Chloe - instructions for use, reviews, analogues and forms of release (tablets) of a medicinal product for contraception. Indications, contraindications and pregnancy

In this article, you can read the instructions for using the drug Chloe. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Chloe in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Chloe in the presence of existing structural analogs. Use for contraception in adult women. Indications, contraindications and presence of pregnancy and lactation.

Chloe - combined low-dose monophasic oral contraceptive with anti-androgenic activity.The mechanism of action is due to the anti-androgenic preparation of the steroid structure, cyproterone acetate and oral estrogen, ethinyl estradiol, which enter into its composition.

Cyproterone acetate

Has the ability to competitively bind to receptors of natural androgens (including testosterone, dihydroepiandrosterone, androstenedione), formed in small amounts in the body of women, mainly in the adrenal glands, ovaries and skin. By blocking the androgen receptors in target organs, it reduces the phenomenon of androgenization in women (due to disruption of the processes mediated by hormone-receptor complexes at the level of the main intracellular mechanisms). Thus, it becomes possible to treat diseases caused by increased formation of androgens or specific sensitivity to these hormones.

Against the background of taking the drug, the increased activity of the sebaceous glands is reduced, which plays an important role in the appearance of acne and seborrhea. After 3-4 months of therapy, the existing rash usually disappears. Excessive fatness of hair and skin disappears even earlier. Also decreases hair loss, often accompanying seborrhea.

Chloe therapy in women of reproductive age reduces clinical manifestations of mild forms of hirsutism; However, the effect of treatment should be expected only after several months of use.

Along with anti-androgenic properties, cyproterone acetate has gestagenic activity that mimics the properties of the hormone of the yellow body. Oppressing pituitary gland secretion of gonadotropic hormones and inhibits ovulation, which causes a contraceptive effect.

Ethinylestradiol

Strengthens the central and peripheral effects of cyproterone acetate on ovulation, retains a high viscosity of the cervical mucus, making it difficult to penetrate the spermatozoon into the uterine cavity and contributing to a reliable contraceptive effect.

Against the background of taking the drug, the cycle becomes more regular, less painful menstruation, less intensity of bleeding, less risk of iron deficiency anemia.

Pharmacokinetics

Cyproterone acetate

After taking the drug inside the cyproterone, the acetate is completely absorbed from the digestive tract. It is excreted primarily in the form of metabolites by the kidneys and through the intestine in a ratio of 1: 2, a small part - unchanged through the intestine.Breast milk releases up to 0.2% of the dose of cyproterone acetate.

Ethinylestradiol

After taking the drug, ethinyl estradiol is quickly and completely absorbed from the digestive tract. Ethinyl estradiol is excreted from the body in the form of metabolites: about 40% - by the kidneys, 60% - through the intestine. With breast milk, up to 0.02% of the dose of ethinyl estradiol is released.

Indications

• contraception in women with androgenation phenomena.

Androgen-dependent diseases in women:

• acne (especially their pronounced forms, accompanied by seborrhea, inflammatory phenomena with the formation of nodes / papular-pustular acne, nodular-cystic acne /);
• androgenic alopecia;
• light forms of hirsutism.

Forms of release

Tablets, film-coated 35 μg + 2 mg.

Instructions for use and how to use them

The drug should be taken orally 1 tablet per day. The tablet is taken without chewing, and washed down with a small amount of liquid. It is recommended to take the drug at the same time, preferably after breakfast or dinner.

Reception Chloe begin on the 1st day of the cycle, using a tablet of the corresponding day of the week from the calendar package.Daily administration of the drug is carried out using tablets from the calendar pack in sequence along the direction of the foil-applied arrow until all the tablets are taken. After the end of taking all yellow-orange tablets from the calendar package, it is necessary to take the remaining white tablets in the next 7 days.

During the last 7 days of the treatment cycle (28 days), menstrual bleeding (due to withdrawal of treatment) should occur. Menstruation usually begins 2-3 days after the 21st day of the drug treatment cycle.

The next package should be started on the next day after the completely finished taking of the tablets from the previous package, regardless of the fact of the continuation / cessation of bleeding.

When switching from combined oral contraceptives, Chloe should be started the day after the last tablet with the active ingredients of the previous preparation, but in no case later than the next day after an ordinary 7-day break (for preparations containing 21 tablets). Then follow the scheme described above.

If the patient took the previous contraceptive daily for 28 days, use Chloe should be started after taking the last inactive tablet.

When switching from contraceptives containing only gestagens ("mini-drank"), Chloe can be used without interruption.

When using injectable forms of contraceptives, Chloe should be used from the day the next injection is to be taken.

When switching from an implant, Chloe should be applied already on the day of its removal.

In all cases it is necessary to use an additional barrier method of contraception during the first 7 days of application of the drug.

After an abortion in the first trimester of pregnancy, a woman can begin using Chloe immediately. In this case, there is no need for additional methods of contraception.

After childbirth or abortion in the 2nd trimester of pregnancy, the drug should be started on the 21-28th day. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of application of the drug.

If a woman has lived sexually during the period between childbirth or abortion and the beginning of the drug,Pregnancy should first be excluded or it is necessary to wait for the first menstruation.

The missed tablet should be taken as soon as possible, the next tablet - at the usual time. At a delay of <12 h, the reliability of contraception does not decrease. If the delay in taking the tablet is> 12 hours, the reliability of contraception can be reduced.

If the delay in taking the tablets is> 12 hours (the interval from the time of taking the last pill> 36 hours) during the 1 st and 2 nd week of taking the drug, the woman should take the last missed tablet as soon as possible: even if this means taking two tablets Simultaneously. The next tablet should be taken at the usual time. Additionally, a barrier method of contraception must be used for the next 7 days.

If the delay in taking the pill is> 12 h (the interval from the moment of taking the last pill> 36 h) during the 3rd week of taking the drug, the woman should take the last missed tablet as soon as possible: even if it means taking two tablets at the same time. The next tablet should be taken at the usual time. Take the pill from the new package should be started, at the end of the current package - without interruption.Probably, bleeding cancellations will not be until the end of the second package, but spotting spotting or bursting uterine bleeding on the days of taking the tablets are possible.

If a woman had vomiting within 3 to 4 hours after taking the drug, the absorption of the active substances may be incomplete. In this case, you need to focus on recommendations when you skip the tablet.

To delay the date of the onset of menstruation, a woman should continue taking the pills from the new package of the drug immediately after taking all the pills from the previous one, without interruption. Tablets from a new package can be taken for as long as the woman wishes (until the package is finished). Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. You should start taking the tablets from the next package after you have finished taking all 28 tablets.

To postpone the day of the onset of menstruation on the next day of the week, the woman should shorten the nearest break in taking the pills for as many days as she wants. The shorter the interval, the higher the risk that it will not have the bleeding cancellation and, in the future,there will be macular bleeding and breakthrough bleeding at the time of taking the second package (as well as in the case when she would like to delay the onset of menstruation).

In the treatment of hyperandrogenic conditions, the duration of drug use is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take the drug for at least 3-4 months. In the case of relapse after a few weeks or months after the completion of the course, you can re-use the drug Chloe.

Side effect

• soreness, soreness, enlargement and discharge from the mammary glands;
• weight gain;
• intermenstrual bleeding;
• changes in the vaginal secretion;
• change in libido;
• headache, migraine;
• decreased mood;
• nausea, vomiting, gastralgia;
• poor tolerance of contact lenses;
• swelling of the eyelids;
• impaired vision;
• conjunctivitis;
• hearing loss;
• allergic reactions;
• thrombophlebitis, thromboembolism;
• generalized itching;
• jaundice;
• appearance of pigment spots on the face (chloasma).

These side effects can develop in the first few months of the drug and usually decrease with time.

Contraindications

• thrombosis and thromboembolism, incl. in the anamnesis (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
• states preceding thrombosis (including transient ischemic attacks, angina pectoris);
• arterial hypertension;
• diabetes mellitus complicated by microangiopathies;
• presence of severe or multiple risk factors for venous or arterial thrombosis;
• diseases or marked violations of liver function;
• liver tumors (including in the anamnesis);
• hormone-dependent malignant tumors, incl. tumors of the mammary gland or genitals (including in the anamnesis);
• congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson, Rotor);
• pancreatitis (including in the anamnesis), if it was accompanied by severe hypertriglyceridemia;
• uterine bleeding of unclear etiology;
• migraine, accompanied by focal neurological symptoms (including in the anamnesis);
• sickle-cell anemia;
• idiopathic jaundice or itching during the last pregnancy;
• otosclerosis with worsening during pregnancy;
• hyperprolactinemia;
• the period of breastfeeding;
• pregnancy or suspected of it;
• age over 40 years;
• hypersensitivity to the components of the drug.

If any of these conditions develop for the first time against the background of taking Chloe, the drug should be immediately discontinued.

Application in pregnancy and lactation

Contraindicated use of the drug during pregnancy, suspected pregnancy and during breastfeeding.

special instructions

Before the beginning of Chloe's application, it is necessary to conduct a general medical examination (including mammary glands and cytological examination of cervical mucus), to exclude pregnancy, violations by the blood coagulation system. With prolonged use of the drug, preventive check-ups should be performed every 6 months.

In the presence of risk factors, the potential risk and the expected benefits of therapy should be carefully evaluated and discussed with the woman prior to the use of the drug.

The estimated incidence of venous thromboembolism (VTE) with oral low-dose estrogen oral contraceptives (<50 μg ethinyl estradiol) is up to 4/10 000 women per year compared with 0.5-3 / 10,000 women who do not take oral contraceptives.In this case, the frequency of VTE when taking combined oral contraceptives is less than the frequency of VTE associated with pregnancy (6/10 000 pregnant women per year).

The patient should be warned that with the development of symptoms of venous or arterial thrombosis, you should immediately consult a doctor. These symptoms include unilateral leg pain and / or swelling, sudden severe chest pain with irradiation to the left arm or without irradiation, sudden dyspnea, sudden coughing, any unusual, severe, prolonged headache, increased frequency and severity of migraine, sudden partial or complete loss of vision, diplopia, slurred speech or aphasia, dizziness, collapse with or without partial seizure, weakness or very significant loss of sensation suddenly appearing on one side or in one part of the body, motor abnormalities, symptom-complex "acute" abdomen.

The relationship between the use of combined oral contraceptives and hypertension has not been established. In the event of persistent arterial hypertension, the drug must be canceled and appropriate antihypertensive therapy should be prescribed.Reception of a contraceptive can be continued at normalization of a BP.

Recurrent cholestatic jaundice that develops for the first time during pregnancy or during previous use of sex hormones, requires discontinuation of COCs.

Despite the fact that the combined oral contraceptives have an impact on the resistance of the tissues to insulin and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be carefully monitored.

Women who are prone to the appearance of chloasma, while taking combined oral contraceptives should avoid prolonged exposure to sunlight and ultraviolet radiation.

If women with hirsutism have recently developed symptoms or have significantly increased, other causes, such as androgen-producing tumors, congenital adrenal cortex dysfunction, should be taken into account in the differential diagnosis.

When using Chloe, irregular bleeding may occur (smearing or breakthrough bleeding), especially during the first months of therapy.Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, nonhormonal causes should be considered and adequate diagnostic measures (including diagnostic scraping) should be considered to exclude malignant neoplasms or pregnancy.

In some cases, bleeding cancellations may not develop during a break in the use of the drug. If the tablets are taken irregularly or if there are no two menstrual bleeding in a row, pregnancy should be ruled out before continuing with the drug.

It is possible to change the results of skin allergic tests, reduce the concentration of LH and FSH on the background of the drug.

Due to the fact that the contraceptive effect is fully manifested by the 7th day from the beginning of the drug intake, in the first week additional nonhormonal methods of contraception are recommended.

The use of the drug after childbirth is recommended not earlier than the first normal menstrual cycle will pass.

Treatment should be immediately discontinued 3 months before the planned pregnancy and approximately 6 weeks before the planned surgical intervention, with prolonged immobilization.

With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, additional non-hormonal methods of contraception should be used).

Smoking women taking hormonal contraceptive medicines have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 30 years of age).

Drug Interactions

With the simultaneous use of Chloe with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidon, Carbamazepine and rifampicin, and also possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinyl estradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or impaired reliability contraception.

With simultaneous use with ampicillin, rifampicin and tetracyclines, the contraceptive reliability of Chloe is reduced.

Analogues of the drug Chloe

Structural analogs for the active substance:

• Bellune 35;
• Diane 35.

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