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Ethinylestradiol Cyproterone Tablets

Function and Efficacy

Overdose There are no reports of serious adverse effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and mild vaginal bleeding in young girls. There is no antidote and further treatment is symptomatic.

Ingredients

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

Name Description Content CAS NO. Manufacturer
Cyproterone acetateIngredients

Overdose There are no reports of serious adverse effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and mild vaginal bleeding in young girls. There is no antidote and further treatment is symptomatic.

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427-51-0 12
Ethinyl EstradiolIngredients

Overdose There are no reports of serious adverse effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and mild vaginal bleeding in young girls. There is no antidote and further treatment is symptomatic.

More
57-63-6 21

Appearance

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

Indication

Ethinyl estradiol cyproterone acetate tablets can be used for oral contraception. Ethinyl estradiol cyproterone acetate tablets 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 hyperandrogenic manifestations in patients with polycystic ovary syndrome.

Usage and Dosage

Ethinylestradiol Cyproterone acetate tablets must be taken regularly to achieve the therapeutic effect and the desired contraceptive protection. The dosage regimen of Ethinylestradiol Cyproterone acetate tablets is similar to the usual regimen of most combined oral contraceptives. Therefore, the same dosing rules must be considered. Irregular use of Ethinylestradiol Cyproterone acetate tablets can lead to intermenstrual bleeding and may reduce the reliability of treatment and contraception. How to take Ethinylestradiol Cyproterone acetate tablets must be taken with a small amount of liquid at approximately the same time each day according to the instructions on the package. 1 tablet per day for 21 consecutive days. The next pack of pills is started 7 days after the pill is stopped, during which time withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after the last pill of the cycle is taken, and bleeding may not end when the next pack of pills is started.   Women who have not used hormonal contraceptives before (in the past 1 month) should start taking pills on the first day of the woman's natural menstrual cycle (i.e. the first day of menstrual bleeding). It is also possible to start on days 2-5, but it is recommended to add a barrier contraceptive method for the first 7 days of taking pills in the first treatment cycle. Switching from another oral contraceptive (COC) is best done by starting cyproterone acetate combination 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. Switching from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) can be switched from minipills (on the day of removal for implants or IUS, and on the day of the next injection for injections) to ethinyl estradiol cyproterone acetate tablets at any time, but in all these cases, a barrier method of contraception should be added during the first 7 days of medication. Medication can be started immediately after an abortion in early pregnancy. In this case, no other contraceptive method is needed. For breastfeeding women after childbirth or abortion in mid-term pregnancy, see the section [Medication for pregnant and breastfeeding women]. Women should be advised to start medication on days 21-28 after childbirth or abortion in mid-term pregnancy. If started later, women should be advised to add a barrier method during the first 7 days of medication. However, if sexual intercourse has already occurred, pregnancy should be excluded before actually starting to take ethinyl estradiol cyproterone acetate tablets, or the tablets should be taken until the woman's first menstrual period.   Treatment of missed pills   If the user forgets to take a pill within 12 hours, the contraceptive protection will not be reduced. Once remembered, it must be taken immediately, and the next pill should still be taken at the regular time. If the time of forgetting to take a pill exceeds 12 hours, the contraceptive protection may be reduced.   The following two basic principles can be followed in the treatment of missed pills:   1. Stop taking the pill for no more than 7 days   2. It is necessary to take it continuously for 7 days to maintain appropriate suppression of the hypothalamus-pituitary-ovarian axis. Accordingly, the following suggestions can be given in daily use:   ·In the first week, users should take the last missed pill as soon as they remember, even if it means taking two pills at the same time, and then continue to take the pill at the regular time. In addition, a barrier contraceptive method such as a condom should be used in the next 7 days. If sexual intercourse has occurred within the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer to the regular pill-free period, the higher the risk of pregnancy.   · Week 2 The user should take the last missed pill as soon as she remembers, even if this means taking two pills at the same time, and then continue to take the pills at the regular time. If the user has taken the pills correctly in the 7 days before the first missed pill, no additional contraceptive method is needed. However, if this is not the case, or if more than one pill is missed, the woman should be advised to use another contraceptive method for 7 days.   · Week 3 The risk of reduced reliability is high because it is close to the 7-day pill-free period. However, a reduction in contraceptive protection can still be prevented by adjusting the time of taking the pills.   If the woman has taken the pills correctly in the 7 days before the first missed pill, the user does not need to take additional contraceptive measures if she follows either of the following two suggestions. If this is not the case, the woman is advised to follow the first of these two suggestions and take additional precautions for the next 7 days.   1. The user must take the last missed pill as soon as she remembers, even if this means taking two pills at the same time, and then continue to take the pills at the regular time. Start taking the next box of pills immediately after this box of pills is finished, that is, there is no pill-free period between the two boxes of pills. Users are unlikely to have withdrawal bleeding before the second box of pills is finished, but spotting or breakthrough bleeding may occur during the pill-free period. 2. Women can also be advised not to continue taking the current cycle of pills. Stop taking the pills for 7 days, including the days missed, and then start taking the next cycle of pills. If a woman misses a pill and no withdrawal bleeding occurs during the first normal pill-free period, the possibility of pregnancy should be considered. Advice on vomiting If severe gastrointestinal discomfort occurs, absorption may be incomplete, so other contraceptive methods need to be used at the same time. If vomiting occurs within 3-4 hours after taking the pills, you can use the advice of "handling missed pills". If you do not want to change the normal pill-taking time, you must take the pills from another box of pills. How to change the menstrual period or postpone the menstrual period To postpone the menstrual period, women can continue to take the next box of ethinyl estradiol cyproterone acetate tablets after taking one box of pills without a pill-free period. If desired, you can continue to take it until the end of the second box of pills. Breakthrough bleeding or spotting may occur with prolonged medication. Regular use of Ethinylestradiol Cyproterone acetate can be resumed after the usual 7-day pill-free period. To change the current menstrual period to another day of the week, she can be advised to shorten the pill-free interval to her desired time. The shorter the interval, the greater the risk of not having a withdrawal bleed and having breakthrough bleeding and spotting (as described for delayed menstruation) during the next pill pack. Length of use As a contraceptive, Ethinylestradiol Cyproterone acetate can be used as long as contraception is required and there are no contraindications. For therapeutic purposes, the duration of use depends on the severity of the clinical lesions, and treatment is usually required for several months. It is generally recommended to continue taking Ethinylestradiol Cyproterone acetate for at least 3-4 cycles after symptoms have subsided. If there is a recurrence after stopping medication for several weeks or months, Ethinylestradiol Cyproterone acetate treatment can be resumed. Or as directed by your doctor.

Adverse Reactions

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.

Precautions

Combination preparations containing estrogen and progestin should not 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. ;*Presence or previous history of venous or arterial thrombotic/thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident;*Presence or previous prodromal symptoms of thrombosis (such as transient ischemic attack, angina pectoris);*History of migraine with focal neurological symptoms;*Diabetes mellitus involving blood vessels;*Presence of severe or multiple risk factors for venous or arterial thrombosis is also a contraindication (see the [Precautions] section);*Pancreatitis or history of hypertriglyceridemia;*Presence or previous severe liver disease, as long as liver function values have not recovered

Special Population Medication

Precautions for children: Ethinyl Estradiol Cyproterone Tablets should not be used in children. Precautions for pregnancy and lactation: Women who are known or suspected of pregnancy or lactation. Precautions for the elderly: Ethinyl Estradiol Cyproterone Tablets should not be used in children.

Drug Interactions

Drug Interactions Drugs used in combination with estrogen and progestin, such as ethinyl estradiol and cyproterone acetate tablets, can interact with other drugs and cause breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature. Hepatic metabolism: Drugs that induce the production of microsomal enzymes can cause drug interactions by causing increased 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. Effects on enterohepatic circulation: There are clinical reports suggesting that the enterohepatic circulation of estrogens will be reduced after the administration of certain antibiotics, which will reduce the concentration of ethinyl estradiol. (such as penicillin, ampicillin, tetracycline) Women who are treated with any of the above drugs should temporarily add a barrier contraceptive method or choose another method 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 add a barrier contraceptive method until 7 days after stopping medication. If a barrier contraceptive is used in combination If the time exceeds the time of taking the last tablet of the ethinyl estradiol cyproterone acetate package, the next box of ethinyl estradiol cyproterone acetate tablets should be taken without the usual drug-free period. The dosage of this drug needs to be changed when taking any antidiabetic drug. Drugs used in combination with estrogen and progesterone such as ethinyl estradiol cyproterone acetate tablets may affect the metabolism of other drugs. Plasma and tissue drug concentrations will also be affected accordingly. (e.g. cyclosporine) Note: To detect possible drug interactions, the prescribing information of the combined drug should be consulted. 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 the normal range of laboratory parameters.

Storage

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

Packaging Specification

Cyproterone acetate 2 mg and ethinyl estradiol 0.035 mg

Validity Period

60 months

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