Lydia Clair

Lydia Clair

cyproterone + ethinylestradiol




Concise Prescribing Info
Cyproterone acetate 2 mg, ethinyl estradiol 0.035 mg
Women w/ severe acne unresponsive to oral antibiotic & other available treatments, w/ associated symptoms of androgenization, including seborrhea & mild hirsutism.
Dosage/Direction for Use
1st treatment course: Take 1 tab daily for 21 consecutive days starting on the 1st day of menstrual cycle, followed by a 7-day tab-free interval. Subsequent courses: Start after a 7-day tab-free interval (following the same 21 days on, 7 days off). Continue treatment for at least another 3-4 cycles after signs have subsided.
May be taken with or without food.
Thrombophlebitis, thromboembolic disorders, or history of these conditions; cerebrovascular disorders; MI or CAD; active liver disease or hepatic adenomas or carcinomas; history of cholestatic jaundice; known or suspected breast carcinoma & estrogen dependent neoplasia; undiagnosed abnormal vag bleeding; any ocular lesion arising from ophth vascular disease eg, partial or complete loss of vision or defect in visual fields; when pregnancy is suspected or diagnosed; previous or existing liver tumors; severe diabetes w/ vascular changes; history of otosclerosis w/ deterioration during pregnancy.
Special Precautions
Do not use solely as contraceptive (consider supplementary non-hormonal contraceptive method). Estrogen &/or progestogen should not be taken during treatment. Predisposing factors for CAD eg, cigarette smoking, HTN, hypercholesterolemia, obesity, diabetes & increasing age. Women >35 yr. Regularly determine lipid profiles in women w/ pre-existent hyperlipoproteinemia. Discontinue at the earliest manifestation of thromboembolic & CV disorders (eg, thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric & retinal thrombosis); partial or complete visual defects; papilledema or ophth vascular lesions; severe headache or worsening pre-existing migraine headache; onset of jaundice or hepatitis; itching of the whole body. Avoid in conditions predisposing to venous stasis & vascular thrombosis eg, immobilization after accidents or confinement to bed during long-term illness. Obtain thorough history & physical exam prior to use. Monitor patients w/ essential HTN. DM; metabolic & endocrine diseases & when metabolism of Ca & phosphorous is abnormal; ocular & connective tissue disease. Women w/ immediate family history of breast cancer. Fibrocystic disease of the breast. Persistent irregular vag bleeding requires special diagnostic judgement to exclude possibility of pregnancy or neoplasm. Patients w/ fibroids. Increased risk of circulatory & metabolic complications in the later reproductive yr of women. History of emotional disturbances. Interpret results of laboratory tests eg, liver function, coagulation & thyroid function tests, lipoproteins, gonadotropins. After discontinuation, patient should delay pregnancy until at least 1 normal menstrual cycle has occurred. Amenorrhea. Thromboembolic complications-post-surgery. Hepatic impairment. Lactation.
Adverse Reactions
Thrombophlebitis; arterial thromboembolism; pulmonary embolism; mesenteric thrombosis; neuro-ocular lesions eg, retinal thrombosis & optic neuritis; MI; cerebral thrombosis; cerebral hemorrhage; HTN; liver tumors; gall bladder disease & congenital anomalies. Nausea & vomiting. Dysmenorrhea. DVT, venous thrombosis w/ pulmonary embolism, arterial emboli involving the extremities & spleen, cerebral ischemic vascular accident; cerebral venous, sinus & retinal vein thrombosis; hypertensive crisis, migraine, pancreatitis, focal nodular hyperplasia of the liver, sub capsular liver hematoma, liver adenoma; hepatocellular & primary bile duct carcinoma; hepatitis, liver dystrophy, cholangitis, pseudomembranous colitis, cholestasis, abdominal pain, epileptic seizures, cerebral tumor symptoms, acute brachiofacial paresis, acute hydrocephalus, manic syndrome, hyperpathia, anaphylactoid reactions, ascites, DM, acute leukemia & breast cancer.
Drug Interactions
Reduced efficacy & increased incidence of breakthrough bleeding w/ ampicillins, analgesics, antihistamines, antimigraine prep, chloramphenicol, griseofulvin, INH, neomycin, nitrofurantoin, penicillin V, phenyl butazone, sulfonamides & tetracyclines. May reduce anticoagulant effect; alter the effects of antihypertensive, benzodiazepines (those that undergo oxidative degradation), β-adrenergic blockers, caffeine, corticosteroids, hypoglycemics, phenothiazines, theophyllines, TCAs & vit. Reduced efficacy w/ carbamazepine, phenobarb, phenytoin, primidone & rifampicin. Antidiabetics. Significant increase in plasma ethinyl estradiol levels w/ vit C.
ATC Classification
G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.
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