Marvelon - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Marvelon

Marvelon: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Marvelon

ATX code: G03AA09

Active ingredient: desogestrel (desogestrel) + ethinylestradiol (ethinylestradiol)

Manufacturer: ORGANON NV (Netherlands)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 800 rubles.

Buy

Marvelon is a combined monophasic contraceptive drug.

Release form and composition

Dosage form - tablets: round biconvex, white, engraved on both sides: on one side the inscription "ORGANON" with the image of a five-pointed star, on the other - "TR" above the number "5" (21 pcs. In blisters, in sachet of aluminum foil 1, 3 or 6 blisters, in a cardboard box 1 sachet and instructions for the use of Marvelon).

Content of active substances in 1 tablet:

• Desogestrel - 0.15 mg;
• Ethinylestradiol - 0.03 mg.

Auxiliary components: lactose monohydrate, stearic acid, povidone, colloidal silicon dioxide, alpha-tocopherol, potato starch.

Pharmacological properties

Pharmacodynamics

Marvelon is a combined oral contraceptive (COC). Its action is based on the interaction of various factors, among the most important are changes in cervical secretion and suppression of ovulation.

In addition to contraceptive properties, COC has a number of other actions that can be taken into account when choosing a method of contraception. Menstrual-like reactions begin to be more regular, are accompanied by less severe bleeding and are less painful, which reduces the likelihood of developing iron deficiency anemia.

Pharmacokinetics

Desogestrel

After oral administration, the substance is rapidly and completely absorbed, then turning into etonogestrel. The time to reach its C _max (maximum concentration) in plasma is 1.5 hours. Bioavailability - from 62 to 81%.

Etonogestrel further binds to SHBG (sex hormone-binding globulin) and plasma albumin. Free form in blood plasma is present from 2 to 4% of the total concentration of etonogestrel, 40-70% of the dose specifically binds to SHBG. With an increase in the concentration of SHBG, the distribution between blood proteins is influenced, which leads to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The apparent V _d (volume of distribution) of the substance is 1.5 l / kg.

Metabolism of etonogestrel occurs in full by the known pathways of sex hormone metabolism. The rate of metabolic elimination from blood plasma is 2 ml / min / kg. The interaction of etonogestrel with ethinyl estradiol taken simultaneously was not found.

The decrease in the plasma concentration of etonogestrel occurs in two stages. The final stage is characterized by T _1/2 (half-life), which is approximately 30 hours. The excretion of desogestrel and its metabolites is carried out by the kidneys and through the intestines in a ratio of approximately 6: 4.

The pharmacokinetic parameters of etonogestrel are influenced by SHBG, the concentration of which increases 3 times under the influence of ethinyl estradiol. In the case of daily intake, the plasma concentration of etonogestrel increases by 2–3 times, reaching a constant value in the second half of the cycle.

Ethinylestradiol

After oral administration, ethinyl estradiol is completely and rapidly absorbed. Its C _max in blood plasma is reached within 1–2 hours. The absolute bioavailability is approximately 60% (the result of presystemic metabolism).

The substance nonspecifically binds to blood plasma albumin in almost full volume (98.5%) and increases the concentration of SHBG. Apparent V _d - 5 l / kg.

Ethinylestradiol undergoes first pass metabolism in the liver and small intestine mucosa. The substance is initially metabolized by aromatic hydroxylation to form various methylated and hydroxylated metabolites, which are present in the free state and as conjugates with sulfates and glucuronides. The rate of metabolic elimination of a substance from blood plasma is approximately 5 ml / min / kg.

Plasma concentration of ethinyl estradiol decreases in two stages. The final stage is characterized by T _{1/2 of} about 24 hours. The substance is not excreted unchanged, its metabolites are excreted through the intestines and kidneys in a ratio of 6: 4. T _{1/2 of} metabolites is approximately 24 hours.

The equilibrium concentration of ethinylestradiol is achieved within 3-4 days of administration, when the concentration in the blood plasma is higher than the concentration after taking one dose by 30-40%.

Indications for use

The use of Marvelon is indicated for women of childbearing age for oral contraception.

Contraindications

• Angina pectoris, transient attack of coronary heart disease and other precursors of thrombosis;
• Arterial or venous thrombosis and / or thromboembolism, including pulmonary embolism, deep vein thrombosis, stroke, myocardial infarction (including a history);
• Migraine with a history of focal neurological symptoms;
• Severe or multiple risk factors for arterial or venous thrombosis, including arterial hypertension with arterial pressure (BP) of 160/100 mm Hg or higher;
• Severe liver disease, including anamnesis (until the moment of complete recovery of liver functional parameters);
• Pancreatitis with severe hypertriglyceridemia (including history);
• Benign and malignant liver tumors, including history;
• Diabetes mellitus complicated by vascular lesions;
• Vaginal bleeding of unknown etiology;
• Hormone-dependent malignant neoplasms of the mammary glands and genitals, or suspicion of them;
• Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
• Children's age (due to the lack of data on the safety and effectiveness of the use of Marvelon in patients under 18 years old);
• Breastfeeding period;
• Pregnancy or suspicion of it;
• Smoking more than 15 cigarettes a day over the age of 35;
• Hypersensitivity to drug components.

If these pathologies first appeared during the period of using Marvelon, you must immediately stop taking the drug.

With caution, after weighing the expected individual effect and the potential risk of using oral contraception, women over the age of 35 should take Marvelon; while smoking, presence of thromboembolic diseases family history at a relatively early age (parents, siblings), dyslipoproteinemia, obesity (body mass index 30 kg / m ²); arterial hypertension, valvular heart disease, migraine, atrial fibrillation, varicose veins, superficial thrombophlebitis, prolonged immobilization after major surgery, surgery on the lower extremities or severe trauma (you must stop using Marvelon 4 weeks before elective surgery, and resume taking after complete remobilization within 2 weeks), diabetes mellitus, hemolytic uremic syndrome, systemic lupus erythematosus, sickle cell anemia, acute and chronic liver diseases (including congenital hyperbilirubinemias such as Gilbert, Rotor, Dabin-Johnson syndrome), hypertriglyceridemia (including familial anamnesis), chronic inflammatory bowel pathologies (ulcerative colitis or Crohn's disease), changes in biochemical parameters (including hyperhomocysteinemia,resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (including antibodies to cardiolipin), lupus anticoagulant); in the postpartum period.

Marvelon, instructions for use: method and dosage

Marvelon tablets are taken orally with a sufficient amount of water.

The dosage regimen involves taking 1 tablet 1 time per day, always at the same time for 21 days, strictly following the specified order of priority on the blister. Then there is a seven-day break in taking the pills, on the 2-3 day of which the woman begins menstrual bleeding. Taking pills from the next blister begins 7 days after the previous one at the set time, even if menstruation has not stopped.

In the absence of oral contraception in the previous month, you should start taking Marvelon on day 1 of the menstrual cycle. If you start taking pills from 2 to 5 days of the menstrual cycle, you must additionally use barrier methods of contraception for the first 7 days of the first cycle.

When switching from another combined hormonal contraceptive, Marvelon must be taken the next day after the last active tablet of the previous drug, but no later than the last tablet that does not contain hormones, or the foreseen seven-day break.

When switching from a transdermal patch or vaginal ring, Marvelon should be taken on the day of their removal, but not later than the intended next application or the introduction of a new ring.

When switching from mini-pili drugs, tablets can be taken on any day of the menstrual cycle, with a progestogen-releasing intrauterine system or implant - on the day they are removed, with injectable contraception - on the day of the next procedure. Each of these transitions must be accompanied by the use of an additional barrier method of contraception during the first 7 days.

After an abortion in the first trimester, taking pills should be started on the day of surgery without using additional contraception.

After an abortion in the second trimester or childbirth, it is recommended to start using Marvelon no earlier than 21-28 days later. If the reception is started at a later period, the first 7 days, you must additionally use non-oral contraceptives. If a woman has had sexual intercourse during the period after an abortion or childbirth, before using Marvelon, you should make sure that there is no pregnancy or postpone the use until the first menstruation.

Delaying the appointment at the prescribed time can reduce the effectiveness of contraception.

If the accidental delay in taking the next pill is less than 12 hours and the woman took the pill in this time interval - contraception is not violated, the reception should be continued as usual.

If the delay in taking the next pill exceeds 12 hours, you need to be guided by the following rules:

• Adequate suppression of the hypothalamic-pituitary-ovarian system is achieved by continuous intake of tablets for 7 days;
• Marvelon should not be interrupted for more than 7 days.

Given the cyclicity of taking the pills, calculated for 3 weeks, the woman's further actions depend on at what point in the cycle there was a delay in taking more than 12 hours.

If you are late in the first week of taking Marvelon, you must take the missed pill as soon as you remember, even if it means taking 2 pills at the same time, and continue taking it in the prescribed mode. Continued use includes additional barrier contraception for the next 7 days.

Having sex in the previous 7 days does not exclude pregnancy.

If the delay (more than 12 hours) occurred at 2 weeks of therapy, the woman should take the missed pill as soon as she remembered, even if it means taking 2 pills at the same time, and continue taking it according to the scheme. With the timely reception of the previous 7 tablets, until late, additional contraceptive measures are not required. If more than 1 tablet is missed in the next 7 days, additional non-hormonal protection methods must be used.

If the delay occurred at 3 weeks of the course, the reliability of contraception can reduce the upcoming seven-day break in taking Marvelon. Provided that all previous blister pills are taken in a timely manner, the woman, having taken the missed pill, continues therapy without the use of additional contraception. Otherwise, it is necessary to adhere to one of the following recommendations while using additional barrier methods of contraception. In the first case, a woman should take the pill as soon as she remembered, and continue taking it according to the scheme. On the first day of the proposed break, it is necessary to start taking the tablets from the next blister at the set time. The absence of a seven-day break can cause spotting or profuse bleeding even before the end of the second pack.

If you are more than 12 hours late in the third week of therapy, you can stop taking the tablets from the current blister and take a break, the duration of which should not exceed 7 days (including the days of missing), then a new package should be started. The absence of withdrawal bleeding during the seven-day break after the end of the tablets from the second blister may be associated with the presence of pregnancy.

In the event of severe gastrointestinal disorders accompanied by vomiting, the absorption process of the drug may be incomplete and cause a decrease in the reliability of contraception. If a woman has vomited within the first 3-4 hours after taking the next pill, and she does not want to change the usual treatment regimen, you can use similar pills from a new blister (their number should be determined when visiting an obstetrician-gynecologist).

To delay menstruation for the desired period, you must continue taking the tablets from the next blister without the usual seven-day break. This period can last until the end of all the tablets of the next blister. Then contraception should be continued as usual. While taking the pills from the second blister, you may experience spotting or breakthrough bleeding.

To shift the onset of menstruation to the desired day, it is necessary to shorten the break in taking Marvelon by a certain number of days. It should be borne in mind that the smaller the break, the more likely the absence of menstruation during the break and the development of bleeding (profuse or smearing) during the period of using the tablets from the next blister.

Side effects

• Cardiovascular system: thromboembolism or thrombosis (including myocardial infarction, deep vein thrombosis, stroke, thromboembolism of retinal arteries, pulmonary artery, mesenteric, hepatic, renal arteries and veins), increased blood pressure;
• Digestive system: ulcerative colitis, Crohn's disease, cholelithiasis, exacerbation or appearance of jaundice and / or pruritus caused by cholestasis;
• Skin: chloasma, especially in women with a history of chloasma during pregnancy;
• Reproductive system: acyclic bloody discharge (more often in the first months of admission);
• Others: systemic lupus erythematosus, porphyria, hemolytic uremic syndrome, herpes of pregnant women, chorea minor, allergic reactions, hearing loss against the background of otosclerosis.

Side effects noted during the period of use of Marvelon (the connection between their occurrence and taking the drug has not been proven):

• Nervous system: often - migraine, headache, depression, decreased libido, mood swings; rarely - increased libido;
• Digestive system: often - abdominal pain, nausea, vomiting, diarrhea;
• Metabolism and nutrition: often - fluid retention, weight gain; rarely - weight loss;
• Immune system: rarely - hypersensitivity;
• Skin and subcutaneous tissue: often - skin rash, urticaria; rarely - erythema multiforme, erythema nodosum;
• Organ of vision: rarely - intolerance to contact lenses;
• Reproductive system: often - tenderness and / or enlargement of the mammary glands, chest pain; rarely - discharge from the mammary glands, discharge from the vagina.

Overdose

The development of any serious complications with an overdose was not noted.

Possible symptoms: vomiting, nausea; young girls have bloody vaginal discharge.

Therapy: symptomatic. The antidote is unknown.

special instructions

The use of Marvelon should be started only after consulting a gynecologist, during which it is necessary to carefully weigh the desired effect and the possible risk of the proposed therapy.

The doctor should prescribe the drug on the basis of a detailed medical history and a thorough examination, based on generally accepted practice, and including measurement of blood pressure, examination of the abdominal cavity, mammary glands and small pelvis (including cytological examination of the cervix). In addition, taking into account individual risk factors, the woman may be offered additional examinations. During the period of oral contraception, such examinations should be carried out at least 1 time in 6 months.

The patient must be informed about the need to immediately consult a doctor in case of deterioration, exacerbation of existing pathologies or when signs of risk factors appear.

A woman should know that the use of Marvelon can increase the risk of developing venous and arterial thrombotic and thromboembolic pathologies, such as deep vein thrombosis, myocardial infarction, pulmonary embolism, stroke, sometimes with a fatal outcome. These diseases occur extremely rarely and more often in the first year of taking combined contraceptives. Sometimes the development of thrombosis is possible in the arteries and veins of the liver, kidneys, mesentery, retina or brain.

A symptom of cerebrovascular disorders can be intense and frequent migraines, requiring immediate withdrawal of Marvelon.

Consideration should be given to the possible effect of prolonged use of the drug on an increased risk of developing cervical and breast cancer.

Very rarely, women taking Marvelon develop benign and even less often malignant neoplasms of the liver, which can cause intra-abdominal bleeding that threatens the patient's life. During a diagnostic examination of a woman taking the drug, the doctor should take into account the possibility of the presence of a tumor with an enlarged liver, complaints of acute pain in the upper abdomen, and symptoms of intra-abdominal bleeding.

With hypertriglyceridemia, including a family history, there is a high risk of developing pancreatitis.

With the development of persistent clinically significant arterial hypertension against the background of hormonal contraception, Marvelon should be discontinued and therapy for arterial hypertension should be prescribed. Resumption of oral contraception is possible only after reaching normal stable blood pressure.

In case of recurrence of cholestatic jaundice, acute or chronic functional disorders, the drug should be discontinued until the liver function indicators normalize.

Women with diabetes need regular medical examinations.

Patients prone to chloasma should avoid ultraviolet radiation and direct sunlight.

The contraceptive effect of Marvelon can be impaired by skipping pills, gastrointestinal disorders, or concurrent use of certain medications.

An accurate assessment of the appearance of irregular spotting or profuse bleeding, especially during the first months of use, should be carried out after three months of adaptation of the body to Marvelon.

Pregnancy or swelling can be a possible cause of ongoing irregular bleeding; to make sure they are absent, it is necessary to conduct appropriate studies, which may include diagnostic curettage.

In the absence of menstrual bleeding more than two times in a row, you should consult a doctor to rule out pregnancy.

Marvelon does not protect against sexually transmitted infections (including HIV (AIDS)).

Hormonal contraceptives can affect laboratory results (changes are usually within the normal range).

The negligible content of lactose in 1 Marvelon tablet poses an unlikely threat of complications in women with lactose intolerance.

Influence on the ability to drive vehicles and complex mechanisms

The use of Marvelon does not affect the patient's ability to drive vehicles and mechanisms.

Application during pregnancy and lactation

Marvelon is not prescribed during pregnancy (including the alleged one) and during lactation.

In the postpartum period, the drug is used with caution.

Pediatric use

The drug is not prescribed to patients under 18 years of age, since the safety and efficacy of using Marvelon in adolescent girls has not been studied.

For violations of liver function

• Severe liver disease (before normalization of liver function indicators) and benign / malignant liver tumors, including a burdened history: the use of Marvelon tablets is contraindicated;
• Acute and chronic liver disease, including congenital hyperbilirubinemia: therapy requires caution.

Drug interactions

To avoid a decrease in the contraceptive effectiveness of Marvelon and the development of undesirable side effects, if necessary, the simultaneous use of other medicines should first consult a doctor.

Possible interactions while taking Marvelon with other drugs:

• Inducers of microsomal liver enzymes (for example, primidone, hydantoins, rifampicin, barbiturates, and possibly felbamate, bosentan, oxcarbazepine, ritonavir, modafinil, topiramate, griseofulvin, rifabutin, preparations containing St. In the first 2-3 weeks of taking a drug containing a combination of desogestrel - ethinylestradiol, the maximum induction of microsomal enzymes is not observed, however, after the drug is discontinued, it can persist for at least 4 weeks. In the case of the simultaneous use of inducers of microsomal liver enzymes, it is necessary to use an additional barrier method of contraceptive protection (for example, a condom) during the entire course of therapy and for 4 weeks after its completion. If there is a need for long-term use of inducer drugs, it is appropriate to consider alternative non-hormonal contraceptive options;
• Ampicillin, tetracycline: reduced contraceptive effect. In the case of the simultaneous use of antibiotics (with the exception of griseofulvin and rifampicin, which are inducers of microsomal enzymes), a barrier method of contraceptive protection should be used during the entire course of therapy and for a week after its completion;
• Atorvastatin and some combined oral contraceptives containing ethinyl estradiol: Ethinyl estradiol AUC increases by approximately 20%;
• Cyclosporine: an increase in its concentration in blood plasma and tissues is possible;
• Lamotrigine, morphine, salicylic acid: it is possible to reduce their concentration in blood plasma and tissues;
• Indirect anticoagulants, tricyclic antidepressants, caffeine, clofibrate, anxiolytics (diazepam), theophylline, hypoglycemic drugs, glucocorticosteroids: their effectiveness decreases;
• Ascorbic acid: an increase in the concentration of ethinyl estradiol in the blood plasma is possible (due to inhibition of conjugation).

Analogs

The analogues of Marvelon are: Mersilon, Novinet, Regulon, Tri-Mersey.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dark, dry place at a temperature of 2-30 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Marvelon

Reviews about Marvelon are mostly positive. Indicate that the drug reliably protects against unwanted pregnancy, improves skin condition. Many people note that they take the remedy for a long time. In some cases, the development of side effects in the form of increased appetite, weight gain and relapse of thrush have been reported. Some users consider the cost of Marvelon affordable, others - high.

The price of Marvelon in pharmacies

The approximate price for Marvelon is 1579-1679 rubles. (21 tablets in the package) or 2595–3375 rubles. (63 tablets in the package).

Marvelon: prices in online pharmacies

Drug name Price Pharmacy

Marvelon 150 mcg + 30 mcg tablets 21 pcs. 800 RUB Buy

Marvelon tablets 21 pcs. 1567 RUB Buy

Marvelon 150 mcg + 30 mcg tablets 63 pcs. 2322 RUB Buy

Marvelon tablets 63 pcs. 3537 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!