AdultPediatricDosage Forms & Strengths drospirenone/ethinyl estradiol/levomefolate tablet 3mg/0.02mg/0.451mg (Beyaz) 3mg/0.03mg/0.451mg (Safyral, Tydemy) Contraception Safyral, Tydemy 1 active tablet (3 mg drospirenone/0.03 mg EE) PO qDay for 21 days, THEN 1 inert tablet PO qDay for 7 days Beyaz 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Moderate Acne Vulgaris Beyaz Indicated for moderate acne in women, but only if oral contraceptive is chosen as method of birth control 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Premenstrual Dysphoric Disorder Beyaz Indicated for symptoms of premenstrual dysphoric disorder (PMDD), but only if oral contraceptive is chosen as method of birth control 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Dosage Modifications Renal impairment: Contraindicated Hepatic impairment: Contraindicated Dosing Considerations Women should be advised to use additional nonhormonal contraception during the first 7 days of therapy Administer tablets in the order directed on the blister pack calendar at the same time each day Increased risk for venous thromboembolism (VTE) with combined hormonal contraceptives following delivery; risk declines rapidly after 21 days but does not return to normal until 42 days after delivery CDC guidelines recommend waiting 21-42 days to initiate therapy in postpartum women without additional VTE risks (MMWR July 7, 2011) Postpartum women who do not breastfeed or after a second trimester abortion: Wait ≥4 weeks to initiate therapy Postpartum women who have had a caesarean section birth: Wait ≥6 weeks to initiate therapy Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptivesDosage Forms & Strengths drospirenone/ethinyl estradiol/levomefolate tablet 3mg/0.02mg/0.451mg (Beyaz) 3mg/0.03mg/0.451mg (Safyral, Tydemy) Contraception <14 years Safety and efficacy not established ≥14 years Safyral, Tydemy 1 active tablet (3 mg drospirenone/0.03 mg EE) PO qDay for 21 days, THEN 1 inert tablet PO qDay for 7 days Beyaz 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Moderate Acne Vulgaris Moderate acne in females ≥14 years, but only if oral contraceptive is chosen as method of birth control <14 years Safety and efficacy not established ≥14 years Beyaz Indicated for moderate acne in women, but only if oral contraceptive is chosen as method of birth control 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Interaction CheckerEnter a drug name and drospirenone/ethinyl estradiol/levomefolateNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Due to system maintenance, the drug interactions feature you are attempting to access is temporarily unavailable. Please try again later. >10% Premenstrual syndrome (13.2%) Migraine/headache (10.7%) 1-10% Breast pain/discomfort/tenderness (8.3%) Menstrual irregularities (4.7%) Nausea/vomiting (4.5%) Abdominal pain/discomfort/tenderness (2.3%) Mood changes, including affect lability, depression, alteration of mood, mood swings, and irritability (2.3%) Frequency Not Defined Irregular uterine bleeding Venous/arterial thromboembolic events, including DVT, PE, stroke, MI, intracardiac thrombosis, sagittal sinus thrombosis, intracranial venous sinus thrombosis, retinal vein thrombosis Hypertension Hypersensitivity Hyperkalemia Chloasma Gallbladder disease Toxic skin eruption Uterine leiomyoma Black Box Warnings Cigarette smoking and risk of cardiovascular disease Women >35 years who smoke should not use oral contraceptives Cigarette smoking increases risk of serious cardiovascular adverse effects from combination oral contraceptive use This risk increases with age (>35 yr) and with heavy smoking (15 or more cigarettes/day) Advise women taking oral contraceptives not to smoke Contraindications Documented hypersensitivity Active/history of breast cancer or estrogen- or progestin-sensitive caner Active/history of arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease Uncontrolled hypertension Diabetes mellitus with vascular involvement History of migraine with aura Undiagnosed abnormal uterine bleeding Benign or malignant liver tumors, hepatic impairment or development of jaundice with prior oral contraceptive use Pregnancy Renal impairment Adrenal insufficiency Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir Cautions Due to increased risk of hyperkalemia, monitor serum potassium during first month if coadministered with potassium-elevating/sparing drugs (eg, spironolactone); consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly; strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin Family history of breast cancer and or DVT/PE Current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE Conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy) Discontinue immediately if any of the following occur: jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant increase in BP, severe depression, increased risk of thromboembolic complications after surgery Discontinue therapy 4 weeks before major surgery or prolonged immobilization; may resume 2 weeks afterwards Monitor patients on oral anticoagulants (eg, warfarin); increased anticoagulant dose may be warranted due to thromboembolic risk with oral contraceptives Studies have shown an increased risk of cervical cancer with OCP use; however, HPV remains the main risk factor for cervical cancer; evidence suggests long-term use of OCPs (≥5 yr) may be associated with increased risk Studies have shown a significantly decreased endometrial cancer risk with OCP use; protective effect increases with longer duration of OCP use and may continue to persist years after OCP discontinuation Risk of ovarian cancer may decrease with increasing duration of OCP use Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use Monitor prediabetic and diabetic women with dyslipidemias Breast cancer Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer Some studies report a small increase in risk of breast cancer among current or recent users(<6 months since last use) and current users with longer duration of COC use A woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early-onset Thromboembolic disorders Discontinue immediately if thrombotic event occurs Risk of VTE is highest during the first year of use; interim data from a large, prospective cohort safety study of various combined oral contraceptives (COCs) suggest that this increased risk, as compared with that in non-COC users, is greatest during the first 6 months of COC use Women taking drospirenone-containing contraceptives may have up to a 3-fold increased risk for developing VTE compared with women taking other combined hormonal contraceptives To decrease risk of VTE events, CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section before initiating use of combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives Pregnancy There is no use for contraception in pregnancy; this medication should be discontinued during pregnancy; epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy Lactation The drug is present in human milk; after a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL; estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose; there is limited information on effects of this drug on breast-fed infant CHCs can reduce milk production in breastfeeding females; this reduction can occur at any time but is less likely to occur once breastfeeding is well-established; when possible, advise nursing female to use other methods of contraception until she discontinues breast-feeding Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation; other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation Absorption Bioavailability: 76% (drospirenone); 40% (ethinyl estradiol) Peak plasma time: 1-2 hr Peak plasma concentration: 88 ng/mL (drospirenone); 99 pg/mL (ethinyl estradiol) AUC: 830-970 ng.hr/mL (drospirenone); 350-470 pg.hr/mL (ethinyl estradiol) Distribution Protein bound Ethinyl estradiol: >98% bound to serum albumin Drospirenone: 97% bound to serum proteins (not SHBG or corticosteroid-binding globulin) Metabolism Hepatic metabolism Metabolites: Two acid forms of DSRP (inactive) Elimination Half-life: 24 hr (ethinyl estradiol); 30 hr (drospirenone) Excretion: Urine (38-47% as inactive metabolites), feces (17-20% as inactive metabolites) No images available for this drug. 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