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Active ingredients
Desogestrel + Ethinyl Estradiol
Release form
Pills
Composition
In 1 tablet: ethinyl estradiol 30 mcg; desogestrel 150 mcg. Auxiliary substances: potato starch - 8 mg, povidone - 2.4 mg, stearic acid - 800 mcg, silicon dioxide colloid - 800 mcg, α-tocopherol - 80 mcg, lactose monohydrate - 68 mg.
Pharmacological effect
Combined contraceptive drug containing estrogen and gestagen. The contraceptive effect of Marvelon, as well as other combined oral contraceptives (CCP), is based primarily on the ability to suppress ovulation and increase the secretion of cervical mucus. The progestogen (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and thus prevents follicle maturation (blocks ovulation). Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, together with the hormone of the corpus luteum regulates the menstrual cycle. Along with these central and peripheral mechanisms, hindering the maturation of an oocyte capable of fertilization, the contraceptive effect is due to an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa. In addition to the contraceptive properties of Marvelon; has a number of effects that can be considered when choosing a method of contraception. Menstrual-like reactions become more regular, less painful, and less bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. When using PDA, a reduction in the risk of ovarian and endometrial cancers has been shown.
Pharmacokinetics
Desogestrel, taken orally, is quickly and completely absorbed and then turns into etonogestrel. Its maximum concentration in blood plasma (approximately 2 ng / ml) is reached in 1.5 hours. Bioavailability is 62-81%. It is associated with plasma albumin and globulin that binds sex hormones (SHBG). Only 2-4% of the total concentration of etonogestrel in plasma are present as a free steroid, 40-70% are specifically associated with SHBG. An increase in the level of SHBG caused by ethinyl estradiol affects the distribution between blood proteins, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction.The apparent volume of distribution of desogestrel is 1.5 l / kg. It is completely metabolized by known pathways of metabolism of steroid hormones; the rate of metabolic elimination from plasma is 2 ml / min / kg. No interaction of etonogestrel with concomitant ethinyl estradiol was detected. The concentration of etonogestrel in plasma decreases in 2 stages. The final stage is characterized by a half-life (T1 / 2) of about 30 hours. Desogesgrel and its metabolites are excreted in urine and bile in a ratio of about 6: 4. ESPG influences the pharmacokinetics of etonogestrel 3 times. When taken daily, the concentration of etonogestrel in plasma increases by 2-3 times, reaching a constant level in the second half of the cycle. Ethinyl estradiol after oral administration is rapidly and completely absorbed. Its maximum concentration in blood plasma (about 80 pg / ml) is reached within 1-2 hours after administration. Absolute bioavailability (the result of presystemic metabolism) is about 60%. Ethinyl estradiol is nonspecificly bound to plasma albumin (98.5%), increases the concentration of SHBG. The apparent volume of distribution of ethinyl estradiol is 5 l / kg. Ethinyl estradiol is subjected to presystemic metabolism in both the mucous membrane of the small intestine and in the liver. Ethinyl estradiol is initially metabolized during aromatic hydroxylation to form various hydroxylated and methylated metabolites, which are present both in the free state and in the form of conjugates with glucuronides and sulfates. The rate of metabolic elimination of ethinyl estradiol from blood plasma is about 5 ml / min / kg. The concentration of etonogestrel in the blood plasma decreases in 2 stages. The final stage is characterized by a T1 / 2 of about 24 hours. The drug is not excreted unchanged, the metabolites of ethinyl estradiol are excreted in the urine and bile in the ratio 4: 6. T1 / 2 metabolites is about days.
Indications
Contraception.
Contraindications
Venous or arterial thrombosis / thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke); - precursors of thrombosis (includingtransient attack of coronary artery disease, angina); - migraine with focal neurological symptoms in history; - diabetes mellitus with vascular lesion; - presence of severe or multiple risk factors for venous or arterial thrombosis (including arterial hypertension with AD 160/100 mm Hg). Art. and above); - pancreatitis (including in history), accompanied by severe hypertriglyceridemia; - severe liver disease (until normalization of liver function indicators) (including in history); - liver tumors (benign and malignant ) (including in history); - go rmonozavisimy malignant neoplasms of the genital organs or mammary glands (including suspects); - vaginal bleeding of unknown etiology; - pregnancy (including suspected); - lactation period (breastfeeding); - smoking over the age of 35 years ( more than 15 cigarettes per day); - lactase deficiency, lactose intolerance, glucose-galactose malabsorption; - hypersensitivity to the components of the drug.If when using the drug Marvelon; (like other PDAs) any of the above diseases (conditions) occur, you should immediately stop taking the drug.
Precautionary measures
If any of the conditions / risk factors listed below are presently present, then the potential risk and the expected benefit of using Marvelon should be carefully weighed; in each individual case: age over 35 years; smoking; family history of thromboembolic diseases (venous or arterial thrombosis / thromboembolism in siblings or parents at a relatively early age); obesity (body mass index more than 30 kg / m2); dyslipoproteinemia; arterial hypertension; migraine; valvular heart disease; atrial fibrillation - prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma (with prolonged immobilization and the above surgical interventions, it is recommended; stop using the drug, with planned surgical interventions no later than 4 weeks before the operation, and not to resume taking within 2 weeks after complete remobilization); varicose veins, superficial thrombophlebitis; postpartum period; changes in biochemical parameters,which may be markers of congenital or acquired susceptibility to venous or arterial thrombosis (including resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, anti-phospholipid antibodies, including antibodies to cardiolipin, lupus, and lachs. ; diabetes; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis); sickle cell anemia; hypertriglyceridemia (including a family history); acute and chronic liver diseases, including congenital hyperbilirubinemia (Gilbert, Dubin-Johnson syndrome, Rotor).
Use during pregnancy and lactation
Use of the drug Marvelon; during pregnancy is contraindicated. In the case of pregnancy with the use of Marvelon should stop taking the drug. Marvelon; may affect lactation, because PDAs reduce the amount and change the composition of breast milk. Therefore Marvelon; It is not recommended to apply until the nursing mother completely stops breastfeeding. A small amount of contraceptive steroids and / or their metabolic products may be excreted in breast milk.
Dosage and administration
Tablets should be taken orally in the order indicated on the packaging, every day at about the same time, with a small amount of water, if necessary. Take 1 tablet / day for 21 days. Acceptance of pills from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual bleeding occurs. It usually starts 2-3 days after taking the last pill and may not stop before the next pack is started. How to start taking Marvelon ;. If hormonal contraceptives have not been used in the last month, then take the drug on the 1st day of the menstrual period. cycle. You can start taking the drug at 2-5 days after the start of the menstrual cycle, but in this case it is recommended to use an additional (non-hormonal) method of contraception during the first 7 days of taking the pills in the first cycle. The transition from combined hormonal contraceptives (CPC,vaginal ring or transdermal patch): it is desirable to start taking the drug Marvelon; the next day after taking the last active tablet of a previously used drug (the last tablet containing the active substances), but no later than the next day after the end of the usual interruption in taking the pills or the next day after taking the last pill that does not contain hormones. In case of using the vaginal ring or transdermal patch, it is advisable to start taking Marvelon; on the day of their removal, but not later than the day when the new ring should have been inserted or the next patch applied. Transition from drugs containing only progestogen (mini-drank, injection, implant) or from the progestogen-releasing intrauterine system (IUD) . A woman taking a mini-drink can go on a drug Marvelon any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - on the day when there should be the next injection, in all cases during the first 7 days of taking Marvelon; It is recommended to use additional methods of contraception. After an abortion made in the first trimester: a woman can start taking the drug immediately. There is no need to use any additional methods of contraception. After a birth or abortion made in the II trimester, it is recommended to start taking the drug no earlier than 21-28 days after the birth or abortion made in the II trimester of pregnancy. When you start taking the drug at a later date, it is recommended during the first 7 days of taking Marvelon; use barrier methods of contraception. In any case, if a woman has a child after childbirth or an abortion before starting to take Marvelon; There were already sexual contacts, you should exclude pregnancy before taking the drug or wait until the first menstruation. If you miss the next drug intake: If the reception of the next pill is delayed for less than 12 hours, the reliability of contraception is not reduced. A woman should take a pill as soon as she remembered about it, and take the next pill at the usual time. If the reception of a regular pill is delayed for more than 12 hours, the reliability of contraception can be reduced.In this case, the following rules should be followed: 1. pill intake should never be interrupted for more than 7 days; 2. for adequate suppression of the hypothalamic-pituitary-ovarian system, you must take the pill 7 days in a row. The cyclical use of the drug involves 3 weeks of use. Therefore, the following recommendations can be given. Week 1. A woman should take a missed pill as soon as she remembers, even if it means taking 2 pills at the same time. Then you should continue to receive the usual pattern. Additionally, use the barrier contraceptive method for the next 7 days. If a woman has had sexual intercourse within the previous 7 days, consider the possibility of pregnancy. The more pills are missed, and the closer the break in taking the drug to the moment of sexual intercourse, the higher the risk of pregnancy. Week 2. The woman should take the missed pill as soon as she remembered about it, even if it means taking two tabs. at the same time. Then you should continue to receive the usual pattern. Provided that the woman took the pills on time within 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if the woman missed more than 1 tablet, it is recommended to use additional methods of contraception for the next 7 days. Week 3. Reliability of contraception may be reduced, due to the subsequent interruption in the administration of the drug. This can be avoided by adapting the regimen. If you use either of the following two schemes, there is no need to use additional contraceptive measures, provided that the woman took the pills on time within 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the two following schemes and also to use additional contraceptive measures over the next 7 days. A woman should take the missed pill as soon as she remembered about it, even if it means taking 2 pills at the same time. Then you should continue to receive the usual pattern. New packaging should start as soon as the current packaging ends, i.e.do not break between packs. The likelihood of withdrawal bleeding before the end of the second package is small, but some may experience a spotting or heavy bleeding even while taking the drug. It may be recommended to stop taking the drug from the current package. A woman should take a break in taking the drug Marvelon; lasting no more than 7 days, including the days when she forgot to take the pills, and then start a new package. When skipping the drug and following no withdrawal bleeding in the near interruption in the pill, consider the possibility of pregnancy. Recommendations in case of gastrointestinal disorders: In severe gastrointestinal disorders, absorption may be incomplete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the drug, you should use the recommendations regarding skipping the next dose of the drug. If a woman does not want to change her usual regimen, she needs to take an extra pill (s) from another package (the number of extra pills is determined when visiting an obstetrician-gynecologist. How to change the period of menstruation: In order to delay menstruation, you should continue taking pills from another package of the drug Marvelon; without the usual interruption in reception. You can postpone menstruation for any period until the end of the table from the second package. During this period, a woman may have spotting or heavy blood Discharge of the drug. The usual pattern should be resumed after a 7-day interval in reception. In order to shift menstruation on a day of the week different from that expected if the usual regimen is observed, it is possible to reduce the usual interruption in reception for so many days, as needed. The shorter the break, the higher the risk of the absence of menstruation during the break and the occurrence of heavy or spotting bleeding while taking the drug from the second package.
Side effects
Since the cardiovascular system: thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, thromboembolism of the pulmonary artery), hepatic thromboembolism, mesenteric,renal arteries and veins, retinal arteries); increase in blood pressure. From the digestive system: Crohn's disease and ulcerative colitis; the occurrence or aggravation of jaundice and / or pruritus associated with cholestasis, cholelithiasis. On the skin side: Chloasma (especially if there is a chloasma in the history of pregnancy). On the part of the reproductive system: acyclic bleeding is more common in the first months of administration. Others: porphyria , systemic lupus erythematosus, hemolytic uremic syndrome, small chorea, herpes of pregnancy, hearing loss caused by otosclerosis; allergic reactions. Side effects that were observed while taking the drug Marvelon; but the relationship with the drug was not proven. Often / Infrequently (more than 1/1000) Rarely (less than 1/1000). On the immune system; hypersensitivity.For metabolism and nutrition; weight gain; fluid retention; weight loss. From the nervous system; headache; migraine; decreased libido; depression; change of mood increase libido. On the part of the organ of vision; contact lenses intolerance. From the side of the digestive system; nausea; vomiting; abdominal pain; diarrhea. From the side of the skin and subcutaneous tissues; skin rash, urticaria, erythema nodosum; erythema multiforme. For the reproductive system; chest pain; breast tenderness; increase in mammary glands discharge from the vagina; discharge from the mammary glands.
Overdose
Symptoms: possible nausea, vomiting, in young girls - bleeding from the vagina. Any serious complications of an overdose of Marvelone; not observed. Treatment: symptomatic therapy. There are no antidotes.
Interaction with other drugs
The interaction between oral contraceptives and other drugs can lead to acyclic bleeding and / or decrease the effectiveness of contraceptives. The following interactions are described in the literature. Hepatic metabolism: interaction may occur with inducers of microsomal liver enzymes, which may lead to an increase in the clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin; and possibly also oxcarbazepine, topiramate, felbampam, felbes. ritonavirGriseofulvin and preparations containing St. John's wort). Effect on Pastohepatic Circulation: According to some cynical data, the enterohepatic circulation of estrogens may decrease with the simultaneous use of certain antibiotics that can reduce plasma concentrations of ethinyl estradiol (for example, penicillins, tetracyclines). use of atorvastatin and some oral contraceptives containing ethinyl estradiol, increases the AUC of ethinyl estradiol by approximately 20%. Ascorbic to slot may increase the plasma concentration of ethinyl estradiol, which is possible due to the inhibition konyugatsii.Marvelon; reduces the effectiveness of indirect anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate and glucocorticoids. Women who take any of the above medications should temporarily use an additional method of barrier contraception or choose another method of contraception. With the simultaneous use of microsomal enzyme inducers, a barrier method of contraception should be used throughout the entire course of treatment and for 28 days after stopping treatment. During antibiotics (with the exception of rifampicin and griseofulvin) it is necessary to use a barrier method of contraception throughout the course of treatment and within 7 days after the end of therapy. If the period during which the barrier method of contraception is used continues even after the end of the pills in the CCP package, the next package of the drug should be started without the usual interval intake. Oral contraceptives can affect the metabolism of other drugs and, accordingly, change their concentrations in plasma and tissues (for example, cyclosporin, salicylic acid, morphine). With the concomitant use of other drugs, users must be Xia instructions for medical use of these medicines.
special instructions
If you have any of the following conditions or factors of risk, you should carefully weigh the benefits and the possible risk of taking Marvelon ;.This issue should be discussed with the patient before taking the drug. In the case of exacerbation of the disease, deterioration of the condition or the appearance of the first symptoms of these conditions or risk factors, the patient should immediately turn to the doctor. The doctor decides on canceling the drug individually. Vascular diseases: In the course of epidemiological studies, it was established that there may be a connection between the use of the drug Marvelon; and an increased risk of arterial venous thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. These diseases are extremely rare. The use of any PDA is associated with an increased risk of venous thromboembolism (VTE), manifested as deep vein thrombosis and / or pulmonary thromboembolism, sometimes with fatal consequences. The risk is higher in the first year of admission than among women who take PDA for more than 1 year. Some epidemiological studies show that women who took low-dose PDA containing III generation progestogens, including desogestrel, have an increased risk of VTE compared to those who take Progestogen Levorestrest . Very rarely, thrombosis occurs in other blood vessels (such as the arteries and arteries of the liver, mesentery, kidneys, brain or retina). There is no single point of view whether this is a thrombosis due to the use of PDA. An increase in the frequency and intensity of migraines when taking the drug Marvelon; (which may be a sign of cerebrovascular disorders) may serve as a basis for immediate withdrawal of the drug. Tumors: The most important factor in the development of cervical cancer is the persistence of human papillomavirus (HPV infection). Some epidemiological studies have noted an increase in the risk of cervical cancer in women who receive Marvelon for a long time; however, to date there are contradictions regarding the extent to which these data mixes various factors, such as screenings of cervicata and sexual behavior, including the use of barrier contraceptive methods. a slight increase in the relative risk (1.24) of breast cancer in women using PDA. The increased risk is gradually decreasing over 10 years after the abolition of COC. SinceBreast cancer of women under 40 years of age is quite rare, the probability of developing breast cancer in women receiving CPC for the time being or recently abandoning their use is not high relative to the initial probability of developing cancer. These studies do not provide data on the etiology of cancer. The increase in breast cancer risk can be explained both by the fact that women receiving CPC, the diagnosis of breast cancer is established more early, and the biological effects of CPC, or a combination of both these factors. There is a tendency that women who have ever taken CPC, mammary gland cancer is less advanced than in women who have never taken a PDA. It is extremely rare when using the drug Marvelon; development of benign, and even more rarely malignant tumors of the liver have been observed. In some cases, these tumors led to a life-threatening intra-abdominal bleeding. The physician should consider the possibility of a liver tumor when diagnosing a disease in a woman receiving Marvelon if the symptoms include acute upper pain of the liver, an enlarged liver, or signs of intra-abdominal bleeding. Other diseases: If a woman or her family members are diagnosed with hypertriglyceridemia, then an increase in the risk of pancreatitis is possible when taking the drug Marvelon. If of tires, receiving Marvelon ;, develops clinically zachimayaarterialnaya resistant hypertension, the doctor should be abolished Marvelon; and prescribe arterial hypertension treatment. In cases where it is possible to achieve normal blood pressure with an antihypertensive therapy, the doctor may find it possible for the patient to resume the drug. There are reports that jaundice and / or itching caused by cholestasis; gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, choreaSidengam (minor chorea), herpes of pregnancy, hearing loss due to sclerosis, (hereditary) angioedema and edema develop or are aggravated both during pregnancy and with the reception of Marvelon; in relation to the drug Marvelon ;, are inconclusive. Acute or chronic liver function disorders can serve as a basis for discontinuing Marvelon; as long as liver function indicators are not normalized.Relapse of cholestatic jaundice, observed earlier in pregnancy or when using sex steroids, requires the abolition of the drug Marvelon. Although Marvelon; peripheral tissue tolerance to insulin and glucose can be influenced; there is no evidence that diabetes patients need to change the therapeutic regimen for taking low-dose CCP (containing less than 50 μg of ethinyl estradiol). In any case, while taking the drug Marvelon; patients with diabetes need medical supervision. There is evidence of a link between taking the drug Marvelon; and Crohn's disease and ulcerative colitis. Sometimes when taking the drug Marvelon; skin pigmentation (chloasma) can be observed, especially if it was previously pregnant. Women with a predisposition to chloasmus should avoid direct sunlight and UV exposure from other sources while taking Marvelone;. Medical examinations / consultations: Before starting or resuming taking Marvelon; the physician must collect a detailed medical history and conduct a thorough examination, taking into account contraindications and warnings. This procedure should be repeated periodically in time for taking the drug Marvelon ;. Periodic medical examinations are important because diseases that are contraindications to Marvelone; (for example, transient episodes of IBS) or risk factors (for example, the presence of venous or arterial thrombosis in the family history) may first appear on the phonological use of the drug Marvelon ;. The frequency and list of surveys should be based on common practice and selected individually for each woman (but not less than 1 time in 6 months). In any case, special attention should be paid to the measurement of blood pressure, the study of the mammary glands, abdominal organs and malotoza, including cytology of the cervix. It should be reported to the woman that oral contraceptives do not protect HIV and other sexually transmitted infections. Marvelone; may decrease if you miss a drug intake, gastrointestinal disorders, or with the concomitant use of certain drugs. Irregular bleeding When taking Marvelon; especially in the first months of use, irregular spotting or heavy bleeding may occur.Therefore, an assessment of irregular bleeding should be carried out only after the end of the adaptation period, lasting 3 months. If irregular bleeding persists or appears after previous regular cycles, consider possible irregular causes of the violation of the cycle and conduct appropriate research to exclude malignant neoplasms or pregnancy. These measures may include diagnostic vyklyblivanie. Some women may not have menstruation-like bleeding in between taking the drug. If taking the drug Marvelon; was carried out according to the above recommendations, the probability of pregnancy is small. Otherwise or if there is no bleeding 2 times in a row, pregnancy should be excluded. Laboratory studies: Oral contraceptives can affect the results of some laboratory studies, including biochemical indicators of liver function, thyroid, adrenal glands and kidneys, and plasma transport proteins, for example, corticosteroid binding globulin lipid / lipoprotein fractions, carbohydrate exchange parameters, coagulation and fibrinolysis parameters. Usually these changes are within normal laboratory values. Lactose: The daily amount of lactose (less than 80 mg) that a woman enters while taking the drug is such that women with lactose intolerance are unlikely to have complications.