Vidora®
If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of using Vidora® should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. If any of these conditions, diseases or risk factors worsen, intensify or manifest for the first time, a woman should consult her doctor, who may decide whether to discontinue the drug.
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 deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking COCs. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking COCs. An increased risk is present after initial use of a COC or resumption of use of the same or a different COC (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients indicate that this increased risk is predominantly present during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (<0.05 mg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth.
VTE can be life-threatening or lead to death (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any COC.
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 deep vein thrombosis: unilateral swelling of the lower extremity or swelling along a vein in the lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, local increase in temperature in the affected lower extremity, redness or discoloration of the skin on the lower extremity.
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).
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 convulsions.
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, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal.
In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the total value of the existing risk factors increases. In this case, taking Vidora® is contraindicated (see section “Contraindications”).
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
- with age;
- in smokers (with an increase in the number of cigarettes smoked or an increase in age, the risk increases, especially in women over 35 years of age);
- 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 under the age of 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 Vidora®;
- prolonged immobilization, extensive surgery, any operation on the lower extremities or major trauma. In these cases, taking Vidora® should be stopped (in the case of a planned operation at least four weeks before it) and not resumed for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of venous thromboembolism, especially in the presence of other risk factors;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation.
The use of any combined hormonal contraceptives increases the risk of developing VTE. The use of drugs containing levonorgestrel, norgestimate or norethisterone carries the lowest risk of developing VTE. The use of other drugs, such as Vidora®, may double the risk. The choice to use a COC with a higher risk of developing VTE can only be made after consultation with the patient to ensure that she fully understands the risk of VTE associated with the use of Vidora®, the effect of the drug on her existing risk factors and that the risk The development of VTE is maximum during the first year of drug use. 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 during the use of COCs (which may precede cerebrovascular events) is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (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 oral contraceptives (<0.05 mg ethinyl estradiol).
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. The possibility of the relationship of these data with screening for cervical diseases or with sexual behavior characteristics (less frequent use of barrier methods of contraception) is discussed.
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. Its connection with 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, the biological effects of sex hormones, or a combination of both factors. 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 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. Malignant tumors can be life-threatening or fatal.
Other states
The progestin component in Vidora® 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, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug in patients with renal failure and when the initial potassium concentration is at the upper limit of normal, especially when taking potassium-sparing drugs concomitantly (see section “Interaction with other drugs and other types of interactions” ),
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 increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking the drug, these drugs should be discontinued and treatment of arterial hypertension should be initiated. The drug can be continued if normal blood pressure values are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship 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 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 may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of the drug until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of the drug.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is generally no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus using low-dose COCs (<0.05 mg ethinyl estradiol). 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 exposure to ultraviolet radiation while taking Vidora®.
Laboratory tests
Taking Vidora® may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein concentrations, carbohydrate metabolism, blood coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values. Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.
Reduced efficiency
The effectiveness of Vidora® may be reduced in the following cases: missed pills, gastrointestinal disorders, or as a result of drug interactions.
Frequency and severity of menstrual-like bleeding
While taking the drug Vidora®, irregular (acyclic) bleeding from the vagina may be observed (“spotting” spotting and/or “breakthrough” uterine bleeding), especially during the first months of use. Therefore, assessment of any irregular menstrual-like bleeding should be carried out after an adaptation period of about 3 cycles of dosing. If irregular menstrual-like bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignancy or pregnancy.
Some women may not develop bleeding during a break from taking the pills; “Contraindications” and “Use with caution”;
— Local compaction in the mammary gland;
- Concomitant use of other medications (see also section “Interaction with other medications and other types of interactions”);
- If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least 4 weeks before the proposed operation);
- Unusually heavy bleeding from the vagina;
- Missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;
— Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).
You should stop taking the tablets and seek medical help 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.
Vidor
The drug is taken orally, swallowed whole, without chewing, with a small amount of water, 1 tablet per day, preferably at the same time of day, continuously for 28 days, in the sequence indicated on the blister pack. While taking inactive pills (placebo), menstrual-like bleeding is observed. It usually begins 2-3 days after taking the last active tablet, and may not end until you start taking tablets from a new pack. Taking the drug from each subsequent package begins without interruption, the next day, as soon as the tablets in the previous package run out.
If you have not taken any hormonal contraceptives in the previous month, the drug should be started on the first day of the menstrual cycle (on the first day of menstrual bleeding). It is possible to start taking it on days 2-5 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.
When switching from another COC, vaginal ring or transdermal patch, it is preferable to start taking the drug the day after taking the last active tablet/dragée, but no later than the next day after the usual 7-day break from taking it (for products containing 21 tablets/dragées) or after taking the last inactive tablet/dragée (for drugs containing 28 tablets/dragées 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 COCs containing only progestogens ('mini-pills', injectable forms, subcutaneous implants and intrauterine systems with controlled release of progestogen)
When switching from a 'mini-pill', you can start taking the drug on any day (without a break), from an implant or intrauterine system with a gestagen - on the day of its removal, from an injection form - from the day when the next injection was due. In all cases, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the drug.
After an abortion in the first trimester of pregnancy, you can start taking the drug immediately. If this condition is met, there is no need for additional contraceptive protection.
After childbirth, in the absence of breastfeeding or abortion in the second trimester of pregnancy, it is recommended to start taking the drug on days 21-28 after childbirth or abortion. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the drug. If you have sexual intercourse, pregnancy should be excluded before starting to take the drug or you must wait until your first menstruation.
Taking missed inactive pills (placebo)
If you miss a tablet from the last row of the blister pack (placebo tablet), no action is required. Untaken tablets should be discarded to avoid inadvertently prolonging the placebo tablet-taking phase.
Taking missed active tablets
If you miss taking active pills and the delay in taking the next pill is less than 12 hours, contraceptive protection is not reduced. The missed tablet should be taken as soon as possible. Subsequent tablets should be taken at the usual time.
If the delay in taking the next pill is more than 12 hours (the interval since taking the last pill is more than 36 hours), contraceptive protection may be reduced. The more tablets are missed in a row, and the closer this omission is to the 7-day break in taking the drug, the higher the likelihood of pregnancy, since 7 days of continuous use of the drug are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. For such situations, the following recommendations can be given:
In the first week of taking the drug. A missed pill should be taken as soon as possible (as soon as the woman remembers), even if this means taking two pills at the same time. Subsequent tablets should be taken at the usual time. Additionally, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within a week before missing the next pill, the likelihood of pregnancy must be taken into account.
In the second week of taking the drug. A missed pill should be taken as soon as possible (as soon as the woman remembers), even if this means taking two pills at the same time. Subsequent tablets should be taken at the usual time. If during the 7 days preceding the first missed dose, all tablets are taken correctly, there is no need to use additional contraceptive measures. Otherwise, as well as in case of missing two or more tablets, it is necessary to use an additional barrier method of contraception for the next 7 days.
At 3 weeks of taking the drug. If you miss a dose in the 3rd week, you must take the last missed tablet as soon as possible (even if this means taking 2 tablets at the same time).
The following tablets are taken at the usual time until the active tablets in the pack are gone. Inactive tablets should be thrown away and tablets from the next pack should be started immediately, i.e. nonstop. Additionally, a barrier method of contraception must be used for the next 7 days. Most likely, bleeding is spotting, spotting or uterine bleeding, spotting or breakthrough uterine bleeding. Regular use of the drug is then resumed after the end of the inactive tablet phase.
To postpone the onset of menstrual bleeding to another day of the week, a woman should reduce the immediate phase of taking inactive pills by the desired number of days. The shorter the interval, the higher the risk that she will not have spotting or breakthrough bleeding while taking the second pack.
Vidora micro, 3 mg+0.02 mg, film-coated tablets, 24+4, 28 pcs.
Before starting to use the drug, pregnancy should be excluded and it is recommended to undergo a thorough general medical and gynecological examination, including examination of the mammary glands and cytological examination of the cervix. In addition, a violation of the blood coagulation system should be excluded. In case of long-term use, preventive control examinations must be carried out at least once every 6 months.
The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
A number of epidemiological studies have revealed an increased incidence of venous and arterial thrombosis and thromboembolism when taking COCs. The greatest risk of developing these complications exists in the first year of taking the drug (especially in the first 3 months) or resuming use after a 4-week break. The use of any COC may be complicated by the development of venous thromboembolism (VTE), manifested as deep vein thrombosis and pulmonary embolism. The estimated incidence of VTE in women taking low-dose estrogen oral contraceptives (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5 to 3 per 10,000 women not using oral contraceptives.
Medicines containing levonorgestrel, norgestimate, or norethindrone have a low risk of developing venous thromboembolism. In drugs that include drospirenone, the risk of developing thromboembolic complications is 2 times higher, therefore, before a woman is recommended to use Vidora® micro, she should be warned about this increased risk.
Per 10,000 women taking COCs with drospirenone, VTE develops in approximately 9-12 within 1 year, and in women taking COCs with levonorgestrel - only 5-7.
However, the incidence of VTE occurring while taking COCs is less than that associated with pregnancy.
In women taking COCs, extremely rare cases of thrombosis of other blood vessels, for example, the hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The connection with taking COCs has not been proven.
A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include unilateral pain in the lower extremities and/or swelling; sudden severe chest pain; with or without irradiation to the left hand; sudden shortness of breath; sudden cough; any unusual, severe, prolonged headache; increased frequency and severity of migraines; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness or fainting with or without an epileptic seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; "acute" stomach.
The risk of thrombosis (venous and/or arterial) and thromboembolism increases: with age; in smokers (with increasing number of cigarettes smoked or increasing age. The risk further increases, especially in women over 35 years of age); in the presence of a family history (i.e., venous or arterial thromboembolism ever in close relatives or parents at a relatively young age), obesity (body mass index more than 30 kg/m2), dyslipoproteinemia; arterial hypertension; heart valve diseases; atrial fibrillation; prolonged immobilization; temporary immobilization, including flights for more than 4 hours; serious surgery, any operation on the lower extremities or major trauma - in these situations it is necessary to stop taking the drug; in case of planned surgery - 4 weeks before it and do not resume taking it for 2 weeks after the end of immobilization.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders may 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 during the use of COCs (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these medications.
Biochemical parameters that may be a sign of hereditary or acquired predisposition to venous or arterial thrombosis include: APS resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C and S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When considering the risk/benefit ratio, the physician should consider that adequate treatment of these conditions may reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy is greater than with COCs.
An increased risk of cervical cancer with long-term use of COCs has been reported in some epidemiological studies. Its connection with COC use has not been proven.
A meta-analysis of 54 epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were using COCs at the time of the study. Its connection with COC use has not been proven. The observed increased risk may be due to earlier diagnosis of breast cancer (women who use COCs have earlier stages of breast cancer than women who have never used them), biological effects of COCs, or a combination of both.
In rare cases, the development of liver tumors has been observed during the use of COCs. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.
Drospirenone is well tolerated when used in patients with mild to moderate hepatic impairment (Child-Pugh class B).
Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during previous use of sex hormones, requires discontinuation of COCs.
Drospirenone is well tolerated when used in women with mild to moderate renal failure.
K+ excretion may be reduced in patients with renal failure. In a clinical study, drospirenone had no effect on plasma concentrations in patients with mild to moderate renal failure. Since theoretically the risk of developing hyperkalemia exists in cases where the concentration of K+ in the blood plasma before treatment was at the upper limit of normal and while taking potassium-sparing drugs, it is recommended to monitor the concentration of K+ in the blood plasma in the first cycle of taking the drug in patients with mild renal failure and moderate severity and with a K+ concentration in the blood plasma at the upper limit of the normal range before taking it and, especially, with the concomitant use of potassium-sparing drugs.
Women with hypertriglyceridemia or a family history of hypertriglyceridemia are at increased risk of developing pancreatitis while taking COCs.
Although slight increases in blood pressure (BP) have been described in many women taking COCs, clinically significant increases have been reported rarely. The relationship between taking COCs and a clinically significant increase in blood pressure has not been established. However, if a persistent, clinically significant increase in blood pressure develops while taking a COC, discontinuation of the drug and treatment of arterial hypertension is necessary. Taking COCs can be continued after consulting a doctor if normal blood pressure values are achieved with antihypertensive therapy.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using COCs. However, women with diabetes mellitus should be carefully monitored while taking COCs.
Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.
The drug can affect biochemical indicators of the function of the liver, thyroid gland, adrenal glands and kidneys, as well as the amount of plasma transport proteins, such as DSG and lipid/lipoprotein fractions, indicators of carbohydrate metabolism, blood clotting and fibrinolysis. Changes usually do not go beyond normal values.
Due to its antimineralocorticoid activity, drospirenone increases the concentration of renin and aldosterone in the blood plasma.
While taking COCs, the course of endogenous depression and epilepsy may worsen.
The use of Vidora® micro as a COC may be especially useful for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. The effectiveness of COCs may be reduced by missed pills, vomiting and diarrhea, or as a result of drug interactions.
While taking COCs, irregular bleeding may occur (“spotting” or “breakthrough” bleeding), especially during the first months of use. Therefore, assessing any irregular bleeding is only meaningful after 3-4 months of contraception.
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 in taking the pills; pregnancy must be ruled out before continuing to take the drug.
Impact on the ability to drive vehicles. Wed and fur.:
There was no effect on the ability to drive vehicles and machinery.
