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Drospirenone

    DEA Class; Rx

    Common Brand Names; Slynd

    • Contraceptives, Oral

    Fourth generation progestin with antimineralocorticoid and antiandrogenic properties
    A progestin-only contraceptive is used for routine contraception in adolescent and adult premenopausal females
    Drospirenone has a potassium-sparing effect; do not use in patients with adrenal, renal, or hepatic insufficiency

    Progestin indicated for use by females of reproductive potential to prevent pregnancy

    Renal impairment

    Adrenal insufficiency

    Presence or history of cervical cancer or progestin-sensitive cancers

    Liver tumors, benign or malignant, or hepatic impairment

    Undiagnosed abnormal uterine bleeding

    • Unscheduled bleeding, cycle 1 (64.4%)
    • Unscheduled bleeding, cycle 13 (40.3%)
    • Acne (3.8%)
    • Metrorrhagia (2.8%)
    • Headache (2.7%)
    • Breast pain (2.2%)
    • Weight increased (1.9%)
    • Dysmenorrhea (1.9%)
    • Nausea (1.8%)
    • Vaginal hemorrhage (1.7%)
    • Libido decreased (1.3%)
    • Breast tenderness (1.2%)
    • Menstruation irregular (1.2%)

    Use leads to decreased estradiol serum levels; unknown if clinically relevant loss of bone mineral density may occur

    Some studies suggest COC containing progestin and estradiol associated with increased risk of cervical cancer or intraepithelial neoplasia; however, controversy continues about the extent to which such findings may be due to differences in sexual behavior and other factors

    Discontinue if jaundice or acute or chronic disturbances of liver function develop; do not resume until LFTs return to normal and causation identified; drospirenone contraindicated with hepatic impairment or benign or malignant liver tumors

    Consider possibility of ectopic pregnancy in women who become pregnant or report lower abdominal pain

    Progestins may decrease insulin sensitivity; patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring

    Bleeding irregularities (eg, breakthrough or intracyclic bleeding or spotting) may occur, especially during the first 3 months; may resolve over time or by changing to different contraceptive; if persists, evaluate for causes (eg, pregnancy, malignancy)

    Carefully observe females for history of depression and discontinue drospirenone if depression recurs to a serious degree

    Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy

    Negligible amounts of drospirenone are excreted in the breast milk

    At therapeutic doses, no effects on breastfed newborns/infants are anticipated

    Adults

    4 mg/day PO.

    Geriatric

    Safety and efficacy have not been established.

    Adolescents

    4 mg/day PO.

    Children

    Not indicated in prepubescent females.

    Infants

    Not indicated.

    Drospirenone

    tablet

    • 4mg (pack contains 24 active [white] and 4 inert [green] tablets)