ethinylestradiol + drospirenone


Bayer HealthCare Pharma


Concise Prescribing Info
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab taken daily for 21 days, followed by 7 tab-free days.
May be taken with or without food: Take at the same time each day. Swallow whole, do not chew/crush.
Pregnancy. Preceding or existing venous thromboembolic events, DM w/ vascular damage, dyslipoproteinemia, preceding or existing pancreatitis, jaundice or inherited or acquired disposition for venous or arterial thrombosis, severe liver disease, severe kidney insufficiency, benign or malignant liver tumors, suspected or established hormone-dependent malignant diseases of the genital organs & of the breast, vag bleeding of unclear origin, migraine w/ focal neurological symptoms, angina pectoris, stroke.
Special Precautions
Cigarette smoking, diabetes, overwt, HTN; heart valve/rhythm disorder, superficial phlebitis; varicose veins; family history of thrombosis, heart attack or stroke, hypercholesterolemia, hypertriglyceridemia, breast cancer; migraine; epilepsy; increased K blood levels; liver or gallbladder disease; Crohn's disease or ulcerative colitis; SLE; hemolytic uremic syndrome; sickle cell anemia; malignancies from previous use of sex hormones, porphyria, herpes gestationis, Sydenham's chorea; chloasma.
Adverse Reactions
Breast tenderness, enlargement & secretion, headache, depression, migraine, nausea, changes in vag secretion, rarely libido changes, contact lens intolerance, vomiting, skin reactions, pruritus, edema, wt changes.
Drug Interactions
Antiepileptic agents (hydantoin, barbiturates, primidone, carbamazepine), anti-TB drugs (rifampicin, rifabutin), oxcarbazepine, topiramate, felbamate, ritonavir, antibiotics (penicillin, griseofulvin, tetracyclines), St. John's wort, ketoconazole, erythromycin, cyclosporin. ACE inhibitors, AIIA & indomethacin may increase K blood levels.
MIMS Class
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
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