Lindynette 20 coated pills 20mg N21
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Active ingredients
Gestoden + Ethinyl Estradiol
Release form
Pills
Composition
Active ingredient: Ethinyl estradiol + Gestodene (Ethinylestradiol + Gestodene) Concentration of the active substance (mg): Ethinyl estradiol 0.02 mg, gestodene 0, 075 mg
Pharmacological effect
Combined oral contraceptives, such as Lindynette 20 coated pills, contain hormones similar to the hormones that your body produces (estrogen and progestogen). They help prevent pregnancy in the same way that your natural hormones would prevent the fertilization of an egg if you were already pregnant. Combined oral contraceptives protect you from pregnancy in three ways: 1. The egg cell will not leave the ovary, and the sperm will not be able to fertilize it. 2. The mucus in the cervix will become more sperm to the egg. 3. The mucous membrane of the uterus becomes thinner, which makes an oocyte not fertilized.
Pharmacokinetics
Gestoden suction After oral administration is rapidly and completely absorbed from the gastrointestinal tract. The source is a portal about medicine. After a single dose, Cmax is noted after 1 hour and is 2-4 ng / ml. Source - portal about medicine Bioavailability - about 99%. The source is a portal about medicine. Distribution Gestodene binds to albumin and sex hormone-binding globulin (SHBG). Source - portal about medicine1-2% is in plasma in free form, 50-75% specifically binds to SHBG. The source is a portal about medicine. 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. Source - portal about medicine. Average Vd - 0. Source - portal about medicine 7-1. Source - a portal about medicine 4 l / kg. Source - portal about medicine. The pharmacokinetics of gestodene depends on the level of SHBG. Source - portal about medicine. The concentration of SHBG in plasma under the influence of estradiol increases 3 times. Source - portal about medicine. With daily intake, the concentration of gestodene in the blood plasma increases by 3-4 times and in the second half of the cycle reaches a state of saturation. The source is a portal about medicine. Metabolism and elimination. Gestoden biotransformed in the liver.Source - medicine portal The average plasma clearance is 0. Source - medicine portal 8-1 ml / min / kg. The source is a portal about medicine. The level of gestodene in serum decreases in two phases. Source - portal about medicine in the β-phase - 12-20 hours. Source - portal about medicine. Gestoden is displayed only in the form of metabolites, 60% - with urine, 40% - with feces. The source is a portal about metabolite medicine - about 1 day. Source - medicine portalEtinilestradiol Absorption After oral administration, ethinyl estradiol is absorbed quickly and almost completely. Source - portal about medicine. The average Cmax in the serum is reached within 1-2 hours after administration and is 30-80 pg / ml. Source - portal about medicine. Absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%. Source - portal about medicine. Distribution Completely (about 98. Source - portal about medicine 5%), but non-specifically associated with albumin and induces an increase in the level of SHBG in blood serum. Source - portal about medicine. Average Vd - 5-18 l / kg. Source - portal about medicine Css is established by 3-4 days of taking the drug, and it is 20% higher than after a single dose. Source - portal about medicineMetabolism Subjected to aromatic hydroxylation with the formation of hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Source - portal about medicineMetabolic clearance from blood plasma is about 5-13 ml. The source is a portal about medicine. Excretion. Serum concentration is reduced in two phases. The source - a portal about medicine in the β-phase is about 16-24 hours. The source is a portal about medicineEtinylestradiol is allocated only in the form of metabolites, in a ratio of 2: 3 with urine and bile. The source is a portal about metabolite medicine - about 1 day.
Indications
Contraception.
Contraindications
Individual hypersensitivity to the drug or its components. The presence of severe or multiple risk factors for venous or arterial thrombosis (including severe complications of the valvular apparatus of the heart, atrial fibrillation, vascular disease of the brain or coronary arteries). Uncontrolled arterial hypertension of moderate or severe with hell 160100 mm Hg. Art. And more).Precursors of thrombosis (in t. Ch. Transient ischemic attack, angina), in t. Ch. In the anamnesis. Migraine with focal neurological symptoms, in t. Ch. A history of. Venous or arterial thrombosis thromboembolism (including t. Ch. Deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) currently or anamnesis. The presence of venous thromboembolism in relatives. Serious surgery with prolonged immobilization. Diabetes mellitus (with the presence of angiopathy). Pancreatitis (in t. Ch. In history), accompanied by severe hypertriglyceridemia. Dyslipidemia. Severe liver disease, cholestatic jaundice (including so on. During pregnancy), hepatitis, including so on. History (until normalization of functional and laboratory parameters and within 3 months after the return of these indicators to normal). Jaundice due to the intake of hp containing steroids. Cholelithiasis currently or history. Syndrome gilbert, cudgel-johnson, the rotor. Liver tumors (in t. Ch. A history of). Severe itching, otosclerosis, or progression of otosclerosis during a previous pregnancy or when taking HQ. Hormone-dependent malignant neoplasms of the genital organs and mammary glands (including those. Suspicion of them). Vaginal bleeding of unknown etiology. Smoking over the age of 35 (more than 15 cigarettes per day). Pregnancy or suspicion of her. Lactation.
Precautionary measures
Diseases of the circulatory system. Oral contraceptives increase the risk of myocardial infarction. The risk of myocardial infarction and thromboembolic complications of different localization increases in smokers who have other risk factors (for example, arterial hypertension, hypercholesterolemia, obesity, diabetes mellitus, family history of high fever, age over 35–40 years). This should be taken into account for women over 35 years old and for many smokers. In women in older age and taking the drug for a long time, an increase in blood pressure has been observed. Increased blood pressure is more often observed when using drugs with large doses of hormones. It is necessary to consult a specialist before using the drug if a woman has: congenital predisposition to thromboembolic diseases, obesity (body mass index is above 30 kg / m2),fat metabolism (dyslipoproteinemia), arterial hypertension, valvular heart disease, atrial fibrillation, in cases of prolonged immobilization, severe surgery, surgery on the legs, severe injury (due to the fact that the risk of thromboembolic diseases increases in the postoperative period, you must stop taking the drug 4 weeks before the planned operation and resume taking 2 weeks after the patient’s activation). The drug should be stopped immediately when symptoms of thromboembolism appear: chest pains that may radiate to the left hand, unusually severe pain in the legs, leg edema, sharp stabbing pain when inhaling or coughing, hemoptysis. Tumors. In some studies, there has been an increase in cervical cancer among women who have taken oral contraceptives for a long time (however, a causal relationship with taking the drug has not been proven). The likelihood of developing cervical cancer depends on sexual behavior and on other factors (human papillomavirus). Studies have not proven a causal link between breast cancer and drug intake: in women taking oral contraceptives, the disease was detected at an earlier stage than in women who did not take these drugs. There have been isolated reports of the development of a benign liver tumor in women who have been taking hormonal contraceptives for a long time, with the development of intra-abdominal bleeding. Other pathological conditions. The drug should be stopped when there is a loss of vision (full or partial), exophthalmos, diplopia, or if papilla of the optic nerve is detected or retinal vessels are broken. According to research, the relative risk of gallstones formation increases with age among women who take oral contraceptives or drugs containing estrogen. Recent studies have found that the risk of gallstone disease is less when using drugs with a low dose of hormones. If a migraine appears, a migraine is worsening, or if it appears constant, or when an unusually severe headache recurs, the drug should be stopped.Taking Lindynette should be stopped immediately when a generalized itching occurs or when an epileptic seizure occurs. The effect of the drug on the metabolism of carbohydrates and lipids. Women taking oral contraceptives may experience a decrease in carbohydrate tolerance. Some women have found an increase in blood triglyceride levels with oral contraceptive use. In women with hereditary hyperlipidemia, taking the drug with estrogen, a sharp increase in plasma triglycerides was found, which could lead to the development of pancreatitis. When using oral contraceptives, especially in the first 3 months, irregular (spotting or breakthrough) bleeding may appear. If bleeding occurs for a long time or appears after regular cycles have formed, the cause is usually non-hormonal, and an appropriate gynecological examination should be carried out to prevent pregnancy or malignant tumors. If a non-hormonal cause can be excluded and intermenstrual bleeding continues for more than 4 months, you should switch to taking another drug. In some cases, menstrual bleeding due to discontinuation of the drug during the 7-day interval does not appear. If, prior to the absence of bleeding, the regimen of drug administration was disrupted or if there is no bleeding after the second pack has been taken, pregnancy should be excluded before continuing with the course of taking the drug. Before starting the use of birth control pills, a detailed family and personal history should be collected and a general gynecological examination should be carried out. These studies are repeated every 6 months. During physical examination, blood pressure is measured, mammary glands are examined, abdominal palpation is performed, gynecological examination is performed with a smear cytology test, and laboratory tests according to indications (liver, kidney, adrenal, thyroid gland, fibrinolytic factors, lipoprotein levels and transport proteins). A woman should be warned that the drug does not protect her from sexually transmitted infections, in particular from AIDS.In acute or chronic impairment of hepatic function, discontinue use of the drug to restore the values of liver enzymes. With impaired liver function, the metabolism of steroid hormones may be disturbed. Those women who have depression when taking contraceptives, it is advisable to cancel the drug and temporarily switch to another method of contraception, to clarify the relationship between the development of depression and taking the drug. Careful observation should be made if there is a history of depression, and when depression is resumed, the course of oral contraceptive use should be completed. When using oral contraceptives, the concentration of folic acid in the blood may decrease. This is of clinical importance only in the case of pregnancy in a short time after completion of the course of oral contraceptive use. In diarrhea, intestinal motility increases and the absorption of the drug decreases.
Use during pregnancy and lactation
If you think you are pregnant, stop taking this drug immediately and consult a doctor. Until you consult with your doctor, use another method of contraception, such as a condom or cap plus spermicide. Consult a doctor or pharmacist before using any medication. Since the active substance contained in oral contraceptives can penetrate into breast milk and reduce the amount of breast milk, the use of Lindynette during breastfeeding is not recommended.
Dosage and administration
Inside, without chewing, drinking plenty of water, regardless of the meal. Take 1 tab. 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 (that is, 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 the cancellation of the hormone.
Side effects
Side effects, the appearance of which requires immediate discontinuation of the drug: arterial hypertension, hemolytic-uremic syndrome, porphyria, hearing loss due to otosclerosis.Rarely encountered, arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary thromboembolism). exacerbation of reactive SCR. Very rare, arterial or venous thromboembolism of the liver, mesenteric, renal, retinal arteries and veins. Chorea of Sidengam (passing after drug withdrawal). Other Side effects, less severe, but more common, the feasibility of continuing the use of the drug is decided individually after consulting with a doctor, based on the polaris ratio. On the part of the reproductive system: acyclic hemorrhages, bloodstained vaginal discharge, amenorrhea after discontinuation of the drug, a change in the state of vaginal mucus, the development of inflammatory processes in the vagina (for example, candidiasis), a change in libido. On the part of the mammary glands: tension, pain, enlargement of the mammary glands, galactorrhea. On the part of the digestive tract and the hepatobiliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the occurrence or worsening of jaundice or itching associated with cholestasis, cholelithiasis. Skin: nodular exudative erythema, rash, chloasma, increased hair loss. From the side of the central nervous system: headache, migraine, mood changes, depressive states. Metabolic disorders: fluid retention in the body, a change (increase) in body weight, an increase in the amount of triglycerides and sugar in the blood, a decrease in carbohydrate tolerance. On the part of the senses: hearing loss, increased sensitivity of the cornea when wearing contact lenses. Other: allergic reactions.
Overdose
No serious side effects were reported after taking a significant dose of oral contraceptives. Symptoms such as nausea, vomiting and, in young girls, slight vaginal bleeding may occur. However, if you have taken more than it should, the number of pills Lindynette 20, immediately inform your doctor or pharmacist.
Interaction with other drugs
Rifampicin (increases clearance), as well as barbiturates, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine can lead to breakthrough uterine bleeding or a decrease in contraceptive action. Contraceptive reliability is reduced when taking ampicillin, tetracycline (the mechanism of this action is not clear).During concomitant use with the above drugs, as well as within 7 days after completion of the course of their reception, it is necessary to use other non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used within 4 weeks after completing the course of its administration. Any drug that increases gastrointestinal motility reduces the level of the drug in the blood. Drugs (for example, ascorbic acid), which undergo sulphation in the intestinal wall, competitively inhibit the sulphation of ethinyl estradiol and increase its bioavailability. Liver enzyme inhibitors (for example, itraconazole, fluconazole), increase the concentration of ethinyl estradiol in the blood plasma. Ethinyl estradiol by inhibiting liver enzymes or accelerating conjugation (primarily glucose) may affect the metabolism of other drugs, increasing or decreasing their concentration in the blood (for example, cyclosporine, theophylline). The use of drugs Hypericum (including tea) reduces the concentration of the drug in the blood, which can lead to breakthrough bleeding, pregnancy (the cause is the inducing effect of Hypericum on liver enzymes, which continues for 2 weeks after completing the course of Hypericum). Ritonavir reduces ethinyl estradiol AUC by 41%. In this regard, during the use of ritonavir should use the drug with a higher dose of ethinyl estradiol (Lindinet 30) or use non-hormonal methods of contraception.
special instructions
The effect of the drug on the ability to drive and work with mechanisms No studies have been conducted to study the possible effect of the drug on the ability to drive and work with mechanisms. Important information about some of the components that make up the Lindynette, coated pills. The product contains milk sugar (lactose) and sucrose. If your doctor has told you that you are intolerant to some sugars, consult your doctor before using this drug. Laboratory tests: If you need a blood test, tell your doctor or laboratory technician that you are taking oral contraceptives, as they may change the results of some tests.