Marvelon - instructions for use, reviews, analogs and forms of release (tablets in 1,3 or 6 packages) drugs for hormonal contraception in women, including during pregnancy and lactation. Composition and interaction with alcohol

In this article, you can read the instructions for using the drug Marvelon. There are reviews of visitors to the site - consumers of this medication, as well as opinions of medical specialists on the use of Marvelona in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Marvelon in the presence of existing structural analogues. Use for hormonal contraception in women, including during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Marvelon - the effect of the drug, as well as other combined oral contraceptives (COCs), is based, first of all, on the ability to suppress ovulation and increase the secretion of cervical mucus.

The gestagenic preparation (desogestrel) inhibits the synthesis of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) by the pituitary gland and, thus, prevents the maturation of the follicle (blocks ovulation).

Ethinyl estradiol - a synthetic analogue of the follicular hormone estradiol, together with the hormone of the yellow body regulates the menstrual cycle.

Along with these central and peripheral mechanisms preventing the maturation of an ovum capable of fertilization, the contraceptive effect is due to an increase in the viscosity of mucus located in the cervix, which makes it relatively impenetrable for spermatozoa.

Along with contraceptive properties, COCs have a number of additional positive effects: the menstrual cycle becomes more regular, menstruation is less painful and is accompanied by less severe bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia.When using a COC with a high content of hormones (50 mcg ethinyl estradiol), a reduced risk of developing fibrocystic mastopathy, ovarian cysts, pelvic inflammatory disease, ectopic pregnancy, ovarian cancer and endometrium was shown. The applicability of these data to COCs with a low content of hormones needs further study.

Marvelon has a beneficial effect on lipid metabolism, increases the high density lipoprotein (HDL) content in plasma, without affecting the content of low density lipoprotein (LDL). Has a beneficial effect on the skin, improves its condition with vulgar acne.

Composition

Ethinyl estradiol + Desogestrel + auxiliary substances.

Pharmacokinetics

Desogestrel, taken orally, quickly and completely absorbed and then converted to etonogestrel. Its maximum concentration in blood plasma (approximately 2 ng / ml) is achieved after 1.5 hours. Bioavailability is 62-81%.

Etonogestrel binds to blood plasma albumin and to sex hormone binding globulin (SHBG). Only 2-4% of the total concentration of etonogestrel in the plasma is present as a free steroid, 40-70% specifically bind to 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.

Etonogestrel is completely metabolized by the known pathways of the metabolism of steroid hormones; the rate of metabolic excretion from the blood plasma is 2 ml / min / kg. No interaction of etonogestrel with concomitant ethinyl estradiol was observed.

The concentration of etonogestrel in the blood plasma is reduced in 2 stages. The final stage is characterized by a half-life (T1 / 2) of about 30 hours. Desogestrel and its metabolites are excreted in the urine and bile in a ratio of approximately 6: 4.

The pharmacokinetics of etonogestrel is influenced by SHBG, the level of which is increased by the action of ethinylestradiol 3 times. With daily intake, the concentration of etonogestrel in the blood plasma increases 2-3 times, reaching a constant level in the second half of the cycle.

Ethinyl estradiol after oral administration is quickly and completely absorbed.Its maximum concentration in blood plasma (about 80 pg / ml) is achieved within 1-2 hours after administration. Absolute bioavailability (the result of presystemic metabolism) is about 60%.

Ethinyl estradiol binds non-specifically to plasma albumin almost completely (98.5%), contributes to an increase in the concentration of SHBG.

Ethinyl estradiol undergoes presystemic metabolism in both the mucosa of the small intestine and the liver. Ethinyl estradiol is initially metabolized during aromatic hydroxylation to form a variety of hydroxylated and methylated metabolites that are present in both the free state and as conjugates with glucuronides and sulfates. The rate of metabolic clearance of ethinylestradiol from plasma is about 5 ml / min / kg.

The concentration of etonogestrel in the blood plasma is reduced in 2 stages. The final stage is characterized by T1 / 2 for about 24 hours. The drug remains unchanged, the metabolites of ethinyl estradiol are excreted in urine and bile in a ratio of 4: 6.

Indications

• contraception.

Forms of release

Tablets in foil bags No. 1, 3 or 6.

Instructions for use and reception scheme

Tablets should be taken orally in the order given on the package, every day at approximately the same time, with a small amount of water, if necessary.

Take 1 tablet a day for 21 days. Receiving tablets from the next package should start 7 days after the end of the previous one. During these 7 days menstrual bleeding occurs. Usually, it begins on day 2-3 after the last pill and may not stop before the next package is taken.

How to start taking Marvelon

If hormonal contraceptives have not been used within the last month, the reception should begin on the first day of the menstrual cycle. You can start taking the drug 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 tablets in the first cycle.

Transition from other combined oral contraceptives: it is advisable to start taking Marvelon on the day after taking the last pill of a previously used drug containing hormones,in extreme cases, immediately after a break in taking pills or after taking a tablet that does not contain hormones.

Transition from preparations containing only progestogen ("mini-saws", injections of the implant). A woman who takes "mini-drank" can switch to taking Marvelon any day; using the implant - on the day of its removal; using the drug in the form of injections - on the day that the next injection is to be given, in all cases it is recommended to use additional methods of contraception during the first seven days of taking Marvelona.

After an abortion made in the first trimester: a woman can start taking the drug immediately. No need to use any additional methods of contraception.

After childbirth or abortion made in the 2nd trimester, it is recommended to start taking the drug on the 21st or 28th day after giving birth or abortion made in the 2nd trimester of pregnancy. At the beginning of taking the drug at a later date, it is recommended that barrier methods of contraception be used during the first seven days of Marvelon's administration. In any case, if a woman has had sexual intercourse after giving birth or having an abortion before starting Marvelon's reception, pregnancy should be excluded before the drug is started or waiting until the first menstrual period.

How to proceed if you miss a regular dose of the drug

If the next pill is delayed for less than 12 hours, the reliability of contraception does not decrease. A woman should take a pill as soon as she remembers it, and follow-up tablets take at the usual time.

If the next pill is delayed for more than 12 hours, the reliability of contraception can be reduced. In this case, the following rules should be followed:

Week 1. A woman should take a missed pill as soon as she remembers it, even if it means taking two tablets at the same time. Then you should continue the reception in the usual way. Additionally, the barrier contraceptive method should be used for the next 7 days. If a woman has had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more pills are missed, and the closer the break in taking the drug at the time of sexual intercourse, the higher the risk of pregnancy.

Week 2. A woman should take a missed pill as soon as she remembers it, even if it means taking two pills at the same time.Then you should continue the reception in the usual way. Provided that the woman took the pill on time for 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if a woman misses more than 1 tablet, it is recommended to use additional methods of contraception within the next 7 days.

Week 3. The reliability of contraception can be reduced, due to a subsequent break in taking the drug. This can be avoided by adapting the drug regimen. If you use either of the following two schemes, you do not need to use additional contraceptive measures, provided that the woman took the pills on time for 7 days preceding the first missed dose.

Otherwise, it is recommended to use one of the two following schemes and also use additional contraceptive measures during the next 7 days.

A woman should take the missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then you should continue the reception in the usual way.New packaging should be started as soon as the current packaging is finished, i.e. do not take a break between the packages. The probability of bleeding cancellation before the end of the second package is small, but some may have smearing or copious bleeding even while taking the drug.

You can recommend stopping the drug from the current package. A woman should take a break from taking Marwelon for up to seven days, including the days when she forgot to take the pills, and then start a new package.

If you miss a drug and the subsequent absence of bleeding at the nearest break in admission, you should consider the possibility of pregnancy.

Recommendations in case of vomiting. If vomiting occurs within 3-4 hours after taking the drug, absorption may be incomplete. In this case, you should use the recommendations for missing the next dose of the drug. If a woman does not want to change her usual admission scheme, she needs to take an extra pill from another package.

How to change the period of menstruation.In order to delay menstruation, you should continue taking the pill from another package of Marvelon without the usual break in admission. Delay menstruation can be for any period until the end of the tablet from the second package. During this period, a woman may have smearing or copious spotting. Admission of the drug according to the usual schedule should be resumed after a 7-day interval in admission.

In order to shift menstruation on a day of the week, which is different from what is expected if the usual intake scheme is followed, you can reduce the usual break in admission for as many days as necessary. The shorter the break, the higher the risk of a lack of menstruation during the break and the occurrence of copious or spotting spotting while taking the drug from the second package.

Side effect

• increased risk of arterial and venous thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism;
• increased frequency and intensity of migraines;
• a slight increase in the relative risk of breast cancer in women;
• extremely rare cases of development of benign, and even more rarely, malignant liver tumors;
• increased risk of pancreatitis;
• increased blood pressure (rarely);
• combined oral contraceptives can cause Crohn's disease and ulcerative colitis;
• pigmentation of facial skin;
• morbidity of mammary glands and the appearance of secretion;
• headache;
• changes in libido;
• depressive state;
• intolerance to contact lenses;
• nausea, vomiting;
• changes in vaginal secretion;
• various skin diseases;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions.

Contraindications

Combined oral contraceptives should not be taken if any of the conditions listed below are present. If any of them occurs against the background of taking the drug, you should immediately stop taking it:

• thrombosis (venous or arterial) at present or in anamnesis (eg, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);
• the presence, at present or in the anamnesis, of possible clinical manifestations of thrombosis (eg, ischemic disease or angina pectoris);
• diabetes mellitus with vascular lesions;
• presence of severe or multiple risk factors for venous or arterial thrombosis;
• the presence at present or in an anamnesis of severe liver diseases (if the liver function indices did not return to normal);
• the presence at present or in the history of liver tumors (benign and malignant);
• established or suspected hormone-dependent malignant tumor of genital organs or mammary glands;
• vaginal bleeding of unclear etiology;
• established or suspected pregnancy;
• lactation period;
• hypersensitivity to any of the components of the drug;
• migraine with focal neurological symptoms;
• hypertriglyceridemia.

Application in pregnancy and lactation

The drug is contraindicated during lactation.

special instructions

When taking rifampicin, the method of barrier contraception should be used in addition to taking a combined oral contraceptive (COC) throughout the course of treatment and within 28 days after discontinuation of the drug.

Women who have been taking enzyme-inducing drugs for a long time are encouraged to increase the dosage of steroid contraceptives.If high dosages of contraceptives are undesirable, or if satisfactory and reliable results can not be achieved with them, for example, in case of irregular bleeding, other methods of contraception should be used.

Medical examinations / consultations

Before appointing a COC, the doctor should carefully read the medical history of the woman, as well as conduct a medical examination, guided by contraindications and warnings; This procedure should be repeated when taking COC at least once a year. Periodic medical examinations are important because diseases that are contraindications to the administration of COCs (for example, transient cerebral blood flow disorders) or risk factors (for example, the presence of venous or arterial thrombosis in family members) may first appear during COC administration. The frequency and the list of studies should be selected individually for each woman, but in any case, special attention should be given to measuring blood pressure. research of mammary glands, organs of the abdominal cavity and small pelvis, including cytology of the cervix and appropriate laboratory tests.

The woman should be informed that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted diseases.

Decreased efficiency

The effectiveness of COCs may decrease in the event of skipping the drug, vomiting, or taking some medications.

Irregular spotting

When taking COC, especially in the first months of use, there may be irregular (not coinciding with the time of menstruation) smearing or copious spotting. Any bleeding becomes clinically significant only after an adaptation period of three menstrual cycles.

If a woman with a previously established menstrual cycle continues to be observed or irregular bleeding occurs, consider possible nonhormonal causes of the cycle and conduct appropriate studies to exclude malignancies or pregnancy. These measures may include diagnostic scraping.

Some women do not bleed during a break between taking the drug. If COCs were taken according to the recommendations given above, the likelihood of a woman being pregnant is low.Otherwise, or if there are no bleeding two consecutive times, the possibility of pregnancy should be excluded before the COC is resumed.

Influence on ability to drive and other mechanisms

The effect of Marvelon on the ability to drive and work with machinery has not been noted.

Drug Interactions

Interaction with certain medicinal substances can lead to heavy bleeding and inefficiency of oral contraceptives. Such cases were observed with the use of hydantoins, barbiturates, primidon, carbamazepine, rifampicin, isoniazid; they are possible with the appointment of oxcarbazepine, topiramate, felbamate and griseofulvin. The mechanism of interaction is based on the induction of these enzymes by certain liver enzymes involved in the metabolism of COCs. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but then it can last up to 4 weeks after drug withdrawal. A decrease in the effectiveness of oral contraceptives was also observed with the administration of certain antibiotics, such as ampicillin, tetracycline, neomycin, penicillins, chloramphenicol, activated carbon, laxatives.

The negative interaction of Marvelon with ethanol (alcohol) is not described.

Reduces the effectiveness of oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate and glucocorticosteroids.

Analogues of the drug Marvelon

Structural analogs for the active substance:

• Mersilon;
• Novinet;
• Regulon;
• Three Mercy.

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