Medical examinations
Before starting or resuming the use of MODEL TREND, it is necessary to familiarize yourself with the history of life, the family history of a woman, to conduct a thorough medical examination (including measurement of blood pressure, heart rate, body mass index) and gynecological examination,including breast examination and cytological examination of scrapes from the cervix (Papanicolaou test), to exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations are determined individually. Usually, follow-up examinations should be conducted at least once every 6 months.
A woman should be informed that MODEL TREND does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
If any of the conditions, diseases and risk factors identified below are present, careful consideration should be given to the potential risk and expected benefit of using COCs in each individual case and to discuss it with the woman before she decides to start taking the drug. With weighting, strengthening, or with the first manifestation of risk factors, it may be necessary to cancel the drug.
Diseases of the cardiovascular system
The results of epidemiological studies indicate the existence of a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs. The increased risk is present after the initial use of COC or the resumption of the use of the same or different COCs (after a break between doses of 4 weeks or more). Data from a large prospective study with 3 groups of patients show that this increased risk is present mainly during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (containing less than 50 μg ethinylestradiol) is 2-3 times higher than in non-pregnant women who do not take COC, however, this risk remains lower compared to the risk of VTE in pregnancy and childbirth. VTE can lead to death (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism (PE), can develop with any COCs.
Very rarely, when using COC, thrombosis occurs in other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels. A common opinion regarding the relationship between the occurrence of these events and the use of COC is absent.Symptoms of deep vein thrombosis (DVT) include unilateral edema lower limb or along veins of the lower limbs, pain or discomfort in the lower limb in a vertical position or during walking, the local temperature rise in the affected lower limb, redness or discoloration of the skin on the lower extremities.
Symptoms of PE are as follows: shortness of breath or rapid breathing; sudden cough, incl. with hemopoiesis; acute pain in the chest, which can increase with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, dyspnea, 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. The symptoms of a stroke: sudden weakness or loss of sensitivity of the face, extremities, especially on one side of the body, sudden confusion, trouble speech and understanding; sudden one- or two-sided loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden,severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without epileptic seizure. Other signs of vascular occlusion: sudden pain, puffiness and weak blueing of the extremities, "sharp" abdomen.
Symptoms of myocardial infarction include: pain; discomfort; feeling of pressure, gravity, a feeling of contraction or bursting in the chest, in the hand or behind the breastbone; discomfort in the left half of the chest with irradiation in the back, cheekbone, larynx, arm, epigastric region; cold sweat. nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; a feeling of rapid 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;
- for smokers (with an increase in the number of cigarettes or an increase in the age, the risk increases, especially in women over 35);
in the presence of: - obesity (body mass index more than 30 kg / m2);
- 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, a woman should be examined by an appropriate specialist to decide on the possibility of taking COC;
- prolonged immobilization, serious surgical intervention, any operation on the lower limbs or extensive trauma. In these situations, it is necessary to stop the use of COCs (in the case of a planned operation, at least four weeks before) and not to resume admission within two weeks of immobilization;
- dyslipoproteinemia;
- arterial hypertension:
- migraine;
- heart valve diseases;
- atrial fibrillation.
The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.
An increased risk of thromboembolism in the postpartum period should be considered. Violations of peripheral circulation can also occur in diabetes mellitus, SLE, 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 disorders) should be grounds for the immediate discontinuation of these medications.
Biochemical indicators indicating hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, insufficiency of antithrombin III, deficiency of protein C, deficiency of protein S, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).
When assessing the relationship between risk and benefit, it should be borne in mind that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be taken into account that the risk of thrombosis and thromboembolism in pregnancy is higher than when taking low-dose oral contraceptives (containing less than 50 μg ethinyl estradiol).
Drugs containing levonorgestrel, norgestimate or norethindrone, have a low risk of developing venous thromboembolism. The drugs, which include drospirenone, the risk of thromboembolic complications is 2 times higher,in this regard, before the woman will be recommended drug MODEL TREND, she should be warned about this increased risk.
Tumors
The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. However, the connection with the reception of the COC has not been proven. Controversial data remain regarding the extent to which these data are associated with screening for the diagnosis of cervical pathology or with features of sexual behavior (the more rare 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 COC (relative risk 1.24). Increased the risk gradually disappears within 10 years after discontinuation of these medications. Due to the fact that breast cancer is rarely seen in women under 40 years of age, an increase in the number of diagnoses of breast cancer in women who are currently taking COCs or who have recently taken COC is insignificant in relation to the overall risk of this disease.The relationship between the development of breast cancer and the use of COC has not been proven. The observed increase in risk may also be due to careful follow-up and earlier diagnosis of breast cancer in women using COCs. Women who have ever used COC have earlier stages of breast cancer than women who have never used them.
In rare cases, the development of benign, and extremely rare, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage, was observed with the use of COCs. In the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis. Tumors can endanger life or lead to death.
Other states
Clinical studies have shown no effect of drospirenone on the potassium concentration in blood plasma in women with mild to moderate renal failure. Theoretically, there is a risk of developing hyperkalemia in women with impaired renal function and the initial content of potassium at the level of the upper limit of the norm or on the background of taking medications leading to a delay in potassium in the body.
In women with hypertriglyceridemia (or in the presence of this condition in a family history), an increased risk of developing pancreatitis during COC administration is possible. Despite the fact that a small increase in blood pressure was described in many women taking COC, clinically significant hypertension was rare. Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of COC, these drugs should be discontinued and the treatment of hypertension should begin. Reception of COCs can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy. The following conditions have been reported to develop or worsen, both during pregnancy and when taking COCs. but their connection with the administration of COC is not proved: jaundice and / or itching associated with cholestasis; formation of stones in the gallbladder; porphyria; SLE; hemolytic-uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis. Cases of Crohn's disease or ulcerative colitis are also described against the background of COC use.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
In acute or chronic violations of liver function, it may be necessary to cancel the drug until the parameters of the functional liver samples return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during the previous intake of sex hormones, requires the cessation of COCs.
Although COCs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in women with diabetes using low-dose COCs (containing less than 50 μg ethinyl estradiol). Nevertheless, women with diabetes require careful monitoring of blood glucose concentrations during the use of the drug.
When using the drug, the development of chloasma is possible, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking COC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Decreased efficiency
The effectiveness of COCs can be reduced by skipping active tablets, vomiting and diarrhea, or as a result of drug interactions.
Effects on the menstrual cycle
Against the background of the use of COC, irregular (acyclic) bleeding ("spotting" bleeding or "breakthrough" bleeding) can 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, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.
Some women during the break in taking active pills may not develop a bleeding "withdrawal". If the COC was administered in accordance with the directions, pregnancy is unlikely. Nevertheless, if before the reception of COC was carried out irregularly or if there are no consecutive two bleeding "cancellations", then the continuation of the drug should be excluded from pregnancy.
Impact on laboratory test scores
The administration of COC can influence the results of some laboratory tests, including liver, kidney, thyroid, adrenal, transport proteins in plasma, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the limits of normal values. Drospirenone increases the concentration of renin and aldosterone in the blood plasma, which is due to its antimineralocorticoid effect.