GMP Certified / Cyproterone Acetate and Ethinylestradiol Tablets

• Customization: Available
• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Model NO.: Tablet
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 2mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Cyproterone Acetate And Ethinylestradiol Tablets
Strength	2mg
Packing	21 tablets /box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Cyproterone Acetate And Ethinylestradiol Tablets

Character:
This product is light yellow sugar-coated tablets, white or quasi-white after removing the coating.

Indications:
Ethinestradiol cyproterone tablets can be used for oral contraception.
Ethoestrel cyproterone tablets are also used for the treatment of androgen-dependent diseases in women, such as acne, especially the obvious type, and acne with seborrhea or inflammation or nodular formation (papular pustule acne, nodular cyst acne), androgenic alopecia in women, mild hirsutism, and hyperandrogenic symptoms in patients with polycystic ovary syndrome.

Drug interactions:
Drug interaction
The interaction of other drugs (enzyme inducers, certain antibiotics) with eprogesterone combined drugs such as acetylenestradiol cyproterone tablets can cause breakthrough bleeding and/or contraceptive failure. Women taking any of these medications should temporarily add barrier contraception or choose another method of contraception along with ethinestradiol cyproterone tablets. When microsomal enzyme induced drugs are used with ethinylestradiol cyproterone tablets, barrier contraception should be added during medication and within 28 days after discontinuation.
Women who are also receiving antibiotics (other than rifampin griseofulvin) should use a barrier method of contraception until 7 days after discontinuation. If the combination of the barrier method is longer than the last pill in the package of ethinestradiol cyproterone tablets, the next pill should be continued without the usual withdrawal period.
Substances that impair the effect of ethinestradiol cyproterone tablets (enzyme inducers and antibiotics)
Enzyme induction (increased liver metabolism) : Drugs that induce microsomal enzyme production can interact by causing increased clearance of sex hormones. (such as phenytoin, barbiturate, primidone, carbamazepine and rifampicin; Suspected drugs include oxcarbazepine, topiramate, phiramate, griseofulvin and products containing St. John's wort.)
In addition, HIV proteases (e.g. Ritonavir), non-nucleoside reverse transcriptase inhibitors (e.g. Nevirapine), and their combination have been reported to have potential effects on liver metabolism.
Antibiotics (affecting hepatoenteric circulation) : There are clinical reports suggesting that the hepatoenteric circulation of estrogen will be reduced after the administration of certain antibiotics, which will reduce the concentration of ethoestradiol. Effects of COCs on other drugs (e.g., penicillin, ampicillin, tetracycline) Estrogen/progesterone combinations, such as ethinylestradiol cyproterone tablets, can affect the metabolism of certain drugs. Correspondingly, its plasma and tissue concentrations may increase (as in cyclosporine) or decrease (as in lamotrigine).
Note: In order to detect possible drug interactions, reference should be made to the prescription information of the combination drug.
Other interaction
Laboratory examination
The use of ethoestradiol cyproterone tablets may affect the results of certain laboratory tests, including biochemical markers of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins such as cortisol nodular proteins and lipid/lipoprotein components, carbohydrate metabolism markers, and coagulation and fibrinolysis markers. Changes are usually kept within the normal range of laboratory indicators.

Pharmacology and toxicology:
Pharmacodynamic characteristics
The follicular sebaceous unit, which consists of sebaceous glands and hair follicles, is a component of the skin that is sensitive to androgens. Acne, seborrheic dermatitis, female hirsutism, and androgenic alopecia are all clinical manifestations of abnormalities in this target organ, possibly due to increased sensitivity or elevated serum levels of androgens. Both of the components contained in estradiol cyproterone tablets have beneficial effects on hyperandrogenic states: cyproterone acetate is a competitive antagonist of male excitolines at the receptor level, which can have an inhibitory effect on androgen synthesis in target cells, and can reduce the blood concentration of androgens through anti-gonadotropin effects. Its antigonadotropin effect is enhanced by ethinylestradiol, which also upregulates the synthesis of sex hormone-binding globulin (SHBG) in plasma. As a result, there are fewer free, bioavailable androgens in circulation.
A large, 3-group cohort study of premaintenance demonstrated the use of low-dose estrogens (ethoestradiol < 0.05mg) The incidence of a diagnosis of VTE in women with COCs ranges from 8 to 10/10000 women-years. Recent data show that the incidence of VTE diagnosis in non-pregnant women who do not use COCs is about 4.4/10000 woman years, and in pregnant women or postpartum women the range is 20-30/10000 woman years.
In this way, the existing acne skin hemorrhoids can be cured after 3-4 months of treatment with ethinestradiol cyproterone tablets. Excess oil in hair and skin tends to fade sooner. The hair loss that usually accompanies seborrheic dermatitis also lessens. However, in women with mild hirsutism, especially those with slightly more facial hair, the results of treatment often take months to become apparent.
The contraceptive effect of ethinestradiol cyproterone tablets is based on the interaction of many factors. The most important of these are inhibiting ovulation and altering cervical secretion. In addition to the contraceptive effect, although the combination of estrogen and progesterone has the unfavorable characteristics mentioned in the "Precautions" and "adverse reactions", there are many favorable characteristics: more regular menstrual cycles, reduced menstrual pain, and reduced blood loss. The latter, in turn, can reduce the incidence of iron deficiency.
Preclinical safety data
ethinylestradiol
The toxic characteristics of ethinestradiol are well known. No preclinical information is available to provide the prescriber with additional safety information other than what is already included in other sections of this product description.
Cyproterone acetate
Systemic toxicity
Preclinical data from traditional studies based on repeated dose toxicity do not indicate a particular risk to humans.
Embryonic toxicity/teratogenicity
Embryonic toxicity studies of this combination of active ingredients showed that the use of this drug during the organogenesis period prior to external genital development did not indicate teratogenic effects. The administration of high doses of cyproterone acetate during the differentiation of hormone-sensitive reproductive organs may result in the feminization of male fetuses. No signs of feminization were observed in male newborns who had been exposed to cyproterone acetate in utero. However, pregnancy is a contraindication to the use of ethinestradiol cyproterone tablets.
Reproductive toxicity and carcinogenicity
The accepted first-line reproductive toxicity test with cyproterone acetate showed negative results. However, further experiments showed that cyproterone acetate could form DNA adducts (with enhanced DNA repair activity) in rat and monkey hepatocytes and in fresh isolated human hepatocytes, and DNA adducts were at very low levels in dog hepatocytes.
This DNA adduct forms on whole-body exposure, which is what is expected to happen under the recommended cyproterone acetate dosing regimen. Cyproterone acetate treatment may cause focal, possibly precancerous liver injury in vivo, manifested by alterations in cellular enzymes in female rats and increased mutation rates in transgenic mice carrying the bacterial gene that is the target mutation.
Clinical experience and high-quality epidemiological trials have so far not supported an increased incidence of liver tumors in humans. Studies on swelling and pain of cyproterone acetate in rodents have also not shown a tendency to specific tumor development.
However, it must be remembered that sex steroids promote the growth of certain hormone-dependent tissues and tumors.
Overall, the available findings did not find evidence against the use of ethinestradiol cyproterone tablets in humans if the recommended dosage is followed for the given indication.

Storage:
Sealed, below 30°C. Store all medications properly. Keep out of reach of children.