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Black Box Warnings .
Smoking and Cardiovascular Events
cigarette smoking incr. risk of serious cardiovascular events from combined hormonal contraceptive use; incr. risk w/ age (particularly for patients >35 yo) and w/ number of cigarettes smoked; contraindicated in smokers >35 yo
Adult Dosing .
Dosage forms: TAB (28-day monophasic pack): 3 mg/20 mcg x24 and inert tab x4
Special Note
- [additional info]
- Info: see Oral Contraceptive Pill (OCP) Hormonal Activity and Therapeutic Equivalence table
contraception
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
premenstrual dysphoric disorder
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
acne vulgaris, moderate
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
dysmenorrhea (off-label)
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: may skip inert tabs for extended or continuous cycle if pain persists; D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
endometriosis (off-label)
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: may skip inert tabs for extended or continuous cycle if pain persists; D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
polycystic ovary syndrome (off-label)
- [1 tab PO qd]
- Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
renal dosing
- [see below]
- renal impairment: contraindicated
- HD/PD: contraindicated
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Peds Dosing .
- Dosage forms: TAB (28-day monophasic pack): 3 mg/20 mcg x24 and inert tab x4
Special Note
- [additional info]
- Info: see Oral Contraceptive Pill (OCP) Hormonal Activity and Therapeutic Equivalence table
contraception
- [postmenarchal patients]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
premenstrual dysphoric disorder
- [postmenarchal patients]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
acne vulgaris, moderate
- [postmenarchal patients, 14 yo and older]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
dysmenorrhea (off-label)
- [postmenarchal patients]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: may skip inert tabs for extended or continuous cycle if pain persists; D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
endometriosis (off-label)
- [postmenarchal patients]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: may skip inert tabs for extended or continuous cycle if pain persists; D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
polycystic ovary syndrome (off-label)
- [postmenarchal patients]
- Dose: 1 tab PO qd; Start: day 1 of menstrual cycle or 1st Sunday after onset of menses; Info: D/C >4wk before, restart >2wk after surgery w/ VTE risk; restart >4wk postpartum or >6wk postpartum if breastfeeding
renal dosing
- [see below]
- renal impairment: contraindicated
- HD/PD: contraindicated
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- <4wk postpartum (except breastfeeding patients)
- <6wk postpartum (breastfeeding patients)
- cancer, estrogen-dependent
- cancer, progestin-dependent
- cancer history, estrogen-dependent
- cancer history, progestin-dependent
- breast CA
- hepatic tumor, benign
- hepatic tumor, malignant
- cholestatic jaundice history, oral contraceptive-associated
- cholestatic jaundice history, pregnancy-associated
- hepatic dz
- hepatic impairment
- renal impairment
- nephrotic syndrome
- hemodialysis
- peritoneal dialysis
- thrombophlebitis
- thrombophlebitis history
- thromboembolism
- thromboembolism history
- major surgery w/ prolonged immobilization
- smokers >35 yo
- heavy smokers
- valvular heart dz, thrombogenic
- rhythm heart dz, thrombogenic
- CAD
- cerebrovascular dz
- thrombophilia, acquired
- thrombophilia, hereditary
- SBP >160 or DBP >100, persistent
- HTN w/ vascular dz
- diabetes mellitus w/ vascular dz
- adrenal insufficiency
- migraine w/ aura
- hyperkalemia
- vaginal bleeding, undiagnosed
- SLE antibody, positive or unknown
- caution: hypersensitivity to tartrazine (some generic forms)
- caution: HTN
- caution: hyperlipidemia
- caution: diabetes mellitus
- caution: inflammatory bowel dz
- caution: breast CA history
- caution: gallbladder dz
- caution: sensitivity to fluid retention
- caution: depression history
- caution: vomiting
- caution: diarrhea
- caution: obesity
- caution: angioedema, hereditary
- caution: smoking habit change
Drug Interactions .
Overview
drospirenone (contraceptive)
progestin
Interaction Characteristics:
- CYP3A4 substrate
- affected by altered gastrointestinal motility
- binds to anion exchange resin/polymer
- binds to encapsulating agent
- hyperglycemic effects
- hyperkalemia
- progesterone agonist
- thrombogenic effects
ethinyl estradiol (contraceptive)
estrogen
Interaction Characteristics:
- CYP1A2 substrate
- CYP2C8 substrate
- CYP2C9 substrate
- CYP2C19 substrate
- CYP3A4 substrate
- SULT1E1 substrate
- UGT1A1 substrate
- P-gp substrate
- CYP1A2 inhibitor, moderate
- CYP2C19 inhibitor, weak
- CYP2D6 inhibitor, weak
- CYP3A4 inhibitor, weak
- CYP2A6 inducer, minor
- CYP2C8 inducer, weak
- UGT1A4 inducer
- affected by altered gastrointestinal motility
- binds to anion exchange resin/polymer
- binds to encapsulating agent
- binds to polyvalent cations
- estrogen
- hyperglycemic effects
- hypertensive effects
- interferes w/ ACTH analog test
- thrombogenic effects
- thyroid hormone synthesis/metabolism effects
Contraindicated
- atazanavir
- cisapride
- cobicistat
- fezolinetant
- thioridazine
- tranexamic acid
Avoid/Use Alternative
- acitretin
- albendazole
- alosetron
- alprazolam
- amiloride
- anastrozole
- apalutamide
- aprepitant
- armodafinil
- artemether/lumefantrine
- avapritinib
- bazedoxifene
- belzutifan
- bendamustine
- bexarotene
- bosentan
- brigatinib
- butalbital
- cannabis
- carbamazepine
- carfilzomib
- cenobamate
- clobazam
- clomiphene
- codeine
- colchicine
- dabrafenib
- danshen
- darolutamide
- darunavir
- deferasirox
- desogestrel (contraceptive)
- dexamethasone
- dicloxacillin
- dienogest (contraceptive)
- dihydrocodeine
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- dulaglutide
- echinacea
- efavirenz
- elafibranor
- elagolix
- eliglustat
- elvitegravir
- enasidenib
- encorafenib
- enzalutamide
- epinephrine inhaled
- eslicarbazepine acetate
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etravirine
- exemestane
- felbamate
- fexinidazole
- fitusiran
- fosamprenavir
- fosaprepitant
- fosphenytoin
- furosemide
- garlic
- ginkgo
- ginseng, Asian
- glecaprevir
- glycerol phenylbutyrate
- grape
- griseofulvin
- hydrocodone
- ivosidenib
- letrozole
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- liraglutide
- lisinopril
- lixisenatide
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- megestrol
- meperidine
- meropenem
- methadone
- midodrine
- mifepristone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- nafcillin
- nelfinavir
- nevirapine
- nirogacestat
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- odevixibat
- olutasidenib
- omaveloxolone
- ospemifene
- oxcarbazepine
- oxycodone
- pacritinib
- pentobarbital
- perampanel
- pexidartinib
- phenobarbital
- phenytoin
- pibrentasvir
- pimozide
- pioglitazone
- pirfenidone
- pitolisant
- posaconazole
- potassium chloride
- potassium phosphate
- pralsetinib
- prednisone
- primidone
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- propafenone
- raloxifene
- relugolix
- repotrectinib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- romidepsin
- rufinamide
- sarilumab
- segesterone (contraceptive)
- simvastatin
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- sugammadex
- sunvozertinib
- suzetrigine
- tacrolimus
- tamoxifen
- tazemetostat
- tecovirimat
- telotristat ethyl
- tesamorelin
- tipranavir
- tirzepatide
- tizanidine
- tocilizumab
- topiramate
- toremifene
- tovorafenib
- tramadol
- turmeric
- ulipristal (post-coital contraceptive)
- vaborbactam
- vaccinia immune globulin
- valproic acid
- valsartan
- vamorolone
- vemurafenib
- vinblastine
- vorasidenib
- zanubrutinib
Monitor/Modify Tx
- abemaciclib
- abiraterone acetate
- abrocitinib
- acalabrutinib
- acarbose
- acebutolol
- acetaminophen
- adagrasib
- aflibercept
- albuterol
- albuterol inhaled
- alfentanil
- aliskiren
- almotriptan
- alogliptin
- aminocaproic acid
- aminophylline
- amiodarone
- amlodipine
- amphetamine
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- aprocitentan
- arformoterol inhaled
- asciminib
- asparaginase
- atenolol
- atidarsagene autotemcel
- atogepant
- atomoxetine
- atropine ophthalmic
- avacopan
- avanafil
- avatrombopag
- axitinib
- azilsartan medoxomil
- baricitinib
- belumosudil
- benazepril
- benzphetamine
- berotralstat
- betamethasone
- betaxolol
- bevacizumab
- bexagliflozin
- binimetinib
- bismuth subsalicylate
- bisoprolol
- botulism immune globulin
- brolucizumab
- bromocriptine
- budesonide
- bumetanide
- bupropion
- C1 esterase inhibitor
- cabozantinib
- caffeine
- caffeine citrate
- calaspargase
- canagliflozin
- candesartan cilexetil
- capivasertib
- captopril
- carvedilol
- celecoxib
- ceritinib
- chloramphenicol
- chlorothiazide
- chlorthalidone
- cholestyramine
- chorionic gonadotropin
- ciprofloxacin
- citalopram
- clarithromycin
- clevidipine
- clofazimine
- clonidine
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- cocaine
- colesevelam
- colestipol
- concizumab
- conivaptan
- copanlisib
- corticotropin
- cortisone
- cosyntropin
- crizotinib
- cyclosporine
- cytomegalovirus immune globulin
- danazol
- dapagliflozin
- darbepoetin alfa
- decitabine
- deflazacort
- desipramine
- desmopressin
- desvenlafaxine
- deuruxolitinib
- dexmethylphenidate
- dextroamphetamine
- diazepam
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- disopyramide
- dobutamine
- docetaxel
- dofetilide
- domperidone
- dopamine
- doxapram
- doxazosin
- dronabinol
- dronedarone
- droxidopa
- duvelisib
- eletriptan
- eltrombopag
- empagliflozin
- enalapril
- enalaprilat
- entrectinib
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- epirubicin
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- ertugliflozin
- erythromycin
- esketamine
- esmolol
- ethacrynic acid
- etodolac
- etrasimod
- everolimus
- exenatide
- factor XIII concentrate
- faricimab
- fedratinib
- felodipine
- fenfluramine
- fenofibrate
- fenofibric acid
- fenoldopam
- fenoprofen
- fentanyl
- ferric maltol
- finerenone
- fingolimod
- flecainide
- flibanserin
- fluconazole
- fludrocortisone
- fluorouracil
- flurbiprofen
- follitropin
- formoterol inhaled
- fosinopril
- fostamatinib
- fostemsavir
- fremanezumab
- frovatriptan
- fruquintinib
- galcanezumab
- gemfibrozil
- gepirone
- glimepiride
- glipizide
- glyburide
- grapefruit
- guanfacine
- heparin
- hepatitis B immune globulin
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- ibrutinib
- ibuprofen
- idelalisib
- imatinib
- immune globulin
- indapamide
- indomethacin
- insulin
- iohexol
- iomeprol
- iopamidol
- irbesartan
- isradipine
- itraconazole
- ivabradine
- ixabepilone
- ketamine
- ketoconazole
- ketoprofen
- ketorolac
- labetalol
- lamotrigine
- landiolol
- lanreotide
- lazertinib
- lefamulin
- leflunomide
- lemborexant
- lenacapavir
- lenalidomide
- lenvatinib
- letermovir
- levalbuterol inhaled
- levoketoconazole
- levomilnacipran
- levothyroxine
- licorice
- lidocaine
- linagliptin
- liothyronine
- lisdexamfetamine
- lomitapide
- lonafarnib
- lorazepam
- losartan
- lovastatin
- lumateperone
- lurasidone
- lurbinectedin
- luspatercept
- lusutrombopag
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- menotropins
- metformin
- methamphetamine
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- metyrapone
- midazolam
- miglitol
- milnacipran
- minoxidil
- mirabegron
- moexipril
- momelotinib
- nabumetone
- nadolol
- naproxen
- naratriptan
- nateglinide
- naxitamab
- nebivolol
- necitumumab
- nefazodone
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- nintedanib
- niraparib
- nisoldipine
- norepinephrine
- nortriptyline
- olaparib
- oliceridine
- olmesartan medoxomil
- olodaterol inhaled
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- pazopanib
- pegaspargase
- pemigatinib
- perindopril
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piroxicam
- pomalidomide
- ponatinib
- ponesimod
- porfimer
- potassium acid phosphate
- potassium bicarbonate
- potassium citrate
- potassium iodide
- pramlintide
- prazosin
- prednisolone
- probenecid
- propranolol
- prothrombin complex concentrate (human)
- pseudoephedrine
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- ramipril
- ramucirumab
- ranibizumab
- rasagiline
- red yeast rice
- regorafenib
- repaglinide
- Rho(D) immune globulin
- ribociclib
- rimegepant
- ripretinib
- ritlecitinib
- rizatriptan
- romiplostim
- ropinirole
- rosiglitazone
- rotigotine transdermal
- ruxolitinib
- ruxolitinib topical
- salmeterol inhaled
- salsalate
- saxagliptin
- selpercatinib
- selumetinib
- semaglutide
- sevelamer
- siponimod
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- sitagliptin
- sodium tetradecyl sulfate
- solriamfetol
- somapacitan
- somatrogon
- somatropin
- sorafenib
- sotatercept
- spironolactone
- succinylcholine
- sufentanil
- sulindac
- sumatriptan
- sunitinib
- tadalafil
- tagraxofusp
- telmisartan
- temsirolimus
- terazosin
- terbutaline
- teriflunomide
- testosterone
- thalidomide
- theophylline
- thyroid
- timolol
- tivozanib
- tofacitinib
- tolmetin
- tolvaptan
- torsemide
- trametinib
- trandolapril
- tretinoin
- triamcinolone
- triamterene
- triazolam
- triclabendazole
- trimethoprim
- tucatinib
- ubrogepant
- upadacitinib
- vadadustat
- valoctocogene roxaparvovec
- vandetanib
- vardenafil
- varicella zoster immune globulin
- vasopressin
- venetoclax
- venlafaxine
- verapamil
- vilanterol inhaled
- viloxazine
- vincristine
- vinorelbine
- voclosporin
- von Willebrand factor
- voriconazole
- vorinostat
- warfarin
- yohimbe
- zavegepant
- ziv-aflibercept
- zolmitriptan
Caution Advised
- cariprazine
- carisoprodol
- clopidogrel
- cobimetinib
- cyclophosphamide
- dantrolene
- daridorexant
- duloxetine
- elacestrant
- fulvestrant
- melatonin
- palovarotene
- perphenazine
- proguanil
- ramelteon
- riluzole
- roflumilast
- roflumilast topical
- selegiline
- sirolimus topical
- trifluoperazine
- trimipramine
- ursodiol
Adverse Reactions .
Serious Reactions
- thrombosis
- thromboembolism
- MI
- stroke
- cerebral hemorrhage
- HTN
- hepatic adenoma
- cholestasis
- gallbladder dz
- pancreatitis
- depression
- anaphylaxis
- anaphylactoid rxn
- erythema multiforme
- hyperkalemia
- SLE exacerbation
- porphyria exacerbation
- chorea exacerbation
- ocular lesions
- cervical dysplasia (contraception or premenstrual dysphoric disorder use)
- breast CA risk (current, recent, or long-term use)
- cervical CA risk
Common Reactions
- bleeding irregularities
- nausea
- vomiting
- breast tenderness
- headache
- abdominal distension
- abdominal pain
- edema
- weight changes
- emotional lability
- depression
- acne
- chloasma
- fatigue
- irritability
- libido changes
- BP elevated
- glucose intolerance
- cholesterol incr.
- contact lens intolerance
- candidiasis, vulvovaginal
Safety/Monitoring .
Monitoring Parameters
glucose if pre-diabetes/diabetes; lipid panel if hyperlipidemia; BP if HTN, HTN-related dz, or renal dz
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; risk of teratogenicity low when inadvertently used during 1st trimester based on human data
Lactation
Clinical Summary
avoid use while breastfeeding if <6wk postpartum, use non-hormonal or progestin-only alternative; weigh risk/benefit while breastfeeding if >6wk postpartum; no human data available, though risk of infant harm not expected based on limited drug excretion into milk; decr. milk production, esp. during early postpartum, based on limited human data w/ estrogens, conflicting human data w/ progestins, and drugs' mechanism of action
Pharmacology .
Metabolism: for drospirenone: liver; CYP450: 3A4 (minor) substrate; for ethinyl estradiol: GI tract, liver; CYP450: 3A4 substrate
Excretion: for drospirenone: feces, urine; Half-life: 30h; for ethinyl estradiol: urine 22-58%, feces 30-53%, bile 26-43%; Half-life: 26h
Subclass: Contraceptives, Oral 1: Monophasic Estrogen/Progestin OCPs
Mechanism of Action
suppresses LH and FSH, inhibiting ovulation; alters cervical mucus and endometrium
Formulary .
No Formulary Selected
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