If any of the conditions, diseases and risk factors outlined below are present, careful consideration should be given to the potential risk and expected benefit of using Genetten® in each individual case and to discuss it with the woman before she decides to start taking preparation. In case of weighting, strengthening or the first manifestation of any of these conditions, diseases or risk factors, a woman should consult a doctor who can decide whether 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 DVT, PE, IM, cerebrovascular disorders). These diseases are rare.
The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs, mainly during the first 3 months.Increased risk is noted after the initial use of COCs or the resumption of use of the same or different COCs (after a break between doses of 4 weeks or more).
The general risk of venous thromboembolism (VTE) in patients taking low-dose COCs (<50 mcg ethinylestradiol) is two to three times higher than in non-pregnant patients who do not take COC, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth.
VTE can lead to death (in 1-2% of cases).
Venous thromboembolism (VTE), manifested as DVT or PE can occur when using any COC.
It is extremely rare when using COCs there is a thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. -The consensus on the relationship between the onset of these events and the use of COC is absent.
Arterial thromboembolism can be clinically manifested by stroke, vascular occlusion, or MI.
Arterial thromboembolism can be fatal.
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- smokers (with the increase in the number of cigarettes or an increase in the age of the risk increases, especially in women older than 35 years);
in the presence of:
- obesity (body mass index more than 30 kg /m2);
- family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by the appropriate specialist to decide the possibility of taking Zhentenen®;
- prolonged immobilization, serious surgical intervention, any foot surgery or extensive trauma. In these situations, it is advisable to discontinue the use of the drug Genetten® (in the case of a planned operation, at least 4 weeks before it) and not to resume it within 2 weeks after the end of immobilization;
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- heart valve diseases;
- atrial fibrillation.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
It should be taken into account the increased risk of thromboembolism in the postpartum period.
Violations of peripheral circulation can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of the drug Genetten® (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of this drug.
Biochemical indicators indicating hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin-III, lack of protein C, protein deficiency S, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
When assessing the relationship between risk and benefit, it should be borne in mind that treatment of an appropriate 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 (<0.05 mg of ethinyl estradiol).
- Tumors
The most significant risk factor for developing cervical cancer is a 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. The possibility of interrelation of these data with screening of cervical diseases and with peculiarities of sexual behavior is discussed (more rare application 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 who used 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, an increase the number of diagnosed breast cancer in women who are currently taking COCs or who have recently taken is small 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, on the background of the use of COC, the development of liver tumors was observed, which in some cases led to life-threatening intra-abdominal internal bleeding. In the event of severe pain in the abdominal region, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
- Other states
Women with hypertriglyceridemia (or having this condition in a family history) may have an increased risk of developing pancreatitis while taking COC. Although a small increase in blood pressure (BP) has been reported in many women taking COC, clinically significant increases were rare. Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of the drug Genetten®, this drug should be discontinued and the treatment of hypertension should begin. Reception of the drug 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 COC, but their relationship with COCs has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis. Cases of Crohn's disease and 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. Acute or chronic liver dysfunction may require the removal of the drug Genetten® until the liver function test results return to normal. Recurrent cholestatic jaundice, which first appeared during pregnancy or previous reception of sex hormones, requires the discontinuation of the drug Genetten®.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need for a change in the therapeutic regimen in diabetics using the Genetten® drug.Nevertheless, women with diabetes should be carefully observed during the administration of this drug. Sometimes chloasma can develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma at the time. taking Zhentenen® should avoid prolonged exposure to sunlight and exposure to ultraviolet radiation.
Preclinical safety data
Preclinical data obtained from toxicity studies with multiple doses of the drug, as well as genotoxicity, carcinogenic potential, and toxicity to the reproductive system, do not indicate a particular risk to humans. Nevertheless, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.
Laboratory Tests
The administration of the drug Zhenethen® may affect the results of some laboratory tests, including, function indicators, liver, kidney, thyroid, adrenal gland, transport protein content in plasma, carbohydrate exchange, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond the limits of normal values.
The effectiveness of the drug Genetten® can be reduced in the following cases: when missing tablets, with vomiting and diarrhea, or as a result of drug interactions.
Frequency and severity of menstrual bleeding
Against the background of taking Zhenetten®, irregular bleeding (spotting bleeding or breakthrough uterine 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 may not develop menstrual bleeding during a break in taking pills. If the drug Zhenten was taken, according to the instructions, it is unlikely that a woman is pregnant. However, if prior to that, the Genetic® drug was taken irregularly or, if there is no contraction, 2 bleeding cancellations before continuing with the drug should be excluded from pregnancy.
Medical examinations
Before you start using the drug, you need to get acquainted with the history of life, a family history of a woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, body mass index) and gynecological examination, including breast examination and cytology of cervical scraping by Papanikolaou), to exclude pregnancy. When you resume taking Zhenethen®, the amount of additional research and the frequency of follow-up visits is determined individually. Usually, follow-up examinations should be conducted at least once every 6 months.
A woman should be warned that the drug Genetten® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!