Before starting the use of the drug, it is necessary to conduct a general medical examination (including investigation of the epithelium of the cervix), to exclude pregnancy, violations by the blood coagulation system. With prolonged use of the drug, preventive check-ups should be performed every 6 months.
In the presence of risk factors, the potential risk and the expected benefits of therapy should be carefully evaluated and discussed with the woman before she decides to start taking the drug.
With weighting, strengthening, or the first manifestation of any of these conditions or risk factors, it may be necessary to cancel the drug.
The use of the drug CHLON leads to an increased risk of venous thromboembolism (VTE), compared with the risk in women who do not take the drug. The additional risk of VTE is the highest during the first year of the use of the drug HLOE, or with the resumption of admission after an interval of 4 weeks or more. Venous thromboembolism in 1-2% of cases can be fatal. The approximate frequency of VTE when taking low-dose COCs (less than 50 μg ethinyl estradiol) is up to 4 per 10,000 women per year compared to 0.5-1 per 10,000 women who do not take COCs.At the same time, the frequency of VTE when taking COC is less than the frequency of VTE associated with pregnancy (6 per 10 000 pregnant women per year).
Epidemiological studies have shown that the frequency of VTE is 1.5 to 2 times higher in women taking the drug CHLOE, compared to COCs containing levonorgestrel, and is similar for COCs containing desogestrel / gestodene / drospirenone.
Patients with polycystic ovary syndrome have an increased risk of developing cardiovascular disease. Epidemiological studies have also shown the connection of the use of hormonal contraceptives with an increased risk of developing arterial thromboembolism (myocardial infarction, transient ischemic attacks).
Very rarely reported on thrombosis of other vessels, namely, veins and arteries of the liver, mesentery, kidneys, brain or retina, in persons taking hormonal contraceptives.
The patient should be warned that with the development of symptoms of venous or arterial thrombosis should immediately consult a doctor. These symptoms include unilateral pain in the lower limb and / or swelling; sudden severe pain in the chest with irradiation in the left arm or without irradiation; sudden shortness of breath; a sudden attack of coughing; any unusual, strong,prolonged headache; increased frequency and severity of migraine: sudden partial or complete loss of vision; Diplomacy; slurred speech or aphasia; dizziness; collapse with or without partial seizure; weakness or significant loss of sensitivity, suddenly appeared on one side or in one part of the body; motor disorders; "sharp" abdomen.
The risk of venous thromboembolism increases:
- with increasing age;
- when smoking (with intensive smoking and with increasing age, the risk is further increased, especially in women over 35. Women over 35 should be strongly advised to quit if they want to take the drug HLOE);
- with a family history (family history of cases of venous thromboembolism at a relatively young age in the parents or close relatives). In case of suspected hereditary predisposition, a woman should consult a specialist before deciding on any hormonal contraception;
- with prolonged immobilization, surgical interventions on the lower extremities, neurosurgical operations or extensive trauma.In these situations, it is necessary to stop using (in the case of a scheduled operation for at least 4 weeks) and not to resume it until two weeks after the complete recovery of the motor activity. If the use of the Chloe® preparation has not been discontinued in advance, consideration should be given to antithrombotic therapy;
- with obesity (body mass index more than 30 kg / m2).
Risk arterial thromboembolic complications or disturbance of cerebral circulation increases:
- with increasing age;
- when smoking (with intensive smoking and with increasing age, the risk is further increased, especially in women over 35. Women over 35 should be strongly advised not to smoke if they want to take the drug HLOE®);
- with dyslipoproteinemia;
- with arterial hypertension;
- with migraine;
- with diseases of the valvular heart;
- with atrial fibrillation;
- with a family history (ie, with a history of arterial thrombosis cases in the relatively young age of the parents or close relatives). In case of suspected hereditary predisposition, a woman should consult a specialist before deciding on any hormonal contraception.
Violations of the peripheral circulation can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (namely, Crohn's disease or ulcerative colitis) and sickle-cell anemia.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period. An increase in the frequency or severity of migraine attacks during the use of the Chloe® preparation (which may be a harbinger of cerebral circulation disorder) is the basis for the immediate discontinuation of the drug.
With regard to the potential role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism, there is no consensus.
Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C (APS), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein deficiency S, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) .
When assessing the risk / benefit ratio, the physician should consider that appropriate treatment of the underlying pathology can reduce the risk of thrombosis. Women taking the drug HLOE® should explain the need for timely communication to the doctor in case of a possible development of possible symptoms of thrombosis. In the case of thrombosis or suspected of its occurrence, treatment with the drug HLOE® should be discontinued. Considering the teratogenicity of coagulants (coumarins), appropriate methods of contraception should be started.
Other states
In women with hypertriglyceridemia, while taking COC (in the presence of this condition in a family history), an increased risk of developing pancreatitis is possible. The relationship between COC admission and hypertension is not established. In the event of persistent arterial hypertension, the drug HLOE® should be discontinued and appropriate antihypertensive therapy should be prescribed. Reception of a contraceptive can be continued at normalization of arterial pressure.
If there are violations of the liver, it may be necessary to temporarily stop the drug HLOE® before the normalization of laboratory indicators.
Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires discontinuation of COCs.
Although COCs affect insulin resistance and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in patients with diabetes mellitus. Nevertheless, this category of patients should be under careful medical supervision. Women with a tendency to chloasma while taking COC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation. If women with hirsutism have recently developed symptoms or have significantly increased, other causes, such as androgen-producing tumors, congenital adrenal cortex dysfunction, should be taken into account in the differential diagnosis.
On the background of taking the drug, sometimes bleeding irregularly ("spotting" or "breakthrough" bleeding) can occur, especially during the first months of therapy. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.
If repeated or develop after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms (including diagnostic curettage of the uterine cavity) or pregnancy.
In some cases, bleeding "cancellation" may not develop during a break in taking the tablets. In case of irregular taking of tablets or in the absence of two menstrual-like bleedings in a row, pregnancy should be excluded until the drug is taken.
It is possible to change the results of skin allergic tests, decrease the concentration of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Due to the fact that the contraceptive effect is fully manifested by the 7th day from the beginning of the drug intake, in the first week additional nonhormonal methods of contraception are recommended.
Prescribe the drug after delivery in the absence of breastfeeding is recommended only after the completion of the first normal menstrual cycle.
Treatment should be stopped 3 months before the planned pregnancy.
With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).
Tumors
There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. The connection with the reception of the COC has not been proved. The question remains to what extent these findings are related to the pathology of the cervix or to the peculiarities of sexual behavior (the more rare use of barrier methods of contraception). The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. 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 after discontinuation of these medications. Due to the fact that breast cancer is rarely seen in women under 40 years of age, the 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. His connection with the use of COC has not been proven.The observed increase in risk may also be a consequence of an 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, against the background of the use of COC, the development of liver tumors was observed, which in some cases led to life-threatening intraabdominal hemorrhage. This should be taken into account when making a differential diagnosis in the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding.
Laboratory Tests
The use of COCs can influence the results of laboratory tests, including biochemical indices of liver, thyroid, adrenal and kidney efficiency, the concentration of plasma proteins, for example, corticosteroid-binding globulin, lipid / lipoprotein composition of blood, carbohydrate metabolism and indicators of the blood coagulation system. However, usually deviations remain within the range of normal laboratory values.