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DIANE-35 (cyproterone acetate and ethinyl estradiol) is indicated for the treatment of women with severe acne, unresponsive to oral antibiotic and other available treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.
Note: DIANE-35 is NOT indicated for the purposes of contraception.
This suggested checklist can assist you when prescribing DIANE-35 (cyproterone acetate/ethinylestradiol) and its generics. Please see the Canadian Product Monograph (PM) for full prescribing information on indications, warnings and precautions, and adverse events.
|Concomitant use with another hormonal contraceptive|
|History of or actual thrombophlebitis or thromboembolic disorders|
|History of or actual cerebrovascular disorders|
|History of or actual myocardial infarction or coronary arterial disease|
|History of cholestatic jaundice, previous or existing liver tumours or active liver disease|
|Smoker AND age > 35 years|
|Known or suspected carcinoma of the breast or estrogen-dependent neoplasia|
|Pregnancy is suspected or diagnosed|
|Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields|
|Severe diabetes with vascular changes|
|History of migraine with aura|
|Very high blood pressure e.g., systolic > 160 or diastolic > 100 mmHg|
|Very high blood lipids|
The following potential additional risk factors have been discussed with the patient:
Patient has been counselled TO SEEK MEDICAL ATTENTION if the following symptoms occur: