In one tablet, coated. sheath contains 3 mg drospirenone0.03 mg ethinyl estradiol.
As auxiliary substances used:
- magnesium stearate (mass - 0.8 mg);
- lactose monohydrate (48 mg);
- corn starch (16 mg);
- pregelatinized corn starch (9.6 mg);
- povidone K 25 (1.6 mg);
- the film coating (2 mg) is Opadry II in white, as well as Colorcon 85G18490, which contains polyvinyl alcohol, soya lecithin, talc, titanium dioxide E 171 and macrogol No. 3350.
It is produced in white tablets of a round biconvex shape, they are covered with a film membrane, on one side they are engraved with "G63". 21 tablets in a blister, 1, 3 blisters in a pack.
Possesses contraceptive action with antiandrogenic and antimineralocorticoid properties.
Pharmacodynamics and pharmacokinetics
The contraceptive effect is based on the interaction of factors, among which the most important is inhibition ovulationand structural and functional changes endometrium.
Midiana is a combined oral contraceptive thanks to such active substances as ethinyl estradioland drospirenone. In addition, drospirenone in a therapeutic dose has antiandrogenic and weak antimineralocorticoid properties, however, it does not have estrogenic, glucocorticoid, antiglucocorticoid activity, which makes drospirenone similar in pharmacological profile to natural progesterone.
Relatively pharmacokinetics: Biotransformation of drospirenone and ainylestradiol occurs in different ways. Drospirenone when administered orally is not completely absorbed, bioavailability is in the range of 76-85%, regardless of nutrition. Its maximum concentration after the first dose in serum is 37 nanograms per ml after a few hours, in the first cycle the equilibrium concentration of 60 nanograms per ml is established after 7-14 hours. A decrease in serum concentration occurs in 2 phases by binding to serum albumin.
Metabolites drospirenone is represented by acid forms formed during the opening of the lactone ring. The average apparent volume of distribution is about 3.7 liters per kg, metabolic rate. clearance - 1.5 ml / min / kg. The elimination process occurs exclusively in trace amounts in an unchanged form, products metabolism excreted by the kidneys and through the intestine in an approximate ratio of 1.2: 1.4 with a half-life of 40 hours.
Unlike drospirenone, ethinyl estradiol is absorbed quickly and completely when taken orally, with an absolute bioavailability of 45%. The maximum concentration after the first dose is reached after several hours and is 30 mcg. It was found that a significant first-pass effect occurs with great individual variability, with the apparent distribution volume usually being 5 liters per kg, approximately 98% of the compounds bind to plasma proteins. Ethinyl estradiol is able to induce the synthesis of globulins that bind sex hormones and transcortin in the liver. Metabolism occurs completely with a metabolic clearance rate of 5 ml / min / kg, 0.02% of the dose passes into breast milk, metabolic products are excreted by the kidneys and through the intestine in a stable ratio of 4 to 6 with a half-life of excretion of 1 day and an elimination half-life of 20 hours.
Indications for use
Contraception. Additional benefits for patients with puffiness, hormone-dependent fluid retention or weight gain, from seborrhea and acne.
Midian tablets cannot be prescribed under the conditions listed below, and also requires cancellation during the first development of them while taking this drug:
- hypersensitivityto the constituent components;
- deep vein thrombosisarteries or pulmonary embolism blood clot, as well as a hereditary or acquired predisposition to them;
- myocardial infarction;
- various harbingers thrombosis: transient ischemic attack (TIA) or angina pectoris;
- atrial fibrillationuncontrollable arterial hypertension;
- complicated lesions of the heart valves;
- cerebrovascular disease;
- long-term surgery immobilization (immobilization);
- smoking after 35 years;
- renal, liver failure, tumor liver
- risk factors for arterial thrombosis: severe hypertension and dyslipoproteinemia, diabetes;
- pancreatitisexpressed hypertriglyceridemia;
- deficiency: antithrombin III, protein C or S;
- severe forms and exacerbations of liver diseases until the liver samples are completely normalized;
- suspicion or established hormone-dependent malignant diseases of the reproductive system;
- vaginal bleeding of unknown origin;
- pregnancy or suspicion breast-feeding;
- Lactase enzyme deficiency galactosemia, glucose-galactose malabsorption.
Caution should be used when obesity, dyslipoproteinemiacontrolled by arterial hypertension, chloasmapostpartum period.
Frequency of occurrence of a spectrum of side effects: often - ≥ one in 100 to <one in 10 patients; sometimes (infrequently) - ≥ 1/1000 to <1/100; rarely - ≥ 1/10000 to <1/1000 relative to organs and systems:
- Nervous system: often - headache and emotional lability depression; infrequently - a case of decline libido; rarely - increased libido.
- Endocrine system: "often" - recorded pain in the mammary glands, cases of interruptions in the menstrual cycle, intermenstrual bleeding; seldom - galactorrhea.
- Sensory organs: rarely - cases of hearing loss, poor lens tolerance.
- Digestive system: often - nausea, abdominal pain; "sometimes" occurs - vomiting, diarrhea.
- Leather: infrequently - blackheads, eczema, hivesknotted or multiform erythema, chloasma.
- The cardiovascular system: sometimes - a change in either side of the blood pressure; seldom - thrombosis, thromboembolism.
- Excretion Complications: sometimes - fluid retention; "rarely" - weight loss was observed.
- The immune system: seldom - bronchospasm.
- Reproductive system: often - fixed cases acyclic vaginal bleeding (spotting spotting, breakthrough bleeding from the uterus), engorgement and enlargement of the mammary glands, candidiasis vagina infrequently - vaginitis; seldom - galactorrheaincreased vaginal discharge.
Instructions for use (Method and dosage)
The tablets should be taken orally, you can drink it with water (a small amount) every day (starting from the 1st day of the natural menstrual cycle, that is, menstrual bleeding) at about the same time in the sequence indicated on the blister: one tablet for 3 weeks, then 7 day interval required for onset menstrual bleeding.
When replaced with another combined oral contraceptive, vaginal ring or transdermal patch it is preferable to start using Midian the day after taking the last pill or on the day of removal of any of the previously used funds.
Switch to taking Midian tablets with mini drank can be on any day, on the day of removal of the implant or other intrauterine contraceptive, on the day of the next injectionsAt the same time, it is desirable to apply additional barrier methods of contraception in the first week.
If the pregnancy was interrupted in the 1st trimester, then they start taking it immediately without additional contraceptive measures, if the pregnancy is interrupted in the 2nd trimester or a baby is born, then the reception begins after 3-4 weeks. A larger interval requires the use of additional barrier methods of contraception in the first week. If sexual contact has occurred, then first you should completely exclude pregnancy or wait for the first menstruation.
Missed pill regimen
In case of delay in taking the pill within 12 hours, the contraceptive protection of the drug will decrease, therefore, it is recommended to take the pill immediately and continue further administration according to the usual scheme. If the delay was more than 12 hours, then in the future tactics of taking the drug, you should use 2 simple rules:
- Stop taking the contraceptive for more than 1 week.
- To achieve adequate oppression hypothalamic-pituitary systemthe functioning of the ovaries, a 7-day continuous intake of the drug is required.
In daily practice, the following recommendations will come in handy:
- In the first week, take the last missed dose as soon as possible, up to taking 2 tablets at a time. In the future, tablets are taken at the usual scheduled time, however, it is recommended to additionally use barrier methods of contraception for 7 days, otherwise the probability of pregnancy is possible, and it directly depends on the number of missed tablets and proximity to the 7-day break of the drug.
- In the second week, take the last missed dose as soon as possible and continue as usual. If the previous 7 days of admission were correct, then you can not use barrier contraceptivesbut if more than 1 tablet is missed, then sexual contact is not advisable without them.
- In the third week, the probability of a decrease in the contraceptive effect is significantly increased, this is due to the upcoming 7-day skipping pills. You can prevent a decrease in contraceptive effects by adjusting the schedule of taking the drug. If the previous 7 days the course was not interrupted, then you can do without barrier contraception, otherwise - it is necessary and it is necessary to act in one of two ways. First: you should take the drug as soon as possible and continue as usual, then you need to start a new package without a break between packages (most often there is no withdrawal bleeding, but spotting or spotting may occur in the form of breakthrough uterine bleeding). Second: stop taking tablets from the current package for 7 days for withdrawal bleeding, including missed days of admission, then continue with a new package.
To defer lifting bleeding, you must not stop taking the drug, that is, do not take a break between packages. The delay may be until the end of the 2nd package, however, with a lengthening of the cycle, spotting spotting from the vagina or complications in the form of breakthrough uterine bleeding can be observed. Then they resume taking, starting with a new pack after the standard 7-day interval. To postpone the onset of withdrawal bleeding to another day, you need to shorten the next break by as much as necessary. Remember that the smaller the interval, the greater the risk of the absence of withdrawal bleeding and spotting bleeding (or complications in the form of breakthrough uterine bleeding) in taking the 2nd package.
If taking Midian tablets is accompanied by severe reactions from the gastrointestinal tract, for example, vomitingor diarrhea, then this means that perhaps the drug is not completely absorbed, therefore, it is recommended to additionally use other contraceptive measures. If an attack of vomiting occurs after taking the pill after 3-4 hours, then you need to take a new pill as soon as possible. If possible, a new tablet should be taken within 12 hours after the usual prescribed time of administration. If more than 12 hours have passed, then in the future you need to act according to the rules of admission. If you are not planning to change the normal regimen, then take an additional one or more tablets from the next package.
There are no cases of overdose. Possible symptoms: nausea, vomiting, spotting, or vaginal bleeding. Symptomatic treatment is prescribed. Specific antidote does not exist.
Due to the interaction of oral contraceptives and other drugs, breakthrough uterine bleeding and / or a decrease in contraceptive protection may occur. The following types of interactions are known:
- Phenytoin, barbiturates, Carbamazepine, Primidon, Rifampicin (a similar action is also possible Oxcarbazepine, Topiramata, Ritonavira, Felbamate, Griseofulvin, herbal remedies based on Hypericum perforatum, lat. Hypericum perforatum) - in connection with the induction of microsomal enzymes, they can increase the clearance of sex hormones.
- HIV protease inhibitors (e.g. Ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. Nevirapine) may affect liver metabolism.
- Some antibiotics (penicillins, tetracyclines) reduce intestinal-hepatic hormone recirculation estrogen, which can reduce the concentration of ethinyl estradiol.
- Cyclosporin - increase in the concentration of Midian in plasma and tissues.
- Lamotrigine - a decrease in the concentration of Midian in plasma and tissues.
- Perhaps the effect of this drug on individual laboratory tests, as well as biochemical parameters of the liver, adrenal glands and kidneys, thyroid gland, on blood coagulation and fibrinolysis, on the concentration of plasma transport proteins (corticosteroid-binding globulin) lipid or lipoprotein fractions. It is important that the results are usually within normal limits.
- Due to its insignificant antimineralocorticoid activity, there is an increase in the activity of the drug Renina and concentrations of mineralocorticosteroid hormone - aldosterone at blood plasma.
Terms of sale
Released by prescription.
In a dark place inaccessible to children, at a temperature of no more than 25 ° Celsius.
If you take any of the drugs listed in the first 3 paragraphs of the Interaction section with this medicine, you need to use barrier methods of contraception or completely switch to other contraceptives. If drugs containing active substances that affect microsomal liver enzymes are used, then non-hormonal contraceptives should be used within 4 weeks after their cancellation. When you start taking the concomitant drug at the end of taking the contraceptive package, then the next contraceptive package is taken without a 7-day interval.
Midian and overweight
No weight gain, sometimes elimination of excess fluid. The drug does not affect body weight. If such a side effect occurs, it is best to consult your doctor.
At reception antibiotics (an exception: Rifampicin, Griseofulvin) It is also necessary to temporarily resort to barrier methods of contraception for at least another 7 days after their cancellation.
During pregnancy and lactation
During the period pregnancy and lactation use the drug Midian is contraindicated. If pregnancy has occurred on the background of contraception, then the drug should be discontinued immediately.
There is little information about the absence of teratogenic effects and an increased risk for a child and a woman during childbirth with the unintentional administration of combined contraceptives orally. In addition, they affect lactation, are able to reduce the amount and change the composition of breast milk, which can have a harmful effect on the baby.
AnalogsMatches for ATX Level 4 code:OvidonRigevidoneNon-ovlonMercilonYarina PlusYarinaMinisiston 20 femNovinetMicrogynonJeanineLindinetCycle-ProginovaRegulonLogestBelaraFemodenJes plusJessZoely
The price of analogues does not differ significantly, most often Midian's contraceptives are replaced with a drug Yarina, since it is easier to find in pharmacies, although it is an order of magnitude more expensive.
Doctors' reviews about Midian are positive, they confirm the effectiveness of the drug as an oral contraceptive, so the drug is prescribed quite often. Regarding patient reviews, there are many different opinions on the forums. In most cases, they indicate the advantages of the drug: there is no effect on weight, skin, libido, it also speaks of a high level of reliability, with one significant drawback - the drug can not be found in all pharmacies. However, in isolated cases, there are statements about the severity of addiction, headaches, gastrointestinal disorders, and others.
Midian price where to buy
The price of Midian birth control pills ranges from 470-520 rubles (21 tablets per pack).
The price of Midian, designed for 3 cycles (in a pack of 63 tablets) - 1555-1600 rubles.
- Online Pharmacies in Russia
- Online pharmacies in UkraineUkraine
- Online pharmacies in Kazakhstan
- Midian Tab. PO n63OAO Gideon Rich1686 rub.order
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- Midiana (tab. P / capt. Vol. 3 mg + 0.03 mg No. 63) 1692 rubles to order
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- Midian №21 tabOAO Gedeon Richter770 rub.order
- Midian №21 tablets ВАТ "Gedeon Richter", Ugorshchina181 UAH to order
- Midiana tablets Midiana tablets poststation number 63 Hungary, Gedeon Richter 470 UAH order
- Midiana tablets Midiana tablets poststation №21 Hungary, Gedeon Richter 186 UAH order
- Midian 3 mg / 0.03 mg No. 21 tablets p.p. Gedeon Richter (Hungary) 2 tg.