Vidora Micro tabs 3mg + 0.02mg #21 + 7

Vidora Micro instruction for use

You can buy Vidora Micro here

Release form, composition and packaging

Film-coated tablets (active) from light pink to pink, round, biconvex; in cross-section, the core is white or almost white (21 or 24 pieces in a blister).
1 tab.
ethinyl estradiol 20 mcg
drospirenone 3 mg
Excipients: lactose monohydrate - 44 mg, pregelatinized corn starch - 38.4 mg, povidone K30 - 6 mg, croscarmellose sodium - 1.2 mg, polysorbate 80 - 0.9 mg, magnesium stearate - 0.5 mg.
The composition of the shell: opadry II pink - 2.82 mg (polyvinyl alcohol partially hydrolyzed - 1.13 mg, titanium dioxide - 0.68 mg, macrogol 3350 - 0.57 mg, talc - 0.42 mg, iron dye yellow oxide - 0.01 mg, iron dye red oxide - 0.01 mg , iron dye black oxide - 0.001 mg).
Tablets, film coated (placebo) white, round, biconvex; in cross-section, the core is white or almost white (7 or 4 pieces in a blister).
Excipients: anhydrous lactose - 89.5 mg, Povidone K30 - 10 mg, magnesium stearate - 0.5 mg.
The composition of the shell: opadry II white - 4 mg (polyvinyl alcohol partially hydrolyzed - 1.6 mg, titanium dioxide - 1 mg, macrogol 3350 - 0.808 mg, talc - 0.592 mg).

pharmachologic effect

Microdose combination monophasic hormonal contraceptive preparation containing ethinyl estradiol and drospirenone. The contraceptive effect of Vidora micro is based on the interaction of various factors, the most important of which are the inhibition of ovulation and an increase in the viscosity of the cervical secretions, with the result that it becomes impermeable to spermatozoa.
If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women using the contraceptive drug during the year) is less than 1. If you skip the pills or misuse, the Pearl index may increase.
At a therapeutic dose, drospirenone also has anti-androgen and weak anti-mineralocorticoid properties. Deprived of estrogenic, glucocorticoid and antiglucocorticoid activity, drospirenone has a pharmacological profile similar to that of natural progesterone. Possessing antiandrogenic activity, it reduces the production of sebaceous glands secretion and improves the clinical course in women with acne (acne vulgaris). This should be considered when choosing a contraceptive drug, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea.
In combination with ethinyl estradiol, it improves the lipid profile and increases the concentration of HDL.
Vidora micro drug regulates menstrual bleeding, helping to reduce the severity of pain and the volume of menstrual bleeding, reducing one of the risk factors for the development of iron deficiency anemia. In addition, there is evidence that the use of combined oral contraceptives (COCs) reduces the risk of developing endometrial cancer and ovarian cancer.

Pharmacokinetics

Ethinyl Estradiol

Suction
Oral administration is rapidly and almost completely absorbed. After a single dose of Cmax is 88-100 ng / ml, Tmax 1-2 hours. Metabolized during absorption and the "first pass" through the liver. Absolute bioavailability when administered orally is 60%. Concomitant food intake reduces bioavailability in approximately 25% of volunteers.
Distribution
Plasma protein binding is about 98.5%. Ethinyl estradiol induces the synthesis of SHBG in the liver. The apparent Vd of ethinyl estradiol is about 5 L / kg.
Css is achieved during the second half of the drug intake cycle.
Ethinyl estradiol in a small amount penetrates into breast milk (0.02% of the dose).
Metabolism
About 50-60% of ethinyl estradiol undergoes systemic conjugation in the mucous membrane of the small intestine and liver (the effect of "first pass"). The main metabolic pathway is aromatic hydroxylation, resulting in the formation of hydroxylated and methylated metabolites, both free and in the form of conjugates with glucuronic and / or sulfuric acids. Part of ethinyl estradiol conjugated with glucuronic acid, after elimination with bile, is reabsorbed in the intestine (enterohepatic recirculation).
Removal
Metabolized completely (almost not displayed unchanged). The rate of metabolic clearance from plasma is 5 ml / min / kg. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine at a ratio of 4: 6, T1 / 2 is about 24 hours.

Drospirenone

Suction
Oral administration is rapidly and almost completely absorbed. After a single dose of Cmax in the blood plasma is about 35 ng / ml, Tmax in the blood plasma is 1-2 hours. Bioavailability is 76-85%. Meal does not affect the bioavailability of drospirenone.
Distribution
It binds to plasma albumin and does not bind to sex hormone binding globulin (SHBG) or corticosteroid-binding globulin (CGC). The concentration of free drospirenone does not exceed 3-5% of the received dose. An estradiol-induced increase in SHBG does not affect the binding of drospirenone to plasma proteins. The average apparent Vd is 3.7 ± 1.2 l / kg.
Css Drospirenone in plasma is reached between the 7th and the 14th day of treatment and is approximately 60 ng / ml. A further increase in concentration is noted approximately between 1 and 6 cycles of taking Vidora micro, a subsequent increase in concentration is not observed.
Metabolism
Metabolized in the liver with little or no involvement of the cytochrome P450 system. Plasma metabolites are mainly represented by the acid forms of drospirenone, which are formed as a result of the rupture of the lactone ring, and 4,5-dihydrodrospirenone-3-sulfate. Metabolized almost completely.
Removal
The metabolic clearance rate is 1.5 ± 0.2 ml / min / kg. Metabolites are excreted through the intestines and kidneys in a ratio of 1.2: 1.4. T1 / 2 metabolites is about 40 hours.

Pharmacokinetics in special clinical situations

Renal failure. Css of drospirenone in blood plasma in women with mild severity of renal failure (CC 50-80 ml / min) is comparable to those in women with normal renal function. Women with renal failure of moderate severity (CC 30-50 ml / min) concentration of drospirenone in the blood plasma, on average, is 37% higher than in women with normal renal function.
Liver failure. In women with impaired liver function of moderate severity (class B on the Child-Pugh scale), AUC is comparable to the corresponding indicator in healthy women with similar Cmax values ​​in the absorption and distribution phases. T1 / 2 of drospirenone in women with moderate hepatic impairment is 1.8 times higher than in healthy volunteers with normal liver function. In women with an impaired liver function of moderate severity, a decrease in the clearance of drospirenone was noted by about 50% compared with women with normal liver function. Pharmacokinetics for severe hepatic insufficiency has not been studied.

Indications

- contraception;
- contraception and treatment of moderate acne (acne vulgaris);
- contraception and treatment of severe premenstrual syndrome (PMS).

Contraindications

- hypersensitivity to any of the components of the drug;
- thrombosis (venous and arterial) at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris) now or in history;
- the presence of multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries;
- uncontrolled arterial hypertension, prolonged immobilization, volumetric surgery, surgery on the lower limbs, extensive injuries, smoking after the age of 35, obesity with a BMI of more than 30 kg / m2;
- hereditary or acquired susceptibility to venous or arterial thrombosis, such as resistance to activated protein C (APS), deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia and the presence of antiphospholipid antibodies (antibodies to heart attack, lupus antioxidant, lupus antioxidant, antiphospholipid antibodies (antibodies to heart attack, lupus antibacterial, antiphospholipid antibodies)
- migraine with focal neurological symptoms at present or in history;
- diabetes mellitus with diabetic angiopathy;
- liver failure and severe liver disease (before normalization of the functional liver function tests and within 3 months after the return of these indicators to normal);
- liver tumors (benign or malignant) now or in history;
- severe or acute renal failure;
- identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;
- bleeding from the vagina of unknown origin;
- pregnancy or suspicion of it;
- breastfeeding period;
- pancreatitis with severe hypertriglyceridemia now or in history;
- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
If any of the above diseases or conditions develop for the first time while taking Vidora micro, it should be immediately canceled.

Carefully

- risk factors for thrombosis and thromboembolism: smoking, obesity with a BMI of less than 30 kg / m2, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, the presence of thrombosis and thromboembolism in family anmes, and in the case of women, and in the case of women, and in the same way, she has a family of women, she has an uncomplicated valvular heart disease; violation of cerebral circulation at a young age in one of the closest relatives); age over 35 years for non-smoking women;
- diseases in which there may be violations of the peripheral circulation: diabetes mellitus without vascular disorders, SLE, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
- hereditary angioedema;
- hypertriglyceridemia;
- liver diseases of mild and moderate severity;
- Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with impairment of hearing, porphyria, herpes during
pregnancy history, Sindenham chorea, chloasma, postpartum period).

Dosage

Inside The tablets are taken whole, without chewing, with a small amount of water.
Assign 1 tablet per day, in order, indicated on the blister, starting with active tablets (pink tablets), preferably at the same time of day, continuously for 28 days. For Vidora Micro, containing 21 active pills and 7 placebo pills, the sequence of administration is: 21 days - active pills, then 7 days - placebo pills. For Vidora Micro, containing 24 active tablets and 4 placebo tablets, the sequence of administration is: 24 days - active tablets, then 4 days - placebo tablets.
Menstrual-like bleeding is observed while taking inactive tablets (placebo, white tablets). It usually starts 2-3 days after taking the last active pill and may not end before taking the pills 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.
Regimens of Vidora Micro, which includes 21 active pills and 7 placebo pills, and Vidora micro, which includes 24 active pills and 4 placebo pills, are different and are determined by the individual characteristics of the woman and the duration of the follicular phase of the menstrual cycle. Violation of the regimen of Vidora micro increases the risk of unwanted pregnancy.
In the absence of taking any contraceptive drugs in the previous month, taking Vidora Micro should be started on the first day of the menstrual cycle (on the first day of the menstrual bleeding). It is allowed to start taking on the 2-5 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.

Transition from one mode of use of the drug Vidora micro to another mode

Widor’s micro preparation, containing 21 active tablets and 7 placebo tablets, and Widor’s micro preparation, including 24 active tablets and 4 placebo tablets, are not therapeutically identical, since at their reception the course (cyclic) dose of active substances differs.
The rules for switching from one packing of Vidora micro to another packing are similar to the rules for switching from another COC described below.
It is imperative that you adhere to the Vidora Micro Drug regimen to ensure optimal efficacy and safety.

Transfer from another combined hormonal contraceptive (COC, vaginal ring or transdermal patch)

It is preferable to start taking Vidora micro the next day after taking the last active tablet / dragee, but no later than the next day after the usual 7-day break in reception (for drugs containing 21 tablets / dragee) or after taking the last inactive tablet / dragee (for drugs containing 28 tablets / dragees per pack). Taking Vidora micro tablets should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is pasted.
Transition from hormonal contraceptives containing only gestagens ("mini-pili", injection forms, subcutaneous implants and intrauterine systems with controlled release of gestagen)
When switching from "mini-pili", you can start taking the drug on any day (without a break), from the implant or the intrauterine system with the gestagen - on the day the implant or intrauterine system is removed, from the injection form - from the day when the next injection was to be made . In all cases, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking Vidora micro tablets.

After abortion in the first trimester of pregnancy

You can start taking Vidora micro immediately. Subject to this condition, there is no need for additional contraceptive protection.

After childbirth or abortion in the II trimester of pregnancy

It is recommended to start taking the drug at 21-28 days after birth, in the absence of breastfeeding, or abortion. If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking Vidora micro tablets. In the case of sexual contact, pregnancy should be excluded or the first menstruation should be avoided before taking Vidora micro.

Reception of the passed inactive tablets (placebo)

If you miss a placebo pill (white pills from the last row of a blister pack), no action is required. Unaccepted tablets should be discarded to avoid an unintended increase in the duration of the placebo pill period.

Acceptance of missed active pills

If the intake of active (yellow) pills is missed and the delay in taking the next pill is less than 12 hours, the contraceptive protection is not reduced. The missed pill should be taken as soon as possible. Next, tablets should be taken at the usual time.
If the delay in taking the regular pill is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), contraceptive protection can be reduced. The more pills missed in a row, and the closer this pass to the 7-day break in taking the drug, the higher the likelihood of pregnancy, because 7 days of continuous taking the drug are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. For such situations the following recommendations may be given.
At 1 week of taking the drug - the missed pill should be taken as soon as possible (as soon as the woman remembers), even if it means taking two pills at the same time. Further tablets should be taken as usual. Additionally, a barrier method of contraception should be used within the next 7 days. If sexual intercourse took place during the week before skipping a regular pill, it is necessary to take into account the probability of pregnancy.
At 2 weeks of taking Vidora micro - the missed pill should be taken as soon as possible (as soon as the woman remembers), even if it means taking two pills at the same time. Next, tablets should be taken at the usual time. If during the 7 days preceding the first skip in the reception, all the pills were taken correctly, there is no need to use additional contraceptive measures. Otherwise, as well as in case of missing two or more pills, it is necessary to use an additional barrier method of contraception for the next 7 days.
At 3 and 4 weeks of taking the drug - if you miss at 3 or 4 weeks of taking Vidora micro, you need to take the last missed pill as soon as possible (even if it means taking two pills at the same time).
If you miss pills should not take more than two active pills in one day.
Next, the tablets should be taken as usual, until the active tablets in the package run out. Inactive tablets should be discarded and immediately start taking the tablets from the next package, i.e. nonstop. Additionally, a barrier method of contraception should be used over the next 7 days.
Most likely, the "cancellation" bleeding will not be until the end of the second package, but there may be a spotting or a uterine bleeding of the "cancellation" on the days of taking the drug from the second package. If a woman missed taking active pills, and while taking inactive pills, no “withdrawal” bleeding occurred, it is necessary to exclude pregnancy.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete, therefore additional contraceptive measures should be taken. If vomiting occurs within 4 hours after taking the active (pink) pill or
was diarrhea, should be guided by the recommendations when skipping pills. If a woman does not want to change the usual regimen and transfer the onset of menstrual bleeding to another day of the week, an additional active pill should be taken from another package.

Change the day of the onset of menstrual bleeding

To delay the onset of menstrual bleeding, a woman should continue taking the pills from the next package of Micro Vidora, skipping inactive tablets from the current package. So the cycle
taking Vidora micro can be extended, if desired, for any period, until the active tablets from the second package run out. While taking the drug from the second package, there may be spotting or "breakthrough" uterine bleeding. Regular intake of the drug Vidora micro resumes after the end of intake of inactive tablets.
To transfer the onset of menstrual-like bleeding to another day of the week, a woman should reduce the duration of inactive pills for the desired number of days. The shorter the interval, the higher the risk that she will not have “withdrawal” bleeding, and in the future there will be spotting and “breakthrough” bleeding while taking the pills from the second package.

Special Clinical Groups

Children. Vidora micro preparation is indicated only after the onset of menarche. The available data do not suggest dose adjustment in this group of patients.
Elderly patients. Vidora micro preparation is not indicated after menopause.
Liver dysfunction. Vidora micro is contraindicated in women with severe liver disease, until liver function tests are normalized.
Impaired renal function. Vidora Micro is contraindicated in women with severe renal insufficiency.

Side effects of Vidora micro

Infectious and parasitic diseases
Candidiasis
Herpes simplex
The immune system
Allergic reactions, including angioedema bronchial asthma
Metabolism
Increased appetite
Weight gain
From the psyche
Emotional lability Depression
The nervous system
Headache
Dizziness
Nervousness
Drowsiness
Paresthesia
From the senses
Visual impairment Hearing loss
Since the cardiovascular system
Extrasystole
Tachycardia
Decrease in blood pressure
Increased blood pressure
Pulmonary embolism
Varicose veins of the lower extremities Venous or arterial thromboembolism *
On the part of the respiratory system
Pharyngitis
From the digestive system
Abdominal pain nausea
Vomiting
Diarrhea
Constipation
Gastroenteritis
Skin and Subcutaneous Tissues
Acne Alopecia
Itching
Rash
Dry skin
Seborrhea Erythema nodosum
Erythema multiforme
From the musculoskeletal system
Pain in the neck
Muscle cramps
On the part of the urinary system
Cystitis
Reproductive system and mammary glands
Breast enlargement
Breast pain
Breast sensitization
Painful menstrual bleeding
Metrorrhagia
Acyclic uterine bleeding
Vaginal discharge
Breast neoplasms
Ovarian cysts
Vulvovaginitis
Candida vulvovaginitis
Colpit
Breast discharge
No menstrual bleeding
Heavy menstrual bleeding
"Tides"
Fibrocystic changes in the mammary gland
Pelvic pain
Pathological changes in Pap smears
Dryness of the mucous membrane of the vagina
Decreased libido
Candida discharge from the mammary glands
General reactions
Edemas
Asthenia
Thirst
Excessive sweating
* Venous or arterial thromboembolism includes the following nosological forms: occlusion of peripheral deep veins, thrombosis and thromboembolism / occlusion of the pulmonary vessels, thrombosis, thromboembolism and myocardial infarction / cerebral infarction and stroke.
The following adverse reactions have been reported in women using COCs, with a very rare occurrence or delayed symptoms, which are believed to be associated with taking COCs:
- mammary cancer;
- liver tumors (benign and malignant);
- pancreatitis in women with hypertriglyceridemia;
- the appearance or worsening of conditions whose connection with the admission of COC is not fully established: porphyria, epilepsy, uterine fibroids, SLE, herpes during pregnancy, Sydenhem chorea, hemolytic-uremic syndrome, cholestatic jaundice and / or pruritus associated with cholestasis; cholelithiasis;
- abnormal liver function;
- change in glucose tolerance and the development of insulin resistance;
- chloasma;
- Crohn's disease, ulcerative colitis.
In women with hereditary angioedema, estrogen administration may cause or exacerbate its symptoms.

Overdose

Symptoms: possible nausea, vomiting, spotting blood from the vagina or metrorrhagia.
Treatment: there is no specific antidote, symptomatic therapy is carried out.

Drug interaction

Long-term treatment with microsomal liver enzyme inducers, which increases the clearance of sex hormones, can lead to a decrease in contraceptive efficacy. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, rifampicin, rifabutin, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.
HIV protease inhibitors (ritonavir), non-nucleoside reverse transcriptase inhibitors (nevirapine), and combinations thereof, also have the potential to affect hepatic metabolism. The maximum induction of enzymes is usually reached about 10 days after the start of administration of these medicines, but can be maintained for at least 4 weeks after their withdrawal. While taking drugs that affect the induction of liver microsomal enzymes and within 28 days after their withdrawal, it is necessary to temporarily use a barrier method of contraception. If it is necessary to continue taking inductors of liver microsomal enzymes after taking the last active pill from the current package of Vidora micro, skip taking the placebo tablets and start taking the pills from the new package.
Contraceptive protection is reduced in the presence of antibiotics of the penicillin and tetracycline series due to their reduced intrahepatic circulation of estrogen, and as a result, a decrease in the concentration of ethinyl estradiol. During the reception of these antibiotics, and within 7 days after their cancellation, it is necessary to additionally use a barrier method of contraception.
Since The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system, inhibitors of this enzyme system do not affect the metabolism of drospirenone.
Oral combined estrogen-progestin contraceptives can affect the metabolism of other drugs, which leads to an increase (cyclosporine), or decrease (lamotrigine) their concentration in plasma and tissues. Despite the fact that taking COCs affects peripheral insulin resistance and glucose tolerance, correction of the dosage regimen of hypoglycemic drugs while taking COCs is not required.
Based on in vitro inhibition studies and in vivo drug interaction studies with female volunteers, it was found that drospirenone at a dose of 3 mg does not affect the metabolism of omeprazole, simvastatin and midazolam.
There is a theoretical possibility of increasing the concentration of potassium (K +) in the blood plasma of women who receive oral contraceptives simultaneously with drugs that increase the concentration of K + in the blood plasma: ACE inhibitors, angiotensin II receptor antagonists, some NSAIDs (for example, indomethacin), potassium-saving diuretics and aldosterone antagonists. However, in a study evaluating the interaction of an ACE inhibitor with the combination of drospirenone + estradiol in women with moderate arterial hypertension who received enalapril and placebo, there was no significant difference between serum K + concentrations.

special instructions for Vidora micro

Before starting to use Vidora micro, pregnancy should be excluded and it is recommended to undergo a thorough general medical and gynecological examination, including an examination of the mammary glands and a cytological examination of the cervix. In addition, there should be a violation of the coagulation system. In the case of long-term use, preventive control examinations should be performed at least 1 time in 6 months.
A 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 increase in the 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 Vidora micro (especially in the first 3 months) or in 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 approximate frequency of VTE in women taking oral contraceptives with a low dose of estrogen (less than 50 μg of ethinyl estradiol) is up to 4 per 10,000 women per year compared to 0.5–3 per 10,000 women who do not use oral contraceptives.
Drugs containing levonorgestrel, norgestimate or norethindrone have a low risk of developing venous thromboembolism. For drugs that include drospirenone, the risk of thromboembolic complications is 2 times higher, and therefore, before a woman is recommended to use Vidora Micro, she should be warned about this increased risk.
In 10,000 women taking COCs with drospirenone, VTE develops in about 9–12 over 1 year, and in women taking COCs with levonorgestel only in 5–7. However, the frequency of VTE, which develops when taking COCs, is less than the frequency associated with pregnancy.
In women taking COCs, extremely rare cases of thrombosis of other blood vessels are described, for example, hepatic, mesenteric, renal arteries and veins, the central vein of the retina and its branches. Connection with taking COC is not 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 limbs and / or edema; sudden severe chest pain; with or without radiation in the left hand; sudden shortness of breath; sudden cough; any unusual, severe, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; diplopia; inarticulate speech or aphasia; dizziness; loss of consciousness or fainting with or without an epileptic seizure; weakness or a very significant loss of sensitivity, suddenly appearing on one side or in one part of the body; movement disorders; symptom complex "acute abdomen".
The risk of thrombosis (venous and / or arterial) and thromboembolism increases: with age, in smokers (with an increase in the number of cigarettes smoked or increased in age. The risk further increases, especially in women over 35 years old), with a family history (i.e. venous or arterial thromboembolism ever with close relatives or parents at a relatively young age), obesity (BMI over 30 kg / m2); dyslipoproteinemia, hypertension, valvular disease, atrial fibrillation; prolonged immobilization; temporary immobilization, including air travel for more than 4 hours; serious surgery; any operation on the lower limbs or extensive trauma - in these situations it is necessary to stop taking Vidora micro; in the case of planned surgery, 4 weeks before it and not to resume reception within 2 weeks after the end of immobilization.
The increased risk of thromboembolism in the postpartum period should be considered.
Peripheral circulatory disorders 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 during the use of COCs (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these medicines.
Biochemical parameters that may be a sign of hereditary or acquired susceptibility to venous or arterial thrombosis include: resistance to APS, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of proteins C and S, anti-phospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant, lupus anti-coagulant).
When considering the risk / benefit ratio, the physician should take into account that adequate treatment of these diseases can reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy is higher than with COC.
An increased risk of developing cervical cancer with prolonged use of COC has been reported in several epidemiological studies. His association with KOC is not proven.
A meta-analysis of 54 epidemiological studies showed that there was a slightly increased relative risk (RR = 1.24) of breast cancer diagnosed in women who at the time of the study used COCs. His association with KOC is not proven. The observed increase in risk may be due to an earlier diagnosis of breast cancer (in women using COC, earlier stages of breast cancer are detected than in women who have never used it), the biological effects of COC or a combination of both of these factors.
In rare cases, the development of liver tumors was observed with the use of COCs. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis.
Drospirenone is well tolerated when used in patients with mild to moderate hepatic insufficiency (Child-Pugh class B).
Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during the previous administration of sex hormones, requires discontinuation of COC.
Drospirenone is characterized by good tolerance when used in women with renal insufficiency of mild and moderate severity.
The excretion of K + can be reduced in patients with renal insufficiency. In a clinical study, the administration of drospirenone had no effect on plasma K + concentration in patients with mild or moderate renal impairment. Since theoretically, the risk of developing hyperkalemia exists in cases where the plasma K + concentration before treatment corresponded to VGN and while taking potassium-sparing drugs, it is recommended to monitor plasma K + concentration in the first cycle of the drug in patients with mild to moderately severe renal insufficiency and with the concentration of K + in the blood plasma on VGN prior to the start of administration and, especially, with the concomitant use of potassium-sparing drugs.
In women with hypertriglyceridemia or a family history, the risk of pancreatitis increases while taking COCs.
Although a small increase in blood pressure has been reported in many women taking COCs, clinically significant increases have been rare. 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, Vidora micro should be withdrawn and hypertension should be treated. Receipt of COC can be continued after consulting a doctor, if with the help of antihypertensive therapy, blood pressure has normalized.
Although COCs may influence insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using COCs. However, women with diabetes should be carefully monitored while taking COCs.
Women with a tendency to chloasma while taking COCs should avoid prolonged exposure to the sun and exposure to UV radiation.
The drug can affect the biochemical indicators of liver function, thyroid, adrenal glands and kidneys, as well as the amount of plasma transport proteins such as CSG and lipid / lipoprotein fractions, carbohydrate metabolism, blood clotting and fibrinolysis. Changes usually do not go beyond the normal range.
Due to the anti-mineralocorticoid activity, drospirenone increases the concentration of renin and aldosterone in the blood plasma.
While taking COCs, worsening of the course of endogenous depression and epilepsy is possible.
The use of the drug Vidora micro as COC can be especially useful for women with hormone-dependent fluid retention, as well as for women with acne and seborrhea.
The effectiveness of COCs can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions.
Irregular bleeding (spotting or "breakthrough" bleeding) may occur during the administration of COCs, especially during the first months of use. Therefore, the assessment of any irregular bleeding is significant only after 3-4 months of contraception.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant neoplasms or pregnancy.
Some women may not develop "withdrawal" bleeding during a break in the pill. If the COC was taken as directed, then pregnancy is unlikely. However, if prior to this, the COC was administered irregularly, or if there are no two “withdrawal” bleeding in a row, then pregnancy should be excluded before continuing to take Vidora micro.

Influence on ability to drive vehicles and mechanisms

No effects on the ability to drive vehicles and mechanisms have been identified.

Pregnancy and lactation

The use of the drug Vidora micro contraindicated during pregnancy.
If pregnancy is detected while taking the drug Vidora micro, the drug should be immediately canceled. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects in cases where sex hormones were taken carelessly in the early stages of pregnancy.
At the same time, data on the results of taking Drospirenone + Ethinyl Estradiol during pregnancy is limited, which does not allow any conclusions about the negative effect of the drug on pregnancy, the health of the fetus and the newborn. There are currently no significant epidemiological data available.
The use of the drug Vidora micro contraindicated during breastfeeding. KOK can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding stops. A small amount of sex hormones and / or their metabolites can be excreted in breast milk.

Use in childhood

Vidora micro preparation is indicated only after the onset of menarche.

In case of impaired renal function

The drug is contraindicated in women with severe or acute renal failure.

With abnormal liver function

The drug is contraindicated in women with severe liver disease as long as the performance of functional liver tests are not normalized; with liver tumors (benign or malignant) now or in history.

Use in old age

Vidora micro preparation is not indicated after menopause.

Pharmacy sales terms

You can buy Vidora micro without a prescription.

Terms and conditions of storage

The drug should be kept out of the reach of children, at a temperature not exceeding 30 ° C. Shelf life - 3 years. Do not use after the expiration date.