Classes
DEA Class; Rx
Common Brand Names; Slynd
- Contraceptives, Oral
Description
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
Indications
Progestin indicated for use by females of reproductive potential to prevent pregnancy
Contraindications
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
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
4 mg/day PO.
Safety and efficacy have not been established.
4 mg/day PO.
Not indicated in prepubescent females.
Not indicated.
How supplied
Drospirenone
tablet
- 4mg (pack contains 24 active [white] and 4 inert [green] tablets)