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.
The drug "Model Trend", reviews of which you can read in this article, is a hormonal contraceptive that works by suppressing ovulation, changing the endometrium and increasing the viscosity of uterine secretions.
Pharmacodynamics
Contraceptive pills "Model Trend", reviews of which are positive, are a very effective drug. According to studies, out of a hundred women who use medications, 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 given in this article, contains drospirenone, which is responsible for maintaining body weight and also prevents 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.
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 use, 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.
Contraindications
“Model Trend” - tablets, reviews of which are written in this article, have a large number of contraindications. Therefore, using them for self-medication is absolutely prohibited. But still, you should not use the drug in the following cases: - all types of thrombosis, and their previous condition; - migraine of unknown origin; - diabetes; - serious liver and kidney diseases; - malignant diseases of the genital organs; - bleeding from the vagina of unknown origin; - During pregnancy and breastfeeding; - allergy to the components of the drug.
"Model Trend": instructions
Tablets should be used as recommended by a specialist. Try to carry out this procedure at the same time every day, washing them down with a small amount of liquid. This should be done continuously for twenty-eight days. New packaging should be started the next day. Your doctor will tell you the exact duration of treatment.
Start taking the drug
"Model Trend" - contraceptives, reviews of which confirm their effectiveness. They are very popular among young women. You should start using the drug on the first day of your period. This can also be done on the second and third days, but in this case you need to use other methods of contraception. This should be done throughout the first week after starting to use the drug from the first package.
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 prolong their use. Other recommendations apply only to active tablets. If you forget to take your pill during the day, don't worry. Just accept it as soon as you remember it. Take the next tablet according to the 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: - in no case stop taking the drug for more than four days; — do not miss a dose in the first week after starting use.
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 pack, 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.
Special Recommendations
Before using the drug, a detailed examination of the female body should be carried out. 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 the cervical smear. 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 every woman. Therefore, before using it, a mandatory consultation with a doctor is necessary.
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 various health problems. Therefore, we strongly recommend not to self-medicate.
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.
Modell Trend
Modella Trend tablets are taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Should be taken 1 tablet/day continuously for 28 days. Taking tablets from the next package should be started the day after taking the last tablet from the previous package.
Withdrawal bleeding usually begins on the 2-3rd day after starting to take inactive tablets and may not yet end before you start taking tablets from a new package.
Start taking the drug
If you have not taken any hormonal contraceptives in the previous month, use of the drug begins on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
Switching from other combined hormonal contraceptives (CPCs, vaginal ring or contraceptive patch)
It is preferable to start taking the drug the day after taking the last active tablet from the previous package, but in no case later than the next day after taking the last inactive tablet (for drugs containing 28 tablets per package). Taking the drug should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.
Switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant or intrauterine systems (IUDs) with controlled release of gestagen)
You can switch from taking the “mini-pill” to the drug on any day (without a break), from an implant or IUD with a progestogen - on the day of its removal, from an injectable contraceptive - on the day when the next injection is due. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.
After an abortion in the first trimester of pregnancy
You can start taking the drug immediately - on the day of the abortion. If this condition is met, the woman does not need additional methods of contraception.
After childbirth or abortion in the second trimester of pregnancy
It is recommended to start taking the drug on the 21-28th day after childbirth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already been sexually active, pregnancy should be ruled out before starting to take the drug or she must wait until her first menstruation.
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.
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.
Modell Trend, 3 mg+0.02 mg, film-coated tablets, 84 pcs.
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, family history, conduct a thorough general medical examination (including measuring blood pressure, heart rate, determining BMI) and gynecological examination, including examination of the mammary glands and cytological examination of scrapings from the cervix (Papanicolaou test). ), 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. A woman should be informed that Modell Trend does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of using COCs should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If risk factors become more severe, intensify, or appear for the first time, discontinuation of the drug may be necessary.
Diseases of the cardiovascular system.
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, and cerebrovascular diseases. These diseases are rare.
The risk of developing VTE is greatest in the first year of taking such drugs. The risk is especially high during initial use of COCs or resumption of use of the same or different COCs (after a break between doses of the drug of 4 weeks or more).
Data from a large prospective study involving 3 groups of patients show that the risk is highest primarily during the first 3 months. The overall risk of VTE in women taking low-dose COCs (containing less than 50 mcg ethinyl estradiol) is 2 to 3 times higher than in non-pregnant women not taking COCs, although the risk remains lower than the risk of VTE in pregnancy and childbirth. VTE can be fatal (in 1–2% of cases). VTE, manifested as DVT or PE, can develop with the use of any COC. It is extremely rare when using COCs that thrombosis of other blood vessels occurs, such as hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the relationship between the occurrence of these events and the use of COCs.
Symptoms of DVT include: unilateral swelling of the lower extremity or along a vein in the lower extremity, pain or discomfort in the lower extremity only when standing or walking, localized warmth in the affected lower extremity, redness or discoloration of the skin on the lower extremity.
Symptoms of PE include: difficulty or rapid breathing; sudden cough, incl. 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 symptoms of other more or less severe events (eg respiratory tract infection).
Arterial thromboembolism 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, problems with speech and understanding; 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, symptom complex of acute abdomen.
Symptoms of myocardial infarction include: pain; discomfort; a feeling of pressure, heaviness, a feeling of squeezing or fullness in the chest, in the arm or behind the sternum; discomfort in the left half of the chest radiating to the back, cheekbone, larynx, arm, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; a feeling of fast or irregular heartbeat.
Arterial thromboembolism can be life-threatening or fatal. The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases: with age; in smokers (with increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years of age);
in the presence of:
— obesity (BMI more than 30 kg/m2);
- a burdened family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be referred to an appropriate specialist to decide on the possibility of using COCs;
- prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these situations, it is necessary to stop using COCs (in the case of a planned operation, at least 4 weeks before it) and not resume use for 2 weeks after the end of immobilization;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation.
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 attacks during the use of COCs (which may precede cerebrovascular events) should be grounds for immediate discontinuation of these drugs. Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of 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. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose COCs (containing less than 50 mcg ethinyl estradiol). Medicines containing levonorgestrel, norgestimate, or norethindrone have a low risk of developing VTE. In drugs that include drospirenone, the risk of developing thromboembolic complications is 2 times higher, and therefore the woman should be warned about this increased risk before prescribing the drug Modell Trend.
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. There remains conflicting evidence regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).
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. 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. The relationship between the development of breast cancer and COC use has not been proven.
The observed increased risk may also be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using COCs. 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 extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intraperitoneal bleeding, was observed. If severe abdominal pain, liver enlargement, or signs of intraperitoneal bleeding occur, this should be taken into account when making a differential diagnosis. Tumors can be life-threatening or fatal.
Other states
Clinical studies have shown no effect of drospirenone on plasma potassium concentrations in women with mild to moderate renal failure. Theoretically, there is a risk of developing hyperkalemia in women with impaired renal function and an initial potassium content at the ULN level or while taking drugs that lead to potassium retention in the body.
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 hypertension has been reported rarely. However, if a persistent, clinically significant increase in blood pressure develops during the use of COCs, these drugs should be discontinued and treatment of arterial hypertension should be initiated. COC use can be continued if normal blood pressure values are achieved with antihypertensive therapy. The following conditions have been reported to develop or worsen during both pregnancy and COC use, but their association with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease or ulcerative colitis have also been described during the use of COCs. In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema. In acute or chronic liver dysfunction, discontinuation of the drug may be necessary until liver function tests return to normal.
Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during previous use of sex hormones, requires discontinuation of COCs. Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in women with diabetes mellitus using low-dose COCs (containing less than 50 mcg ethinyl estradiol). However, women with diabetes need careful monitoring of blood glucose concentrations while using the drug.
When using the drug, the development of chloasma is possible, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to UV radiation while using COCs.
Reduced efficiency.
The effectiveness of COCs may be reduced by missing active tablets, vomiting and diarrhea, or as a result of drug interactions.
Effect on the menstrual cycle.
During the use of COCs, irregular (acyclic) bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 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 withdrawal bleeding during a break from taking active pills. If you take COCs as directed, pregnancy is unlikely. However, if you have not previously taken COCs regularly or if there are no two withdrawal bleedings in a row, then pregnancy must be ruled out before continuing to take the drug.
Impact on laboratory test performance.
Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values. Drospirenone increases the concentration of renin and aldosterone in the blood plasma, which is associated with its antimineralocorticoid effect.
Influence on the ability to drive vehicles and operate machinery.
There was no effect on the ability to drive vehicles and machinery.
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 increase in temperature, 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.