B-Lady

Cyproterone acetate 2 mg, ethinylestradiol 0.035 mg

Contraception in women w/ androgen-dependent symptoms eg, acne, androgenetic baldness. Acne.

1 tab daily for 21 days starting on 1st day of menstruation, then 7 tab-free days.

May be taken with or without food.

Hypersensitivity. Current or history of breast cancer or other estrogen-dependent or progestin-dependent neoplasm. History of cholestatic jaundice; otosclerosis w/ deterioration during pregnancy. Undiagnosed abnormal vag bleeding. Ocular lesions arising from ophth vascular disease. Women at high risk of arterial or venous thrombotic disease including cerebrovascular disease, CAD, MI, DM w/ vascular disease. Hepatic tumors or liver disease. Pregnancy.

Discontinue if arterial or venous thrombotic event occurs; diabetes, HTN & obesity develops; if symptoms of angioedema exacerbates. Feeling of discomfort, headaches, nausea, or other GI upsets, breast tenderness, spotting or breakthrough bleeding. Malignant liver tumors leading to isolated cases of life-threatening intra-abdominal hemorrhage. Increased risk of thromboembolism; CV side effects in women who smoke (≥15 cigarettes per day) & >35 yr. Changes in lab tests eg, coagulation factors, lipids, glucose tolerance, binding proteins. Women w/ diabetes; cardiac disease, depression, asthma, epilepsy, or history of migraine; hereditary angioedema. Conduct physical exam at 6-mth intervals during long term treatment. Include liver tumors in differential diagnostic considerations if severe upper-abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur. Not to be used concomitantly w/ progesterone &/or estrogen. Hepatic or renal impairment. Discontinue treatment if pregnancy occurs. Not recommended in lactation.

Varicosities, edema, arterial thromboembolism, cerebral hemorrhage & thrombosis, HTN, mesenteric thrombosis, MI, Raynaud's phenomenon; headache, nervousness, depression, dizziness, migraine, pre-menstrual syndrome, stroke; chloasma, acne, angioedema, erythema multiforme & nodosum, hirsutism, loss of scalp hair, melasma, rash; dysmenorrhea, breast tenderness & changes, libido & menstrual flow changes, amenorrhea, breakthrough bleeding, carbohydrate intolerance, decreased lactation, spotting, temporary infertility, increased thyroid-binding globulin & triglycerides; nausea, abdominal bloating/cramps, appetite changes, cholestasis, colitis, gallbladder disease, pancreatitis, vomiting, wt gain/loss; cervical erosion & secretion change, cystitis-like syndrome, endocervical hyperplasia, enlarged uterine fibroid, vag candidiasis, vaginitis; increased factors VII, VIII, IX, & X, & prothrombin, decreased folate levels, hemolytic uremic syndrome, porphyria; increased alkaline phosphatase, AST & γ-glutamyl transferase, benign liver tumors, Budd-Chiari syndrome, cholestatic jaundice, hepatic adenomas, jaundice; chorea, RA & synovitis exacerbation; cataracts, change in corneal curvature, contact lens intolerance, optic neuritis, retinal thrombosis; auditory disturbances; impaired renal function; pulmonary thromboembolism, rhinitis; hemorrhagic eruption, SLE.

Concomitant use w/ anastrozole, conivaptan, pimozide, pirfenidone. Increased effects of aripiprazole, benzodiazepines, corticosteroids, CYP1A2 substrates, HMG-CoA reductase inhibitors, lomitapide, pimozide, pirfenidone, ropinirole, selegiline, theophylline derivatives, tipranavir, tizanidine, tranexamic acid, voriconazole. Increased level w/ ascorbic acid, conivaptan, strong & moderate CYP3A4 inhibitors, ivacaftor, mifepristone, NSAID (COX-2 inhibitor), voriconazole. Decreased effects of anastrozole, chenodiol, CYP1A2 & CYP2E1 substrates, hyaluronidase, lamotrigine, thyroid products, ursodiol, vit K antagonists. Decreased level w/ aminoglutethimide, aprepitant, armodafinil, artemether, barbiturates, bexarotene, bile acid sequestrants, boceprevir, bosentan, carbamazepine, clobazam, cobicistat, colesevelam, strong CYP3A4 inducers, deferasirox, elvitegravir, exenatide, felbamate, fosaprepitant, fosphenytoin, griseofulvin, mifepristone, modafinil, mycophenolate, nafcillin, nevirapine, oxcarbazepine, phenytoin, PIs, prucalopride, retinoic acid & rifamycin derivatives, rufinamide, St. John's wort, telaprevir, tipranavir, tocilizumab, topiramate.

Oral Contraceptives / Acne Treatment Preparations

G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.

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