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Active ingredients
Desogestrel
Release form
Pills
Composition
In 1 tablet: desogestrel 75 mcg. Auxiliary substances: lactose monohydrate - 55.095 mg, potato starch - 6.5 mg, povidone K30 - 1.95 mg, colloidal silicon dioxide - 0.65 mg, stearic acid 50 - 0.65 mg, all-rac-α-tocopherol - 0.08 mg.
Pharmacological effect
Gestagen-containing contraceptive for oral use, the active ingredient of which is desogestrel. Similar to other gestagen-containing oral contraceptives (mini-pilli), Lactinet; Richter is best suited for use during breastfeeding and for women who are contraindicated or who do not want to take estrogens. In contrast to the mini-pili, the contraceptive effect of the drug Lactinet; -Richter is achieved mainly by suppressing ovulation. Other effects include an increase in the viscosity of cervical mucus. When using Lactinet; Richter in the first 56 days, the frequency of ovulation does not exceed 1%, after cessation of the 56-day administration of the drug, ovulation occurs after 7-30 days (on average, after 17 days). a study of efficacy (in which the missed pills were allowed to be taken for a maximum of 3 hours), the general Pearl index (an indicator reflecting the pregnancy rate in 100 women during the year of using the contraceptive), desogestrel was 0.4 per group ppe of all patients included in the study. The Pearl Index for Lactinet; -Richter is comparable to the Pearl Index of Combined Oral Contraceptives (CCP) in the general population of women taking oral contraceptives. Acceptance of the drug Lactinet; -Richter leads to a decrease in plasma concentration of estradiol to values characteristic of the early follicular phase. At the same time, no clinically significant changes in carbohydrate, lipid metabolism and hemostasis parameters were revealed.
Pharmacokinetics
Absorption When ingested, desogestrel is absorbed quickly. The average Cmax in serum is reached after 1.8 h (Tmax) after taking the pill. The bioavailability of etonogestrel is about 70%. DistributionEthonogestrel is 95.5-99% bound to plasma proteins, mainly albumin and, to a lesser extent, to sex hormone-binding globulin (SHBG) .Css in plasma is 4–5 days later. Metabolism Dezogestrel by hydroxylation and dehydrogenation is metabolized to the active metabolite etonogestrel.Etonogestrel is metabolized by the formation of sulfate and glucuronide conjugates. Injection The average T1 / 2 of etonogestrel is about 30 hours, both in a single dose and in a multiple dose. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines (1.5: 1 ratio) as free steroids and conjugates. In nursing mothers, etonogestrel is excreted in breast milk in a milk / serum ratio of 0.37-0.55. Thus, with an approximate consumption of mother's milk in the amount of 150 mg / kg of body weight / day, the newborn can receive 0.01-0.05 mcg etonogestrel / kg / day.
Indications
Contraception.
Contraindications
The use of the drug Lactinet; -Richter is contraindicated in the presence of at least one of the following conditions; when any of these conditions appear for the first time during the use of the drug Lactinet; -Richter, it should be stopped immediately: - the presence or history of venous thromboembolism (including deep venous thrombosis of the lower extremities, thromboembolism of the pulmonary artery) - severe liver disease at present or in history (before normalization of liver function indicators); - liver failure at present or in history; - established or suspected malignant hormone-dependent tumors (incl. breast cancer); - bleeding from the vagina of unknown etiology; - established or suspected pregnancy; - children and adolescents under 18 years of age - due to the lack of information confirming the efficacy and safety of using the drug in girls and girls under 18. - lactose intolerance , lactase deficiency, glucose-galactose malabsorption; - hypersensitivity to desogestrel or any other component of the drug. Contraindicated for use in severe liver diseases, incl. in history (until normalization of liver function indicators), as well as in case of liver failure, including in the anamnesis.
Precautionary measures
Measures taken in case of vomiting If vomiting develops within 3-4 hours after taking the pill, the tablet is not completely absorbed. In this case, you should do the same as in the case of missed pills. The required pill (necessary pills) should be replenished from another package. With caution. If any of the conditions / risk factors listed below are present, consider the benefits of using the progestogen and the possible risk for each woman. This should be discussed with the woman before she decides to start taking the drug.In case of worsening, exacerbation of the disease or the occurrence of any of these conditions, for the first time, the woman should consult a doctor. The physician should decide on the appropriateness of the further use of the drug Lactinet; Richter. — Persistent hypertension (with a significant increase in blood pressure or failure of antihypertensive therapy, the drug should be stopped) .— Long-term immobilization associated with surgery, illness or injury. — Because it is impossible to eliminate biological effects of gestagens on the development of liver cancer, an individual assessment should be made of the ratio of benefits and risks of prescribing the drug to women with com liver.— Chloasma, especially in women with chloasma during pregnancy in history. Diabetes mellitus (due to the possible effect of progestogens on peripheral insulin resistance and glucose tolerance) .— Porphyria.— Systemic lupus erythematosus.— Herpes (during pregnancy in history). Based on the pharmacodynamic profile, it is believed that the drug Lactinet; -Richter does not affect the ability to drive vehicles and mechanisms.
Use during pregnancy and lactation
The drug is contraindicated for use in pregnancy. In preclinical studies with the introduction of progestogen, very high doses observed masculinization of the female fetus. In epidemiological studies, there was no increased risk of teratogenic effects and congenital developmental defects among children whose mothers took oral hormonal contraceptives before pregnancy or unintentionally in early pregnancy. preparations containing only progestogen, Lactinet; -Richter does not affect the quality and quantity of breast milk, but a small amount metabolite of desogestrel (etonogestrel) is released from the mother's milk and is approximately 0.01-0.05 g / kg / day (when the amount of breast milk consumed 150 ml / kg / day). The results of the 7-month observation did not reveal increased risks for breastfed children when assessing their growth, psychomotor and physical development. However, careful dynamic monitoring of the development and growth of the child during breastfeeding is necessary if the woman uses the drug for contraception Laktine; -Richter.
Dosage and administration
In the absence of previous use of hormonal contraceptives (during the last month), taking pills starts from the 1st day of the menstrual cycle 1 tablet / day, if possible at the same time of day, following the direction indicated on the package to take a break between doses. two pills was 24 hours, if necessary with a small amount of liquid. This drug does not require a break in reception. Each subsequent package should be started immediately after the end of the previous one. The first dose of the drugWomen who did not take oral contraceptives in the previous month. The first pill should be taken from the 1st day of the menstrual cycle (menstruation). In this case, the use of additional methods of contraception is not required. You can also begin taking pills from the 2nd to 5th day of menstruation, but in this case, additional methods of contraception should be applied in the first cycle in the first 7 days of taking the pills. Transition from a combined hormonal contraceptive (CPC , vaginal ring or transdermal patch) The administration of the drug Lactinet; Richter should be started the next day after taking the last active tablet of the PDA (the last tablet containing the active substance) or on the day Enia vaginal ring or patch. In these cases, there is no need for additional contraception. Intake of Lactinet; Richter can also be started the next day after the end of the usual interval in taking the pills, the patch, the ring or the next day after taking the placebo of the previous PDA (i.e., when it would be necessary to start using a new PDA package, introduce a new ring or stick a new patch), but during the first 7 days of taking the pills, it is recommended to use an additional barrier method of contraception. Transfer from other drugs combs containing only progestogen (mini-pili, injection, implant, or gestagen-releasing intrauterine system) A woman taking mini-pili can switch to taking Lactinet; Richter on any given day. A woman using an implant or intrauterine system is on the day they are removed. A woman who uses injectable contraceptive forms is on the day when the next injection is to be given.In all these cases, an additional method of contraception is not required. Taking the drug after an abortion in the first trimester of pregnancy. After an abortion in the first trimester of pregnancy, it is recommended to start taking the drug immediately after the abortion, in this case there is no need to use additional methods of contraception. pregnancy in the second trimester. The drug is started no earlier than the 21-28th day after the termination of pregnancy in the second trimester or after delivery. If taking the drug is supposed to begin later, then it is necessary to use a barrier method of contraception during the first 7 days. In addition, if an unprotected sexual contact took place before starting to use the drug, it is necessary to exclude pregnancy or postpone the start of the drug on the first day of the next menstruation (when the menstrual cycle is restored). Missed (forgotten) pills The effectiveness of the contraceptive decreases if more than 36 h. If the break does not exceed 12 hours, the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. Taking the rest of the pills is continued according to the usual schedule. In the case of a more than 12-hour break, the contraceptive effect may be reduced. To achieve effective blockage of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. Thus, at a break exceeding 12 hours, the drug is continued as usual, however, in the next 7 days it is necessary to use additional (barrier) methods of contraception. If the pill was missed in the first week of use of the drug and in the previous 7 days there was unprotected sexual intercourse, then the likelihood of pregnancy cannot be excluded.
Side effects
In clinical trials, desogestrel at a dose of 75 μg as side effects were most often noted (> 2.5%): irregular bleeding, acne, mood changes, breast tenderness, nausea, and weight gain. Adverse adverse reactions are presented according to the classes of organ systems according to the MedDRA classification and with the frequency of occurrence: often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10 000,<1/1000). The adverse effects presented in the table below were evaluated by researchers as having an established, probable and possible connection with taking the drug. Frequency of undesirable reactions Often (≥1 / 100, <1/10) Infrequently (≥1 / 1000, <1/100) Rarely (≥1 / 10 000, <1/1000) Mental disorders. Mood changes, decreased libido, depressive disorder. From the nervous system: Headache. From the organ of vision: Intolerance to contact lenses. From the digestive system: Nausea Vomiting Skin & Subcutaneous Tissue: Acne Alopecia Skin Rash l, urticaria, erythema nodosum: From the genitals and mammary gland: Soreness of the mammary glands, irregular menstrual bleeding, amenorrhea Dysmenorrhea, ovarian cyst, vaginitis Discharge from the mammary glands, ectopic pregnancyGeneral reactions: Increased body weight. Fatigue In women who received (combined) oral contraceptives, various serious adverse effects were rarely observed: venous and arterial thrombosis and thromboembolism, hormone-dependent tumors (for example, breast cancer) and chloasma. A reliable connection with the reception of gestagens has not been established: jaundice and / or itching skin associated with cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Chorea Sydenham; herpes pregnant; hearing loss associated with otosclerosis; (hereditary) angioedema
Overdose
Symptoms: nausea, vomiting, bloody discharge / bleeding from the vagina. Treatment: no specific antidote. Symptomatic therapy is performed.
Interaction with other drugs
The interaction between oral contraceptives and other drugs can lead to breakthrough bleeding and / or to a decrease in contraceptive efficacy. The following interactions are reported in the literature (mainly with PDA, but sometimes gestagen-containing contraceptives are also reported). Hepatic metabolism Possible drug interaction with drugs that induce microsomal enzymes, which leads to an increase in the clearance of sex hormones, for example, hydantoins (phenytoin), barbiturates (phenobarb) a), primidone, carbamazepine, rifampicin; and probably also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and preparations containing St. John's wort.Women using any of these drugs should temporarily use a barrier method in addition to Lactinet; Richter, or choose another method of contraception. Barrier contraceptive method should be used during the use of these drugs and within 28 days after discontinuation. For women who receive long-term treatment with hepatic enzyme inducers, the possibility of using a non-hormonal method of contraception should be considered. With activated carbon, absorption of desogestrel may be reduced and, therefore, contraceptive efficacy may decrease. In this case, you should be guided by the recommendations regarding the missed pills. Hormonal contraceptives can affect the metabolism of other drugs. Accordingly, drug concentrations in the blood plasma and tissues can both increase (for example, cyclosporine) or decrease. To assess possible drug interactions, you should obtain information from the instructions of the simultaneously used drugs.
special instructions
Before the appointment of the drug should be carefully collected history from a woman and conduct a thorough gynecological examination to exclude pregnancy. Before the appointment of the drug should establish the cause of violations of the menstrual cycle, for example, oligomenorrhea and amenorrhea. The interval between the control medical examinations is determined by the doctor in each individual case (the frequency of examinations - at least 1 time per year). If the prescribed drug can affect a latent or existing disease, an appropriate schedule of follow-up medical examinations should be drawn up. Despite regular intake of the drug Lactinet; Richter, irregular spotting can sometimes occur. If the bleeding is very frequent and irregular, you should consider using another method of contraception. If the above symptoms are persistent, then in this case it is necessary to exclude organic pathology. Tactics for amenorrhea during the use of the drug depends on whether the pills were taken in accordance with the instructions, and may include a pregnancy test.In the event of pregnancy, the drug should be stopped. In the event of acute or chronic liver dysfunction, the woman should consult a specialist for examination and consultation. Women should be informed that Laktinet; Richter does not protect against HIV infection (AIDS) and from other sexually transmitted diseases. Reducing the effectiveness The effectiveness of gestagen-containing oral contraceptives can be reduced if you miss the use of pills, gastrointestinal disorders or and taking other medicines preparatov.Izmeneniya character menstruatsiyVo time application gestagensoderzhaschih contraceptives in some women, vaginal bleeding may become more frequent or longer, while the other women bleeding may become less frequent or even stop. These changes are often the reason that a woman refuses this method of contraception or ceases to strictly follow the instructions of the doctor. With detailed consultation with the woman who decided to start taking the drug Lactinet; - Richter, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. Evaluation of vaginal bleeding should be carried out on the basis of the clinical picture and may include examination in order to exclude malignant neoplasms or pregnancy. Follicular development When all low-dose hormonal contraceptives are taken, follicles develop, and occasionally the size of the follicle may reach sizes that exceed those in the normal cycle. Usually these enlarged follicles disappear spontaneously. This is often asymptomatic, but in some cases there is mild pain in the lower abdomen. Surgical intervention is rarely required. Laboratory studies Data obtained for KPC showed that the use of hormonal contraceptives may influence the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, the content of transport plasma (eg, globulin , corticosteroids binding, lipid / lipoprotein fractions), carbohydrate metabolism and blood clotting and fibrinolysis.Usually these changes remain within the normal range. It is not known to what extent this also applies to contraceptives containing only gestagen. Breast cancer The risk of breast cancer increases with age. During the application of the CCP, the risk that a woman will be diagnosed with breast cancer increases slightly. This increased risk gradually decreases over 10 years after discontinuation of oral contraceptives, it is not related to the duration of use, but depends on the woman’s age during the use of PDA. The expected number of diagnosed cases of breast cancer among 10,000 women who used CCP (within 10 years after discontinuing their use), relative to women who have never used them for the same period, calculated for the relevant age groups, is presented in the table below. group Expected number of cases among women using CPC Expected number of cases among women who did not use KPK16-19 years 4.5 420-24 years 17.5 1625-29 years 48.7 4430-34 years 110 10035-39 years 180 16040-44 years 260 230Risk among women applying oral These contraceptives containing only progestogen, for example, the drug Lactinet; Richter, may be similar to that of the CPC. However, the data for oral contraceptives containing only progestogen are not so specific. Compared with the risk of breast cancer throughout life, the increase in risk associated with taking PDA is small. Women taking CPC are diagnosed with earlier clinical stages of breast cancer than women who have never used them. Increased risk in women using CPC may be due to earlier diagnostics, biological effects of the drug, or a combination of these two factors. Venous thromboembolism In epidemiological studies, a link was established between the use of CPC and the increased incidence of venous thromboembolism (VTE, deep vein thrombosis and pulmonary embolism). And although the clinical significance of these data for desogestrel as a contraceptive that does not contain an estrogen component, is unknown, Laktinet; Richter should be discontinued if thrombosis develops.Consideration should be given to discontinuing Lactinet; -Richter in case of prolonged immobilization associated with an operation or disease. Sugar diabetesAlthough gestagens can affect peripheral insulin resistance and glucose tolerance, as a rule, dose adjustment and dosing regimen of hypoglycemic drugs in diabetic patients does not required. However, such patients should be carefully monitored during the first months of use of the drug. Bone mineral density. Use of Lactinet; Richter reduces plasma plasma estradiol to values corresponding to the early follicular phase. Until now, it is not known whether this reduction has any clinically significant effect on bone mineral density. Preventing ectopic pregnancy Preventing ectopic pregnancy with traditional gestagen-containing oral contraceptives (mini-pili) is not as effective as with PDA, because when using mini-pili often ovulation occurs. Although Lactinet; -Richter effectively suppresses ovulation, in case of amenorrhea or abdominal pain, ectopic pregnancy should be excluded during differential diagnosis. Chloasma Chloasma may occur from time to time, especially in women who have already had a chloasma of pregnant women in history. Women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation during the use of the drug Lactinet; Richter. Auxiliary substances Patients with lactose intolerance should be borne in mind that 1 tablet Lactinet; Richter contains 55.095 mg of lactose monohydrate. Patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption, should not take this drug. The effect on the ability to drive vehicles and control mechanisms