Drospirenone

FDA label

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Renal Contraindicated in renal impairment (hyperkalemia risk)

Hepatic Contraindicated in hepatic impairment or liver tumors

Instructions

• Swallow whole once daily at about the same time each day (24-h interval between tablets).
• Day 1 start: take first white active tablet on the first day of menses; 24 white active tablets, then 4 green inert tablets; begin the next pack the following day with no break.
• Missed 1 active tablet: take as soon as possible, then continue 1 tablet daily. Missed >=2 active tablets: take the last missed tablet ASAP, continue 1 tablet daily; use back-up non-hormonal contraception if sex within 7 days after the missed tablets. Missed inert tablets: skip and continue.
• Vomiting or diarrhea within 3-4 h of a tablet: take the next tablet as soon as possible, within 12 h of the usual time if possible.
• Switching: from a COC start the day the new COC pack would have started; patch/ring/injection start the day the next application/insertion/injection was due; IUD/implant start the day of removal.

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

Cautions

• Hyperkalemia: anti-mineralocorticoid activity comparable to spironolactone 25 mg; check serum potassium during the first treatment cycle in females on long-term daily medications that raise potassium; consider monitoring with chronic strong CYP3A4 inhibitor use.
• Thromboembolic disorders: discontinue if an arterial or venous thromboembolic event occurs; consider stopping during prolonged immobilization; VTE risk (if any) expected lower than drospirenone/ethinyl estradiol COCs.
• Bone loss: lowers estradiol levels; clinical relevance to bone mineral density unknown.
• Liver disease: discontinue if jaundice or disturbed liver function develops.
• Ectopic pregnancy: be alert in users who become pregnant or report lower abdominal pain.
• Hyperglycemia risk in diabetes (decreased insulin sensitivity with progestins).
• Bleeding irregularities and amenorrhea: unscheduled bleeding common early (64% cycle 1, 40% cycle 13); rule out pregnancy/malignancy if persistent; rule out pregnancy after two missed periods.
• Depression: observe patients with a history of depression; discontinue if depression recurs to a serious degree.

Adverse reactions

• 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%)
• Decreased libido, breast tenderness, irregular menstruation (1-1.3%)

Pregnancy Discontinue if pregnancy occurs (no reason to use during pregnancy); epidemiologic data show little or no increased birth-defect risk from inadvertent oral progestin exposure in early pregnancy.

Lactation Negligible drospirenone in breast milk (relative infant dose 1.5%); no effects on breastfed infants anticipated; progestin-only pills generally without adverse effects on milk production or infant.