Ethinyl Estradiol, Drospirenone, and Levomefolate

• Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium
• Ethinyl Estradiol, Drospirenone, and Levomefolate Calcium
• Levomefolate Calcium, Drospirenone, and Ethinyl Estradiol
• Levomefolate, Drospirenone, and Ethinyl Estradiol

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Beyaz: Ethinyl estradiol 0.02 mg, drospirenone 3 mg, and levomefolate calcium 0.451 mg [24 pink tablets] and levomefolate calcium 0.451 mg [4 light orange tablets] (28s)

Rajani: Ethinyl estradiol 0.02 mg, drospirenone 3 mg, and levomefolate calcium 0.451 mg [24 white tablets] and levomefolate calcium 0.451 mg [4 light orange tablets] (28s)

Safyral: Ethinyl estradiol 0.03 mg, drospirenone 3 mg, and levomefolate calcium 0.451 mg [21 orange tablets] and levomefolate calcium 0.451 mg [7 light orange tablets] (28s)

• Contraceptive
• Estrogen and Progestin Combination

Abnormal uterine bleeding

Based on the American College of Obstetricians and Gynecologists, ethinyl estradiol, drospirenone, and levomefolate (among other oral contraceptive combinations) is effective and recommended for the management of abnormal uterine bleeding [ACOG 2013].

Dysmenorrhea

Based on the American College of Obstetricians and Gynecologists, ethinyl estradiol, drospirenone, and levomefolate (among other oral contraceptive combinations) is effective and recommended for the management of dysmenorrhea [ACOG 2010].

Menstrual bleeding (menorrhagia)

Based on the American College of Obstetricians and Gynecologists, ethinyl estradiol, drospirenone, and levomefolate (among other oral contraceptive combinations) is effective and recommended for the management of menstrual bleeding (menorrhagia) [ACOG 2010].

Pain associated with endometriosis

Based on the American College of Obstetricians and Gynecologists, ethinyl estradiol, drospirenone, and levomefolate (among other oral contraceptive combinations) is effective and recommended for the management of pain associated with endometriosis [ACOG 2010].

Polycystic ovary syndrome (PCOS) in women with menstrual irregularities and hirsutism/acne

Based on the Endocrine Society Clinical Practice Guideline for the Diagnosis and Treatment of Polycystic Ovary Syndrome, ethinyl estradiol, drospirenone, and levomefolate (among other oral contraceptive combinations) is effective and recommended for the treatment of menstrual irregularities and hirsutism/acne in women with PCOS [ES [Legro 2013]].

Adrenal insufficiency, breast cancer or other estrogen- or progestin-dependent neoplasms (current or a history of), hepatic tumors (benign or malignant) or hepatic disease, pregnancy, renal impairment, undiagnosed abnormal uterine bleeding.

Use is also contraindicated in women at high risk of arterial or venous thrombotic diseases including: Cerebrovascular disease, coronary artery disease, diabetes mellitus with vascular disease, DVT or PE (current or history of), hypercoagulopathies (inherited or acquired), headaches with focal neurological symptoms, hypertension (uncontrolled), migraine headaches if >35 years, thrombogenic valvular or rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease or atrial fibrillation), women >35 years who smoke.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to ethinyl estradiol, drospirenone, levomefolate, or any component of the formulation; myocardial infarction (current or history of); persist blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic; steroid-dependent jaundice, cholestatic jaundice, or history of jaundice during pregnancy; any ocular lesion arising from ophthalmic vascular disease (such as partial or complete loss of vision or visual field defect); prodromi of a thrombosis (eg, transient ischemic attack, angina pectoris; current or history of); major surgery associated with an increased risk of postoperative thromboembolism; prolonged immobilization; pancreatitis associated with severe hypertriglyceridemia (current or history of); severe dyslipoproteinemia; women with hereditary or acquired predisposition for arterial or venous thrombosis, for example: Factor V Leiden mutation, activated protein C (APC-) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia (eg, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant); coadministration with paritaprevir, ritonavir, ombitasvir (with or without dasabuvir).