ethinylestradiol + drospirenone




Zuellig Pharma
Concise Prescribing Info
Ethinylestradiol 0.02 mg, drospirenone 3 mg
OC. Moderate acne vulgaris in women seeking OC. Symptomatic treatment of premenstrual dysphoric disorder in women.
Dosage/Direction for Use
1 tab daily for 28 days.
May be taken with or without food.
Hypersensitivity. Venous thrombosis (deep venous thrombosis, pulmonary embolism); present or history of arterial thrombosis or CVA; severe or multiple risk factor(s) for arterial thrombosis eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinemia; hereditary or acquired predisposition for venous or arterial thrombosis; pancreatitis associated w/ severe hypertriglyceridemia; severe hepatic disease; severe renal insufficiency or acute renal failure; benign or malignant liver tumours; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding; history of migraine w/ focal neurological symptoms. Pregnancy.
Special Precautions
Circulatory disorders; venous or arterial thrombotic/thromboembolic events or CVA. Tumors. Hypertriglyceridemia, HTN, hereditary angioedema, DM. Endogenous depression, epilepsy, Crohn's disease, ulcerative colitis. GI disturbance. Chloasma; avoid exposure to sun or UV radiation while on COCs. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Lactation.
Adverse Reactions
Emotional lability, headache, nausea, breast pain, metrorrhagia, amenorrhea.
Drug Interactions
Increased clearance of sex hormones w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, bosentan & HIV-medication (eg, ritonavir, nevirapine) & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & St. John's wort-containing products. Increased ciclosporin or decreased lamotrigine plasma & tissue conc.
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Liz film-coated tab
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