Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Slynd: 4 mg [contains corn starch, fd&c blue #2 aluminum lake]
Pharmacology
Mechanism of Action
Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity that provides contraception primarily by suppressing ovulation.
Pharmacokinetics/Pharmacodynamics
Distribution
Vd: ~4 L/kg
Metabolism
Minor metabolism hepatically via CYP3A4 to inactive metabolites
Excretion
Urine and feces
Time to Peak
2 to 6 hours
Half-Life Elimination
Terminal: ~30 hours
Protein Binding
95% to 97% to serum albumin
Use: Labeled Indications
Contraception: Prevention of pregnancy in females of reproductive potential
Contraindications
Renal impairment; adrenal insufficiency; cervical cancer or progestin-sensitive cancers (presence or history of); liver tumors (benign or malignant); hepatic impairment; undiagnosed abnormal uterine bleeding
Dosage and Administration
Dosing: Adult
Note: Day 1 start: Dose starts on first day of menstrual cycle.
Contraception: Females: Oral: 1 tablet once daily.
Switching from a different contraceptive:
Oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have been taken.
Transdermal patch, vaginal ring, injection: Start on the day the next dose would have been due.
Intrauterine device or implant: Start on the day of removal.
Missed doses:
If 1 hormonal (active) tablet is missed: Take the missed tablet as soon as possible. Continue taking 1 tablet a day until the pack is finished.
If vomiting or diarrhea occurs within 3 to 4 hours after taking 1 hormonal (active) tablet: Take the next scheduled tablet as soon as possible (preferably within 12 hours of the usual scheduled time).
If ≥2 consecutive hormonal (active) tablets are missed: Take the most recently missed tablet as soon as possible. Continue taking 1 tablet a day until the pack is finished (1 or more missed tablets will remain in the pack). Use additional nonhormonal contraception until hormonal (active) tablets have been taken for 7 consecutive days.
Dosing: Pediatric
Contraception: Postmenarche females: Oral: Take 1 tablet daily.
Patients currently not taking hormonal contraceptives: Start on first day of menstrual period.
Patients switching from a different contraceptive method:
Oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have been taken.
Transdermal patch, vaginal ring, injection: Start on the day the next dose would have been due.
Intrauterine device or implant: Start on the day of removal.
Administration
Oral: Swallow tablet whole at the same time each day at intervals not >24 hours.
Storage
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Drug Interactions
Acitretin: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Given the potential for progestin-only preparations to fail to prevent pregnancy during acitretin therapy, such products should not be relied upon. Alternative, nonhormonal forms of contraception must be employed during acitretin therapy. Consider therapy modification
Aliskiren: Drospirenone may enhance the hyperkalemic effect of Aliskiren. Monitor therapy
Angiotensin II Receptor Blockers: May enhance the hyperkalemic effect of Drospirenone. Monitor therapy
Angiotensin-Converting Enzyme Inhibitors: May enhance the hyperkalemic effect of Drospirenone. Monitor therapy
Anticoagulants: Progestins may diminish the therapeutic effect of Anticoagulants. More specifically, the potential prothrombotic effects of some progestins and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of progestins against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Consider therapy modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
Aprepitant: May decrease the serum concentration of Progestins (Contraceptive). Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Consider therapy modification
Artemether: May decrease the serum concentration of Progestins (Contraceptive). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. Consider therapy modification
Atazanavir: May increase the serum concentration of Progestins (Contraceptive). However, atazanavir may lead to decreased ethinyl estradiol concentrations and decreased effectiveness of oral contraceptive products. Management: Consider an alternative or additional method of contraception, particularly with combined estrogen/progestin products. Depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification
Barbiturates: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification
Bexarotene (Systemic): May decrease the serum concentration of Progestins (Contraceptive). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). Consider therapy modification
Bile Acid Sequestrants: May decrease the serum concentration of Progestins (Contraceptive). Management: Administer oral progestin-containing contraceptives at least 1 to 4 hours prior to or 4 to 6 hours after administration of a bile acid sequestrant. Consider therapy modification
Bosentan: May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative (i.e., non-hormonal) means of contraception for all women of childbearing potential who are using bosentan, and do not rely on hormonal contraceptives alone. Consider therapy modification
Brigatinib: May decrease the serum concentration of Progestins (Contraceptive). Management: Females of childbearing potential should use an alternative, non-hormonal contraceptive during brigatinib therapy and for at least 4 months after the final brigatinib dose. Consider therapy modification
C1 inhibitors: Progestins may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy
CarBAMazepine: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification
Carfilzomib: May enhance the thrombogenic effect of Progestins (Contraceptive). Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib. Consider therapy modification
Cenobamate: May decrease the serum concentration of Hormonal Contraceptives. Management: Women should use additional or alternative non-hormonal birth control while taking cenobamate. Consider therapy modification
Cladribine: May diminish the therapeutic effect of Hormonal Contraceptives. Management: Women using systemically acting hormonal contraceptives should add a barrier method during cladribine dosing and for at least 4 weeks after the last dose in each treatment course. Consider therapy modification
CloBAZam: May decrease the serum concentration of Progestins (Contraceptive). Consider therapy modification
Cobicistat: May increase the serum concentration of Progestins (Contraceptive). Management: Consider an alternative, nonhormone-based contraceptive in patients receiving cobicistat-containing products. Drospirenone is specifically contraindicated with atazanavir and cobicistat. Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Drospirenone. Management: Drospirenone use is contraindicated specifically when the strong CYP3A4 inhibitors atazanavir and cobicistat are administered concurrently. Caution should be used when drospirenone is coadministered with other strong CYP3A4 inhibitors. Consider therapy modification
Dabrafenib: May decrease the serum concentration of Progestins (Contraceptive). Management: Females of reproductive potential should use an alternative, highly effective, non-hormonal means of contraception during and at least 2 weeks (dabrafenib alone) or 4 months (dabrafenib + trametinib) after discontinuation of dabrafenib treatment. Consider therapy modification
Darunavir: May decrease the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification
Efavirenz: May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification
Elexacaftor, Tezacaftor, and Ivacaftor: Hormonal Contraceptives may enhance the adverse/toxic effect of Elexacaftor, Tezacaftor, and Ivacaftor. Specifically, the risk for rash may be increased. Monitor therapy
Encorafenib: May decrease the serum concentration of Progestins (Contraceptive). Avoid combination
Eslicarbazepine: May decrease the serum concentration of Progestins (Contraceptive). Management: Alternative, non-hormonal means of birth control should be considered for women of child-bearing potential. Consider therapy modification
Exenatide: May decrease the serum concentration of Progestins (Oral Contraceptive). Management: Administer oral contraceptives at least one hour prior to exenatide. Consider therapy modification
Felbamate: May decrease the serum concentration of Progestins (Contraceptive). Management: Contraceptive failure is possible. Use of an alternative, nonhormonal method of contraception is recommended. Consider therapy modification
Flibanserin: Progestins (Contraceptive) may increase the serum concentration of Flibanserin. Monitor therapy
Fosamprenavir: Progestins (Contraceptive) may decrease serum concentrations of the active metabolite(s) of Fosamprenavir. Fosamprenavir may decrease the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification
Fosaprepitant: May decrease the serum concentration of Progestins (Contraceptive). The active metabolite aprepitant is likely responsible for this effect. Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Consider therapy modification
Fosphenytoin: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification
Griseofulvin: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Avoid combination
Heparin: May enhance the hyperkalemic effect of Drospirenone. Monitor therapy
Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca): May enhance the adverse/toxic effect of Progestins. Monitor therapy
Ivosidenib: May decrease the serum concentration of Progestins (Contraceptive). Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. Consider therapy modification
Ixazomib: May decrease the serum concentration of Progestins (Contraceptive). More specifically, use of ixazomib with dexamethasone may decrease the serum concentrations of contraceptive progestins. Management: Patients of childbearing potential should use a nonhormonal barrier contraceptive during and 90 days following ixazomib treatment. Avoid combination
LamoTRIgine: May decrease the serum concentration of Progestins (Contraceptive). Monitor therapy
Lesinurad: May decrease the serum concentration of Progestins (Contraceptive). Management: Use of an additional, nonhormonal contraceptive is recommended in patients being treated with lesinurad who desire effective contraception. Consider therapy modification
Lixisenatide: May decrease the serum concentration of Progestins (Contraceptive). Management: Administer oral contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. Consider therapy modification
Lopinavir: May decrease the serum concentration of Progestins (Contraceptive). Lopinavir may increase the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate and etonogestrel implants may be used without a need for additional contraception. Consider therapy modification
Lumacaftor and Ivacaftor: May decrease the serum concentration of Hormonal Contraceptives. Management: Do not rely on hormone-based contraceptives with concurrent use of lumacaftor/ivacaftor; an alternative, non-hormonal, method of contraception should be used if this combination is required. Consider therapy modification
Metreleptin: May decrease the serum concentration of Progestins (Contraceptive). Metreleptin may increase the serum concentration of Progestins (Contraceptive). Monitor therapy
MiFEPRIStone: May diminish the therapeutic effect of Progestins (Contraceptive). MiFEPRIStone may increase the serum concentration of Progestins (Contraceptive). Management: Women of childbearing potential should use an effective, nonhormonal means of contraception during and 4 weeks following mifepristone treatment. Consider therapy modification
Mycophenolate: May decrease the serum concentration of Progestins (Contraceptive). Management: Use of an additional or alternative (nonhormonal) method of contraception should be considered. Consider therapy modification
Nelfinavir: May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents: May enhance the hyperkalemic effect of Drospirenone. Monitor therapy
OXcarbazepine: May decrease the serum concentration of Progestins (Contraceptive). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. Consider therapy modification
Perampanel: May decrease the serum concentration of Progestins (Contraceptive). Management: Patients should use an alternative, nonhormonal-based form of contraception both during the concurrent use of perampanel and for 1 month after discontinuing perampanel. Consider therapy modification
Phenytoin: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification
Pitolisant: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with pitolisant and for at least 21 days after discontinuation of pitolisant treatment. Consider therapy modification
Pomalidomide: Progestins may enhance the thrombogenic effect of Pomalidomide. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. Consider therapy modification
Potassium Salts: May enhance the hyperkalemic effect of Drospirenone. Monitor therapy
Potassium-Sparing Diuretics: Drospirenone may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Monitor therapy
Primidone: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification
Retinoic Acid Derivatives: May diminish the therapeutic effect of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease the serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Microdosed progesterone-only preparations (ie, minipills that do not contain estrogen) are considered an inadequate method of contraception. Exceptions: Adapalene; Alitretinoin (Topical); Bexarotene (Topical); Tretinoin (Topical). Consider therapy modification
Rifamycin Derivatives: May decrease the serum concentration of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification
Saquinavir: May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification
Selegiline: Progestins (Contraceptive) may increase the serum concentration of Selegiline. Monitor therapy
St John's Wort: May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Consider using a product other than St John's wort. Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification
Sugammadex: May decrease the serum concentration of Progestins (Contraceptive). Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. Consider therapy modification
Tazemetostat: May decrease the serum concentration of Hormonal Contraceptives. Management: Women of reproductive potential should use a non-hormonal contraceptive method during treatment with tazemetostat and for 6 months after. Men with female partners should use contraception during treatment and for 3 months after. Consider therapy modification
Tetrahydrocannabinol and Cannabidiol: May decrease the serum concentration of Hormonal Contraceptives. Management: Women using hormonal contraceptives should consider adding a barrier contraceptive due to the potential for tetrahydrocannabinol and cannabidiol to decrease concentrations and effectiveness of hormonal contraceptives. Consider therapy modification
Thalidomide: Progestins (Contraceptive) may enhance the thrombogenic effect of Thalidomide. Monitor therapy
Tipranavir: May increase the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification
Topiramate: May decrease the serum concentration of Progestins (Contraceptive). Management: Caution patients that this combination may be associated with reduced contraceptive effectiveness. Consider adding an additional (non-hormonal) contraceptive method. Consider therapy modification
Tranexamic Acid: Progestins (Contraceptive) may enhance the thrombogenic effect of Tranexamic Acid. Avoid combination
Triazolam: Hormonal Contraceptives may increase the serum concentration of Triazolam. Monitor therapy
Ulipristal: Progestins may diminish the therapeutic effect of Ulipristal. Ulipristal may diminish the therapeutic effect of Progestins. Management: Ulipristal for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping ulipristal; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping ulipristal. Avoid combination
Vitamin K Antagonists (eg, warfarin): Progestins (Contraceptive) may diminish the anticoagulant effect of Vitamin K Antagonists. In contrast, enhanced anticoagulant effects have also been noted with some products. Management: When possible, concomitant hormonal contraceptives and coumarin derivatives should be avoided in order to eliminate the risk of thromboembolic disorders. Consider using an alternative, nonhormonal contraceptive. Consider therapy modification
Adverse Reactions
1% to 10%:
Central nervous system: Headache (3%)
Dermatologic: Acne vulgaris (4%)
Endocrine & metabolic: Weight gain (2%), decreased libido (1%), menstrual disease (1%)
Gastrointestinal: Nausea (2%)
Genitourinary: Breakthrough bleeding (64%), abnormal uterine bleeding (3%), dysmenorrhea (2%), mastalgia (2%), vaginal hemorrhage (2%), breast tenderness (1%)
Frequency not defined: Endocrine & metabolic: Decreased plasma estradiol concentration
<1%, postmarketing, and/or case reports: Hyperkalemia
Warnings/Precautions
Concerns related to adverse effects:
- Bone loss: Treatment with drospirenone lowers serum estradiol levels; clinical relevance to bone mineral density is unknown.
- Cervical cancer: Some studies suggest an association between the use of combination hormonal contraceptives and an increased risk of cervical cancer and intraepithelial neoplasia; however, studies are not consistent and may be related to additional risk factors (Gierisch 2013).
- Ectopic pregnancy: Consider the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while taking drospirenone.
- Hyperkalemia: Drospirenone has antimineralocorticoid activity that may lead to hyperkalemia. Use is contraindicated in patients with conditions that predispose to hyperkalemia (eg, renal insufficiency, hepatic dysfunction, adrenal insufficiency); use caution with medications that may increase serum potassium. Monitor potassium if clinically indicated.
- Thromboembolic disorders: Combination hormonal contraceptives containing drospirenone and ethinyl estradiol may be associated with a higher risk of venous thromboembolism than those containing some other progestins in combination with ethinyl estradiol. It is unknown if there is an increased risk with drospirenone alone; discontinue use if an arterial or venous thrombotic event occurs.
- Vaginal bleeding: Unscheduled bleeding (breakthrough or intracyclic) and spotting may occur, especially during the first 3 months of therapy. In addition, occasional missed periods may occur. Presentation of irregular, unresolving vaginal bleeding warrants further evaluation to rule out malignancy or pregnancy.
Disease-related concerns:
- Depression: Use with caution in patients with depression; discontinue if serious depression recurs.
- Diabetes: May decrease insulin sensitivity and increase risk for hyperglycemia in patients with diabetes.
- Hepatic impairment: Discontinue if jaundice develops during therapy or if liver function becomes abnormal; use is contraindicated in patients with liver tumors (benign or malignant) or hepatic impairment.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Surgical patients: Consider discontinuation in cases of prolonged immobilization due to surgery or illness.
Other warnings/precautions:
- Laboratory changes: The use of contraceptive steroids may change the results of some laboratory tests (eg, adrenal, liver, renal, and thyroid function; binding proteins; coagulation factors; glucose tolerance; lipids).
Monitoring Parameters
Pregnancy status (prior to therapy and with missed periods if clinically indicated); signs and symptoms of thromboembolic disorders; signs and symptoms of depression; glycemic control in patients with diabetes.
In patients taking concomitant medications that increase serum potassium, monitor serum potassium prior to therapy and during the first treatment cycle; consider monitoring serum potassium in patients taking concomitant strong CYP3A4 inhibitors and other patients if clinically indicated.
Pregnancy
Pregnancy Considerations
Use is contraindicated in pregnancy. Drospirenone is used to prevent pregnancy; treatment should be discontinued if pregnancy occurs. In general, the use of progestin contraceptives, when inadvertently used early in pregnancy, have not been associated adverse fetal effects.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience menstrual changes. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood), severe headache, depression, or mood changes (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
