The hormonal drug lindinet 20. Lindinet contraceptive is an effective monophasic contraceptive

I have been using Lindinet for a long time, for me this is the best type of contraception! It is very convenient and how nice))

I started with Lindinet 20, but then there was some kind of failure after the cancellation, most likely the dose of the hormone was small, and I had to switch to Lindinet 30. What can I say about the differences? While taking 20, my stomach did not hurt before menstruation. Sometimes it is very, sometimes not very much, but still better than before taking contraceptives. Then I couldn't get out of bed at all.

Do you know what is a huge plus of this tool for me? The discharge during menstruation is minimal! I don’t buy pads at all, I use dailies. The monthly period lasts 3 days, literally a few drops per day.

Second plus:if for some reason you need to prevent periods, then it is very simple to do this: after drinking 21 tablets, you do not take a seven-day break, but start drinking the next pack immediately. I do this periodically, no problems arose. PMS on the days of the expected period also does not bother. In general, it is very convenient. You need to be prepared that when the period does come (at the end of the second pack) they can be more abundant than usual.

Dear girls, if you decide to use hormonal contraceptives, be prepared for the fact that without lubrication you may not be able to make love! I use this and this as a lubricant. Just do not try to combine the first with condoms! Unless of course you want a baby.

I am not attaching the instruction, because it is HUGE! You can find it on the Internet

I will attach only the most important.

And now I’ll tell you how I once bought lindinet 30. I decided, therefore, to buy myself 3 packs, in reserve. I went to one of the cheapest pharmacies, bought 1 pack for 543 rubles. I thought it was a little expensive, so I did not buy 2 more And in the evening, when we were walking with my beloved, I looked into another pharmacy, and there ... There one pack (from one batch) cost 327 rubles, but this pack was the last, and they gave me another (from another batch) it cost 407 p .. Here is such a fun in our pharmacies!

So do not rush to take it right away, it is better to find out the price of the medicine in different pharmacies.

Happy shopping and quality sex to everyone!)))))

In this article, you can read the instructions for using the drug Lindinet 20 and 30... The reviews of website visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Lindinet in their practice are presented. A big request to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, which may not have been declared by the manufacturer in the annotation. Lindinet's analogs in the presence of available structural analogs. Use of hormonal contraceptive for contraception in women, including during pregnancy and breastfeeding. Side effects (bleeding, pain).

Lindineth - monophasic oral contraceptive. Inhibits the secretion of pituitary gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which, together with the corpus luteum hormone, participates in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which surpasses in strength and selectivity of action not only the natural hormone of the corpus luteum progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has practically no effect on lipid and carbohydrate metabolism.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

The difference between Lindinet 20 and Lindinet 30

The main difference between both drugs lies in the different amount of ethinyl estradiol included in the component, one type of drug contains 30 μg, the other 20 μg. Hence the different names for nevertheless similar drugs. Also, both drugs contain 75 μg of gestodene.

Pharmacokinetics

Gestoden

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability is about 99%. Gestodene is biotransformed in the liver. It is excreted only in the form of metabolites, 60% - with urine, 40% - with feces.

Ethinylestradiol

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. Ethinylestradiol is excreted only in the form of metabolites, in a ratio of 2: 3 with urine and bile.

Indications

• contraception.

Release forms

Film-coated tablets.

Instructions for use and reception scheme

Assign 1 tablet per day for 21 days, if possible at the same time of day. After taking the last pill from the package, take a 7-day break, during which withdrawal bleeding occurs. The next day after a 7-day break (i.e. 4 weeks after taking the first tablet, on the same day of the week), the drug is resumed.

The first tablet of Lindinet should be taken from the 1st to the 5th day of the menstrual cycle.

When switching to taking Lindinet from another combined oral contraceptive, the first Lindinet tablet should be taken after taking the last tablet from the package of another oral hormonal contraceptive, on the first day of withdrawal bleeding.

When switching to Lindinet from drugs containing only progestogen ("mini-pills", injections, implant), when taking "mini-pills", you can start taking Lindinet on any day of the cycle, you can switch from using an implant to taking Lindinet on the day after the removal of the implant, when using injections - on the eve of the last injection. In these cases, additional methods of contraception should be used in the first 7 days.

After an abortion in the 1st trimester of pregnancy, you can start taking Lindinet immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the 2nd trimester of pregnancy, the drug can be taken on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. At a later start of taking the drug in the first 7 days, an additional, barrier method of contraception should be used. In the case when sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude pregnancy or postpone the start of taking until the first menstruation.

If you miss a pill, the missed pill should be taken as soon as possible. If the interval in taking the pills is less than 12 hours, then the contraceptive effect of the drug does not decrease, and in this case there is no need to use an additional method of contraception. The rest of the tablets should be taken at the usual time. If the interval is more than 12 hours, then the contraceptive effect of the drug may decrease. In such cases, you should not replenish the missed dose, continue taking the drug as usual, but in the next 7 days you need to use an additional method of contraception. If there are less than 7 tablets left in the package, you should start taking the drug from the next package without interruption. In this case, withdrawal bleeding does not occur until the completion of taking the drug from the second package, but spotting or breakthrough bleeding may appear.

If withdrawal bleeding does not occur after the completion of taking the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

If vomiting and / or diarrhea begins within 3-4 hours after taking the drug, a decrease in the contraceptive effect is possible. In such cases, you should follow the directions for skipping pills. If the patient does not want to deviate from the usual contraceptive regimen, the missed pills should be taken from a different package.

To speed up the onset of menstruation, you should reduce the break in taking the drug. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking the tablets from the next pack (similar to cases with delayed menstruation).

To delay the onset of menstruation, the drug must be continued from a new package without a 7-day break. You can delay your period as long as necessary until the end of the last pill from the second pack. With a delay in menstruation, breakthrough or spotting bleeding may appear. Regular use of Lindinet can be restored after the usual 7-day break.

Side effect

Side effects requiring discontinuation of the drug:

• arterial hypertension;
• arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism);
• arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins;
• hearing loss due to otosclerosis;
• hemolytic uremic syndrome;
• porphyria;
• exacerbation of reactive systemic lupus erythematosus;
• sydenham's chorea (disappearing after drug withdrawal).

Other side effects (less severe):

• acyclic bleeding / spotting from the vagina;
• amenorrhea after drug withdrawal;
• changes in the state of vaginal mucus;
• development of inflammatory processes of the vagina;
• candidiasis;
• tension, pain, enlargement of the mammary glands;
• galactorrhea;
• epigastric pain;
• nausea, vomiting;
• crohn's disease;
• ulcerative colitis;
• the onset or exacerbation of jaundice and / or pruritus associated with cholestasis;
• liver adenoma;
• erythema nodosum;
• exudative erythema;
• rash;
• chloasma;
• increased hair loss;
• headache;
• migraine;
• lability of mood;
• depression;
• hearing loss;
• increased sensitivity of the cornea (when wearing contact lenses);
• fluid retention in the body;
• change (increase) in body weight;
• decreased tolerance to carbohydrates;
• hyperglycemia;
• allergic reactions.

Contraindications

• the presence of severe and / or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries, severe or moderate arterial hypertension with BP ≥ 160/100 mm Hg . st.);
• the presence or indication of a history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, incl. in the anamnesis;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
• a history of venous thromboembolism;
• surgical intervention with prolonged immobilization;
• diabetes mellitus (with angiopathy);
• pancreatitis (including in history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in anamnesis (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking GCS;
• gallstone disease at present or in history;
• gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including a history);
• severe itching, otosclerosis, or its progression during a previous pregnancy or taking GCS;
• hormone-dependent malignant neoplasms of the genitals and mammary glands (including if they are suspected);
• vaginal bleeding of unknown etiology;
• smoking over the age of 35 (more than 15 cigarettes per day);
• pregnancy or suspicion of it;
• lactation period;
• hypersensitivity to drug components.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

In small amounts, the components of the drug are excreted in breast milk.

When used during lactation, milk production may decrease.

special instructions

Before starting to use the drug, it is necessary to conduct a general medical (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). A similar examination during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women within 1 year), when used correctly, is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of taking is fully manifested by the 14th day, then in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before the appointment of hormonal contraceptives, the advantages or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make a final decision on the preference for hormonal or some other method of contraception.

The health status of a woman must be carefully monitored. If, while taking the drug, any of the following conditions / diseases appears or worsens, you must stop taking the drug and switch to another, non-hormonal method of contraception:

• diseases of the hemostatic system;
• conditions / diseases that predispose to the development of cardiovascular, renal failure;
• epilepsy;
• migraine;
• the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
• diabetes mellitus, not complicated by vascular disorders;
• severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B6 can be used for correction);
• sickle cell anemia; in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests to assess liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a link between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (heavy smoking and age over 35 are risk factors);
• if you have a family history of thromboembolic disease (for example, in a parent, brother or sister). If you suspect a genetic predisposition, it is necessary to consult a specialist before using the drug;
• with obesity (body mass index over 30 kg / m2);
• with dyslipoproteinemia;
• with arterial hypertension;
• with diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus complicated by vascular lesions;
• with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed that the drug should be temporarily discontinued (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Postpartum women have an increased risk of venous thromboembolic disease.

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

It should be borne in mind that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin 3 deficiency, the presence of antiphospholipid antibodies, increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit / risk ratio of taking the drug, it should be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism. The symptoms of thromboembolism are:

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that persists for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half of the body, movement disorders, severe one-sided pain in the gastrocnemius muscle, sharp abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who have taken hormonal contraception for a long time, but research results are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in breast cancer risk among women taking oral hormonal contraceptives, but higher breast cancer detection rates may have been associated with more regular medical check-ups. Breast cancer is rare among women younger than 40 years old, whether they are taking hormonal contraception or not, and increases with age. Taking pills can be one of many risk factors. However, the woman should be made aware of the potential for breast cancer risk based on an assessment of the benefit / risk ratio (protection against ovarian and endometrial cancer).

There are few reports on the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be borne in mind in the differential diagnostic assessment of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Lindinet.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, the simultaneous use of other drugs that reduce the effectiveness of contraceptive pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, smearing or breakthrough bleeding appears, in such cases it is advisable to continue taking the pills until they end in the next package. If at the end of the second cycle menstrual bleeding does not start or acyclic spotting does not stop, stop taking the pills and resume it only after excluding pregnancy.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogenic component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking the drug, you must use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35) and on the number of cigarettes smoked.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and use mechanisms

No studies have been conducted to study the effect of Lindinet on the ability to drive a car and production mechanisms.

Drug interactions

The contraceptive activity of Lindinet decreases when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. The contraceptive effect of oral contraceptives decreases with the use of these combinations, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet with the above drugs, as well as within 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional contraceptive methods should be used within 4 weeks after completion of the course.

When used simultaneously with Lindinet, any drug that increases gastrointestinal motility, reduces the absorption of active substances and their level in the blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that also undergo sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinylestradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine). Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), interfering with the intrahepatic circulation of estrogen, reduce the level of ethinyl estradiol in plasma.

Ethinyl estradiol by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation) can affect the metabolism of other drugs (including cyclosporine, theophylline); the concentration of these drugs in blood plasma may increase or decrease.

With the simultaneous use of Lindinet with St. John's wort preparations (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding, pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for 2 more weeks after the completion of the course of taking St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher content of ethinyl estradiol (Lindinet 30) should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives can decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic drugs.

Analogues of the drug Lindinet

Structural analogues for the active substance:

• Logest;
• Mirelle;
• Femoden.

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

Lindinet 20 (ethinyl estradiol + gestodene) is a monophasic tablet combination (estrogen + progestogen) contraceptive. Manufacturer - Hungarian pharmaceutical company "Gedeon Richter". Date of entry into the world market - 2004. The drug is valued for its ability to provide reliable contraception and effectively control the menstrual cycle. Lipndinet 20 is well tolerated, does not affect blood pressure and aldosterone concentration, which is especially important for women in the premenopausal and climacteric periods. Lindinet 20 is also an excellent choice for women of middle reproductive age (22 to 35 years old) who need long-term, reliable and safe contraception, as well as for girls who are just starting to use hormonal contraception. Despite the low quantitative content of active ingredients, the drug reliably controls the menstrual cycle and is guaranteed to eliminate the characteristic pain in the lower abdomen. Lindinet 20 is the best choice in cases where a woman has developed undesirable effects due to a high dose of an estrogenic or progestin component. Lindinet 20 contains in its composition a minimum dose of ethinylestradiol and progestogen (gestodene), which ensures a rapid drop in the concentration of estrogen in plasma. Gestodene is included in the drug at a dose that does not have clinically significant glucocorticoid activity, which helps maintain a stable body weight.

This is confirmed by studies of the drug, demonstrating the absence of a significant increase in body weight in women. Gestodene is one of the most potent and highly selective progestins on the pharmaceutical market today. Due to its high activity, this substance is used in low concentrations, in which it does not affect the metabolism of fats and carbohydrates and does not exhibit androgenic properties. In addition to contraceptive, the drug also has a therapeutic effect, preventing the development of a number of gynecological diseases, incl. tumor etiology.

Before using Lindinet 20, a woman must undergo a medical examination, including the collection of family and personal anamnestic data, blood pressure measurement, laboratory tests, and a gynecological examination. In the future, a similar examination, provided that the woman takes oral contraceptives, should be carried out at a frequency of 1 every six months. Before the start of contraceptive therapy with the use of hormonal contraceptives, all possible benefits and potential risks are weighed for each woman, after which the doctor together with the woman makes a joint decision on the choice of one or another method of contraception. If, after starting to take the drug, a woman has developed or worsened diseases of the circulatory system, cardiovascular diseases, epilepsy, diabetes mellitus, depression, then contraceptive therapy should be discontinued.

Pharmacology

Monophasic oral contraceptive. Inhibits the secretion of pituitary gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which, together with the corpus luteum hormone, participates in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which surpasses in strength and selectivity of action not only the natural hormone of the corpus luteum progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has practically no effect on lipid and carbohydrate metabolism.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. After a single dose, C max is noted after 1 hour and is 2-4 ng / ml. Bioavailability is about 99%.

Distribution

Gestodene binds to albumin and sex hormone binding globulin (SHBG). 1-2% is in plasma in free form, 50-75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases, and the fraction associated with albumin decreases. Average V d - 0.7-1.4 l / kg. The pharmacokinetics of gestodene depends on the level of SHBG. The concentration of SHBG in the blood plasma under the action of estradiol increases 3 times. With daily intake, the concentration of gestodene in the blood plasma increases by 3-4 times and in the second half of the cycle it reaches a saturation state.

Metabolism and excretion

Gestodene is biotransformed in the liver. The average plasma clearance is 0.8-1 ml / min / kg. The serum gestodene level decreases in two phases. T 1/2 in β-phase - 12-20 hours. Gestodene is excreted only in the form of metabolites, 60% - with urine, 40% - with feces. T 1/2 metabolites - about 1 day.

Ethinylestradiol

Suction

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. The average C max in serum is reached within 1-2 hours after administration and is 30-80 pg / ml. The absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%.

Distribution

Completely (about 98.5%), but nonspecifically binds to albumin and induces an increase in the level of SHBG in the blood serum. Average V d - 5-18 l / kg.

C ss is established by 3-4 days of taking the drug, and it is 20% higher than after a single dose.

Metabolism

Undergoes aromatic hydroxylation to form hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). The metabolic clearance from blood plasma is about 5-13 ml.

Withdrawal

Serum concentration decreases in two phases. T 1/2 in the β-phase - about 16-24 hours. Ethinylestradiol is excreted only in the form of metabolites, in a ratio of 2: 3 with urine and bile. T 1/2 metabolites - about 1 day.

Release form

Film-coated tablets of light yellow color, round, biconvex, both sides without inscriptions; at the fracture white or almost white with a light yellow edging.

Excipients: sodium calcium edetate - 0.065 mg, magnesium stearate - 0.2 mg, colloidal silicon dioxide - 0.275 mg, povidone - 1.7 mg, corn starch - 15.5 mg, lactose monohydrate - 37.165 mg.

Shell composition: quinoline yellow dye (D + C yellow No. 10) (E104) - 0.00135 mg, povidone - 0.171 mg, titanium dioxide - 0.46465 mg, macrogol 6000 - 2.23 mg, talc - 4.242 mg, calcium carbonate - 8.231 mg, sucrose - 19.66 mg.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

Dosage

Assign 1 tablet / day for 21 days, if possible at the same time of day. After taking the last pill from the package, take a 7-day break, during which withdrawal bleeding occurs. The next day after a 7-day break (i.e. 4 weeks after taking the first tablet, on the same day of the week), the drug is resumed.

Taking the first tablet of Lindinet 20 should be started from the 1st to the 5th day of the menstrual cycle.

When switching to taking Lindinet 20 from another combined oral contraceptive, the first Lindinet 20 tablet should be taken after taking the last tablet from the package of another oral hormonal contraceptive, on the first day of withdrawal bleeding.

When switching to Lindinet 20 with drugs containing only gestagen ("mini-pills", injections, implant), when taking "mini-pills", Lindinet 20 can be taken on any day of the cycle, switch from using an implant to taking Lindinet 20 is possible the next day after the removal of the implant, when using injections - on the eve of the last injection. In these cases, additional methods of contraception should be used in the first 7 days.

After an abortion in the first trimester of pregnancy, you can start taking Lindinet 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the II trimester of pregnancy, the drug can be taken on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. At a later start of taking the drug in the first 7 days, an additional, barrier method of contraception should be used. In the case when sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude pregnancy or postpone the start of taking until the first menstruation.

If you miss a pill, the missed pill should be taken as soon as possible. If the interval in taking the pills is less than 12 hours, then the contraceptive effect of the drug does not decrease, and in this case there is no need to use an additional method of contraception. The rest of the tablets should be taken at the usual time. If the interval is more than 12 hours, then the contraceptive effect of the drug may decrease. In such cases, you should not replenish the missed dose, continue taking the drug as usual, but in the next 7 days you need to use an additional method of contraception. If, at the same time, less than 7 tablets remain in the package, you should start taking the drug from the next package without interruption. In this case, withdrawal bleeding does not occur until the completion of taking the drug from the second package, but spotting or breakthrough bleeding may appear.

If withdrawal bleeding does not occur after the completion of taking the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

If vomiting and / or diarrhea begins within 3-4 hours after taking the drug, a decrease in the contraceptive effect is possible. In such cases, you should follow the directions for skipping pills. If the patient does not want to deviate from the usual contraceptive regimen, the missed pills should be taken from a different package.

To speed up the onset of menstruation, you should reduce the break in taking the drug. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking the tablets from the next pack (similar to cases with delayed menstruation).

To delay the onset of menstruation, the drug must be continued from a new package without a 7-day break. You can delay your period as long as necessary until the end of the last pill from the second pack. With a delay in menstruation, breakthrough or spotting bleeding may appear. Regular use of Lindinet 20 can be restored after the usual 7-day break.

Overdose

No severe symptoms have been described after taking the drug in high doses.

Symptoms: nausea, vomiting, in girls - bleeding from the vagina.

Treatment: symptomatic therapy is prescribed, there is no specific antidote.

Interaction

The contraceptive activity of Lindinet 20 decreases when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. The contraceptive effect of oral contraceptives decreases with the use of these combinations, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet 20 with the above drugs, as well as within 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional contraceptive methods should be used within 4 weeks after the end of the course.

When used simultaneously with Lindinet 20, any drug that increases gastrointestinal motility, reduces the absorption of active substances and their level in the blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that also undergo sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinylestradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine).

Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), interfering with the intrahepatic circulation of estrogen, reduce the level of ethinyl estradiol in plasma.

Ethinyl estradiol by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation) can affect the metabolism of other drugs (including cyclosporine, theophylline); the concentration of these drugs in blood plasma may increase or decrease.

With the simultaneous use of Lindinet 20 with St. John's wort preparations (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding, pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for 2 more weeks after the completion of the course of taking St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher content of ethinyl estradiol should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives can decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic drugs.

Side effects

Side effects requiring drug withdrawal

From the side of the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

Others: hemolytic uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (disappearing after drug withdrawal).

Other side effects are more common but less severe. The feasibility of continuing to use the drug is decided individually after consulting a doctor, based on the benefit / risk ratio.

From the reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina, candidiasis, tension, pain, enlargement of the mammary glands, galactorrhea.

From the digestive system: epigastric pain, nausea, vomiting, Crohn's disease, ulcerative colitis, the onset or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the side of the central nervous system: headache, migraine, mood lability, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Others: allergic reactions.

Indications

Contraception.

Contraindications

• the presence of severe and / or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries, severe or moderate arterial hypertension with BP ≥ 160/100 mm Hg . st.);
• the presence or indication of a history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, incl. in the anamnesis;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
• a history of venous thromboembolism;
• surgical intervention with prolonged immobilization;
• diabetes mellitus (with angiopathy);
• pancreatitis (including in history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking GCS;
• gallstone disease at present or in history;
• gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including a history);
• severe itching, otosclerosis, or its progression during a previous pregnancy or taking GCS;
• hormone-dependent malignant neoplasms of the genitals and mammary glands (including if they are suspected);
• vaginal bleeding of unknown etiology;
• smoking over the age of 35 (more than 15 cigarettes per day);
• pregnancy or suspicion of it;
• lactation period;
• hypersensitivity to drug components.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), hemolytic uremic syndrome, hereditary angioedema, liver disease, diseases that first appeared or worsened during pregnancy or against the background of previous intake of sex hormones (including porphyria, herpes of pregnant women, chorea / Sydenham's disease /, Sydenham's chorea, chloasma) , obesity (BMI over 30 kg / m 2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis , postpartum period (n e lactating women / 21 days after childbirth /; lactating women after the end of the lactation period), the presence of severe depression (including in the history), changes in biochemical parameters (resistance of activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases.

Application features

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

In small amounts, the components of the drug are excreted in breast milk.

When used during lactation, milk production may decrease.

Application for violations of liver function

Contraindicated in liver dysfunction.

Application for impaired renal function

The drug is not recommended for use in kidney disease.

special instructions

Before starting to use the drug, it is necessary to conduct a general medical (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). A similar examination during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women within 1 year), when used correctly, is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before the appointment of hormonal contraceptives, the advantages or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make a final decision on the preference for hormonal or some other method of contraception.

The health status of a woman must be carefully monitored. If, while taking the drug, any of the following conditions / diseases appears or worsens, you must stop taking the drug and switch to another, non-hormonal method of contraception:

• diseases of the hemostatic system;
• conditions / diseases that predispose to the development of cardiovascular, renal failure;
• epilepsy;
• migraine;
• the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
• diabetes mellitus, not complicated by vascular disorders;
• severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used for correction);
• sickle cell anemia; in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests to assess liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a link between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (heavy smoking and age over 35 are risk factors);
• if you have a family history of thromboembolic disease (for example, in a parent, brother or sister). If you suspect a genetic predisposition, it is necessary to consult a specialist before using the drug;
• with obesity (BMI over 30 kg / m 2);
• with dyslipoproteinemia;
• with arterial hypertension;
• with diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus complicated by vascular lesions;
• with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed that the drug should be temporarily discontinued (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Postpartum women have an increased risk of venous thromboembolic disease.

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

It should be borne in mind that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, the presence of antiphospholipid antibodies, increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit / risk ratio of taking the drug, it should be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism. The symptoms of thromboembolism are:

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that persists for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half of the body, movement disorders, severe one-sided pain in the gastrocnemius muscle, acute abdomen symptom complex.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who have taken hormonal contraception for a long time, but research results are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in breast cancer risk among women taking oral hormonal contraceptives, but higher breast cancer detection rates may have been associated with more regular medical screening. Breast cancer is rare among women younger than 40 years old, whether they are taking hormonal contraception or not, and increases with age. Taking pills can be one of many risk factors. However, the woman should be made aware of the potential for breast cancer risk based on an assessment of the benefit / risk ratio (protection against ovarian and endometrial cancer).

There are few reports on the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be borne in mind in the differential diagnostic assessment of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of chloasma should avoid contact with sunlight or ultraviolet radiation while taking Lindinet 20.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, the simultaneous use of other drugs that reduce the effectiveness of contraceptive pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, smearing or breakthrough bleeding appears, in such cases it is advisable to continue taking the pills until they end in the next package. If at the end of the second cycle menstrual bleeding does not start or acyclic spotting does not stop, stop taking the pills and resume it only after excluding pregnancy.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogenic component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking the drug, you must use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35) and on the number of cigarettes smoked.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and use mechanisms

No studies have been conducted to study the effect of Lindinet 20 on the ability to drive a car and industrial machinery.

Recently, more and more women are choosing the drug lindinet 20 as an oral contraceptive. It is believed that this hormonal agent has a rather mild effect on the female body. According to statistics, the number of people who become pregnant while taking a contraceptive varies within 0.05%. Despite this, you should be very serious about its use. This will help the reviews of the women and specialists who took it.

Lindinet 20: drug features

Lindinet 20 is a film-coated tablet. They are sold in separate blisters and are designed for specific courses of admission. Moreover, all pills have the same dose of hormones.

The effect of the drug is due to the presence of ethinyl estradiol and gestodene in its composition. The first is a synthetic analogue of a hormone that affects the menstrual cycle. How the drug works: Its components affect ovulation. They also make the mucus in the cervix more viscous. Due to this, sperm cannot continue to move towards the egg.

The drug is interesting in that it can have a positive therapeutic effect on the female body. It manifests itself in the fact that menstruation becomes less painful. The cycle is also getting better. Lindinet 20 is believed to have a preventive effect. In particular, it can prevent fibroids and ovarian cancer.

How to take lindinet 20?

The main feature of the drug is the method of administration. The tablets in the blaster are numbered. You need to drink them in this sequence, 1 piece per day. Better to choose the same time. There is a nuance. Oral hormonal contraceptives are thought to increase appetite. Therefore, it is better to drink them in the evening when you are less hungry. Some doctors believe that the optimal time is 9 hours, since hormones begin to be better absorbed during this time. The drug is taken according to the following scheme:

• Begin to drink lindinet 20 from 1 to 5 days of the menstrual cycle. On the first days of admission, menstruation may stop. Don't be alarmed. This is the reaction of the body.
• In the first 14 days of taking the contraceptive, non-hormonal methods of contraception should be used. This is due to the fact that the contraceptive effect may not occur at this time. A similar reaction is associated with the absorption of hormones and their effect on the body.
• Then, 1 tablet is drunk for 21 days. Then you need to take a 7-day break. During this period, your period may begin. During this period of time, you can do without other methods of contraception if you continue the course.
• Resume drinking lindinet strictly on the 8th day of the break. This is done even if your month has begun.
• The drug has a number of features. Often they are associated with how to take lindinet 20 after other contraceptives. The dosage regimens depend on the course of the previous drugs. If there were 28 tablets in it, then Lindinet 20 is taken the next day. It happens that contraceptives are designed for 21 days. In this case, you can take Lindinet 20 immediately the next day after the last tablet. It is also allowed to take a 7-day break and drink it for 8 days.
• A separate scheme exists if you put on a hormonal contraceptive patch or put on a ring. Then you can start drinking lindinet 20 after you have removed them. Or they drink it on the day when they need to be replaced.
• The instructions for the drug also indicate how it should be drunk in case of "skipping" tablets. If this happened in the period from 1 to 7 days, then the drug should be drunk as soon as possible. Double dose is allowed. By the way, it has the desired effect only for 12 hours. In the next week you will have to use additional protection. In the period from 8 to 14 days, they do the same. If there were no missed pills in the previous week, then you can not use other methods of protection. The same rule applies to a pass in the period of 15-21 days.

Lindinet 20: side effects

The side effects of Lindinet 20 may be intimidating to some women. The manufacturer claims that in some cases, the drug can also lead to hearing loss! The main unpleasant symptoms from taking the drug include:

1. Deterioration of the condition - there is a headache up to migraines, nausea, weakness. A sudden change in mood is possible, and even the onset of depression.
2. Skin and Hair Problems - Hair may begin to fall out. Eczema or rash occurs on the skin.
3. Changes are also possible in the reproductive system. Discharge or inflammation may begin. Sometimes in women, sexual activity is greatly reduced.
4. The digestive system reacts with stomach pain and even ulcerative colitis!
5. Reduced vision is also possible.
6. Do not take this drug for diabetics, women who have problems with blood clots, in the presence of liver tumors, jaundice, during pregnancy and lactation, and in a number of other cases.

Lindinet 20: reviews of doctors

Lindinet 20 is a special drug. The instructions for it say that it cannot be prescribed independently. If you want to switch to this contraceptive, then first you need to contact your gynecologist. He will conduct a routine examination and prescribe the necessary tests. The drug is prescribed only on the basis of diagnosis!

Special attention should be paid to the reviews of doctors about the action of lindinet 20. There are opinions that the drug is "capricious". This means that there are times when it is difficult for a woman's body. This is manifested, among other things, in the manifestation of some side effects. The woman becomes ill elementary. The condition worsens to the point that bright red discharge occurs, the temperature rises and severe weakness.

No less important are the reviews on lindinet of 20 women taking it. On the Internet, opinions about this drug vary. So you can find references to strong side effects. Some have spotting, pain in the lower abdomen, which radiates to the lower back. Those who have not approached lindineitis 20 may also be tormented by nausea, up to and including rejection of food. It happens that due to the drug migraines occur.

In some women, on the contrary, there are positive side effects due to the intake of lindinet 20. Thus, the fair sex, in some cases, according to reviews, pleases the enlarged breasts. In some cases, it becomes larger by 1-1.5 sizes! Weight normalization is also noted. One of the women in responses to lindinite 20 wrote that she started taking it when her daughter was 6 months old. At that moment, with a height of 165 cm, she weighed 80 kg. As a result, within six months of taking her, her weight decreased to 68 kg!

Lindinet 20 can be used only after consulting a gynecologist. He is prescribed according to the results of examinations and analyzes. They drink a contraceptive from 1 to 5 days of the cycle for 21 days. Then take a break for 7 days and resume taking on the 8th day. In the 1st 14 days, you need to use additional contraception. There are different reviews for the drug. In some cases, the woman's body rejects it. This causes severe side effects.

The last updated description by the manufacturer 07/13/2015 Filtered list Active substance: ATX Pharmacological group Nosological classification (ICD-10) 3D images Composition Film-coated tablets 1 tab. active substances: ethinyl estradiol 0.02 mg gestodene 0.075 mg excipients nucleus: sodium calcium edetate - 0.065 mg; magnesium stearate - 0.2 mg; colloidal silicon dioxide - 0.275 mg; povidone - 1.7 mg; corn starch - 15.5 mg; lactose monohydrate - 37.165 mg shell: quinoline yellow dye (D + C yellow No. 10 - E104) - 0.00135 mg; povidone - 0.171 mg; titanium dioxide - 0.46465 mg; macrogol 6000 - 2.23 mg; talc - 4.242 mg; calcium carbonate - 8.231 mg; sucrose - 19.66 mg Description of the dosage form Pills: round, biconvex, covered with a shell of light yellow color, both sides without inscription. At the break: white or almost white, with light yellow edging. pharmachologic effect pharmachologic effect - estrogen-gestagenic, contraceptive. Pharmacodynamics Combined remedy, the action of which is due to the effects of the components that make up its composition. Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is a highly effective oral drug - ethinyl estradiol (a synthetic analogue of estradiol, which, together with the corpus luteum hormone, participates in the regulation of the menstrual cycle). The gestagenic component is a derivative of 19-nortestosterone - gestodene, which surpasses not only the natural corpus luteum hormone progesterone in strength and selectivity, but also modern synthetic gestagens (levonorgestrel). Due to its high activity, gestodene is used in very low dosages, in which it does not exhibit androgenic properties and practically does not affect lipid and carbohydrate metabolism. Along with the indicated central and peripheral mechanisms that prevent the maturation of an ovum capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of mucus in the cervix, which makes it relatively impassable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature. Pharmacokinetics Gestoden Suction. When taken orally, it is rapidly and completely absorbed. After taking a single dose, C max in plasma is measured in an hour and is 2-4 ng / ml. Bioavailability is about 99%. Distribution. Binds to albumin and sex hormone binding globulin (SHBG). 1-2% are in a free state, 50-75% are specifically associated with SHBG. An increase in SHBG levels due to ethinyl estradiol affects the level of gestodene, leading to an increase in the SHBG-associated fraction and a decrease in the albumin-associated fraction. V d gestodene - 0.7-1.4 l / kg. Metabolism. Corresponds to steroid metabolism. Average plasma clearance is 0.8-1 ml / min / kg. Excretion. The blood level decreases in two stages. Half-life in the final phase is 12-20 hours. It is excreted exclusively in the form of metabolites - 60% with urine, 40% with feces. T 1/2 metabolites - about 1 day. Stable concentration. The pharmacokinetics of gestodene largely depends on the level of SHBG. Under the influence of ethinylestradiol, the concentration of SHBG in the blood increases by 3 times; with daily intake of the drug, the level of gestodene in the plasma increases 3-4 times and in the second half of the cycle reaches a saturation state. Ethinylestradiol Suction. When taken orally, it is absorbed quickly and almost completely. C max in the blood is measured after 1-2 hours and is 30-80 pg / ml. Absolute bioavailability "60% (due to presystemic conjugation and primary metabolism in the liver). Distribution. It easily enters into a nonspecific bond with blood albumin (about 98.5%) and causes an increase in SHBG levels. Average V d - 5-18 l / kg. Metabolism. It is carried out mainly due to aromatic hydroxylation with the formation of large amounts of hydroxylated and methylated metabolites, which are partially in free, partially in conjugated form (glucuronides and sulfates). Plasma clearance "5-13 ml / min / kg. Excretion. The serum concentration is reduced in 2 steps. T 1/2 in the second phase "16-24 hours. It is excreted exclusively in the form of metabolites in a ratio of 2: 3 with urine and bile. T 1/2 metabolites "1 day. Stable concentration. It is established by the 3-4th day, while the level of ethinyl estradiol is 20% higher than after taking a single dose. Indications of the drug Lindinet 20 Contraception. Contraindications individual hypersensitivity to the drug or its components; the presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valve apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries); uncontrolled arterial hypertension of moderate or severe degree with blood pressure 160/100 mm Hg. Art. and more); precursors of thrombosis (including transient ischemic attack, angina pectoris), incl. in the anamnesis; migraine with focal neurological symptoms, incl. in the anamnesis; venous or arterial thrombosis / thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) at present or with a history; the presence of venous thromboembolism in relatives; serious surgical intervention with prolonged immobilization; diabetes mellitus (with the presence of angiopathy); pancreatitis (including in history), accompanied by severe hypertriglyceridemia; dyslipidemia; severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before the normalization of functional and laboratory parameters and within 3 months after the return of these indicators to normal); jaundice due to the intake of drugs containing steroids; gallstone disease at the present time or history; gilbert's syndrome, Dubin-Johnson, Rotor; liver tumors (including a history); severe itching, otosclerosis or progression of otosclerosis during a previous pregnancy or when taking GCS; hormone-dependent malignant neoplasms of the genitals and mammary glands (including suspicion of them); vaginal bleeding of unknown etiology; smoking over the age of 35 (more than 15 cigarettes per day); pregnancy or suspicion of it; lactation. Carefully: conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism (age over 35, smoking, hereditary predisposition to thrombosis - thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives); hemolytic uremic syndrome; hereditary angioedema; liver disease; diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, chorea minor - Sydenham's disease, Sydenham's chorea, chloasma); obesity (body mass index over 30); dyslipoproteinemia; arterial hypertension; migraine; epilepsy; valvular heart disease; atrial fibrillation; prolonged immobilization; extensive surgical intervention; surgery on the lower limbs; severe injury; varicose veins and superficial thrombophlebitis; postpartum period (non-lactating women - 21 days after childbirth; lactating women - after the end of the lactation period); the presence of severe depression, incl. in the anamnesis; changes in biochemical parameters (resistance of activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant); diabetes mellitus, not complicated by vascular disorders; systemic lupus erythematosus (SLE); Crohn's disease; ulcerative colitis; sickle cell anemia; hypertriglyceridemia (including a family history); acute and chronic liver diseases. Application during pregnancy and lactation The use of the drug during pregnancy and lactation is contraindicated. Side effects Side effects that require immediate discontinuation of the drug: Arterial hypertension; Hemolytic uremic syndrome; Porphyria; Hearing loss due to otosclerosis. Rarely found - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); exacerbation of reactive SLE. Very rare - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; chorea Sydenham (passing after drug withdrawal). Other side effects, less severe, but more common -the expediency of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit / risk ratio. On the part of the reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of vaginal inflammatory processes (eg candidiasis), changes in libido. From the side of the mammary glands: tension, pain, breast enlargement, galactorrhea. From the gastrointestinal tract and hepatobiliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the onset or exacerbation of jaundice and / or pruritus associated with cholestasis, cholelithiasis. From the skin side: nodular / exudative erythema, rash, chloasma, increased hair loss. From the side of the central nervous system: headache, migraine, mood changes, depression. Metabolic disorders: fluid retention in the body, a change (increase) in body weight, an increase in the amount of triglycerides and blood sugar, a decrease in carbohydrate tolerance. From the senses: hearing loss, increased sensitivity of the cornea of \u200b\u200bthe eye when wearing contact lenses. Others: allergic reactions. Interaction The contraceptive effect of oral contraceptives decreases with the simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent. A similar, but less studied, interaction exists between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin, and presumably griseofulvin, ampicillin and tetracyclines. During treatment with the above drugs, it is recommended to use an additional method of contraception (condom, spermicidal gel) simultaneously with oral contraception. After completion of the course of treatment, the use of an additional method of contraception should be continued for 7 days, in the case of rifampicin treatment - within 4 weeks. Drug absorption interactions During diarrhea, the absorption of hormones decreases (due to increased intestinal motility). Any drug that shortens the residence time of the hormone in the colon will result in low blood levels of the hormone. Interactions related to drug metabolism Intestinal wall. Drugs that undergo sulfation in the intestinal wall like ethinyl estradiol (for example, ascorbic acid) inhibit metabolism and increase the bioavailability of ethinyl estradiol. Liver metabolism. Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oxcarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma. Effect on intrahepatic circulation. Some antibiotics (for example, ampicillin, tetracycline), interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma. Influence on the exchange of other drugs By blocking liver enzymes or accelerating conjugation in the liver, mainly enhancing glucuronidation, ethinyl estradiol affects the metabolism of other drugs (eg cyclosporine, theophylline), leading to an increase or decrease in their plasma concentrations. The simultaneous use of St. John's wort preparations is not recommended ( Hypericum perforatum) with Lindinet 20 tablets (due to a possible decrease in the contraceptive effect of the active substances of the contraceptive, which may be accompanied by the appearance of breakthrough bleeding and unwanted pregnancy). St. John's wort activates liver enzymes; after discontinuation of St. John's wort preparations, the effect of enzyme induction can persist for the next 2 weeks. The simultaneous use of ritonavir and combined contraceptive is accompanied by a decrease in the average AUC of ethinyl estradiol by 41%. During treatment with ritonavir, it is recommended to use a drug with a higher ethinyl estradiol content or a non-hormonal method of contraception. It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives can decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic drugs. Method of administration and dosage Inside, without chewing, drinking plenty of water, regardless of the meal. Take 1 table. per day (if possible at the same time of day) for 21 days. Then, after taking a 7-day break in taking the pills, resume oral contraception (i.e. 4 weeks after taking the 1st table, on the same day of the week) During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal. First intake of the drug: taking the drug Lindinet 20 should be started from the 1st to the 5th day of the menstrual cycle. Switching from a combined oral contraceptive to taking Lindinet 20. 1st table Lindinet 20 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the 1st day of withdrawal bleeding. Switching from progestogen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 20. You can start switching from mini-pills any day of your menstrual cycle; in the case of an implant - the day after its removal; in the case of injections, the day before the last injection. In this case, in the first 7 days of taking Lindinet 20, an additional method of contraception must be used. Taking Lindinet 20 after an abortion in the first trimester of pregnancy. Contraceptive use can be started immediately after an abortion, without the need for an additional method of contraception. Taking Lindinet 20 after childbirth or after an abortion in the second trimester of pregnancy. Contraceptive use can be started on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. At a later start of taking a contraceptive, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case when sexual intercourse took place before the start of contraception, before you start taking the drug, you should exclude the presence of a new pregnancy or wait for the next menstruation. Missed pills. If the next scheduled pill intake was missed, then the missed dose should be replenished as soon as possible. With a delay not exceeding 12 hours, the contraceptive effect of the drug does not decrease, and there is no need to use an additional method of contraception. The rest of the tablets are taken as usual. For more than 12 hours, the contraceptive effect may decrease. In such cases, you should not replenish the missed dose, continue taking the drug as usual, but in the next 7 days you need to use an additional method of contraception. If, at the same time, less than 7 tablets remained in the package, then they start taking the tablets from the next package without observing a break. In such cases, withdrawal uterine bleeding occurs only after the completion of the 2nd package; while taking pills from the 2nd package, spotting or breakthrough bleeding is possible. If, at the end of taking the pills from the 2nd package, withdrawal bleeding does not occur, then pregnancy should be excluded before continuing to take the contraceptive. Measures to be taken in case of vomiting and diarrhea. If vomiting occurs in the first 3-4 hours after taking the next tablet, the tablet is not completely absorbed. In such cases, proceed in accordance with the instructions described in paragraph Missed pills. If the patient does not want to deviate from the usual contraceptive regimen, the missed pills should be taken from a different package. Delay of menstruation and acceleration of the onset of menstruation. In order to delay menstruation, they start taking pills from a new package without observing a break. Menstruation can be delayed as desired until all pills from the 2nd pack are gone. With a delay in menstruation, breakthrough or spotting uterine bleeding is possible. You can return to the usual pill intake after observing the 7-day break. For an earlier onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking the tablets from the next pack (similar to cases with delayed menstruation). Overdose The use of large doses of contraceptive was not accompanied by the development of severe symptoms. Symptoms: nausea, vomiting, young girls have slight vaginal bleeding. Treatment: symptomatic, no specific antidote. special instructions Before starting to use the drug, it is recommended to collect a detailed family and personal history and subsequently every 6 months undergo a general medical and gynecological examination (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, control of blood pressure, blood cholesterol concentration, urinalysis). These studies must be periodically repeated due to the need for timely identification of risk factors or emerging contraindications. The drug is a reliable contraceptive drug - the Pearl index (an indicator of the number of pregnancies that occurred during the use of the method of contraception in 100 women within 1 year), when used correctly, is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception. In each case, before the appointment of hormonal contraceptives, the advantages or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make a final decision on the preference for hormonal or some other method of contraception. The health status of a woman must be carefully monitored. If, while taking the drug, any of the following conditions / diseases appears or worsens, you must stop taking the drug and switch to another, non-hormonal, method of contraception: Diseases of the hemostatic system; Conditions / diseases predisposing to the development of cardiovascular, renal failure; Epilepsy; Migraine; The risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases; Diabetes mellitus not complicated by vascular disorders; Severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used for correction); Sickle cell anemia; in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism; The appearance of abnormalities in laboratory tests to assess liver function. Thromboembolic diseases Epidemiological studies have shown that there is a link between the use of oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal or retinal vessels is very rarely observed. The risk of arterial or venous thromboembolic disease increases: With age; When smoking (heavy smoking and age over 35 are risk factors); If you have a family history of thromboembolic disease (for example, in a parent, brother or sister). If you suspect a genetic predisposition, it is necessary to consult a specialist before using the drug; With obesity (body mass index above 30); With dyslipoproteinemia; With arterial hypertension; With diseases of the heart valves, complicated by hemodynamic disorders; With atrial fibrillation; With diabetes mellitus complicated by vascular lesions; With prolonged immobilization, after major surgery, surgery on the lower limbs, severe trauma. In these cases, a temporary cessation of the drug is assumed. It is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization. The risk of venous thromboembolic diseases in women after childbirth increases. Diseases such as diabetes mellitus, SLE, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases. Biochemical abnormalities such as resistance to activated protein C, hyperhomocysteinemia, protein C, S deficiency, antithrombin III deficiency, the presence of antiphospholipid antibodies, increase the risk of arterial or venous thromboembolic diseases. When assessing the benefit / risk ratio of taking the drug, it should be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism. Signs of thromboembolism are: Sudden chest pain that radiates to the left arm; Sudden shortness of breath; Any unusually severe headache that persists for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half of the body, movement disorders, severe one-sided pain in the gastrocnemius muscle, sharp abdomen. Tumor diseases Some studies have reported an increased incidence of cervical cancer in women who have taken hormonal contraception for a long time, but research results are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer. A meta-analysis of 54 epidemiological studies showed that there is a relative increase in breast cancer risk among women taking oral hormonal contraceptives, but higher rates of breast cancer could be associated with more regular medical examinations. Breast cancer is rare among women younger than 40 years old, whether they are taking hormonal contraception or not, and it increases with age. Taking pills can be one of many risk factors. However, the woman should be made aware of the potential for breast cancer risk based on an assessment of the benefit versus risk ratio (protection against ovarian, endometrial and colon cancer). There are few reports on the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be borne in mind in the differential diagnostic assessment of abdominal pain, which may be associated with an increase in liver size or intra-abdominal bleeding. A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases. The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, concomitant use of other drugs that reduce the effectiveness of birth control pills. If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used. The effectiveness of the drug may decrease if, after several months of their use, irregular, smearing or breakthrough bleeding appears, in such cases it is advisable to continue taking the pills until they end in the next package. If at the end of the 2nd cycle menstrual bleeding does not begin or acyclic spotting does not stop, you should stop taking the pills and resume it only after excluding pregnancy. Chloasma Chloasma can sometimes occur in women who have had a history of it during pregnancy. Those women who are at risk of chloasma should avoid contact with the sun or UV while taking the pills. Changes in laboratory parameters Under the influence of oral contraceptive pills - due to the estrogenic component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change. After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months). With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug intake, additional non-hormonal methods of contraception must be used). Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35) and the number of cigarettes smoked. During lactation, milk secretion may decrease; in small amounts, the components of the drug are excreted in breast milk. The effect of the drug on the ability to drive a car and working mechanisms. No studies have been conducted to study the possible effect of Lindinet 20 on the ability to drive a car or other vehicles.	ICD-10 heading	Synonyms for ICD-10 diseases
Z30 Monitoring contraceptive use	Hormonal contraception
	Contraception
	Intrauterine contraception
	Local contraception
	Oral contraception
	Contraception in women with androgenic symptoms
	Local contraception
	Installation and removal of an intrauterine device
Z30.0 General advice and advice on contraception	Safe sex
	Intrauterine contraception
	Contraception
	Intrauterine contraception
	Contraception in adolescents
	Oral contraception
	Oral contraception during lactation and when estrogen is contraindicated
	Postcoital contraception
	Preventing pregnancy
	Pregnancy prevention (contraception)
	Prevention of unwanted pregnancy
	Emergency contraception
	Occasional pregnancy protection

 

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