cyproterone + ethinylestradiol




Concise Prescribing Info
Cyproterone acetate 2 mg, ethinylestradiol 35 mcg
Contraception in women, control of acne & hirsutism.
Dosage/Direction for Use
1 tab starting on the 1st day of menses for 21 days. Start new pack after 7 tab-free days.
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Impaired liver function or cholestasis, Dubin-Johnson or Rotor syndromes, hepatic adenoma, estrogen-dependent neoplasms eg, breast or endometrial cancer, CV disease including previous or current thromboembolic disorders, arterial disease disorders of lipid metabolism, undiagnosed vag bleeding, history of pruritus or cholestatic jaundice during pregnancy, chorea, herpes gestationis, pemphigoid gestationis, deteriorating otosclerosis, severe or focal migraine. Pregnancy & lactation.
Special Precautions
History of clinical depression, gallbladder disease, sickle-cell disease, condition influenced by fluid retention. Patients w/ varicose veins, risk factor for CV disease eg, DM, smoking, obesity, HTN, family history of CV disease.
Adverse Reactions
Nausea, vomiting, chloasma (melasma), skin or hair changes, headache, water retention, slight wt changes, breast tenderness, changes in libido. Menstrual irregularities eg, spotting, breakthrough bleeding & amenorrhea.
Drug Interactions
May reduce contraceptive efficacy &/or increase breakthrough bleeding w/ hepatic microsomal enzyme inducers (eg, carbamazepine, griseofulvin, oxcarbazepine, phenytoin, phenobarb, primidone, St. John's wort, topiramate & rifampicin). May decrease contraceptive efficacy w/ anti-infective drugs (eg, ampicillin, neomycin, nitrofurantoin, penicillin V, sulfonamides, tetracyclines), analgesics, INH, antimigraine drugs & tranquilizers). May increase risk of cholestatic jaundice w/ troleandomycin. May increase plasma conc w/ CYP3A4 inhibitors eg, clarithromycin, erythromycin, grapefruit juice, itraconazole, ketoconazole, ritonavir. Alcohol may reduce the effectiveness of cyproterone acetate.
MIMS Class
Oral Contraceptives / Acne Treatment Preparations
ATC Classification
G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Althea tab
21's (P489.15/pack)
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