drospirenone (Rx)

Brand and Other Names:Slynd
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

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

Contraception

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

1 tablet qDay for 28 consecutive days; 1 white active tablet/day during the first 24 days and 1 green inert tablet/day during the 4 following days

Starting with no current hormonal contraception use

  • Take first white active tablet on the first day of menses
  • Take subsequent white active tablets qDay at the same time each day for a total of 24 days
  • Take 1 green inert tablet daily for 4 days and at the same time of day that active tablets were taken
  • Begin each subsequent pack on the same day of the week as the first cycle pack (ie, on the day after taking the last inactive tablet)

Switching from another contraceptive method

  • Combined oral contraceptive (COC): Start drospirenone on the day when the new pack of the previous COC would have started
  • Transdermal patch: Start drospirenone on the day when next application would have been scheduled
  • Vaginal ring: Start drospirenone on the day when next insertion would have been scheduled
  • Injection: Start drospirenone on the day when next injection would have been scheduled
  • Intrauterine contraceptive: Start drospirenone on the day of removal
  • Implant: Start drospirenone on the day of removal

Dosage Modifications

Renal or hepatic impairment: Contraindicated

Dosing Considerations

Consider the possibility of ovulation and conception prior to initiation of this product

Premenarche: Not indicated

Safety and efficacy have been established in females of reproductive age

Safety and efficacy are expected to be the same for postpubertal adolescents aged <16 yr and users aged ≥16 yr

Refer to adult dosing

Next:

Interactions

Interaction Checker

and drospirenone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Unscheduled bleeding, cycle 1 (64.4%)

            Unscheduled bleeding, cycle 13 (40.3%)

            1-10%

            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%)

            Previous
            Next:

            Warnings

            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

            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

            Thromboembolic risk

            • Thromboembolism risk with combined oral contraceptives containing drospirenone and ethinyl estradiol higher than those containing some other progestins plus ethinyl estradiol
            • Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism
            • Discontinue if arterial or venous thromboembolic events occur; consider discontinuing with prolonged immobilization due to surgery or illness

            Hyperkalemia

            • Drospirenone has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to spironolactone 25 mg
            • Contraindicated in females with conditions that predispose to hyperkalemia (eg, renal impairment, hepatic impairment, adrenal insufficiency, long-term coadministration with strong CYP3A4 inhibitor)

            Drug interaction overview

            • Effects of other drug on hormonal contraception
              • Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease systemic concentrations of hormonal contraceptives and potentially diminish the effectiveness or increase breakthrough bleeding
              • Instruct women to use a nonhormonal backup contraceptive for 28 days after discontinuing the enzyme inducer
              • Strong CYP3A4 inhibitors may result in a moderate increase of drospirenone systemic exposure
            • Effects of drospirenone on other drugs
              • Potential for increased serum potassium concentration if drospirenone coadministered with other drugs that increase potassium levels
            Previous
            Next:

            Pregnancy

            Pregnancy

            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

            Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy

            Human data

            • Epidemiologic studies and meta-analyses have not found increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following maternal use of oral progestins before conception or during early pregnancy

            Lactation

            Negligible amounts of drospirenone are excreted in the breast milk

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

            Human data

            • After daily administration of 4 mg, the average drospirenone concentration in breast milk over 24-hour period is 5.6 ng/mL
            • Based on this concentration, the estimated average infant daily dosages for an exclusively breastfed infant is 840 ng/kg/day (relative infant dose is 1.5%)

            Pregnancy 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.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Spironolactone analogue with antimineralocorticoid and antiandrogenic activity; suppresses luteinizing hormone and ovulation by binding to the progesterone receptor; also alters cervical mucus, causing unfavorable sperm penetration; changes to the endometrial lining may decrease implantation

            Absorption

            Peak plasma time: 2-6 hr

            Peak plasma concentration: 27 ng/mL (single ingestion); 41 ng/mL (steady state [~10 days])

            Distribution

            Vd: 4 L/kg

            Protein bound: 95-97% (albumin)

            Metabolism

            Extensively metabolized

            Nonactive metabolites: Acid form of drospirenone (formed by opening of lactone ring) and 4,5-dihydrodrospirenone (formed by reduction and subsequent sulfation)

            Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4

            Elimination

            Half-life: ~30 hr

            Excretion: Nearly complete after ~10 days; amounts excreted in feces slightly higher compared with urine

            Previous
            Next:

            Administration

            Oral Administration

            Swallow table whole once daily

            Take every day at about the same time of the day so that the interval between 2 tablets is always 24 hr

            Missed dose(s)

            • 1 active tablet missed: Take missed tablet as soon as possible; continue taking 1 tablet/day until pack finished
            • ≥2 active tablets missed: Take the last missed tablet as soon as possible; continue 1 tablet/day until the pack is finished (1 or more missed tablet[s] will remain in the blister pack); instruct patient to use additional nonhormonal contraception (eg, condoms or spermicide) as backup if patient has sex within 7 days after missing tablets
            • ≥1 insert tablets missed: Skip the missed pill days and continue taking 1 tablet/day until pack finished

            Vomiting or diarrhea

            • If vomiting or diarrhea occurs within 3-4 hr after taking tablet, the new tablet (scheduled for the next day) should be taken as soon as possible
            • The new tablet should be taken within 12 hr of the usual time of tablet-taking if possible
            • If >2 tablets missed, the advice concerning missed tablets, including using backup nonhormonal contraception, given above is applicable

            Storage

            Store at 25°C (77°F); excursions permitted from 15-30°C (59-86°F)

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.