Minisiston 20 Fem

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

Minisiston 20 fem: instructions for use and reviews

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

Latin name: Minizistone 20 fem

ATX code: G03AA07

Active ingredient: ethinylestradiol + levonorgestrel (ethinylestradiol + levonorgestrel)

Producer: Bayer Pharma AG (Germany)

Description and photo update: 2019-14-08

Prices in pharmacies: from 359 rubles.

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Minisiston 20 fem is a combined monophasic contraceptive.

Release form and composition

Dosage form of Minisiston 20 fem - coated tablets: pink (21 pcs. In a blister, in a cardboard box 1 or 3 blisters).

Content of active ingredients in 1 tablet:

Levonorgestrel - 0.1 mg;
Ethinylestradiol - 0.02 mg.

Auxiliary components: corn starch, lactose monohydrate, sucrose, povidone 25,000, pregelatinized corn starch, magnesium stearate, macrogol 6000, calcium carbonate, titanium dioxide, povidone 700,000, glycerol 85%, iron dye red oxide, iron dye yellow oxide, wax mountain glycolic, talc.

Pharmacological properties

Pharmacodynamics

Minisistone 20 fem is a low-dose, monophasic oral combined estrogen-progestogen contraceptive. Its contraceptive effect is due to the presence of complementary mechanisms, the most important of which are considered to be a change in the viscosity of cervical mucus, as a result of which its permeability to sperm is minimized, and the suppression of ovulation.

With proper use, the Pearl index (a parameter indicating the frequency of pregnancy in 100 patients taking contraceptives throughout the year) for Minisiston 20 fems is less than 1. If the intake regimen is incorrect or pills are missed, the Pearl index may increase.

In women who took Minisiston 20 fem, there is a greater regularity of the cycle, the intensity of menstrual bleeding and painful sensations that accompany them decrease, which leads to a decrease in the risk of iron deficiency anemia.

Pharmacokinetics

Levonorgestrel is absorbed fairly quickly when taken orally. Its maximum concentration in the blood is determined after 1 hour. The bioavailability of the substance reaches 100%. Up to 65% of levonorgestrel binds to albumin and sex hormone-binding globulin. Its equilibrium concentration in the blood is reached after 3-4 days. The level of levonorgestrel in the blood remains unchanged after 3 courses of contraceptive use. The compound is subject to steroid-type biotransformation. Its metabolites have no pharmacological activity and are excreted in bile and urine. The decrease in the concentration of levonorgestrel is biphasic: in the first phase, the half-life is 30 minutes, and in the second phase - 20 hours.

When taken orally, ethinyl estradiol is absorbed almost completely. Its maximum concentration in the blood is determined 1.5-2 hours after ingestion. Metabolism is carried out due to the effect of "first pass" through the liver, which leads to a decrease in the bioavailability of ethinylestradiol (it is equal to 40-60%). The substance binds to albumin by about 98%.

The concentration of ethinyl estradiol in the blood decreases in two phases: in the first phase, the half-life is about 1 hour, and in the second - 10–20 hours. The substance is excreted only in the form of metabolites with bile and urine. In total, the half-life can be up to 24 hours.

Indications for use

According to the instructions, Minisiston 20 fem is indicated for oral contraception.

Contraindications

Diabetes mellitus with vascular complications;
Arterial and venous thrombosis, including pulmonary thromboembolism, deep vein thrombosis, cerebrovascular disorders, myocardial infarction (including a history);
Severe or multiple risk factors for arterial and venous thrombosis;
Transient ischemic disorders of cerebral circulation, angina pectoris and other pathologies preceding thrombosis (including anamnesis);
Severe liver disease, including anamnesis (before the normalization of laboratory parameters of liver function tests);
Benign or malignant neoplasms of the liver (including history);
Vaginal bleeding of unknown etiology;
Diagnosed hormone-dependent malignant tumors of the mammary glands, genitals or suspicion of them;
Pregnancy or suspicion of it;
Breastfeeding period;
Hypersensitivity to drug components.

In the event of the appearance of these pathologies and conditions against the background of the use of Minisiston 20 fem, contraception should be stopped immediately.

Instructions for use of Minisiston 20 fem: method and dosage

The tablets are taken orally, washed down with a sufficient amount of water, always strictly at the same time (set by each woman individually), 1 pc. per day.

Reception should start with the tablet corresponding to the day of the week and continue in the order indicated on the package for 21 days. Then there is a seven-day break in use, on the 2-3 day of which menstrual bleeding begins. Taking pills from the next blister should be started at the set time on the eighth day after taking the last pill from the previous one, even if the withdrawal bleeding has not ended.

In the absence of hormonal contraception in the previous month, you should start taking Minisiston 20 fem on the first day of menstrual bleeding.

If the application is started from 2 to 5 days of the menstrual cycle, then during the first 7 days, an additional barrier method of contraception is required.

When switching from other oral combined contraceptives, Minisiston 20 fem should be taken from the next day after taking the last tablet from the package of the previous drug, but no later than the eighth day after a break in taking (for contraceptives containing 21 tablets) or after taking the last inactive tablet (for products containing 28 pills per package).

When switching from gestagenic contraception, you can start taking pills without interruption: after taking a mini-drink - any day, after injection forms - on the day of the next injection, when using an implant - on the day of its removal.

In all these cases, during the first 7 days of taking Minisiston 20 fem, you should additionally use barrier contraceptives.

With an abortion in the first trimester of pregnancy, the drug can be taken immediately without additional methods of contraception.

After an abortion in the second trimester or childbirth, it is recommended to start the application between 21 and 28 days. If you start oral contraception later, condoms should be used additionally during the first 7 days. If a woman has had sexual intercourse after an abortion in the second trimester or childbirth, then the drug should be started only after the exclusion of pregnancy or the first menstruation.

The effectiveness of contraception is impaired when taking Miniziston 20 fem. It should be borne in mind that suppression of the function of the hypothalamic-pituitary-ovarian system occurs after 7 days of continuous use of the drug, and the interruption in admission should never exceed 7 days.

If you are late up to 12 hours (no more than 36 hours from the moment of taking the previous pill), the reliability of contraception does not decrease, therefore, an accidentally missed dose should be taken as soon as you remember, and the next one - at the set time.

If more than 12 hours have passed since the intended intake, there is a risk of reducing the reliability of contraception. If you are late in the first week of taking the pill, you should take the pill as soon as you remember, even if you have to take 2 pills at the same time, then continue using the drug at the set time and use additional barrier methods of contraception for the next 7 days. If a woman has had sexual intercourse during the previous skipping week, there is a risk of pregnancy.

The likelihood of pregnancy increases with repeated skipping of Minisiston 20 fem and if the drug is missed shortly before the prescribed break in admission.

If the accidental delay of the next pill was more than 12 hours and occurred in the second week of contraception, then the drug should be taken as soon as possible, even if you have to take 2 pills at the same time, then continue using as usual. Provided that Minisiston 20 fem is regularly taken during the previous 7 days, the use of additional contraceptive measures is not required. If you missed taking several pills or there was a violation of the dosing regimen within 7 days before the late admission, then during the next 7 days additional use of a condom is required.

If a woman forgot to take a pill on time in the third week, and the delay lasted more than 12 hours, then the likelihood of a decrease in the effect of the drug increases due to the approach of a seven-day break. In this situation, in order to maintain the contraceptive effect, it is recommended to choose one of the options for further actions. If during the previous 7 days the drug was taken without violations, then the further use of Minisiston 20 fem does not require the use of additional methods of contraception.

The first option involves taking the last missed pill as soon as possible, as soon as the woman remembers, even if it will be taking 2 pills at the same time. Then you can continue taking at the usual time until the end of all the tablets in the current blister and without interruption in use, start the next blister. Menstrual bleeding may not occur until the end of taking the pills from the next blister, but the likelihood of spotting and breakthrough bleeding is high.

The second option is to prematurely interrupt the intake of Minisiston 20 fems from the current blister: you should take the prescribed seven-day break, including the day of skipping, and start taking pills from a new blister. If withdrawal bleeding does not occur at the right time, you should make sure that there is no pregnancy.

If vomiting appears in the next 3-4 hours after taking the pill, then the absorption process is likely to be partial. In this case, you can take the appropriate pill from a new blister without violating the contraceptive regimen, or consider the pill taken before vomiting as missed and use the recommendations for the missed dose of the drug.

To delay withdrawal bleeding, it is necessary to start taking pills from a new blister without interruption and continue using until the desired day, until the last pill. During this period, the appearance of spotting bleeding or breakthrough uterine bleeding is possible. After a seven-day break, the reception of Minisiston 20 fems is resumed as usual.

To change the day of the onset of menstruation to another day of the week, shorten the break by the desired number of days. It should be borne in mind that the shorter the break, the greater the likelihood of spotting and breakthrough bleeding during the period of taking the next blister.

Side effects

In rare cases, while taking Minisiston 20 fem, the following undesirable effects may appear:

Reproductive system: disorders of vaginal secretion;
Digestive system: vomiting, nausea;
Nervous system: headache, change or worsening of mood, migraine;
Endocrine system: soreness and tension of the mammary glands, enlargement of the mammary glands, secretion from the mammary glands, changes in body weight, changes in libido;
Others: fluid retention in the body, poor tolerance of contact lenses, allergic reactions.

Sometimes - the development of chloasma, more often with a history of chloasma in pregnant women.

Overdose

There are no reports of serious health problems with a single large dose of Minisiston 20 fem. Overdose may hypothetically be accompanied by symptoms such as bleeding from the vagina, nausea and vomiting. In this case, a specialist consultation is required.

special instructions

The use of Minisiston 20 fem should be started after a complete general medical examination aimed at mammological examination of the mammary glands, cytological examination of cervical mucus, exclusion of pregnancy and disorders of the blood coagulation system.

With prolonged use of the drug, a woman should undergo control checks at least 1 time per year.

Minisiston 20 fem does not protect against sexually transmitted diseases, including HIV infection (AIDS).

Before using the drug, women with risk factors are advised to carefully assess the need for oral contraception in case of a potential threat to their health.

The action of combined oral contraceptives increases the incidence of thromboembolism, arterial and venous thrombosis.

In extremely rare cases, women taking Minisiston 20 fem are diagnosed with thrombosis of the hepatic and mesenteric blood vessels, veins and arteries of the kidneys and retina, although a direct connection with a combined contraceptive has not been proven.

Symptoms of venous or arterial thrombosis include sudden shortness of breath, one-sided leg pain and / or leg swelling, sudden onset of coughing, severe, sharp chest pain with or without radiation to the left arm, dizziness, severe prolonged headache, increased frequency, and severity of migraine, diplopia, sudden loss of vision (partial or complete), slurred speech, collapse with or without partial seizure, sudden significant loss of sensation in one of the body parts, weakness, acute abdomen, movement disorders. If you experience any of these ailments, you should immediately consult a doctor.

Biochemical parameters may indicate a tendency to thrombosis: deficiency of antithrombin III, protein S, protein C, hyperhomocysteinemia, resistance to activated protein C, antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin).

Factors contributing to an increased risk of thromboembolism, venous or arterial thrombosis: family history (venous or arterial thromboembolism in parents at a young age, brothers or sisters), smoking (especially after 35 years and with a large number of cigarettes per day), dyslipoproteinemia, obesity (body mass index exceeds 30 kg per 1 m ²), arterial hypertension, atrial fibrillation, heart valve disease, prolonged immobilization, major surgeries, any surgery on the legs, severe trauma, postpartum period.

With a hereditary predisposition to thrombosis, an examination by an appropriate specialist is required.

You should stop using Minisiston 20 fem 4 weeks before the planned operation and resume taking after complete immobilization only after 2 weeks.

Circulatory disorders are possible in patients with diabetes mellitus, hemolytic uremic syndrome, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, sickle cell anemia.

An increase in the frequency and severity of migraine while taking Minisiston 20 fem is the basis for its immediate cancellation.

Diagnostics of the development of cervical and breast cancer on the background of long-term use of combined contraceptive pills is slightly higher than in women who do not take them. Nevertheless, the exact relationship between pathology and the effect of the drug has not been established.

There is a risk of developing liver neoplasms, in some cases accompanied by intra-abdominal bleeding. The doctor should take this into account in the differential diagnosis of patients with complaints of severe pain in the abdomen, enlarged liver, or symptoms of intra-abdominal bleeding.

Taking the drug increases the risk of pancreatitis in women with hypertriglyceridemia (including a family history).

If the action of Minisiston 20 fem causes a persistent, clinically significant increase in blood pressure, its further use should be canceled or continued in combination with adequate antihypertensive therapy.

If you are prone to chloasma, avoid exposure to direct sunlight or ultraviolet radiation.

When conducting laboratory tests, the medical staff should be warned about taking Miniziston 20 fem.

The adaptation of the body to the action of the drug lasts 3 cycles; during this period, spotting spotting or breakthrough bleeding can be observed. In case of frequent recurrence or development of these ailments for no apparent reason after established regular cycles, a woman should undergo a thorough examination to exclude pregnancy or malignant tumors.

In the absence of withdrawal bleeding in two consecutive cycles, it is impossible to start taking the next blister until pregnancy is excluded.

The influence of Minisiston 20 fem on the ability to drive vehicles and mechanisms has not been established.

Application during pregnancy and lactation

Reception of Miniziston 20 fem is contraindicated during pregnancy and lactation. If a pregnancy test is positive while using the drug, it must be canceled immediately. However, repeated epidemiological studies do not confirm the presence of an increased risk of malformations in children born to patients who took sex hormones before pregnancy, or a teratogenic effect when such drugs were taken accidentally in early pregnancy.

Taking Miniziston 20 fem can reduce the production of breast milk and change its composition, so its use is not recommended during lactation. Small amounts of levonorgestrel, ethinyl estradiol and / or their metabolites are sometimes excreted in milk.

Drug interactions

With the simultaneous administration of barbiturates, phenytoin, primidone, rifampicin, carbamazepine, possibly topiramate, griseofulvin, oxcarbazepine, felbamate (drugs that induce liver microsomal enzymes), as well as tetracyclines and ampicillins with Minisistone 20 females, it is possible to develop a decrease in the reliability of contraceptives. Therefore, during the period when this combination is needed and within 7 days after stopping the use of these funds, it is recommended to additionally use barrier contraceptives.

The entire period of combination with rifampicin and within 28 days after the termination of its administration should be additionally used barrier contraception. If rifampicin is prescribed several days before the end of the blister, a new blister should be started without the usual seven-day break.

Analogs

The analogues of Minisiston 20 fem are: Ovidon, Trigestrel, Triziston, Trikvilar, Oralkon, Anteovin, Mikroginon, Rigevidon.

Terms and conditions of storage

Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Minisiston 20 fem

According to reviews, Minisiston 20 fem is suitable for many women, since they have been taking it for a long time (2-5 years) without developing any significant side effects. In the majority of patients, who nevertheless showed side reactions, they were expressed in the form of headaches, the appearance of cellulite and "spider veins" on the lower extremities, hair loss, severe drowsiness, nausea, decreased libido, and sudden mood swings. In some cases, after the cancellation of Minisiston 20 fems, menstruation was absent for 3-9 months, so some women do not advise using this drug.

Minisiston 20 fem can be prescribed for emergency postcoital contraception according to a special scheme. However, gynecologists do not recommend using it for such purposes due to the high risk of menstrual irregularities. This method is considered an emergency and in no case should be used for several menstrual cycles in a row.

Price for Minisiston 20 Fem

The approximate price for Minisiston 20 fems is 380-550 rubles (21 pcs in a package).

Minisiston 20 fem: prices in online pharmacies

Drug name

Price

Pharmacy

Minisiston 20 fem 0.1 mg + 0.02 mg dragee 21 pcs.

359 r

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Minisiston 20 FEM tablets p.o. 21 pcs.

443 r

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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!