Cybelle

Cybelle

cyproterone + ethinylestradiol

Manufacturer:

Laboratorios Leon Farma

Distributor:

Embil
Concise Prescribing Info
Contents
Cyproterone acetate 2 mg, ethinylestradiol 35 mcg
Indications/Uses
Treatment of women w/ severe acne which has not improved after long-term use of oral antibiotics; excessive hair growth on the face & body (moderately severe hirsutism). OC.
Dosage/Direction for Use
1 tab daily starting on the 1st day of menstrual cycle for 21 days, followed by a 7 tab-free days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ or history of DVT, pulmonary embolism; heart attack, stroke; cancer of the breast or genital organs; benign or malignant liver tumor. History of angina pectoris, transient ischemic attack or small reversible stroke; migraine accompanied by visual symptoms, speech disability, weakness or numbness in any body part. DM w/ blood vessel damage; pancreatitis; jaundice or severe liver disease; unexplained vag bleeding. Men. Pregnancy & lactation.
Special Precautions
Smoking; diabetes; overwt; high BP; valve or heart rhythm disorder; superficial phlebitis; varicose veins; family history of thrombosis, heart attack or stroke, breast cancer & high levels of cholesterol or triglycerides; migraine; epilepsy; liver or gallbladder disease; Crohn's disease, ulcerative colitis; polycystic ovary syndrome; SLE; hemolytic uremic syndrome; sickle cell disease; hearing loss, porphyria, herpes gestationis, Sydenham's chorea; chloasma; hereditary angioedema.
Adverse Reactions
Nausea, abdominal pain; increased body wt; headache, depressive & altered mood; breast tenderness & pain.
Drug Interactions
Primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate; rifampicin, rifabutin; nelfinavir, nevirapine, efavirenz; ampicillin, tetracyclines; griseofulvin; St. John's wort; cyclosporine, lamotrigine.
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
Cybelle FC tab
Packing/Price
21's (P495.57/pack)
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