Minizistone® 20 fem (Minizistone® 20 fem)
If any of the conditions, diseases and risk factors listed below currently exist, then you should carefully weigh the potential risks and expected benefits of using COCs, including Miniziston® 20 Fem, in each individual case and discuss them with woman before she decides to start taking the drug. In case of worsening, intensification or first manifestation of any of these conditions, diseases or risk factors, the woman should consult with her doctor, who may decide whether to discontinue the drug.
— Diseases of the cardiovascular system
Postmarketing safety studies (PASS) have shown that the incidence of venous thromboembolism (VTE) varies between 7 and 10 per 10,000 woman-years with low-dose estrogen (<50 mcg ethinyl estradiol) in women taking COCs. The most recent data suggest that the diagnosis rate of VTE is approximately 4 per 10,000 woman-years in non-pregnant women not taking COCs, and ranges from 20 to 30 per 10,000 pregnant or postpartum women.
The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PE, myocardial infarction, cerebrovascular disorders) when taking COCs. These diseases are rare.
The risk of VTE is highest during the first year of COC use. An increased risk is present after initial use of COCs or resumption of use of the same or different COCs (after a dosing interval of 4 weeks or more). Data from a large prospective cohort study involving 3 groups of patients indicate that this increased risk exists during the first 3 months of COC use or resumption of use after a break of 4 weeks or more.
The overall risk of VTE in patients taking low-dose COCs (<50 mcg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth .
VTE can be life-threatening or fatal (in 1-2% of cases).
VTE, manifested as DVT or PE, can occur with all COCs. It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of DVT: unilateral swelling of the lower extremity or along the vein, pain or discomfort only in an upright position or when walking, local fever, redness or discoloration of the skin on the lower extremity.
Symptoms of PE include: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other less severe conditions (eg, respiratory tract infection). Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of feeling in the face, arm or lower limb, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, “acute abdomen.”
Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or behind the breastbone; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be fatal.
In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. COCs should not be prescribed if the potential risk outweighs the expected benefit (see section "Contraindications").
The risk of developing thrombosis (venous and/or arterial) and thromboembolism, as well as stroke, increases:
- with age;
- in 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:
- a burdened family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years); in case of hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;
— obesity (body mass index more than 30 kg/m2);
- dislipoproteinemia;
- arterial hypertension;
- migraine;
- heart valve defects;
- atrial fibrillation;
- prolonged immobilization, major surgery, any leg surgery or major trauma. In these cases, you should stop using the drug (in the case of a planned operation, at least four weeks before it) and not resume taking it for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of venous thromboembolism, especially in the presence of other risk factors.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period (see sections “Pharmacodynamics”).
Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular events) is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the associated risk of thrombosis.
Tumors
The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs has not been proven. The possibility of the relationship of these data with screening for cervical diseases and with characteristics of sexual behavior (less frequent use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies found that there was a slightly increased relative risk of developing breast cancer diagnosed in women who used COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in current or recent COC users is small relative to the overall risk of breast cancer. Its connection with COC use has not been proven. The observed increase in the risk of developing breast cancer (BC) may be associated with the biological effect of COCs, earlier diagnosis of breast cancer. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.
In rare cases, during the use of COCs, the development of benign, and in even more rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Malignant tumors can be life-threatening or fatal.
— Other states
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs.
Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have been reported rarely. However, if a persistent clinically significant increase in blood pressure develops while taking a COC, the COC should be discontinued and treatment of arterial hypertension should be initiated. COCs can be continued if normal blood pressure levels are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic red lupus, hemolytic-uremic syndrome, Sydenham's chorea, gestational herpes, hearing loss associated with otosclerosis. Cases of worsening the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during the use of COCs have also been described.
In women with hereditary forms of angioedema, estrogen may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COC use.
Although COCs may have an effect on insulin resistance and glucose tolerance, generally no adjustment of the dosage regimen of hypoglycemic drugs is required in patients with diabetes mellitus using low-dose COCs (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.
Preclinical safety data
Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.
Laboratory tests
Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins (for example, corticosteroid binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values.
Reduced efficiency
The effectiveness of COC drugs may be reduced in the following cases: when pills are missed, gastrointestinal disorders (vomiting and diarrhea) or as a result of drug interactions.
Insufficient control of the menstrual cycle
While taking COCs, irregular bleeding may occur (“spotting” or “breakthrough” bleeding), 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, careful evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop bleeding during a break in taking pills; “ooContraindications” and “Use with caution”;
— local compaction in the mammary gland;
- simultaneous use of other medications (see section “Interaction with other medications”);
- if long-term immobilization is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least 4 weeks before the proposed operation);
- unusually heavy bleeding from the vagina;
- missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;
- vomiting or diarrhea;
- absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).
You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis: new unusual cough, unusually severe chest pain radiating to the left arm, sudden shortness of breath, unusual, severe or prolonged headache or migraine attack, partial or complete loss of vision or double vision, slurred speech, sudden changes in hearing, smell or taste, dizziness or fainting, weakness or loss of sensation.
Similar drugs:
- Lindynette 30 Oral tablets
- Livial Oral tablets
- Lindynette 20 Oral tablets
- Evian Oral tablets
- Ladybon Oral tablets
- Femoden Dragee
- Mercilon Oral tablets
- Evista Oral tablets
- Femoston Oral tablets
- Kliogest Oral tablets
** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Miniziston, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
Are you interested in the drug Miniziston? Do you want to know more detailed information or do you need a doctor's examination? Or do you need an inspection? You can make an appointment with a doctor - the Euro lab is always at your service! The best doctors will examine you, advise you, provide the necessary assistance and make a diagnosis. You can also call a doctor at home . Euro lab clinic is open for you around the clock.
** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Miniziston is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
If you are interested in any other drugs and medications, their descriptions and instructions for use, information about the composition and form of release, indications for use and side effects, methods of use, prices and reviews of drugs, or you have any other questions and suggestions - write to us, we will definitely try to help you.
Drug interactions
With the simultaneous use of barbiturates, phenytoin, primidone, rifampicin, carbamazepine, possibly topiramate, griseofulvin, oxcarbazepine, felbamate (drugs that induce microsomal liver enzymes), as well as tetracyclines and ampicillins with Miniziston 20 fem, a decrease in the reliability of contraception and the development of breakthrough bleeding is possible. Therefore, during the period of need for this combination and for 7 days after stopping taking these drugs, it is recommended to additionally use barrier contraceptives.
During the entire period of combination with rifampicin and for 28 days after stopping its use, additional barrier contraception should be used. If rifampicin is prescribed several days before the end of the blister, a new blister should be started without the usual seven-day break.
Use during pregnancy and lactation
Taking Miniziston 20 fem is contraindicated during pregnancy and lactation. If a pregnancy test is positive while using the drug, it must be discontinued 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.
Release form and composition
The dosage form of Miniziston 20 fem is film-coated tablets: pink (21 pieces in a blister, 1 or 3 blisters in a cardboard pack).
Content of active ingredients in 1 tablet:
- Levonorgestrel – 0.1 mg;
- Ethinyl estradiol – 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%, red iron oxide dye, yellow iron oxide dye, wax mountain glycol, talc.
Pharmacological properties
Pharmacodynamics
Miniziston 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 suppression of ovulation.
When used correctly, the Pearl index (a parameter indicating the frequency of pregnancy in 100 patients taking a contraceptive throughout the year) for Miniziston 20 fem is less than 1. If the dosage regimen is incorrect or pills are missed, the Pearl index may increase.
Women who took Miniziston 20 fem noted greater cycle regularity, a decrease in the intensity of menstrual-like bleeding and the pain that accompanies it, which reduces 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 is bound to albumin and sex hormone-binding globulin. Its equilibrium concentration in the blood is achieved after 3-4 days. The level of levonorgestrel in the blood remains unchanged after 3 courses of taking the contraceptive. The compound is subject to steroid-like biotransformation. Its metabolites do not have pharmacological activity and are excreted in bile and urine. The decrease in levonorgestrel concentration is biphasic: in the first phase the half-life is 30 minutes, and in the second phase it is 20 hours.
When taken orally, ethinyl estradiol is absorbed almost completely. Its maximum concentration in the blood is determined 1.5–2 hours after administration. Metabolism occurs due to the “first pass” effect through the liver, which leads to a decrease in the bioavailability of ethinyl estradiol (it is 40–60%). The substance binds to albumin by approximately 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 in bile and urine. In total, the half-life can reach 24 hours.
Contraindications
- Diabetes mellitus with vascular complications;
- Arterial and venous thrombosis, including pulmonary embolism, 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 medical history);
- Severe liver diseases, including medical history (until normalization of laboratory parameters of liver tests);
- Benign or malignant neoplasms of the liver (including medical history);
- Vaginal bleeding of unknown etiology;
- Diagnosed or suspected hormone-dependent malignant tumors of the mammary glands, genital organs;
- Pregnancy or suspicion of it;
- Breastfeeding period;
- Hypersensitivity to the components of the drug.
If the indicated pathologies and conditions appear during the use of Miniziston 20 fem, contraception should be stopped immediately.
