Faye

Faye

cyproterone + ethinylestradiol

Manufacturer:

Unicure

Distributor:

AAA Pharma

Marketer:

Evexia
Concise Prescribing Info
Contents
Ethinylestradiol 0.035 mg, cyproterone acetate 2 mg
Indications/Uses
Androgen-dependent diseases eg, acne, especially pronounced forms & accompanied by seborrhea or inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenetic alopecia & mild forms of hirsutism.
Dosage/Direction for Use
1 tab once daily starting on the 1st day of menstrual period for 21 days. Start new pack after 7-day tab-free interval.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events or CVA, prodomi of thrombosis; severe or multiple risk factors for venous or arterial thrombosis; history of migraine w/ focal neurological symptoms; DM w/ vascular involvement; pancreatitis or history associated w/ severe hypertriglyceridemia; presence or history of liver tumors (benign/malignant); known/suspected sex-steroid influenced malignancies; undiagnosed vag bleeding. Not for use in men. Severe hepatic disease. Known or suspected pregnancy. Lactation.
Special Precautions
Increased risk of arterial & venous thrombotic & thromboembolic diseases (eg, MI, DVT, pulmonary embolism & CVA), patients w/ CVA, HTN, hypertriglyceridemia; smoking patients; increased frequency/severity of migraine, changes in glucose tolerance or effect on peripheral insulin resistance; liver tumours (benign & malignant); chloasma. Periodic medical assessment for contraindications (eg, transient ischaemic attack) or risk factors (eg, family history of venous or arterial thrombosis), irregular bleeding may occur. Acute/chronic liver function disturbances. Not indicated during pregnancy & lactation.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed/altered mood; breast pain, breast tenderness.
Drug Interactions
Decreased effect w/ drugs that induce microsomal enzymes (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort), HIV protease (eg, ritonavir) & NNRTIs (eg, nevirapine), increased plasma & tissue conc w/ cyclosporine, decreased plasma & tissue conc w/ lamotrigine. Ethinylestradiol: Decreased conc w/ antibiotics.
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.
Presentation/Packing
Form
Faye FC tab
Packing/Price
21's
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