxar
- Voriconazole
- Warfarin
- Zolmitriptan
- Zonisamide
