Median

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The description is actual on 06.01.2015

  • Latin name: Midiana
  • ATH code: G03AA12
  • Active ingredient: Drospirenon + Ethinylestradiol (Drospirenone + Ethinylestradiol)
  • Producer: GEDEON RICHTER (Hungary)

Structure

In one tablet, it is covered. a cover, 3 mg of a drospirenon, 0,03 mg of ethinylestradiol contain.

As excipients are used:

  • magnesium stearate (weight — 0,8 mg);
  • monohydrate of lactose (48 mg);
  • starch corn (16 mg);
  • prezhelatinizirovanny corn starch (9,6 mg);
  • K 25 povidone (1,6 mg);
  • film cover (2 mg) — Opadry II of white color, and also Colorcon 85G18490, as a part of which polyvinyl alcohol, soy lecithin, talc, E 171 titanium dioxide and a macrogoal No. 3350.

Release form

Is issued in tablets of white color of a round biconvex form, they are covered with a film cover, on one party have an engraving of "G63". On 21 tablets in the blister, 1, 3 blisters in a pack.

Pharmacological action

Possesses contraceptive action with anti-androgenic and antimineralokortikoidny properties.

Pharmacodynamics and pharmacokinetics

The contraceptive effect is based on interaction of factors among which braking of an ovulation and structurally functional changes of an endometria is considered most important.

The median is the combined oral contraceptive thanks to such active agents as ethinylestradiol and drospirenon. Besides, drospirenon in a therapeutic dose has anti-androgenic and weak antimineralokortikoidny properties, nevertheless, does not possess oestrogenic, glucocorticoid, anti-glucocorticoid activity that gives to a drospirenon similarity on a pharmacological profile to natural progesterone.

Concerning pharmacokinetics: biotransformation of a drospirenon and an einilestradiol occurs differently. Drospirenon at oral administration is absorbed not completely, bioavailability within 76-85% regardless of food. Its maximum concentration after the first dose in serum makes 37 nanograms on ml in several hours, in the first cycle equilibrium concentration of 60 nanograms on ml is established in 7-14 hours. Decrease in concentration in serum happens in 2 phases by linkng with a seralbumin.

Metabolites of a drospirenon are provided by the acid forms formed in the course of disclosure of a lactonic ring. The average seeming volume of distribution makes about 3,7 liters on kg, speed a metaball. clearance — 1,5 ml/min. Process of elimination happens only in trace quantities in not changed form, products of a metabolism are removed by kidneys and by means of intestines in an approximate ratio 1,2:1,4 at half-life of 40 h.

Unlike a drospirenon ethinylestradiol at oral administration is absorbed quickly and completely, and absolute bioavailability — 45%. The maximum concentration after the first dose is reached in several hours and makes 30 mkg. It is established that the considerable effect of the 1st passing happens to big individual variability, and the seeming distribution volume usually makes 5 liters on kg, about 98% of connections contact proteins of plasma. Ethinylestradiol is capable to induce synthesis globulin, connecting sex hormones and transcortinum in a liver. The metabolism happens completely to speed of metabolic clearance of 5 ml/min., 0,02% from a dose gets to breast milk, products of a metabolism are removed by kidneys and by means of intestines in a steady ratio 4 to 6 at excretion half-life 1 day and eliminative half-life of 20 hours.

Indications to use

Contraception. Additional benefits for patients with puffiness, a hormonedependent delay of liquid or increase in body weight, with seborrhea and an acne.

Contraindications

It is impossible to appoint Midian's tablets at the listed below states, and also demands cancellation at the first development them against reception of this drug:

  • hypersensitivity to the making components;
  • deep vein thrombosis, arteries or an embolism of a pulmonary artery blood clot, and also the hereditary or acquired predisposition to them;
  • myocardial infarction;
  • various harbingers of thrombosis: tranzitorny ischemic attack (TIA) or stenocardia;
  • the fibrillation of auricles which is not giving in to control arterial hypertension;
  • the complicated defeats of valves of heart;
  • cerebrovascular diseases;
  • surgical intervention with the long term of an immobilization (immobilization);
  • smoking after 35 flyings;
  • renal, liver failure, liver tumor;
  • risk factors of arterial thrombosis: the expressed arterial hypertension and a dislipoproteinemiya, a diabetes mellitus;
  • gipergomotsisteinemiya;
  • pancreatitis, the expressed gipertriglitseridemiya;
  • insufficiency: antithrombin III, protein of C or S;
  • severe forms and exacerbations of diseases of a liver before full normalization of hepatic tests;
  • suspicion or the established hormonedependent malignant diseases of a reproductive system;
  • bleeding from a vagina of an unclear origin;
  • migraine;
  • pregnancy or suspicion, breastfeeding;
  • insufficiency of enzyme of lactase, galactosemia, glyukozo-galaktozny malabsorption.

With care it is necessary to apply at obesity, a dislipoproteinemiya, controlled arterial hypertension, a hloazma, a puerperal period.

Side effects

Frequency of emergence of a range of side effects: often — ≥ one on 100 to <one on 10 patients; sometimes (infrequently) — ≥ 1/1000 to <1/100; seldom — ≥ 1/10000 to <1/1000 concerning bodies and systems:

  • Nervous system: often — headaches and emotional lability, depressions; infrequently — a case of decrease in a libido; seldom — there was a strengthening of a libido.
  • Endocrine system: "often" — fixed mammary gland pains, cases of interruptions of a menstrual cycle, intermenstrual bleedings; seldom — a galactorrhoea.
  • Sense bodys: seldom — cases of decrease in hearing, bad portability of lenses.
  • Alimentary system: often — nausea, abdominal pains; "sometimes" arises — vomiting, diarrhea.
  • Skin: infrequently — eels, eczema, urticaria, a knotty or multiformny erythema, a hloazma.
  • Cardiovascular system: sometimes — change in any of the parties of the ABP; seldom — fibrinferments, thromboembolisms.
  • Removal complications: sometimes — a liquid delay; "seldom" — weight reduction was observed.
  • Immune system: seldom — a bronchospasm.
  • Reproductive system: often — the cases of acyclic vaginal bleedings (smearing bloody allocations, breakthrough bleedings from a uterus), a nagrubaniye and increase in mammary glands, vagina candidiases are fixed; infrequently — vaginita; seldom — a galactorrhoea, increase in allocations from a vagina.

Application instruction (Way and dosage)

It is necessary to take a pill inside, it is possible to wash down with water (small amount), every day (since 1st day of a natural menstrual cycle, that is menstrual bleeding) approximately at the same time in the sequence designated on the blister: on one tablet 3 weeks, then the 7-day interval is necessary for approach of menstrualnopodobny bleeding.

When replacing by other combined oral contraceptive, a vaginal ring or a transdermalny plaster it is preferable to begin Midiana's use next day after the use of the last tablet or in day of removal of any of earlier used means.

To pass to reception of tablets of Midian with mini-saw it is possible in any day, in day of removal of an implant or other intrauterine contraceptive, in day of the following injection, at the same time, it is desirable to apply additional barrier methods of contraception in the first week.

If pregnancy was interrupted in the 1st trimester, then begin reception immediately without additional measures of contraception if pregnancy in the 2nd trimester is interrupted or the child is given birth, then reception is begun in 3-4 weeks. The bigger interval demands use of additional barrier methods of contraception in the first week. If there was a sexual contact, then at first it is necessary to exclude completely pregnancy or to wait for the 1st periods.

The scheme of reception of the passed tablets

In case of delay of reception of a tablet within 12 hours, contraceptive protection of drug will decrease therefore it is recommended to take a pill immediately and to continue further reception according to the usual scheme. If delay made more than 12 h, then in further tactics of administration of drug it is necessary to use 2 simple rules:

  • It is impossible to stop reception of a contraceptive more, than for 1 week.
  • Achievement of adequate oppression by gipotalamo-pituitary system of functioning of ovaries, requires 7-day continuous administration of drug.

In daily practice the following recommendations will be useful:

  • On the first week accept the last passed dose as soon as possible, up to reception of 2 tablets at the same time. Further a pill is taken in the usual determined time, however, it is recommended to apply in addition barrier methods of contraception for 7 days, otherwise the probability of approach of pregnancy is possible, and it directly depends on quantity of the passed tablets and proximity to a 7-day break of administration of drug.
  • On the second week accept the last passed dose as soon as possible and continue according to the usual scheme. If the last 7 days of reception were correct, then it is possible not to use barrier contraceptives, but if more than 1 tablet are passed, then without them sexual contacts are not desirable.
  • On the third week the probability of decrease in contraceptive effect is significantly increased, it is connected with the forthcoming 7-day admission of reception of tablets. It is possible to prevent decrease in contraceptive action correction of the schedule of administration of drug. If previous 7 dn. the course was not interrupted, it is possible to do without barrier contraception, otherwise – it is necessary and it is necessary to work on one of two ways. The first: it is necessary to accept drug as soon as possible and to continue in the usual mode, further – it is necessary to begin new packaging without interruption between packagings (most often bleedings of cancellation are not observed, but there can be smearing bloody allocations or complications in the form of breakthrough uterine bleeding). The second: to stop taking a pill from the current packaging for 7 days for cancellation bleeding, including the missed days of reception, further — to continue from new packaging.

To delay cancellation bleeding, it is necessary not to stop administration of drug, that is not to do a break between packagings. The delay can be before the end of the 2nd packaging, however when lengthening a cycle the smearing bloody allocations from a vagina or complication in the form of breakthrough uterine bleeding can be observed. Further resume reception, since a new pack after a standard 7-day interval. To postpone the beginning of bleeding of cancellation to other day, it is necessary to reduce the next break on so many — it is how necessary. Remember that the interval is less, the risk of absence of bleeding of cancellation and the smearing bleedings (or complications in the form of breakthrough uterine bleeding) in reception of the 2nd packaging is more.

If reception of tablets of Midian is followed by heavy reactions from a gastrointestinal tract, for example, vomiting or diarrhea, then it means that perhaps drug is soaked up not completely therefore it is recommended to apply other measures of contraception in addition. If the attack of vomiting arose after reception of a tablet in 3–4 h, then it is necessary to take a new pill as soon as possible. The new pill whenever possible should be taken during 12 h after the usual established reception time. If there passed more than 12 hours, then further it is necessary to work according to Regulations of Admission. If change of the normal mode of reception is not planned, then take an additional one or several pill from the following packaging.

Overdose

Cases of overdose are not recorded. Possible symptomatology: nausea, vomiting, bloody allocations or bleedings from a vagina. Appoint a symptomatic treatment. The specific antidote does not exist.

Interaction

Owing to interaction of oral contraceptives and other medicines there can be breakthrough uterine bleedings and/or decrease in contraceptive protection. The following types of interactions are known:

  • Phenytoinum, barbiturates, Carbamazepine, Primidonum, Rifampicin (Okskarbazepin, Topiramat, Ritonavir, Felbamat's also perhaps similar action, Griseofulvin, vegetable means on the basis of the St. John's Wort which is made a hole lat. Hypericum perforatum) — in connection with induction of microsomal enzymes can increase clearance of sex hormones.
  • HIV protease inhibitors (for example, Ritonavir) and nenukleozidny inhibitors of the return transcriptase (for example, Nevirapin) can influence a liver metabolism.
  • Some antibiotics (penicillin, tetracyclines) reduce enterohepatic recirculation of hormones of estrogen that can reduce concentration of ethinylestradiol.
  • Cyclosporine – increase of concentration of Midiana in plasma and fabrics.
  • Lamotridzhin – decrease in concentration of Midiana in plasma and fabrics.
  • Influence of this drug on separate laboratory tests, and also biochemical indicators of functions of a liver, adrenal glands and kidneys, thyroid gland, on a blood coagulation and a fibrinolysis, on concentration of transport proteins of plasma (kortikosteroidsvyazyvayushchy globulin) lipidic or lipoprotein fractions is possible. It is important that results usually are in norm limits.
  • Thanks to the insignificant antimineralokortikoidny activity – there is an increase of activity of drug of the Renin and concentration of mineralokortikosteroidny hormone — Aldosteronum in a blood plasma.

Terms of sale

It is released according to the recipe.

Storage conditions

In unavailable to children, the dark place, at a temperature no more than 25 ° Celsius.

Period of validity

Two years.

Special instructions

If with this medicine to accept any of the drugs listed in the first 3 points of the section "Interaction", then it is necessary to use barrier methods of contraception or to pass completely to other contraceptives. If the drugs containing the active agents influencing microsomal enzymes of a liver are used, then for 4 weeks after their cancellation it is necessary to use non-hormonal contraceptives. When begin reception of the accompanying drug at the end of reception of packaging of a contraceptive, reception of the following packaging of a contraceptive happens without 7-day interval.

Median and excess weight

Any set of excess weight, removal of excess liquid is sometimes observed. Drug does not influence body weight. If there is such side effect, then it is better to consult at the attending physician.

With antibiotics

At reception of antibiotics (exception: Rifampicin, Griseofulvin) it is also necessary to resort temporarily to barrier methods of contraception at least on an extent of 7 days after their cancellation.

The price of analogs significantly does not differ, most often Midian's contraceptives replace with Yarin's drug as it is easier to find it in drugstores though it much more expensive.

About Midiana

Comments of doctors on Midiana are positive, they confirm efficiency of drug as oral contraceptive therefore drug is appointed rather often. Concerning responses of patients — at forums it is possible to meet a set of various opinions. In most cases they point to advantages of drug: there is no influence on weight, skin, a libido, it is also told about the high level of reliability, at one essential shortcoming – drug can be found not in all drugstores. However, in single cases statements about weight of accustoming, headaches, disorders of a gastrointestinal tract and other meet.

Midiana's price where to buy

The price of contraceptive tablets of Midian fluctuates within 470-520 rubles (in packaging 21 tablets).

The price of Midiana expected 3 cycles (in a pack 63 tablets) — 1555-1600 rubles.

Zdravzona

  • Median No. 21 tabletkigedeon Richter
  • Median of 3 mg No. 63Gedeon Richter
  • Median No. 21х3 tabletkigedeon Richter

Drugstore of IFC

  • Median tbl p / about No. 21, Gedeon Richtervengriya
  • Median tbl p/pl/o 3 mg +0,03mg No. 63, Gedeon Richtervengriya
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BIOSPHERE

  • Median of 3 mg / 0,03 mg No. 21 tabl.p.p.o.
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Section: Contraceptives
in more detail

Education: Graduated from the Nikolaev national university of V. A. Sukhomlinsky, gained the diploma of the specialist with honors as "An embryologist, a cytologist, a histologist". Also, the human physiology and animals, the teacher of biology" graduated from a magistracy majoring in ". The course on discipline "Pharmacology" is with honors passable.

Experience: Worked as the senior laboratory assistant of department of Physiology and biochemistry of the Nikolaev national university of V. A. Sukhomlinsky in 2010 - 2011.

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