cyproterone + ethinylestradiol




Zuellig Pharma
Concise Prescribing Info
Cyproterone acetate 2 mg, ethinylestradiol 0.035 mg
Hormonal contraceptive. Moderate to severe acne related to androgen-sensitivity (w/ or w/o seborrhoea) &/or hirsutism in women of reproductive age including patients w/ polycystic ovary syndrome. Acne after topical therapy or systemic antibiotic treatments have failed.
Dosage/Direction for Use
1 tab daily on 1st day of menstrual cycle for 21 consecutive days followed by 7 tab-free days.
May be taken with or without food.
Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events or CVA; prodromi of thrombosis eg, transient ischaemic attack, angina pectoris; high risk of venous or arterial thrombosis; history of migraine w/ focal neurological symptoms; DM w/ vascular involvement; benign or malignant liver tumors. Known or suspected sex-steroid influenced malignancies; undiagnosed vag bleeding. Concomitant use w/ another hormonal contraceptive; ombistavir/paritaprevir/ritonavir & dasabuvir-containing medicinal products. Severe hepatic disease. Pregnancy & lactation. Not to be used in men.
Special Precautions
Discontinue use if increased frequency or severity of migraine occurs. Not for protection against HIV infections & other STD. Increased risk of arterial & venous thrombotic & thromboembolic diseases; +ve family history of venous or arterial thromboembolism, smoking, age, obesity, prolonged immobilization, major surgery or trauma, any leg surgery, dyslipoproteinemia, HTN, migraine, valvular heart disease, atrial fibrillation; DM, SLE, hemolytic uremic syndrome, Crohn’s disease or ulcerative colitis, sickle cell disease; benign or malignant liver tumors. Hypertriglyceridaemia; pancreatitis; gallstone formation; porphyria; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; pancreatitis; hereditary angioedema exogenous estrogens; history of chloasma gravidum; GI disturbances. Irregular bleeding (eg, spotting or breakthrough bleeding) during 1st mth of use. Avoid sun or ultraviolet radiation exposure. Concomitant use w/ HCV combination drugs. Benign or malignant liver tumors; jaundice &/or pruritus related to cholestasis. Renal impairment. Not indicated during pregnancy & lactation. Not for post-menopausal patients.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed & altered mood; breast pain & tenderness.
Drug Interactions
Increased clearance w/ drugs inducing microsomal enzymes. Diminished efficacy by phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort. Increased or decreased plasma conc w/ HIV/HCV PIs & NNRTIs. Increased plasma & tissue conc of cyclosporin. Decreased plasma & tissue conc of lamotrigine. Increased risk of ALT elevations w/ ombistavir/paritaprevir/ritonavir & dasabuvir-containing medicinal products.
MIMS Class
Oral Contraceptives / Acne Treatment Preparations
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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