Drospirenone+Ethinyl Estradiol

DRUG INFORMATION

  ADULT
    - Preventive Services Task Force recommends that women of childbearing age consume
      supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily. 1 Consider
      other folate supplementation that a woman may be taking before prescribing
      drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate
      calcium tablets.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'dosage and
      administration', retrieved 2026-08-29
    - Take one tablet daily by mouth at the same time every day. ( 2.1 ) Tablets must be
      taken in the order directed on the blister. ( 2.1 ) 2.1 How to Take Drospirenone,
      Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium
      Tablets Take one tablet by mouth at the same time every day. The failure rate may
      increase when pills are missed or taken incorrectly.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and efficacy of drospirenone, ethinyl estradiol and levomefolate calcium
      tablets and levomefolate calcium tablets has been established in women of
      reproductive age. Efficacy is expected to be the same for postpubertal adolescents
      under the age of 18 and for users 18 years and older. Use of this product before
      menarche is not indicated.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - Use of this product before menarche is not indicated. 8.5 Geriatric Use
      Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate
      calcium tablets has not been studied in postmenopausal women and is not indicated
      in this population.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29
    - In subjects with creatinine clearance (CLcr) of 50 to 79 mL/min, serum DRSP
      concentrations were comparable to those in a control group with CLcr ≥ 80 mL/min.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29
    - In addition, there is a potential to develop hyperkalemia in subjects with renal
      impairment whose serum potassium is in the upper reference range, and who are
      concomitantly using potassium-sparing drugs [see Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In addition, there is a potential to develop hyperkalemia in subjects with renal
      impairment whose serum potassium is in the upper reference range, and who are
      concomitantly using potassium-sparing drugs [see Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29
    - The mean exposure to DRSP in women with moderate liver impairment is approximately
      three times higher than the exposure in women with normal liver function.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29
    - Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate
      calcium tablets has not been studied in women with severe hepatic impairment. 8.8
      Race No clinically significant difference was observed between the
      pharmacokinetics of DRSP or EE in Japanese versus Caucasian women [see Clinical
      Pharmacology ( 12.3 )].
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There is no use for contraception in pregnancy; therefore,
      Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate
      calcium tablets should be discontinued during pregnancy.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'pregnancy', retrieved
      2026-08-29
    - 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.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'pregnancy', retrieved
      2026-08-29
    - In the U.S. general population, the estimated background risk of major birth
      defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and
      15 to 20 percent, respectively.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary DRSP is present in human milk.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'nursing mothers',
      retrieved 2026-08-29
    - 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.
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'nursing mothers',
      retrieved 2026-08-29
    - The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal
      dose (see Data).
      Source: US FDA label for drospirenone (drospirenone, ethinyl estradiol and
      levomefolate calcium and levomefolate calcium), section 'nursing mothers',
      retrieved 2026-08-29