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Microgonon - instructions for use, reviews, analogs and formulations (30 μg + 150 μg tablets) of the contraceptive drug for contraception and prevention of pregnancy in women. Composition and side effects

Microgynon - instructions, analogues, reviews

In this article, you can read the instructions for using the drug Microgynon. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of experts on the use of Microgynon 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 the Microgonon in the presence of existing structural analogues. Use for contraception and prevent pregnancy in women. Composition of the contraceptive.

 

Microgynon - low-dose monophasic oral combined estrogen-gestagen contraceptive drug.

 

The contraceptive effect of the Microgonon is realized through three complementary mechanisms:

  • suppression of ovulation at the level of hypothalamic-pituitary regulation;
  • changes in the properties of the cervical secret, as a result of which it becomes impenetrable for spermatozoa;
  • changes in the endometrium, which makes it impossible to implant a fertilized egg.

 

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, less painful menstruation is observed, the intensity of bleeding is reduced, resulting in a reduced risk of iron deficiency anemia.

 

Composition

 

Ethinyl estradiol + levonorgestrel + auxiliary substances.

 

Pharmacokinetics

 

Levonorgestrel

 

After oral administration, levonorgestrel is rapidly and completely absorbed. When administered orally, the bioavailability of levonorgestrel is almost complete. Levonorgestrel is bound by serum albumin and globulin binding the sex hormones (SHBG). In the free form is only 1.3% of the total concentration in the blood serum; while 64% are specifically associated with SHBG and about 35% - not specifically with albumin.As a result of induction with ethinylestradiol synthesis of SHBG, the fraction associated with SHBG increases, while the albumin bound fraction decreases. The apparent volume of distribution of levonorgestrel is approximately 184 liters after a single dose. Levonorgestrel is completely metabolized. The rate of clearance from serum is approximately 1.3-1.6 ml / min / kg. Levonorgestrel in unmodified form is not excreted, but only in the form of metabolites, which are excreted in urine and bile in a ratio of approximately 1: 1.

 

Ethinylestradiol

 

After ingestion, ethinylestradiol is absorbed rapidly and completely. During the absorption and the first passage through the liver, ethinyl estradiol is metabolized, resulting in an average bioavailability of about 45%, with significant individual differences ranging from 20 to 65%. Ethinyl estradiol is almost completely (98%), although non-specific, bound by albumin. Ethinylestradiol induces the synthesis of GSN. Ethinyl estradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main pathway of metabolism is aromatic hydroxylation.Metabolites of ethinyl estradiol are excreted by the kidneys and liver in a ratio of 4: 6.

 

Indications

  • contraception.

 

Forms of release

 

The tablets covered with a cover 30 mkg + 150 mkg (in blisters on 21 tablet).

 

Instructions for use and reception scheme

 

Tablets (or dragees) should be taken orally in the order given on the package, every day at about the same time, with a small amount of water. Take one tablet a day continuously for 21 days. Acceptance of the next package begins after a 7-day break in taking the tablets, during which usually bleeding cancellation occurs. Bleeding, as a rule, begins on day 2-3 after the last pill and may not end before the start of the new package.

 

How to start taking Microinon

 

In the absence of taking any hormonal contraceptives in the previous month

 

The reception of the Microgonon begins on the first day of the menstrual cycle (ie on the first day of menstrual bleeding). You can start taking the 2-5 menstrual cycle, but in this case it is recommended to use the barrier method of contraception during the first 7 days of taking the tablets from the first package.

 

When switching from other combined oral contraceptives

 

It is preferable to start taking Microginone the day after taking the last active tablet from the previous package, but in no case later than the day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive dragee (for preparations containing 28 dragees in the package).

 

In the transition from contraceptives containing only gestagens ("mini-pili", injection forms, implant) or with the progestogen-releasing progestogen (Mirena)

 

A woman can switch from a mini-drink to a Microinon on any day (without interruption), from an implant or an intrauterine contraceptive with gestagen - on the day of its removal, from the injection form - from the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

 

After abortion in the first trimester of pregnancy

A woman can start taking it immediately. If this condition is met, the woman does not need additional contraceptive protection.

 

After childbirth or abortion in the second trimester of pregnancy

 

It is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already lived a sexual life, pregnancy should be excluded before the beginning of taking the Microgonon or it is necessary to wait for the first menstruation.

 

Acceptance of missed tablets

 

If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next one is taken at the usual time.

 

If the delay in taking the tablet is more than 12 hours, the contraceptive protection may be reduced. In this case, you can follow the following two basic rules:

  1. The drug should never be interrupted for more than 7 days.
  2. 7 days of continuous intake of tablets are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

 

Accordingly, the following advice may be given if the delay in taking the tablet was more than 12 hours (the interval from the time of taking the last tablet is more than 36 hours):

 

The first week of taking the drug

 

A woman should take the last missed pills as soon as possible, as soon as she remembers (even if it means taking two pills at the same time). The next dragee is taken at the usual time. In addition, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragees, the probability of pregnancy should be taken into account.

 

The more pills are missed, and the closer they are to the break in the intake of active substances, the greater the probability of pregnancy.

 

The second week of taking the drug

 

The woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two pills simultaneously). The next dragee is taken at the usual time.

 

Provided that the woman took the dragees correctly for 7 days preceding the first missed pellet, there is no need to use additional contraceptive measures. Otherwise, as well as when two or more pills are missed, barrier methods of contraception (for example, a condom) should be used additionally within 7 days.

 

The third week of taking the drug

 

The risk of a decrease in reliability is inevitable due to the upcoming break in the reception of pills.

 

A woman should strictly adhere to one of the following two options. In this case, if in 7 days preceding the first missed pellet, all pills were taken correctly, there is no need to use additional contraceptive methods.

 

1. A woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time, until the dragee runs out of the current packaging. The next package should be started immediately. Withdrawal bleeding is unlikely until the end of the second pack, but may occur spotting and breakthrough bleeding during the tablet-taking.

 

2. A woman can also interrupt the reception of pills from the current package. Then, she should take a break for 7 days, including the day of skipping the dragees and then start taking a new package.

 

If the woman missed taking the pills, and then during a break in taking the pills, she does not have a withdrawal bleeding, it is necessary to exclude pregnancy.

 

Recommendations in case of vomiting and diarrhea

 

If a woman has vomiting or diarrhea within up to 4 hours after taking active pills, suction may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on recommendations when skipping the dragee.

 

Changing the day of the beginning of the menstrual cycle

 

In order to delay the onset of menstruation, the woman should continue taking the pills from the new Microgonone package immediately after all the pills are taken from the previous one, without interruption in the reception. Dragee from this new package can be taken for as long as the woman wishes (until the packaging is finished). Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Microginone from the new package follows the usual 7-day break.

 

In order to postpone the day of the onset of menstruation on the next day of the week, the woman should be recommended to shorten the nearest break in taking the dragees for as many days as she wants. The shorter the interval, the higher the risk that it will not have a withdrawal bleeding,and later there will be spotting and breakthrough bleeding during the second package (as well as in the case when she would like to delay the onset of menstruation).

 

Side effect

  • tenderness and tension of the mammary glands;
  • increased mammary glands;
  • discharge from the mammary glands;
  • Spotting bleeding and breakthrough uterine bleeding;
  • headache;
  • migraine;
  • change in libido;
  • decrease / change in mood;
  • poor tolerance of contact lenses;
  • impaired vision;
  • nausea; vomiting;
  • stomach ache;
  • changes in vaginal secretion;
  • skin rash;
  • erythema nodosum;
  • erythema multiforme;
  • generalized itching;
  • cholestatic jaundice;
  • fluid retention;
  • change in body weight;
  • allergic reactions;
  • increased fatigue;
  • diarrhea;
  • Chloasma;
  • development of thrombosis and thromboembolism.

 

Contraindications

  • thromboses (venous and arterial) and thromboembolism now or in the anamnesis (including, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  • conditions preceding thrombosis (including, transient ischemic attacks, angina pectoris) at present or in the anamnesis;
  • Migraine with focal neurologic symptoms in history;
  • diabetes mellitus with vascular complications;
  • multiple or expressed risk factors for venous or arterial thrombosis, including valvular heart disease, cardiac arrhythmias, cerebrovascular disease or coronary arteries of the heart; uncontrolled arterial hypertension;
  • Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis;
  • hepatic insufficiency and severe liver disease (until liver tests are normal);
  • liver tumors (benign or malignant) at present or in the anamnesis;
  • identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspected of them;
  • vaginal bleeding of unknown origin;
  • pregnancy or suspected of it;
  • the period of breastfeeding;
  • prolonged immobilization, serious surgical intervention, surgical operations on the legs, extensive injuries;
  • hypersensitivity to any of the components of the Microinon.

 

Carefully:

  • pronounced disorders of fat metabolism (obesity, hyperlipidemia);
  • thrombophlebitis of superficial veins;
  • otosclerosis with hearing impairment, idiopathic jaundice or pruritus during an earlier pregnancy;
  • migraine;
  • congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor);
  • diabetes;
  • systemic lupus erythematosus;
  • hemolytic uremic syndrome;
  • Crohn's disease;
  • sickle-cell anemia;
  • arterial hypertension.

 

Application in pregnancy and lactation

 

Microgynon is not prescribed during pregnancy and during lactation.

 

If the pregnancy is detected during the intake of the Microgonone, the drug is immediately canceled. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received sex hormones before pregnancy or teratogenicity, when sex hormones were mistaken for early pregnancy.

 

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated in lactation. A small amount of sex steroids and / or their metabolites can be excreted with milk,However, there is no evidence of their negative impact on the health of the newborn.

 

Use in children

 

It does not apply until the onset of menarche.

 

special instructions

 

In the case of a planned operation, it is recommended to stop taking the drug at least 4 weeks before it and not to resume taking it within 2 weeks after the end of immobilization.

 

During the administration of drugs that affect microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be used additionally.

 

During the administration of antibiotics (such as ampicillins and tetracyclines) and within 7 days after their withdrawal, the barrier method of contraception should be used additionally.

 

If the period of use of the barrier method of protection ends later than the pellet in the package, you need to proceed to the next packaging of the Microgonon without the usual break in taking the tablets.

 

If any of the conditions / risk factors listed below are currently available, then carefully weigh the potential risk and the expected benefit of treating Microgynon in each individual case and discuss it with the woman before she decides to start taking the drug.In case of weighting, strengthening, or the first manifestation of any of these conditions or risk factors, a woman should consult with her doctor who can decide whether to cancel the drug.

 

Diseases of the cardiovascular system

 

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.

 

However, the frequency of venous thromboembolism (VTE) developing with combined oral contraceptives is less than the frequency associated with pregnancy (6 per 10 000 pregnant women per year).

 

Women who take combined oral contraceptives describe extremely rare cases, thrombosis of other blood vessels, for example, liver, mesenteric, renal arteries and veins, the central vein of the retina and its branches. The connection with the use of combined oral contraceptives has not been proven.

 

A woman should stop taking the drug and consult a doctor when developing symptoms of venous or arterial thrombosis or cerebrovascular disorders, which may include: unilateral leg pain and / or swelling; sudden strongchest pain, with irradiation or without in the left arm; sudden shortness of breath; sudden attack of cough; any unusual, strong, prolonged headache; sudden partial or complete loss of vision; Diplomacy; slurred speech or aphasia; dizziness; loss of consciousness with or without convulsive seizure; weakness or very significant loss of sensitivity, suddenly appeared on one side or in one part of the body; motor disorders; symptoms of an "acute abdomen." The risk of thrombosis (venous and / or arterial) and thromboembolism increases:

  • with age
  • smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);

 

in the presence of:

  • family history (ie venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); in the case of hereditary predisposition, a woman should be examined by the appropriate specialist to decide on the possibility of taking COC;
  • Obesity (body mass index more than 30 kg / m2);
  • dyslipoproteinemia;
  • arterial hypertension;
  • migraine;
  • heart valve diseases;
  • atrial fibrillation;
  • prolonged immobilization, serious surgical intervention, any foot surgery or extensive trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of a planned operation at least four weeks before) and not to resume admission within two weeks after the end of immobilization.

 

An increased risk of thromboembolism in the postpartum period should be considered.

 

Circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.

 

The increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be the basis for the immediate discontinuation of these medications.

 

Biochemical parameters, which can be indicators of a hereditary or acquired predisposition to venous or arterial thrombosis,include resistance to activated protein C, hyperhomocysteinemia, antithrombin-2 deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).

 

Tumors

 

There are reports of an increased risk of developing cervical cancer with long-term use of combined oral contraceptives. His association with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings relate to the characteristics of sexual behavior and other factors, such as human papillomavirus (HPV).

 

It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. His association with the use of combined oral contraceptives has not been proven. The observed increase in risk may be the result of an earlier diagnosis of breast cancer in women using combined oral contraceptives.

 

In rare cases, combined with oral contraceptives, the development of liver tumors has been observed.In the event of severe pain in the abdominal region, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

 

Other states

 

Women with hypertriglyceridemia (or having this condition in a family history) may have an increased risk of developing pancreatitis while taking combined oral contraceptives.

 

Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically relevant increases have been rare. Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the intake of combined oral contraceptives, these drugs should be discontinued and the treatment of hypertension should begin. Reception of combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

 

The following conditions have been reported to develop or worsen, both during pregnancy and when taking combined oral contraceptives,but their relationship with the use of combined oral contraceptives has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis. Also, cases of Crohn's disease and ulcerative colitis are described in combination with combined oral contraceptives.

 

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires discontinuation of combined oral contraceptives.

 

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0.05 mg ethinyl estradiol).Nevertheless, women with diabetes should be carefully observed during the intake of combined oral contraceptives.

 

Women with a tendency to chloasma when taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

 

Laboratory Tests

 

Admission of combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal, transport protein levels in the plasma, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the limits of normal values.

 

Effects on the menstrual cycle

 

On the background of taking combined oral contraceptives, irregular bleeding (spotting bleeding or breakthrough bleeding) can occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.

 

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.

 

Some women during the break in taking a dragee may not develop withdrawal bleeding. If combined oral contraceptives are taken as directed, it is unlikely that a woman is pregnant. However, if previously combined oral contraceptives were not taken regularly or if there are no consecutive two bleeding cancellations, pregnancy should be excluded before continuing with the drug.

 

Medical examinations

 

Before the application of the Microgonon to a woman is recommended to undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), to exclude pregnancy. In addition, violations of the blood coagulation system should be avoided.

 

In the case of long-term use of the drug, it is necessary to conduct control examinations every 6 months.

 

A woman should be warned that preparations of the Microgynon type do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

 

Influence on ability to drive a car and machinery

 

Not found.

 

Drug Interactions

 

Sulfonamides, derivatives of pyrazolone are able to enhance the metabolism of steroid hormones included in the preparation.

 

Long-term treatment with drugs that induce liver enzymes, which increases the clearance of sex hormones, can lead to breakthrough bleeding and / or a decrease in the contraceptive efficacy of the drug Microinone.

 

Such medicines include: phenytoin, barbiturates, primidone, Carbamazepine and rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin, and preparations containing St. John's Wort.

 

Contraceptive protection decreases with the administration of antibiotics (such as ampicillins and tetracyclines), because, according to some reports, some antibiotics can reduce intrahepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

 

Oral combined contraceptives can affect the metabolism of other drugs (including cyclosporine), which leads to a change in their concentration in plasma and tissues.

 

When taking estrogen-progestin drugs, you may need to adjust the dosage regimen for hypoglycemic drugs and indirect anticoagulants.

 

Analogues of the drug Microginone

 

Structural analogs for the active substance:

  • Antotevin;
  • Miniziston;
  • Miniziston 20 fems;
  • Ovidon;
  • Oralcon;
  • Rigevidone;
  • Trigestrel;
  • Trikwilar.

 

Analogues for the pharmacological group (estrogens and gestagens and their analogs):

  • Agesta;
  • Angelique;
  • Belara;
  • Byzanne;
  • Ginepristone;
  • Gynodian Depot;
  • Daillah;
  • Depot Provera;
  • Jess;
  • Jess Plus;
  • Diane 35;
  • Dimia;
  • Duphaston;
  • Evra;
  • Janine;
  • Implanon;
  • Clira;
  • Climadinone;
  • Climara;
  • Klimodien;
  • Clomiphene;
  • Lactineth;
  • Lindineth 20;
  • Lyndyneth 30;
  • Logest;
  • Marvelon;
  • Mersilon;
  • Midian;
  • Microlus;
  • NovaRing;
  • Novinet;
  • Non Ovlon;
  • Norkolut;
  • Ovestin;
  • Pausogest;
  • Postinor;
  • Provera;
  • Progesterone;
  • Proginova;
  • Revmelid;
  • Silhouettes;
  • Tamoxifen;
  • Triogynal;
  • Femoden;
  • Femoston;
  • Cycle;
  • Escapel;
  • Estriol;
  • Yarina;
  • Yarina Plus.

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