ethinylestradiol + drospirenone




Concise Prescribing Info
Drospirenone 3 mg, ethinylestradiol 0.03 mg
OC. W/ antimineralocorticoid & antiandrogenic effects, for women who experience hormone-related fluid retention & the resulting symptoms, & for women w/ acne & seborrhea.
Dosage/Direction for Use
1 tab daily for 21 consecutive days, followed by a 7-day tab-free interval.
May be taken with or without food: Take at the same time each day. Swallow whole, do not chew/crush.
Venous or arterial thrombotic/thromboembolic events or CVA; prodromi of a thrombosis; migraine w/ focal neurological symptoms; DM w/ vascular involvement; venous or arterial thrombosis; pancreatitis, hypertriglyceridemia; hepatic disease; renal insufficiency or acute renal failure; liver tumors; sex-steroid influenced malignancies; vag bleeding; hypersensitivity. Pregnancy.
Special Precautions
Circulatory disorders, tumors, renal insufficiency, hypertriglyceridemia or a family history thereof, HTN, jaundice &/or pruritus related to cholestasis, gallstone formation, porphyria, SLE, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss, diabetes, Crohn's disease, ulcerative colitis, chloasma.
Adverse Reactions
Nausea, emotional liability, migraine, decreased/increased libido; depressed or altered mood; breast pain, unscheduled uterine bleeding, genital tract bleeding (not further specified).
Drug Interactions
Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, products containing St. John's wort, cyclosporin, lamotrigine, drugs that increase serum K levels (angiotensin-II-receptor antagonists, K-sparing diuretics & aldosterone antagonists). HIV/HCV protease inhibitors non-NRTIs can increase or decrease plasma conc of estrogen or progestin. Drospirenone causes an increase in plasma renin activity & plasma aldosterone induced by its mild antimineralocorticoid activity.
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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