Diane-35 - instructions for use, reviews, counterparts and formulations (tablets or pills) of the hormonal contraceptive drug for contraception and acne treatment in women, children and pregnancy. Composition and scheme of admission

In this article, you can read the instructions for using the drug Diane-35. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Diane-35 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 of Diana 35 in the presence of existing structural analogues.Use of hormonal contraceptive medication for contraception and acne treatment in adults, children, as well as during pregnancy and lactation.

Diane-35 - combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen-ethinyl estradiol and anti-androgen with gestagenic activity - cyproterone acetate.

Cyproterone acetate, contained in Diane-35, inhibits the effect of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased formation of androgens or specific sensitivity to these hormones.

Against the background of Diane-35, the increased activity of the sebaceous glands decreases, which plays an important role in the appearance of acne and seborrhea. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive fatness of hair and skin disappears even earlier. Also decreases hair loss, often accompanying seborrhea. Therapy of Diane-35 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 the above-described anti-androgenic effect of cyproterone, acetate also has a pronounced gestagenic effect.

The contraceptive effect of Diane-35 is based on the interaction of various factors, the most important of which are inhibition of ovulation and a change in the secretion of cervical mucus.

The cycle becomes more regular, less painful menstruation is observed, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

Composition

Ethinylestradiol + cyproterone acetate + excipients.

Pharmacokinetics

Cyproterone acetate

After taking Diane-35 cyproterone acetate is completely absorbed from the digestive tract. Ciproterone acetate almost completely binds to blood plasma albumin, approximately 3.5-4.0% is in the free state. Since protein binding is not specific, changes in the level of globulin binding to sex steroids (HESC) do not affect the pharmacokinetics of cyproterone acetate. Breast milk releases up to 0.2% of the dose of cyproterone acetate. It is excreted mainly in the form of metabolites with urine and bile in the ratio 1: 2, a small part - in unchanged form with bile.

Ethinylestradiol

After taking Diane-35, ethinyl estradiol is quickly and completely absorbed from the digestive tract. In the process of absorption and "first passage" through the liver, ethinyl estradiol undergoes intensive metabolism, which causes bioavailability of approximately 45%, and its significant individual variability. Ethinyl estradiol is excreted from the body in the form of metabolites; about 40% - with urine, 60% - with bile.

Indications

• contraception in women with androgenization 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 and mild forms of hirsutism.

Forms of release

Dragee 35 μg + 2 mg (sometimes mistakenly called a pill, although the tablet forms of hormonal contraceptive Diane-35 does not exist).

Instructions for use and reception scheme

Diane-35 take inside 1 tablet a day. Dragee is taken without chewing and washed down with a small amount of liquid. The timing of taking the drug does not play a role, but the subsequent reception should be done at the same selected hour, preferably after breakfast or dinner.

Admission Diane-35 begins on the 1st day of the cycle, using a pellet of the corresponding day of the week from the calendar package.

The daily intake of the drug is carried out using pellets from the calendar pack in succession along the direction of the arrow applied to the foil, until all the pills are taken. After the end of taking all 21 tablets from the calendar package, a break is taken in taking the drug for 7 days, during which menstrual bleeding occurs.

After 28 days from the beginning of taking the drug (21 days of admission and 7 days of interruption), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.

When switching from combined oral contraceptives, Diane-35 should be taken the next day after the last beverage with the active ingredients of the previous preparation, but in no case later than the next day after the usual 7-day suspension (for preparations containing 21 tablets) . Then follow the scheme described above. If the patient took the previous contraceptive daily for 28 days, Diane-35 should be taken after the last inactive dragee was taken.

When switching from contraceptives containing only gestagens ("mini-drank"), Diane-35 can be used without interruption. When using injectable forms of contraceptives, Diane-35 is taken from the day the next injection is to be taken. When moving from the implant - the day it was removed. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the 2nd trimester of pregnancy, the drug should be taken 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 taking the pills.

If a woman had a sex life between childbirth or abortion and the beginning of Diane-35, first you should exclude pregnancy or you must wait for the first menstrual period.

Missed pills woman should take as soon as possible, the next dragee is taken at the usual time. At a delay of less than 12 hours, the reliability of contraception is not reduced.If the delay in taking the dragee is more than 12 hours, the reliability of contraception can be reduced. It should be borne in mind that the dragee should never be interrupted for more than 7 days, and that 7 days of continuous intake of pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.

If the delay in taking the dragee was more than 12 hours (the interval from the last pill taken over 36 hours) during the first and second weeks of taking the drug, the woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking two pills simultaneously). The next dragee is taken at the usual time. Additionally, a barrier method of contraception should be used for the next 7 days.

If the delay in taking the dragee is more than 12 hours (the interval from the moment of reception of the last dragee is more than 36 hours) during the third week of taking the drug, the woman should take the last missed pellet as soon as possible, as soon as it remembers (even if it means taking two pills simultaneously ). The next dragee is taken at the usual time.In addition, the reception of a dragee from a new package should be started as soon as the current packaging is finished, i. E. nonstop. Most likely, the woman will not have withdrawal bleeding until the end of the second package, but she may have spotting spotting or breakthrough uterine bleeding on the days of taking the pills.

If a woman had vomiting within 3 to 4 hours after taking Diane-35, the absorption of active substances may be incomplete. In this case, it is necessary to focus on the recommendations when skipping the dragees.

In order to delay the onset of menstruation, a woman should continue taking the pills from the new Diane-35 package immediately after taking all the pills from the previous one, without taking a break. Dragee from this new package can be taken for as long as the woman wishes (until the packaging is finished). Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume reception Diane-35 from a new package follows after usual 7-day break.

In order 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 dragee for as many days as she wants.The shorter the interval, the higher the risk that it will not have withdrawal bleeding, and thereafter will be spotting spot bleeding and breakthrough bleeding during the second package (just like when it wants to delay the onset of menstruation).

In the treatment of hyperandrogenic conditions, the duration of admission is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 at least another 3-4 months. In the case of relapse within a few weeks or months after the completion of the course, Diana-35 can be re-treated.

Side effect

• soreness, tenderness, enlargement of the mammary glands and discharge from them;
• chest pain;
• change in body weight;
• intermenstrual bleeding (bleeding without menstruation);
• changes in the vaginal secretion;
• change in libido;
• headache;
• migraine;
• decreased mood;
• nausea, vomiting;
• poor tolerance of contact lenses;
• allergic reactions;
• appearance of pigment spots on the face (chloasma).

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);
• 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);
• uterine bleeding of unclear etiology;
• pancreatitis (including in the anamnesis), if it was accompanied by severe hypertriglyceridemia;
• presence in the anamnesis of migraine, which was accompanied by focal neurological symptoms;
• lactation (breastfeeding);
• pregnancy or suspected of it;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Diane-35 is contraindicated in pregnancy and lactation.

special instructions

Before the application of Diane-35 it is necessary to conduct a general medical examination (including mammary glands and cytological examination of cervical mucus), exclude pregnancy, violations of the blood coagulation system.With prolonged use of the drug, preventive check-ups should be performed every 6 months.

The approximate frequency of venous thromboembolism (VTE) with oral low-dose oral contraceptives (less than 50 μg ethinyl estradiol) is up to 4 per 10,000 women per year compared to 0.5-3 per 10,000 women who do not take oral contraceptives. At the same time, the frequency of VTE when taking combined oral contraceptives is less than the frequency of VTE associated with pregnancy (6 per 10 000 pregnant women per year).

The patient should be warned that with the development of symptoms of venous or arterial thrombosis should immediately consult a doctor. These symptoms include unilateral leg pain and / or swelling; sudden severe pain in the chest with irradiation in the left arm or without irradiation; sudden shortness of breath; a sudden attack of coughing; any unusual, strong, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; Diplomacy; slurred speech or aphasia; dizziness; collapse with or without partial seizure; weakness or very significant loss of sensitivity, suddenly appeared on one side or in one part of the body; motor disorders; symptomatic complex "acute" abdomen.

The relationship between the administration of combined oral contraceptives and hypertension has not been established. If there is persistent arterial hypertension, Diane-35 should be canceled and appropriate antihypertensive therapy should be prescribed. Reception of a contraceptive can be continued at normalization of a BP.

If there are violations of the liver function, it may be necessary to temporarily cancel Diane-35 before normalizing laboratory parameters. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on insulin resistance and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in diabetic patients. Nevertheless, this category of patients should be under careful medical supervision.

Women with a tendency to chloasma when taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to 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.

Against the background of Diane-35, occasional bleeding (spotting or breakthrough bleeding) can occur, 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, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These can include diagnostic scraping.

In some cases, bleeding cancellation may not develop during a break in taking the pills. If the pellet is taken irregularly or if there are no two menstrual bleeding in a row, you should exclude pregnancy before continuing with the drug.

Drug Interactions

With simultaneous application of Diane-35 with inducers of microsomal hepatic enzymes (hydantoins, barbiturates, primidon, Carbamazepine and rifampicin, and also possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or reduce the reliability of contraception.

With simultaneous use with ampicillins and tetracyclines, the contraceptive reliability of Diane-35 decreases.

Analogues of the drug Diane-35

Structural analogs for the active substance:

• Bellune 35;
• Chloe.

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