Ethinylestradiol Cyproterone Tablets

Pharmacodynamic properties The pilosebaceous unit, which consists of sebaceous glands and hair follicles, is a skin component that is sensitive to androgens. Acne, seborrheic dermatitis, hirsutism and androgenic alopecia are all clinical manifestations caused by abnormalities in this target organ, possibly due to increased sensitivity or increased serum concentrations of androgens. Both ingredients contained in ethinyl estradiol cyproterone acetate tablets have a beneficial effect on the hyperandrogenic state: cyproterone acetate is a competitive antagonist of androgens at the receptor level, which can inhibit androgen synthesis in target cells and reduce the blood concentration of androgens through anti-gonadotropin effects; its anti-gonadotropin effect is enhanced by ethinyl estradiol, which also upregulates the synthesis of sex hormone binding globulin (SHBG) in plasma.

This product is a compound preparation, which consists of 2 mg of cyproterone acetate and 0.035 mg of ethinyl estradiol.

This product is a light yellow coated tablet, which appears white or off-white after removing the coating.

It is used for oral contraception and can also be used to treat androgen-dependent diseases in women, such as acne, especially the obvious type, and acne with seborrheic, inflammatory or nodular formation (papulopustular acne, nodular cystic acne), androgenic alopecia in women, mild hirsutism, and hyperandrogenism in patients with polycystic ovary syndrome.

Ethinyl estradiol cyproterone acetate tablets should be taken regularly to achieve the therapeutic effect and the required contraceptive protection. The dosage regimen of ethinyl estradiol cyproterone acetate tablets is similar to the common regimen of most combined oral contraceptives. Therefore, the same medication rules must be considered. Irregular use of ethinyl estradiol cyproterone acetate tablets can cause intermenstrual bleeding and may reduce the reliability of treatment and contraception. 1. How to take ethinyl estradiol cyproterone acetate tablets must be taken with a small amount of liquid at approximately the same time every day according to the instructions on the package. 1 tablet per day, for 21 consecutive days. Start the next box of pills after 7 days of stopping the drug, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after the last pill of the cycle is taken, and the bleeding may not end when the next box of pills is started. 2. How to start taking ethinyl estradiol cyproterone acetate tablets Those who have not used hormonal contraceptives in the past (in the past 1 month) should start taking the pills on the first day of the woman's natural menstrual cycle (i.e. the first day of menstrual bleeding). It can also be started on the 2nd to 5th day, but it is recommended to add a barrier contraceptive method during the first 7 days of taking the first treatment cycle. When switching from another oral contraceptive (COC), it is best to start taking cyproterone acetate tablets immediately after taking the last active tablet of the previous COC, but at the latest at the end of the withdrawal period of the previous COC. When switching from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS), you can switch from the minipill to ethinylestradiol cyproterone acetate tablets at any time (implant or IUS should be on the day of removal, injection should be on the day of the next injection) but in all these cases, a barrier method of contraception should be added within the first 7 days of taking the pills. After an abortion in early pregnancy, the pills can be started immediately. In this case, no other contraceptive method is needed.

These adverse reactions have been reported in users of ethinyl estradiol cyproterone acetate tablets, and the connection between them is neither confirmed nor denied: 1. Breast: tenderness, pain, enlargement 2. Central nervous system: headache, migraine, changes in libido, depression/changes in mood 3. Gastrointestinal tract: nausea, vomiting 4. Skin: various skin diseases (such as rash, erythema nodosum, erythema multiforme) 5. Urogenital system: vaginal discharge 6. Changes in eyes: intolerance to contact lenses 7. Others: fluid retention; weight changes; allergic reactions; abnormal liver function; increased serum triglycerides.

1. Combination preparations containing estrogen and progesterone cannot be used in any of the following situations. If any of the following situations occur for the first time during the use of these preparations, the drug must be discontinued immediately. 2. Thrombosis (venous or arterial) or history of thrombosis (such as deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident; 3. Presence or past prodromal symptoms of thrombosis, such as transient ischemic attack, angina pectoris; 4. Severe or multiple risk factors for venous or arterial thrombosis; 5. History of vascular involvement of diabetes and pancreatitis associated with hypertriglyceridemia; 6. Migraine with focal neurological symptoms; 7. Presence or past severe liver disease, as long as liver function values have not returned to normal; Presence or past history of liver tumors; 8. Undiagnosed vaginal bleeding; 9. Known or suspected pregnancy, breastfeeding; 10. Ethinyl estradiol cyproterone acetate tablets cannot be used in men.

Precautions for children: Ethinyl estradiol cyproterone acetate tablets cannot be used in children. Precautions for pregnancy and lactation: Ethinyl estradiol cyproterone acetate tablets are contraindicated during pregnancy. If pregnancy occurs while taking Ethinyl estradiol cyproterone acetate tablets, the drug should be discontinued immediately. Ethinyl estradiol cyproterone acetate tablets are also contraindicated during lactation. Cyproterone acetate can enter the breast milk of lactating women. About 0.2% of the maternal dose can reach the newborn through breast milk, which is equivalent to a dose of about 1g/kg. During lactation, 0.02% of the mother's daily ethinyl estradiol dose is transferred to the newborn through breast milk. Precautions for the elderly: Ethinyl estradiol cyproterone acetate tablets cannot be used in children.

1. Estrogen-progestogen combination drugs such as ethinyl estradiol cyproterone acetate tablets interact with other drugs and may cause breakthrough bleeding and/or contraceptive failure. 2. Liver metabolism: Drugs that induce microsomal enzyme production can cause drug interactions by increasing the clearance of sex hormones, such as hydantoins, barbiturates, primidone, carbamazepine and rifampicin; suspected drugs include oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and products containing St. John. swort. 3. Impact on enterohepatic circulation: Clinical reports suggest that the enterohepatic circulation of estrogen will be reduced after the administration of certain antibiotics, which will reduce the concentration of ethinyl estradiol. (such as penicillin, ampicillin, tetracycline) If women are treated with any of the above drugs, they should temporarily add a barrier contraceptive method or choose other methods of contraception while using ethinyl estradiol cyproterone acetate tablets. When using microsomal enzyme inducing drugs simultaneously with ethinyl estradiol cyproterone acetate tablets, a barrier contraceptive method should be added during medication and within 28 days after stopping medication. Women receiving antibiotics (except rifampicin and griseofulvin) should use a barrier method of contraception for 7 days after discontinuation of the medication. If a barrier method of concomitant contraception is used beyond the time of taking the last tablet of the ethinyl estradiol cyproterone acetate package, the next ethinyl estradiol cyproterone acetate package should be continued without the usual drug-free period. The dosage of this medication may need to be changed while taking any antidiabetic medication. Co-administration of estrogen-progestin drugs such as ethinyl estradiol cyproterone acetate tablets may affect the metabolism of other drugs. Plasma and tissue drug concentrations may also be affected accordingly. (e.g., cyclosporine) Note: The prescribing information of the co-administered medication should be consulted to detect possible drug interactions. Laboratory tests. The use of ethinyl estradiol cyproterone acetate tablets may affect the results of certain laboratory tests, including biochemical indices of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins such as cortisol binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism indices, and coagulation and fibrinolysis indices. Changes usually remain within normal laboratory parameters.

Closed, below 30°C. Store all medicines out of the reach of children.

Cyproterone acetate 2 mg and ethinyl estradiol 0.035 mg

60 months