Modell Trend, 3 mg+0.02 mg, film-coated tablets, 84 pcs.

Pharmacodynamics

Contraceptive pills "Model Trend", reviews of which are positive, are a very effective drug. According to studies, out of a hundred women using the medicine, a maximum of one becomes pregnant. According to doctors, the risk of pregnancy increases only in cases of irregular use.

Women who use this contraceptive notice that their menstrual cycle stabilizes very quickly, and menstruation becomes less painful. Due to this, the amount of blood released is significantly reduced, which helps reduce anemia. In addition, according to scientific research, this drug can reduce the risk of developing ovarian cancer.

The Model Trend contraceptive, reviews of which are described in this article, contains drospirenone, which is responsible for maintaining body weight and also preventing the appearance of edema associated with improper functioning of female hormones. According to women's reviews, this component has an excellent effect on premenstrual syndrome. In addition, drospirenone actively fights acne, as well as oily skin and hair.

The drug “Model Trend” has the form of film-coated tablets, colored light pink. Inactive tablets are white.

Compound

Indications for use

Consumer reviews of the drug “Model Trend” are mostly positive. However, this does not mean that you can prescribe a contraceptive for yourself. Before using it, you should undergo certain tests and consult a doctor.

This drug can be prescribed by a gynecologist in the following cases:

— the main method of contraception;

— contraception and a way to combat acne;

- contraception and a method of treating severe premenstrual syndrome.

Taking missed pills

If you forget to take an inactive pill, then nothing bad will happen. But in any case, it is better to throw them away so as not to extend their useful life. The remaining recommendations apply only to active tablets.

If you forget to take a pill during the day, don't worry. Just accept it as soon as you remember it. Take the next tablet according to your schedule.

If the period is more than forty-eight hours, then the risk of pregnancy begins to increase. The more pills you miss, the more likely you are to get pregnant.

Pay attention to two factors that are responsible for the failure of an unwanted pregnancy:

- under no circumstances stop taking the drug for more than four days;

- Do not miss a dose in the first week after starting use.

Pharmacokinetics

Drospirenone

Suction. After oral administration, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. After a single dose of the drug, the Cmax of drospirenone in the blood serum is reached after 1–2 hours and is 35 ng/ml. The bioavailability of drospirenone is 76–85%. Food intake does not affect its bioavailability.

Distribution. Drospirenone binds to serum albumin and does not bind to SHBG or corticosteroid binding globulin (CBG).

The estradiol-induced increase in the concentration of SHBG in the blood plasma does not affect the binding of drospirenone to plasma proteins. During cyclic treatment, the Css of drospirenone is achieved in the second half of the cycle. A further increase in concentration is observed after approximately 1–6 cycles of taking the drug; no further increase in concentration is observed.

Metabolism. After oral administration, drospirenone is completely metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the participation of isoenzymes of the cytochrome P450 system.

Excretion. After oral administration, a two-phase decrease in the concentration of drospirenone in the blood serum is observed. It is excreted in the form of metabolites through the intestines and kidneys in a ratio of approximately 1.2:1.4. T1/2 of metabolites is approximately 40 hours.

Pharmacokinetics in special groups of patients

Css of drospirenone in blood plasma in women with mild renal failure (Cl creatinine 50–80 ml/min) is comparable to the corresponding values ​​in women with normal renal function. In women with moderate renal failure (creatinine clearance 30–50 ml/min), serum drospirenone concentrations are on average 37% higher than in women with normal renal function.

In women with moderate liver dysfunction (class B on the Child-Pugh scale), AUC is comparable to the corresponding indicator in healthy women with similar Cmax values ​​in the absorption and distribution phases. T1/2 of drospirenone in women with moderate liver dysfunction is 1.8 times higher than in healthy volunteers with normal liver function. In women with moderate hepatic impairment, a decrease in the clearance of drospirenone by approximately 50% was observed compared to women with normal liver function, while no differences were noted in the concentration of potassium in the blood plasma in the studied groups. There was no change in potassium concentration even in the case of a combination of factors predisposing to its increase (concomitant diabetes mellitus or treatment with spironolactone).

Ethinyl estradiol

Suction. After taking the drug orally, ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax in blood serum is reached after 1–2 hours and is 88–100 pg/ml. Ethinyl estradiol undergoes a first-pass effect through the liver, resulting in its oral bioavailability averaging 60%.

Distribution. Binding to plasma proteins (albumin) is about 98%. Ethinyl estradiol induces an increase in the concentration of SHBG in the blood plasma.

Css is established during the second half of the first cycle of dosing, with the concentration of ethinyl estradiol increasing by approximately 1.4–2.1 times.

Metabolism. Ethinyl estradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation.

Excretion. The decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic. Ethinyl estradiol is excreted as metabolites in urine and feces in a ratio of approximately 4:6. T1/2 of metabolites is about 24 hours.

How can I change the day the bleeding starts?

In order to delay the period of menstrual bleeding, you should continue to take the tablets from the second package, while skipping the inactive tablets from the first. Thanks to this, you can extend the cycle for the desired period. When using the drug from the second package, you may notice spotting.

If you continue to use the pills as usual, your cycle will be restored immediately.

Interaction

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Modell Trend or choose another method of contraception.

Drugs that reduce the effectiveness of Modell Trend

The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or reduced contraceptive reliability. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV protease inhibitors (eg ritonavir) and NNRTIs (eg nevirapine) and combinations thereof also have the potential to affect hepatic metabolism. While taking medications that affect microsomal liver enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.

Some antibiotics (eg penicillins and tetracyclines) may reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol. While taking antibiotics (such as penicillins and tetracyclines) and for 7 days after their discontinuation, you should additionally use a barrier method of contraception. If during these 7 days of using a barrier method of contraception you run out of active pills, you should skip taking inactive pills from the current package and start taking active pills from the next package of Modell Trend.

Other interaction

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely. COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentrations in plasma and tissues.

Based on in vitro interaction studies, as well as studies in female volunteers taking omeprazole, simvastatin and midazolam, it was found that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely. There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving the drug Modell Trend simultaneously with other drugs that can increase the concentration of potassium in the blood plasma. These drugs include ACE inhibitors, ARB II, some anti-inflammatory drugs, potassium-sparing diuretics and aldosterone antagonists. However, in studies examining the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference in plasma potassium concentrations compared with placebo.

Special Recommendations

Before using the drug, you need to conduct a detailed examination of the female body. To do this, heart rate, body mass index, and blood pressure are checked. A gynecological examination is a prerequisite. This should include examination of the mammary glands, exclusion of pregnancy, as well as examination of cervical scrapings. Screening examinations must be completed at least once every six months.

It is worth paying attention to the fact that the drug does not protect against sexually transmitted diseases at all.

Side effects

Like any other medicine, the Model Trend contraceptive may have side effects. Every woman should take this into account before taking the pills. Most often, patients noticed the development of allergic reactions or hypersensitivity to the components of the drug. There were cases of constant depression, decreased libido, insomnia or, conversely, increased drowsiness.

From the gastrointestinal tract, diarrhea, abdominal pain, nausea, and vomiting may be observed. In some cases, the development of anorexia or increased appetite.

It is worth noting that the drug has a special effect on each woman. Therefore, before using it, a mandatory consultation with a doctor is necessary.

Modell® Trend

If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of drospirenone + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting taking the drug. If any of these conditions, diseases or risk factors worsen, intensify or appear for the first time, a woman should consult her doctor to decide whether to stop taking the drug.

Risk of developing VTE and ATE

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 TEV, PE, myocardial infarction, cerebrovascular disorders). These diseases are rarely reported. The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition.

Drugs containing levonorgestrel, norgestimate, or norethisterone as a progestogen component are associated with the lowest risk of VTE. When using other COCs, such as the combination of drospirenone + ethinyl estradiol, the risk of developing VTE is 2 times higher.

The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking COCs (mainly during the first 3 months). An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more).

VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/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 limb or along the vein, pain or discomfort only in an upright position or when walking, local fever, redness or discoloration of the skin in the affected lower limb.

Symptoms of pulmonary embolism: 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 more common and less severe conditions (eg, respiratory tract infection).

ATE can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, one- or two-sided loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.

Other signs of vascular occlusion: sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.

Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

ATE can be life-threatening and lead to death.

In women with a combination of several risk factors or high severity of one of the factors, 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. In this case, the combination of drospirenone + ethinyl estradiol is contraindicated.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:

- with age;

- in women who smoke (with an increase in the number of cigarettes smoked or an increase in age, the risk increases, especially over the age of 35 years);

- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 50 years); in the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;

— for obesity (with a BMI more than 30 kg/m2);

- with dislipoproteinemia;

- for arterial hypertension;

- for migraine;

- for diseases of the heart valves;

- with atrial fibrillation;

- in case of prolonged immobilization, major surgery, any operation on the lower extremities, pelvis or major trauma: in these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not restarted within two weeks after the woman’s mobility is completely restored.

Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for VTE, especially in the presence of other risk factors.

The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

The increased risk of thromboembolism in the postpartum period should be taken into account.

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 (which may precede cerebrovascular events) during the use of COCs is grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be borne in mind that adequate therapy for the relevant condition/disease can reduce the associated risk of thrombosis.

Tumors

The most significant risk factor for the development of cervical cancer (CC) 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, but the connection with COC use has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to women's sexual behavior (lower use of barrier methods of contraception, greater number of sexual partners).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increased risk may be a consequence of earlier diagnosis of breast cancer in women taking COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors. In rare cases, during the use of COCs, the development of benign, and in extremely 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.

Other states

Drospirenone is an aldosterone antagonist with potassium-sparing properties. In most cases, there should be no increase in plasma potassium concentration. In clinical studies in some patients with mild to moderate renal impairment and concomitant use of potassium-sparing drugs, plasma potassium concentrations were slightly increased while taking drospirenone. Therefore, it is necessary to monitor the concentration of potassium in the blood plasma during the first cycle of taking the drug in patients with renal failure or with an initial potassium concentration at the upper limit of normal, especially when taking potassium-sparing drugs concomitantly.

In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs. Although slight increases in blood pressure (BP) have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops during the use of COCs. COCs should be discontinued and treatment of arterial hypertension should be started. If normal blood pressure values ​​are achieved with antihypertensive therapy, COC use can be continued.

The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their association with COC use has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; 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, exogenous estrogens can cause or worsen the symptoms of angioedema.

Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests normalize. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.

Although COCs may have an effect on insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose COCs, as a rule, no dose adjustment of hypoglycemic drugs is required. 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 ultraviolet radiation while taking COCs.

Low mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be serious and is a known risk factor for suicidal behavior and suicide. Women should be advised to consult a doctor if mood changes or symptoms of depression occur, including soon after starting contraception.

Effect on liver function tests

In clinical trials of hepatitis C viral therapy with drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin), increases in ALT levels greater than 5 times the upper limit of normal were significantly more common in patients using ethinyl estradiol-containing drugs such as like COC. Women taking MODELL® TREND should switch to an alternative method of contraception (progestogens only or non-hormonal methods of contraception).

Taking MODELL® TREND should be discontinued before starting antiviral therapy and can be resumed no earlier than 2 weeks after completion of therapy with a combination of antiviral drugs.

Laboratory tests

The use of drugs such as drospirenone + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis ). These changes usually remain within normal physiological values.

Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.

Reduced efficiency

The effectiveness of COCs may be reduced in the following cases: in case of missed pills, gastrointestinal disorders or as a result of drug interactions.

Effect on the menstrual cycle

While using COCs, irregular bleeding may occur (“spotting” and/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 drug cycles.

If irregular bleeding recurs or develops after previous regular cycles, the woman should be carefully examined to rule out malignancy or pregnancy.

Some women may not develop withdrawal bleeding during a break in taking contraceptive pills; pregnancy should be excluded before continuing to take it.

Medical examinations

Before starting or resuming the use of the drug MODELL® TREND, it is necessary to familiarize yourself with the woman’s life history and family history, conduct a thorough general medical examination (including measuring blood pressure, determining BMI) and gynecological examination (with mandatory examination of the mammary glands and cytological studies of the cervical epithelium), and exclude pregnancy. The scope of additional studies and frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months. It must be remembered that the drug does not protect against HIV infection

You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and 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 in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.

Contraceptive pills "Model Trend": reviews

This drug is very popular among women as a primary and secondary method of contraception, as well as an excellent means for normalizing hormonal levels. Most women agree that the drug is a very effective method of contraception that does not require additional protection.

“Model Trend” - tablets, customer reviews of which indicate the effectiveness of the drug. They are quite often used by women to normalize hormonal levels, and also as an additional method of getting rid of acne.

However, those women who prescribed the drug to themselves very often encountered all sorts of health problems. Therefore, we strongly recommend not to self-medicate.

Use during pregnancy and breastfeeding

The use of Modell Trend is contraindicated during pregnancy. If pregnancy is detected while using Modell Trend, the drug should be discontinued immediately. Extensive epidemiological studies have not found an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or a teratogenic effect in cases where sex hormones were taken inadvertently in early pregnancy.

In animal studies, the effects of drospirenone and ethinyl estradiol were related to their pharmacological actions. In particular, embryotoxic and fetotoxic effects have been identified in animal reproductive toxicity studies, but these effects have been considered species-specific. At exposure levels in animals exceeding those in patients receiving drospirenone and ethinyl estradiol, effects on sex differentiation in rat embryos were observed that were not observed in monkeys. According to data obtained from animal studies, the possibility of the development of undesirable effects caused by the hormonal activity of the active substances in humans cannot be excluded. However, the cumulative experience with the use of COCs during pregnancy has not provided evidence of the development of undesirable effects in humans. Data on the results of taking the drug Modell Trend during pregnancy are limited, which does not allow us to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and newborn. Currently, no significant epidemiological data are available.

The use of Modell Trend is contraindicated during breastfeeding. COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex hormones and/or their metabolites may be excreted in milk.