Medicinal reference book geotar. Medicinal reference book geotar Contraindications to Diana 35

Diane-35 is a combined low-dose monophasic oral contraceptive with an antiandrogenic effect.

The drug contains an estrogen - ethinyl estradiol and an antiandrogen with progestogenic activity - cyproterone acetate. This component inhibits the influence of androgens, which are also produced in the female body. Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.

On this page you will find all the information about Diana-35: complete instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Diane-35. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Monophasic oral contraceptive with antiandrogenic properties.

Terms of dispensing from pharmacies

Released by prescription.

Prices

How much does Diana-35 cost? The average price in pharmacies is at the level of 1,200 rubles.

Release form and composition

Diane-35 contraceptive pills are produced in the form of dragees, which are contained in a blister - a special calendar package of 21 pcs. It is enclosed in a cardboard pack.

• Diane-35 tablets contain the active components of cyproterone acetate and ethinyl estradiol, as well as a number of additional components: lactose monohydrate, povidone, corn starch, magnesium stearate, magnesium hydrosilicate.

Dragee light yellow, round, biconvex.

Pharmacological effect

The contraceptive effect is achieved through the complementary action of active substances that contribute to the following effects:

1. Suppress the process of ovulation.
2. They affect the composition of cervical mucus.

As a result, spermatozoa cannot penetrate the cervical mucus. Patients who take monophasic oral contraceptives are less likely to develop anemia. Taking Diana 35 normalizes the menstrual cycle, eliminates the pain syndrome that can occur during menstruation, reduces the intensity and duration of bleeding.

In patients who take Diane 35, the functioning of the sebaceous glands decreases, which, in turn, prevents the development of seborrhea and acne.

Indications for use

Diane-35 is used for contraception in women with increased production of male hormones (androgenization).

Also, the drug is prescribed for patients with androgen-dependent diseases: seborrhea, acne, acne, hirsutism, mild androgenetic alopecia, excessive hair growth or baldness due to excessive production of male hormones in the female body.

Contraindications

To refuse the consumption of contraceptive pills Diane-35 is in the presence of:

1. Dubin-Johnson/Rotor syndromes.
2. Tumors of the endometrium.
3. Pregnancy and lactation.
4. Diseases of the liver.
5. Idiopathic jaundice.
6. Itching of the skin layer.
7. Thrombosis / thromboembolism.
8. Angina.
9. Diabetes.
10. Vaginal bleeding.
11. breast cancer.
12. Obesity.
13. Dermatosis of the blistering form.
14. Otosclerosis.
15. Tumors of a malignant nature, dependent on hormones.

Instructions for use

The instructions for use indicate that Diane-35 tablets are taken orally, without chewing, with a small amount of liquid, preferably immediately after breakfast or dinner.

• Dosing of the drug - 1 tablet per day.

Reception begins on the first day of the cycle, using from the calendar package of dragees of the corresponding day of the week, at a time convenient for the patient, with the condition that subsequent doses will necessarily be carried out at this particular hour of the day.

For each subsequent reception, dragees are used from the cell, which is indicated by the arrow applied to the foil from the previous one. Following the direction on the calendar package, the woman takes all 21 pills and takes a break of 7 days, during which bleeding similar to menstruation passes. One course of therapy lasts 28 days, of which 21 days are pills and 7 days are a break. It must be remembered that the reception should not be interrupted for more than 7 days and the first 7 days of taking the dragee are required to achieve an appropriate suppression of the function of the hypothalamic-pituitary-ovarian system.

The day of taking the drug from the next package should coincide with the day of the week on the calendar package of the previous course and begin on the 8th day after the start of the break at a strictly set time.

• To switch from combined oral contraceptives to the use of Diane-35, it is necessary to start taking the next day after the last pill from the package with the active substances of the previous remedy, for a calendar pack of 28 pills and no later than 1 day after a 7-day break, for contraceptives from 21 dragee.
• To switch from preparations consisting only of gestagens (“mini-pills”), Diane-35 can be taken without interruption, with injectable forms of contraception - from the day of the next injection, from the implant - on the day of its removal. With each of these transitions, it is additionally necessary to use a barrier method of contraception during the first 7 days.

When performing an abortion in the 1st trimester of pregnancy, oral contraception is started immediately, in which case additional methods of contraception are not required.

In the absence of sexual intercourse after an abortion in the second trimester of pregnancy or childbirth, it is recommended to start using the drug on the 21-28th day. If a woman started taking later, then during the first 7 days, a barrier method of contraception should be used in parallel. Patients who lived sexually between abortion or childbirth and the start of the drug should wait until the first menstruation or exclude the presence of pregnancy.

If a woman misses taking a pill at the set time, it should be taken as soon as possible, and the next pill at the usual time. The reliability of contraception is not impaired if the delay is less than 12 hours.

In the case when more than 36 hours have passed since the last dose (more than 12 hours late), the missed pill should be taken as soon as remembered, even if it will be taking two pills at the same time, while the next dose is taken at the usual time. If the violation occurred in the first or second week of use, it is necessary to use a barrier method of contraception for the next 7 days. In case of a delay of more than 12 hours during the third week of admission, at the end of the calendar package, there is no need to take a break in the reception, it is necessary to continue taking it from the next blister. While taking from the second package, a woman may experience bloody spotting or breakthrough uterine bleeding.

If the patient vomited after taking the dragee (in the first 3-4 hours), the absorption of the active substances may be impaired and incomplete, so you should use the recommendations for the case when you miss a dose.

To delay the onset of menstruation, it is necessary to continue taking the pills from the new calendar package without taking a 7-day break. You can take dragees from the second package until it ends. You should be aware that during this period, the patient may experience spotting or breakthrough bleeding. After a 7-day break, you should continue using Diane-35 from a new package.

To change the day of the beginning of the menstrual cycle to another, the next break should be reduced by the required number of days. The fewer days of the break, the greater the likelihood of the absence of withdrawal bleeding and the presence of spotting spotting during the period of taking the dragee.

The duration of the drug in the treatment of hyperandrogenic pathologies depends on the severity of the condition, after the disappearance of the signs of the disease, it is recommended to continue taking the dragee for 3-4 months. If a relapse occurs, you can repeat the course of therapy.

Side effects

Taking Diane-35 dragees can lead to the development of side effects from various organs and systems, they include:

1. Eyes - development of intolerance to contact lenses.
2. Digestive system - nausea, vomiting, abdominal pain, diarrhea, changes in the functional activity of the liver and biliary tract.
3. Metabolic disorders - fluid retention in the body with the development of peripheral edema, increased body weight and triglyceride levels in the blood.
4. Reproductive system and mammary glands - intermenstrual bleeding, enlargement of the mammary glands in volume, their soreness, the appearance of vaginal discharge or secretion from the mammary glands.
5. Nervous system - headache, migraine, the development of transient mental disorders (depressed mood, depression, excessive increase or decrease in libido).
6. Cardiovascular system - an increase in systemic arterial pressure (arterial hypertension), thromboembolism (the formation of a blood clot in the lumen of the vessel with its subsequent migration in the bloodstream).
7. Allergic reactions - rash and itching of the skin, urticaria (a characteristic rash and swelling of the skin that looks like a nettle burn). Less commonly, skin changes may develop in the form of erythema nodosum (the appearance of characteristic red spots). The development of severe allergic reactions in the form of Quincke's edema (pronounced swelling of soft tissues) or anaphylactic shock (vascular collapse with a decrease in blood pressure and multiple organ failure) was not recorded.

In the event of side effects, the drug should be discontinued and consult a doctor.

Overdose

Overdose symptoms: nausea, vomiting, slight vaginal bleeding (in girls).

special instructions

1. Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. With prolonged use of the drug, preventive control examinations should be carried out every 6 months.
2. In the presence of risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before she decides to start taking the drug. With aggravation, intensification, or at the first manifestation of any of these conditions or risk factors, drug withdrawal may be required.
3. 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 or without radiating to the left arm; sudden shortness of breath; sudden onset of 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/without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.
4. The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 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).
5. If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.
6. The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.
7. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
8. Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.
9. While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.
10. If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.
11. 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 may include diagnostic curettage.
12. In some cases, withdrawal bleeding may not develop during a break in taking the dragee. In case of irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

drug interaction

With the simultaneous use of Diane-35 with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and, possibly, with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.

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

Dosage form

Compound

One dragee contains

active substances: cyproterone acetate 2.0 mg

ethinylestradiol 0.035 mg,

excipients: lactose monohydrate, corn starch, povidone 25000, talc, magnesium stearate,

dragee shell: sucrose, povidone 700,000, macrogol 6000, calcium carbonate, talc, 85% glycerin, titanium dioxide (E171), iron oxide yellow (E172), motaglycolic wax.

Description

Round, biconvex beige dragees

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Antiandrogens. Antiandrogens and estrogens. Cyproterone and estrogens

ATX code G03HB01

Pharmacological properties

Pharmacokinetics

Cyproterone acetate Absorption

Orally administered cyproterone acetate is rapidly and completely absorbed. The maximum serum concentration of 15 ng / ml is reached after about 1.6 hours. Bioavailability is about 88%.

Distribution

Cyproterone acetate binds almost completely to serum albumin. Only 3.5-4.0% of the total serum level of cyproterone acetate is in the free form. The ethinylestradiol-induced increase in the level of sex hormone-binding globulin (SHBG) does not affect the binding of cyproterone acetate to serum proteins. The apparent volume of distribution of cyproterone acetate is approximately 986 ± 437 liters.

Metabolism

Cyproterone acetate is almost completely metabolized.

The main metabolite in human plasma is the 15ß-hydroxyl derivative, which is formed with the participation of the CYP 3A4 enzyme of the cytochrome P450 system. The rate of clearance from blood serum is approximately 3.6 ml / min / kg.

breeding

Equilibrium concentration

The pharmacokinetics of cyproterone acetate is not affected by the level of SHBG in the blood serum. As a result of daily intake of the drug, the level of substances in the serum increases by about 2.5 times, and the equilibrium concentration is reached in the second half of the course.

Ethinylestradiol Absorption

After oral administration, ethinylestradiol is absorbed rapidly and completely. The maximum concentration in blood serum, equal to approximately 71 pg / ml, is reached in 1 hour and 40 minutes. During absorption and the first passage through the liver, ethinylestradiol is extensively metabolized, resulting in its oral bioavailability averaging about 45%, with significant individual differences ranging from 20-65%.

Distribution

Ethinylestradiol is almost completely (98%), although non-specific, associated with albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8-8.6 l/kg.

Metabolism

Ethinylestradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, with the formation of a variety of hydroxylated and methylated metabolites, presented both in the form of free metabolites and in the form of conjugates with glucuronic and sulfuric acids.

The rate of metabolic clearance of ethinyl estradiol varies from 2.3 to 7.0 ml / min / kg.

breeding

Metabolites of ethinylestradiol are excreted by the kidneys and liver in a ratio of 4:6 with a half-life of about 24 hours.

Equilibrium concentration

The equilibrium concentration is reached approximately in the second half of the treatment cycle, when the level of the drug in the blood serum is 60% higher compared to a single dose.

Pharmacodynamics

The sebaceous-hair complex, consisting of the sebaceous gland and the hair follicle, is an androgen-sensitive component of the skin. Acne and seborrhea are due in part to sebaceous gland dysfunction, which may result from androgen hypersensitivity or elevated plasma androgen levels. Both active substances of Diane® 35 have a positive therapeutic effect.

Cyproterone acetate contained in Diane 35 is a competitive androgen receptor antagonist, has an inhibitory effect on the synthesis of androgens in target cells and helps to reduce the concentration of androgens in the blood due to the antigonadotropic effect.

The antigonadotropic effect of the drug is enhanced by ethinyl estradiol, which also increases the synthesis of SHBG, which helps to reduce the free biologically active level of androgens in the blood.

Treatment with Dianeâ 35 leads - usually after 3-4 months of therapy - to the healing of existing acne lesions. Excessive oiliness of hair and skin, as a rule, disappears earlier. Androgen-dependent hair loss is also reduced. However, in women suffering from hirsutism, the results become visible only after a few months of use.

Cyproterone acetate is also a potent progestogen with a contraceptive effect when used in combination with ethinyl estradiol. This effect is based on the interaction of the central and peripheral mechanisms, the most important of which should be considered the suppression of ovulation and changes in the properties of the cervical secret. In addition, as a result of morphological and enzymatic changes in the endometrium, extremely unfavorable conditions for implantation arise.

Contraceptive protection begins on the first day of taking the drug.

Indications for use

Treatment of moderate and severe androgen-dependent forms of acne (without seborrhea or accompanied by seborrhea) and / or hirsutism in women of reproductive age.

For the treatment of acne, Diane® 35 should be used when topical or systemic antibiotic treatment is not effective.

Since Diane® 35 is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section "Contraindications").

Dosage and administration

Dianeâ 35 prevents ovulation and thus has a contraceptive effect. Patients taking Diane® 35 should not use additional hormonal contraceptives, as this leads to an overdose of hormones and is not necessary for effective contraceptive action.

For the same reason, Diane® 35 should not be used by women who wish to become pregnant.

Reception Dianeâ 35 should be regular to achieve the required therapeutic efficacy and the required contraceptive protection.

Mode of application

For oral administration.

The pills should be taken in the order indicated on the package, every day at about the same time with a little water. Take one tablet per day continuously for 21 days. Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts 2-3 days after taking the last pill and may not end before the start of a new package. Contraceptive protection starts from the first day of taking the dragee and also lasts for 7 days when the drug is not taken. Simultaneous use of hormonal contraceptives should be discontinued.

Medical examination / doctor's consultation

Before starting the use of the drug, it is recommended to conduct a complete general medical examination (including measurement of body weight, blood pressure, examination of the heart, legs and skin, urinalysis for diabetes, liver tests if necessary), a gynecological examination is also necessary (including examination of the mammary glands and cytological examination of cervical mucus taken from the vaginal part of the cervix and cervix), a detailed family medical history should be taken to determine diseases requiring treatment and possible risks. It is necessary to exclude pregnancy. When using the drug, it is recommended to conduct control examinations every six months.

Disorders of the blood coagulation system should be ruled out if blood relatives had thromboembolic complications (eg, deep vein thrombosis, stroke, heart attack) at an early age. It should also be noted that taking oral contraceptives does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

How to start taking Dianeâ 35

In the absence of taking any hormonal contraceptives in the previous month

Dianeâ 35 is started on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

Women with amenorrhea can start taking the drug immediately after being prescribed by a doctor; in this case, the day of taking the first dragee corresponds to the first day of the menstrual cycle, and then the reception continues as recommended.

When switching from combined hormonal contraceptives (combined oral contraceptive, vaginal ring, transdermal patch)

It is preferable to start taking Dianea 35 the next day after taking the last hormone-containing dragee from the previous package, but in no case later than the next day after the usual 7-day break in taking (for preparations containing 21 pills) or after taking the last hormone-free dragee ( for preparations containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Dianeâ 35 on the day the last ring or patch of the cycle pack is removed, but in no case later than the day when the next ring or patch should have been applied.

When switching from contraceptives containing only gestagens (mini-pili, injectable forms, implant), or a progestogen-releasing intrauterine system (IUD).

A woman can switch from a mini-pill to Diana 35 any day (without a break), from an implant or IUD with a progestogen - on the day it is removed, from an injection form - from the day the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.

After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After childbirth or abortion in the second trimester of pregnancy

A woman should be advised to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. 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. However, if the woman has already been sexually active, pregnancy should be ruled out before Diane 35 is started, or the first menstruation should be waited for.

Application duration

The duration of taking Diane® 35 is determined by the severity of the disease and the effectiveness of the treatment. In the treatment of acne and seborrhea, the effect usually occurs earlier than in the treatment of hirsutism. After the intensity of symptoms decreases, it is recommended to take Diane-35 for at least another 3 or 4 cycles.

In case of no effect on therapy or in case of insufficient effect on treatment

Severe acne or seborrhea for at least six months or

Hirsutism for at least 12 months

concomitant administration of Dianeâ-35 and Androkur® 10 mg tablets or Androkur® 50 mg tablets should be considered or, which is more preferable, reconsider the method of treatment.

When the symptoms of androgenization subside, but contraceptive action is still required, the use of a low-dose oral contraceptive should be switched to. In the event of recurrence of androgenic symptoms, it is possible to resume therapy with Dianeâ-35.

In the case of resuming the use of Diane® 35 (after a break between doses of the drug for 4 weeks or more), an increased risk of developing venous thromboembolism should be taken into account (see section "Special Instructions").

Taking missed pills

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next pill is taken at the usual time.

If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

Reception of a dragee should never be interrupted, more than for 7 days.

7 days of continuous tablet intake are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.

Accordingly, the following advice can be given if the delay in taking the pill was more than 12 hours (the interval from the moment the last pill was taken was more than 36 hours):

First week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, it is necessary to take into account the likelihood of pregnancy.

The more pills missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.

Second week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time.

Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of a decrease in reliability is inevitable due to the upcoming break in taking pills.

A woman must strictly adhere to one of the two following options. At the same time, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pill as soon as possible (even if it means taking two pills at the same time). The next dragee is taken at the usual time until the dragees from the current package run out. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but spotting or breakthrough bleeding may occur while taking the pills.

2. A woman can also stop taking the dragee from the current package. Then she should take a break for 7 days, including the day she skipped the dragee, and then start taking a new package.

If a woman misses taking the pills, and then during the break in taking the pills she does not have withdrawal bleeding, pregnancy should be excluded. No withdrawal bleeding

In the absence of withdrawal bleeding, the drug should be discontinued until pregnancy has been ruled out.

Tips for intermenstrual bleeding

It is absolutely necessary to continue taking Diane-35 in case of intermenstrual bleeding. Small bleeding usually stops spontaneously or disappears within 4 to 5 days - as well as intermenstrual bleeding of the same intensity as menstruation (breakthrough bleeding) - as a result of additional simultaneous use of 25 - 50 micrograms of ethinyl estradiol (i.e. not after taking the last dragee from Diane's package -35).

If breakthrough bleeding persists or recurs, a thorough evaluation, including curettage, should be performed to rule out an organic cause.

The above also applies to spotting that occurs at irregular intervals over several consecutive cycles or occurs for the first time after long-term use of Diane-35. In such cases, bleeding is usually the result of organic changes, and not the action of the drug.

Tips for gastrointestinal disorders

With severe vomiting or diarrhea, the absorption of the active substances of the drug may be incomplete. In this case, additional contraceptive measures should be taken.

If a woman vomits within 3-4 hours after taking the Diane® 35 dragee, it is necessary to focus on the advice regarding skipping the dragee. If a woman does not want to change the normal regimen of taking the drug, she should take, if necessary, an additional tablet (or several tablets) from another package.

Liver disease

In the case of viral hepatitis, drugs such as Diane-35 should not be used until about six months after recovery (when liver tests return to normal).

Elderly patients

Diane® 35 is contraindicated in women with severe liver disease until liver function tests return to normal Patients with renal impairment

Diane® 35 has not been specifically studied in patients with impaired renal function. Available data do not suggest a change in treatment in these patients.

Side effects

All women taking Diane® 35 have an increased risk of developing thromboembolism.

Additional factors may increase the risk (smoking, arterial hypertension, blood clotting disorders or lipid metabolism disorders, obesity, varicose veins, previous phlebitis and thrombosis), see section "Special Instructions".

For information on other side effects such as liver tumors, cervical cancer and breast cancer, see the "Special Instructions" section. The following undesirable effects have been described in women taking Diane® 35 and their relationship with the drug has not been confirmed or refuted:

Often (≥1/100)

Nausea, abdominal pain

Weight gain

Headache, depressed mood, mood changes

Soreness and tension of the mammary glands, intermenstrual bleeding

Uncommon (≥1/1000,<1/100)

Vomiting, diarrhea

Fluid retention

Migraine

Decreased libido

Breast enlargement

Rash, hives, chloasma (appearance of age spots on the face)

Rarely (<1/1000)

Hypersensitivity reactions

Poor tolerance to contact lenses

Thromboembolism

Weight loss

Increased libido

Vaginal discharge, discharge from the mammary glands

Erythema nodosum, erythema multiforme

Post-marketing data:

Increase in blood pressure

The following serious side effects described in the "Special Instructions" section have been reported in women using Diane® 35:

Venous thromboembolic disorders

Arterial thromboembolic disorders

Cerebrovascular disorders

Arterial hypertension

Hypertriglyceridemia

Impaired glucose tolerance or effects of peripheral insulin resistance

Liver tumors (benign and malignant)

Liver dysfunction

Chloasma

The appearance or worsening of the following conditions, the relationship of which with the use of combined oral contraceptives has not been reliably established: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea of ​​Sydenham (small chorea), herpes of pregnant women; hearing loss associated with otosclerosis, Crohn's disease and ulcerative colitis, cervical cancer

In women with hereditary angioedema, provoking or exacerbating symptoms of the disease under the influence of exogenous estrogens

The frequency of breast cancer diagnosis is slightly increased among women taking oral contraceptives. Since breast cancer is rare in women under 40 years of age, the increase in the number of diagnoses is small in relation to the overall risk of developing this disease. Detailed information is contained in the section "Special Instructions" and "Contraindications".

Action on breast tissue

Sex hormones have an effect on breast tissue, as they probably increase its sensitivity to the effects of other carcinogenic factors. Sex hormones are really just one of various possible risk factors unrelated to oral contraceptive use. In epidemiological studies that have analyzed the possible association between the use of hormonal contraceptives and the development of breast cancer, it was not possible to unequivocally answer the question of whether this disease is indeed more common before middle age in women who use contraceptives for a long time starting at a young age.

Also, while taking combined oral contraceptives, an increase in endogenous depression and epilepsy was noted.

If a significant increase in symptoms is observed in women suffering from hirsutism, other causes should be considered in the differential diagnosis (androgen-producing tumor, fermentopathy in the adrenal cortex).

Deviation of indicators of clinical biochemical analysis from the norm Erythrocyte sedimentation rate may increase without the presence of a disease. There have been cases of increased levels of copper and iron in the blood serum, as well as cases of increased activity of leukocyte alkaline phosphatase.

Other metabolic functions

Rare disorders of folic acid and tryptophan metabolism may occur.

With regular use, Dianeâ 35 has a contraceptive effect due to its composition. Irregular use of Dianeâ 35 may lead to menstrual irregularities. Regularity in taking Diane 35 is very important both to prevent menstrual irregularities and to prevent pregnancy (because cyproterone acetate may affect the developing baby).

Contraindications

Preparations containing a combination of estrogen/gestagens should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be immediately discontinued.

Hypersensitivity to any of the components of the drug

Combined use with other hormonal contraceptives

Current or history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism)

Having a personal or family history of known idiopathic venous thromboembolism (VTE) in which there is a family history of VTE in a sibling or parent at a relatively early age)

Current or history of arterial thrombosis (eg, myocardial infarction) or previous disorders (eg, angina pectoris and transient ischemic attacks)

Cerebrovascular disorders at present or in history

The presence of pronounced or multiple risk factors for the development of venous or arterial thrombosis (see section "Special Instructions"), for example:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Hereditary or acquired predisposition to venous or arterial thromboembolism (eg, resistance to activated protein C (APC resistance), deficiency of antithrombin III, protein C, protein S, hyperhomocysteinemia, and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

sickle cell anemia

Severe liver disease, including disorders of the excretory system such as Dubin-Johnson and Rotor syndrome until liver function tests return to normal

Liver tumors (benign or malignant) at present or in history

Unexplained vaginal bleeding

Migraine with a history of focal neurological symptoms

Smoking

Identified or suspected hormone-dependent malignant diseases (for example, genital or mammary glands)

History of idiopathic jaundice in pregnancy, severe pruritus or herpes in pregnancy, worsening of otosclerosis during previous pregnancies

Desired pregnancy, pregnancy and breastfeeding period

Dianeâ 35 does not apply to men.

Drug Interactions

Effects of other drugs on Diane â 35

Interaction with drugs that induce microsomal liver enzymes is possible, which may contribute to an increase in the clearance of sex hormones and lead to breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug.

While taking these drugs, the woman should additionally use a barrier method of contraception in addition to Diane® 35 or choose another method of contraception. In this case, the barrier method of contraception should be used during the period of concomitant use of drugs and within 28 days after their withdrawal.

If the period of use of the barrier method of protection ends later than the tablets in the package, you need to move on to the next package of Dianeâ 35 without the usual break in taking the tablets.

Substances that increase the clearance of Dianeâ 35 (reducing the effectiveness due to the induction of liver enzymes), for example:

barbiturates, rifampicin and antiepileptic drugs (such as barbexaclone, carbamazepine, phenytoin, primidone); there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

Substances with different effects on the clearance of Dianeâ 35

When used concomitantly with Diane® 35, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors may increase or decrease plasma levels of estrogens or progestins. These changes may in some cases be relevant.

Effects of estrogen/progestogen combinations on other drugs

Estrogen/progestogen combinations like Diane 35 may interfere with the metabolism of certain other drugs, resulting in increased (eg, cyclosporine) or decreased (eg, lamotrigine) plasma and tissue concentrations.

It may be necessary to adjust the dose of hypoglycemic drugs, given the effect on glucose tolerance.

Other interactions

Laboratory tests

Taking drugs like Dianeâ 35 may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, such as corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism, coagulation parameters, and fibrinolysis. However, these changes usually do not go beyond the limits of normal values.

A woman should be warned that Diana® 35 should not be used in addition to other hormonal contraceptives. These drugs must be discontinued before starting treatment with Diane 35.

special instructions

Precautions and Warnings

Diane® 35 contains the progestogen cyproterone acetate and the estrogen ethinyl estradiol and is used for 21 days of the monthly cycle. The drug has a composition similar to other combined oral contraceptives.

Application duration

The time to relief of the symptoms of the disease is at least three months. The attending physician should conduct regular examinations to determine the need for continued treatment.

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of treatment with Diane® 35 should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen or appear for the first time, the woman should consult her doctor. The doctor needs to decide when to stop the drug.

· Circulatory disorders

Patients taking Diane® 35 have an increased risk of developing venous thromboembolism (VTE) compared to women not taking this drug. The greatest additional risk of VTE occurs during the first year of taking Diane-35 or when taking it again, as well as when switching to this drug after a break in taking at least one month. Venous thromboembolism can be fatal in 1-2% of cases.

The results of epidemiological studies indicate that the incidence of VTE among users of Dianeâ 35 is 1.5-2 times higher than in women using combined hormonal contraceptives containing levonorgestrel and may be similar to the risk while taking combined hormonal contraceptives containing desogestrel / gestodene / drospirenone.

There is a possibility that among women using the drug Diane® 35, there may be patients with a congenital increased risk of developing cardiovascular diseases, for example, associated with polycystic ovary syndrome.

In addition, data from epidemiological studies indicate a relationship between the use of hormonal contraceptives and an increased risk of arterial thromboembolism, such as myocardial infarction and transient ischemic attacks.

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, as well as retinal vessels, have been described.

Symptoms of venous or arterial thrombosis or cerebrovascular disorders may include:

unusual unilateral pain and / or swelling in the leg, sudden sharp pain in the chest, regardless of radiating to the left arm, sudden attack of coughing, any unusual, severe or prolonged headache, sudden partial or complete loss of vision, diplopia, speech impairment or loss of speech, dizziness, loss of consciousness or fainting with or without a local epileptic seizure, weakness or severe numbness, suddenly occurring on one side of the body or one part of the body, movement disorders, symptoms of an "acute abdomen".

The risk of developing venous thromboembolic disorders increases:

With age

If there is a family history (venous thromboembolism in close relatives or parents at a relatively young age). If a hereditary predisposition is known or suspected, a woman should consult a doctor to decide on the possibility of taking a hormonal contraceptive.

Prolonged immobilization, major surgery, any leg surgery, or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization. If Diane® 35 has not been discontinued in advance, antithrombotic therapy should be considered.

The risk of developing arterial thromboembolic complications or cerebrovascular disorders increases:

With age

In smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old. Women over 35 years old who want to use Dianeâ 35 are strongly advised to stop smoking).

Dyslipoproteinemia

Obesity (body mass index over 30 kg/m2)

arterial hypertension

Migraine

valvular heart disease

atrial fibrillation

If there is a family history (arterial thrombosis in close relatives or parents at a relatively young age). If a hereditary predisposition is known or suspected, a woman should consult a doctor to decide on the possibility of taking a hormonal contraceptive.

Circulatory disturbances may also be noted:

with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increased risk of developing thromboembolism in the postpartum period should be taken into account (see section "Pregnancy and lactation").

An increase in the frequency and severity of migraine during the use of Diana® 35 (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

Women taking Diana 35 should be specifically instructed to contact their doctor if possible symptoms of thrombosis appear. Diane 35 should be discontinued if thrombosis is suspected or confirmed. Given the teratogenic effect of anticoagulants (coumarin series), appropriate methods of contraception should be used.

Arterial thromboembolic processes can be life-threatening or fatal.

Consideration should be given to the possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors.

In such cases, the increased risk may be greater than just the combined risk when all factors are considered.

Diane 35 should not be prescribed in case of a negative risk/benefit ratio (see section "Contraindications").

Tumors

The most significant risk factor for developing cervical cancer is a viral infection - persistent human papilloma (HPV). There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral

contraceptives, but there is conflicting evidence about the extent to which this may be due to other factors, including the frequency of cervical examination and sexual behavior, including the use of barrier methods of contraception.

A meta-analysis of 54 epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women currently taking combined oral contraceptives or who have recently taken it is insignificant in relation to the overall risk of developing this disease. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effects of combined oral contraceptives, or a combination of both factors. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors was observed. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. In the event of severe pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, a liver tumor should be considered in the differential diagnosis.

Malignant tumors can be life-threatening or fatal.

Other conditions

In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives or Diane® 35, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops during Dianeâ 35, Dianeâ 35 should be discontinued and treatment of arterial hypertension should be started. Reception Diane 35 can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions observed during pregnancy may also appear or worsen when taking combined oral contraceptives: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. However, the relationship between the development of these conditions and the use of combined oral contraceptives has not been proven.

In women with hereditary angioedema, exogenous estrogens may provoke or exacerbate the symptoms of this disease.

In the presence of acute or chronic liver dysfunction, it is necessary to decide whether to stop taking Dianeâ 35 until the liver function returns to normal. With the development of recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, Diane® 35 should be discontinued.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.

Against the background of the use of combined oral contraceptives, manifestations of Crohn's disease and ulcerative colitis were observed.

Women with a tendency to chloasma while taking Dianeâ 35 should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Reduced efficiency

The contraceptive effectiveness of Diane 35 may be reduced by skipping pills, gastrointestinal disturbances, or co-administration of certain drugs.

irregular bleeding

While taking all combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

Some women may not develop withdrawal bleeding during the 7-day break from taking the pills. If Dianeâ-35 was taken according to the instructions given in the Dosage and Administration section, it is unlikely that the woman is pregnant. However, if Diane was not taken as directed before the first withdrawal bleeding occurred, or if there are no consecutive withdrawal bleedings, pregnancy must be ruled out before continuing with the drug.

One tablet of Dianeâ-35 contains 31 mg of lactose monohydrate and 19 mg of sucrose. Patients with rare hereditary disorders such as galactose or fructose intolerance, lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take Diane-35.

If women suffering from hirsutism have developed symptoms recently or have significantly increased, other causes, such as an androgen-producing tumor, congenital dysfunction of the adrenal cortex, should be considered in the differential diagnosis.

Pregnancy and lactation

It is necessary to exclude pregnancy. Dianeâ 35 is contraindicated during pregnancy. If pregnancy is detected while taking the drug, you should immediately stop taking it.

Dianeâ 35 is also contraindicated during lactation, since cyproterone acetate may be excreted in milk. About 0.2% of the dose taken by the mother can be delivered to the newborn, which corresponds to a dose of about 1 µg/kg. 0.02% of the daily dose of ethinylestradiol taken by the mother can enter the body of a newborn with breast milk during established lactation.

Preclinical safety data for ethinylestradiol

The toxicity profile of ethinylestradiol is well understood. There are no preclinical data that supplement the information on the safety of ethinylestradiol specified in other sections of the instructions for medical use of the drug.

Cyproterone acetate Systemic toxicity

Data from standard preclinical toxicity studies with repeated use of cyproterone acetate do not indicate a specific risk to humans.

Embryotoxicity/teratogenicity

Embryotoxicity studies with a combination of both active substances of the drug do not indicate the presence of teratogenic effects at the stage of organogenesis before the development of the external genital organs.

Taking high doses of cyproterone acetate in the hormone-sensitive phase of genital differentiation leads to the appearance of female sexual characteristics in male fetuses. Monitoring of newborn boys whose mothers took cyproterone acetate during pregnancy did not reveal the development of any female sexual characteristics in them. However, taking Dianeâ 35 is contraindicated during pregnancy.

Genotoxicity and carcinogenicity

The results of standard basic tests for cyproterone acetate genotoxicity were negative. However, additional tests showed that cyproterone acetate has the ability to form DNA adducts, which leads to increased DNA repair in rat and monkey liver cells, as well as freshly isolated human hepatocytes, while the level of DNA adducts was extremely low in dog liver cells.

The formation of adducts with DNA developed with systemic exposure, presumably expected at the recommended dosages of cyproterone acetate. With the introduction of cyproterone acetate in vivo in female rats, an increase in the frequency of focal, possibly preneoplastic, foci with changes in cellular enzymes was observed, and an increase in the frequency of mutations in transgenic mice carrying a bacterial gene as a target for mutation.

During the clinical use of the drug and in epidemiological studies, there was no increase in the incidence of liver tumors in humans. In studies on rodents, no carcinogenic properties of the drug were found. However, it must be kept in mind that sex steroids can stimulate the growth of some hormone-dependent tumors and tissues. In general, according to existing data, there are no contraindications regarding the use of Dianeâ 35 in humans, provided that the instructions for its use and recommended doses are followed.

Additional information for special categories of patients Children and adolescents

Dianeâ 35 is indicated only after the onset of menarche.

Elderly patients

Not applicable. Dianeâ 35 is not indicated for women after menopause.

Patients with liver disorders

Diane® 35 is contraindicated in women with severe liver disease until liver function tests return to normal. Patients with kidney disorders

In this article, you can read the instructions for using the drug Diana-35. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Diane-35 in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Diana 35 analogs in the presence of existing structural analogs. Use of a hormonal contraceptive drug for contraception and acne (acne) treatment in adults, children, and pregnancy and breastfeeding.

Diana-35- combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with progestogenic activity - cyproterone acetate.

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

Against the background of taking Diane-35, the increased activity of the sebaceous glands decreases, which plays an important role in the occurrence of acne (pimples) and seborrhea. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea. Diane-35 therapy in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of the treatment should be expected only after several months of use.

Along with the above-described antiandrogenic effect of cyproterone acetate, it also has a pronounced progestogenic effect.

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

The cycle becomes more regular, painful periods are less often observed, the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.

Compound

Ethinylestradiol + cyproterone acetate + excipients.

Pharmacokinetics

Cyproterone acetate

After taking Diane-35 cyproterone acetate is completely absorbed from the gastrointestinal tract. Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4.0% is in the free state. Since protein binding is nonspecific, changes in the level of sex steroid-binding globulin (SHBG) do not affect the pharmacokinetics of cyproterone acetate. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk. It is excreted mainly in the form of metabolites with urine and bile in a ratio of 1: 2, a small part - unchanged with bile.

Ethinylestradiol

After taking Diane-35, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. In the process of absorption and "first passage" through the liver, ethinylestradiol undergoes intensive metabolism, which leads to a bioavailability of approximately 45%, and its significant individual variability. Ethinylestradiol is excreted from the body as 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)), androgenetic alopecia and mild forms of hirsutism.

Release form

Dragee 35 mcg + 2 mg (sometimes erroneously called tablets, although there are no tablet forms of the hormonal contraceptive Diane-35).

Instructions for use and regimen

Diane-35 is taken orally 1 tablet per day. Dragees are taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not play a role, but the subsequent dose should be taken at the same selected hour, preferably after breakfast or dinner.

Diane-35 intake is started on the 1st day of the cycle, using pills of the corresponding day of the week from the calendar package.

The daily intake of the drug is carried out using dragees from the calendar package sequentially in the direction of the arrow printed on the foil until all the dragees are taken. After the end of taking all 21 pills from the calendar package, a break is made in taking the drug for 7 days, during which menstrual-like bleeding occurs.

After 28 days from the start of taking the drug (21 days of admission and 7 days off), 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 started the next day after taking the last pill with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 pills) . Further according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive dragee.

When switching from contraceptives containing only gestagens ("mini-pill"), Diane-35 can be used without interruption. When using injectable forms of contraceptives, Diane-35 begins to be taken from the day the next injection is to be made. When switching from an implant - 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 taking the dragee.

After an abortion in the 1st 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 started on the 21st-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 sexual life between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or it is necessary to wait for the first menstruation.

A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that taking pills should never be interrupted for more than 7 days, and that 7 days of continuous pills are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

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

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time ). The next dragee is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.

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

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 interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Diane-35 from a new package should be after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).

In the treatment of hyperandrogenic conditions, the duration of administration is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse a few weeks or months after the completion of the course, repeated therapy with Diane-35 can be performed.

Side effect

• engorgement, soreness, 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 to contact lenses;
• allergic reactions;
• the appearance of age spots on the face (chloasma).

Contraindications

• thrombosis and thromboembolism, incl. in history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
• diabetes mellitus complicated by microangiopathies;
• the presence of severe or multiple risk factors for venous or arterial thrombosis;
• diseases or severe violations of the liver;
• liver tumors (including history);
• hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including history);
• uterine bleeding of unknown etiology;
• pancreatitis (including history), if it was accompanied by severe hypertriglyceridemia;
• a history of migraine, which was accompanied by focal neurological symptoms;
• lactation (breastfeeding);
• pregnancy or suspicion of it;
• hypersensitivity to the components of the drug.

Use during pregnancy and lactation

Diane-35 is contraindicated for use during pregnancy and lactation.

special instructions

Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. With prolonged use of the drug, preventive control examinations should be carried out every 6 months.

The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 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, you should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain with or without radiating to the left arm; sudden shortness of breath; sudden onset of 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/without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.

The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.

If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.

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

If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done 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 may include diagnostic curettage.

In some cases, withdrawal bleeding may not develop during a break in taking the dragee. In case of irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

drug interaction

With the simultaneous use of Diane-35 with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and, possibly, with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.

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

Analogues of the drug Diane-35

Structural analogues for the active substance:

• Belluna 35;
• Chloe.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Some modern contraceptives are endowed with not only a contraceptive property. They are successfully used to eliminate a certain range of ailments and the consequences of hormonal disorders. These include the drug Diane-35, which will be discussed today.

In this article, you can learn about the mechanism of its influence, possible contraindications and adverse reactions, as well as many other characteristics.

pharmachologic effect

The drug Diane-35 is part of a group of combined oral contraceptives.

In addition to contraception, it also has several actions at the same time on the female body:

• Gestagennoe.
• Estrogen.
• Antiandrogenic.

Contraceptive effectiveness occurs due to the thickening of mucous secretions. So it is very difficult for spermatozoa to overcome the path to the intended goal, which is why pregnancy does not occur.

Diane-35 contraceptive with antiandrogenic effect. This is achieved due to the presence of cyproterone acetate in the composition.

The substance helps to reduce or eliminate completely signs of a woman's masculinization:

1. Decreased secretion of subcutaneous lipids.
2. Reduces hair loss.
3. Stops the growth of unwanted hair.

As a result of the reception process, the some diseases caused by an excess of androgens. Thanks to the drug Diane-35, you can get rid of acne.

The contraceptive inhibits ovulation, monthly bleeding becomes less painful and intense. The menstrual cycle itself is regulated to the state of the norm.

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Composition and form of release

The drug is created in tablet form based on cyproterone acetate and ethinyl estradiol.

One pack contains 21 Diane-35 tablets

As additional ingredients in the production of Diane-35 tablets, the following are used:

• Lactose monohydrate.
• Povidone.
• Corn starch.
• magnesium stearate.
• Magnesium hydrosilicate.
• Sucrose.
• Glycerol.
• Macrogol -6000.
• calcium carbonate.
• Titanium dioxide.
• Wax.
• iron oxide.

Indications for use

The contraceptive Diane-35 is used to prevent pregnancy only by those women who suffer from androgenization, namely against:

1. Seborrhea.
2. Alopecia in a mild form.

Photo gallery of testimony:

seborrhea

Also, the contraceptive Diane-35 is actively used for polycystic ovaries. Like many other COCs, the drug is effective for endometriosis.

Contraindications

To refuse the consumption of contraceptive pills Diane-35 is in the presence of:

• Diseases of the liver.
• Idiopathic jaundice.
• Itching of the skin layer.
• Thrombosis / thromboembolism.
• Angina.
• Dubin-Johnson/Rotor syndromes.
• Tumors of the endometrium.
• Pregnancy.
• breast cancer.
• Obesity.
• Dermatosis of the blistering form.
• Diabetes.
• Vaginal bleeding.
• Tumors of a malignant nature, dependent on hormones.

Photo of contraindications:

Liver disease

Thrombosis

Pregnancy

Side effects

The drug Diane-35 sometimes causes adverse reactions.

No. p / p	Name of the organ system	Adverse reactions from birth control pills
1	visual organs	contact lens intolerance
2	Digestive system	Nausea, vomiting Diarrhea Pain in the abdomen
3	General	Weight gain Weight loss
	Metabolic processes	Fluid retention
	CNS	Headache Migraine
	Psychiatric disorders	Bad mood Mood volatility Decreased libido Increased libido
	Organs of the reproductive system	Pain in the mammary glands Breast engorgement Hypertrophic processes in the mammary glands Vaginal discharge Discharge from the mammary glands
	Epidermis and subcutaneous tissue	Rash Hives Erythema nodosum or multiforme Hair loss

drug interaction

The contraceptive Diane-35 should not be combined with medicines that treat epileptic syndrome, tuberculosis and have antibacterial properties. Such a compound will reduce the effectiveness of the tablets.

Useful video:

Alcohol compatibility

The drug of the new generation Diane-35 is not advised to be combined with alcoholic beverages, although the official description does not provide this information.

Dosage and overdose

The established dose of the contraceptive Diane-35 is not capable of provoking an overdose.

The negative effect on the body of tablets on the body is possible only with a significant excess of the dosage.

Instructions for use

How to take the drug Diane-35 without harm to health, without lowering its effectiveness, is of interest to many women.

No. p / p	Categories	Features of the use of contraceptive pills
1	General information	The drug is taken one pill per day orally for 21 days. Then comes a week break, during which menstruation begins. One of the most important aspects in the consumption of Diane-35 tablets is the time of administration. It should be the same every day. The first time the use of the drug coincides with the first day of monthly bleeding. In this case, there is no need for additional protection against pregnancy. If the pills started to be used later, for the period of the first week it is worth additional protection.
2	Switching to Yarina or any other hormonal contraceptives	In this case, you need to contact a specialist. Only he is able to advise how to properly switch and drink a new drug.
3	Abortion / early miscarriage	You can start taking birth control pills from the first day.
4	Late miscarriage/abortion/delivery	The drug should be taken no earlier than 21 and no later than 28 days after.
5	Missed pill	Drink within 12 hours.

Shelf life and storage of the drug

The contraceptive Diana-35 is allowed to be stored at a temperature not higher than + 30 degrees. Term - 5 years.

special instructions

The drug Diane-35 is used to treat the symptoms of androgenization of the female body, including against increased hairiness.

The duration of therapy depends on the neglect of the disease. Improvement in the condition of the skin and hair occurs after it is possible to lower prolactin by taking pills.

Take the contraceptive Diane-35 and Duphaston at the same time in order to get pregnant

If the skin layer of a woman is prone to pigmentation, a woman not worth it stay in the sun a lot and often.

For pregnancy, you need to stop using the contraceptive Diane-35. Conception can successfully occur, both immediately after the abolition of pills, and after a certain period of time.

Sometimes after discontinuation of the drug Diane-35 there is no menstruation. In a short time, regular bleeding is restored.

Price

The drug Diane-35 has a cost of 990 rubles.

Have you taken contraceptive pills Diane-35 and how would you rate the effectiveness?

Dragee: 21 pcs. in concurrency, 3 and 6 concurrencies per pack. One dragee contains ethinylestradiol 35 mcg; cyproterone acetate 2 mg. Excipients: lactose monohydrate, corn starch, povidone, talc (hydrous magnesium silicate), magnesium stearate.

Pharmacological action

Combined low-dose monophasic oral contraceptive with antiandrogenic effect, containing estrogen - ethinyl estradiol and antiandrogen with progestogenic activity - cyproterone acetate.

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

Against the background of taking Diane-35, the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea, decreases. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive oiliness of hair and skin disappears even earlier. It also reduces hair loss, which often accompanies seborrhea. Diane-35 therapy in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of the treatment should be expected only after several months of use.

Along with the above-described antiandrogenic effect of cyproterone acetate, it also has a pronounced progestogenic effect.

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

The cycle becomes more regular, painful periods are less often observed, the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.

Indications for use

• 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/), androgenetic alopecia and mild forms of hirsutism.

Dosage and administration

Diane-35 is taken orally 1 tablet per day. Dragees are taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not play a role, but the subsequent dose should be taken at the same selected hour, preferably after breakfast or dinner.

Starting the drug

• In the absence of taking any hormonal contraceptives in the previous month.
  Diane-35 intake is started on the 1st day of the cycle, using pills of the corresponding day of the week from the calendar package. The daily intake of the drug is carried out using dragees from the calendar package sequentially in the direction of the arrow printed on the foil until all the dragees are taken. After the end of taking all 21 pills from the calendar package, a break is made in taking the drug for 7 days, during which menstrual-like bleeding occurs. After 28 days from the start of taking the drug (21 days of admission and 7 days off), 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.
  Reception of Diane-35 should be started the next day after taking the last pill with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in admission (for drugs containing 21 pills). Further according to the scheme described above. If the patient has taken the previous contraceptive daily for 28 days, Diane-35 should be started after taking the last inactive dragee.
• When switching from contraceptives containing only gestagens ("mini-drank").
  Diane-35 can be started without interruption. When using injectable forms of contraceptives, Diane-35 begins to be taken from the day the next injection is to be made. When switching from an implant - 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 taking the dragee.
• 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 second 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 taking the pills.

If a woman had a sexual life between childbirth or abortion and the start of taking Diane-35, then pregnancy should first be excluded or it is necessary to wait for the first menstruation.

Taking missed pills

A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that taking pills should never be interrupted for more than 7 days, and that 7 days of continuous pills are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

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

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time ). The next dragee is taken at the usual time. In addition, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken. If a woman vomits within 3 to 4 hours after taking Diane-35, absorption of the active substances may not be complete. In this case, it is necessary to focus on the recommendations when skipping the dragee.

How to change menstrual cycles or how to delay the onset of menstruation

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 interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Diane-35 from a new package should be after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).

Reception of Diane-35 for medicinal purposes

In the treatment of hyperandrogenic conditions, the duration of administration is determined by the severity of the disease. After the disappearance of symptoms, it is recommended to take Diane-35 for at least another 3-4 months. In the event of a relapse a few weeks or months after the completion of the course, repeated therapy with Diane-35 can be performed.

Side effect

While taking combined oral contraceptives in women, the following undesirable side effects were observed:

System organ class	Side effects
From the digestive system	nausea, abdominal pain, vomiting, diarrhea
From the reproductive system	engorgement, breast tenderness, hypertrophy (enlargement) of the mammary glands, vaginal discharge, discharge from the mammary glands
From the CNS	headache, decreased mood, mood swings, decreased libido, migraine
From the organ of vision	intolerance to contact lenses (discomfort when wearing them)
From the side of metabolism	weight gain, fluid retention in the body
Dermatological reactions	rash, urticaria, erythema nodosum, erythema multiforme

As with other combined oral contraceptives, in rare cases, thrombosis and thromboembolism may develop. These side effects may develop in the first few months of taking Diane-35 and usually decrease over time.

Contraindications

• thrombosis and thromboembolism, incl. in history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
• diabetes mellitus complicated by microangiopathies;
• the presence of severe or multiple risk factors for venous or arterial thrombosis;
• diseases or severe violations of the liver;
• liver tumors (including history);
• hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including history);
• uterine bleeding of unknown etiology;
• pancreatitis (including history), if it was accompanied by severe hypertriglyceridemia;
• a history of migraine, which was accompanied by focal neurological symptoms;
• lactation (breastfeeding);
• pregnancy or suspicion of it;
• hypersensitivity to the components of the drug.

If any of these conditions develop for the first time while taking Diane-35, the drug should be immediately discontinued.

The use of Diane-35 during pregnancy and lactation

Diane-35 is contraindicated for use during pregnancy and lactation.

Application for violations of liver function

special instructions

Before starting the use of Diane-35, it is necessary to conduct a general medical examination (including the mammary glands and a cytological examination of cervical mucus), exclude pregnancy, disorders of the blood coagulation system. With prolonged use of the drug, preventive control examinations should be carried out every 6 months.

In the presence of risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before she decides to start taking the drug. With aggravation, intensification, or at the first manifestation of any of these conditions or risk factors, drug withdrawal may be required.

The approximate incidence of venous thromboembolism (VTE) when taking oral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 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, you should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling; sudden severe chest pain with or without radiating to the left arm; sudden shortness of breath; sudden onset of 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/without partial seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptom complex "acute" abdomen.

The relationship between taking combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, Diane-35 should be canceled and appropriate antihypertensive therapy prescribed. Reception of a contraceptive can be continued with the normalization of blood pressure.

If abnormal liver function occurs, Diane-35 may need to be temporarily discontinued until laboratory parameters return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, it is usually not necessary to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under close medical supervision.

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

If symptoms in women with hirsutism have developed recently or have increased significantly, other causes, such as an androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.

While taking Diane-35, irregular bleeding (spotting or breakthrough bleeding) can sometimes occur, especially during the first months of therapy. Therefore, evaluation of any irregular bleeding should be done 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 may include diagnostic curettage.

In some cases, withdrawal bleeding may not develop during a break in taking the dragee. In case of irregular intake of pills or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to take the drug.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding (in girls).

Treatment: carry out symptomatic therapy. There is no specific antidote.

drug interaction

With the simultaneous use of Diane-35 with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and, possibly, with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinylestradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decrease in the reliability of contraception.

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