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

Instruction for Vidora Micro

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Vidora micro - microdose combined monophasic hormonal contraceptive.

Release form and composition

Dosage form - film-coated tablets [28 pcs. (21 active and 7 placebo tablets or 24 active and 4 placebo tablets) in a blister, in a cardboard box 1 or 3 blisters and instructions for use of Vidora micro]:
    active tablets: biconvex, round, from light pink to pink; on a cross section, the core is almost white or white (21 or 24 pcs. in a blister);
    placebo tablets: biconvex, round, white; in cross section, the core is almost white or white (7 or 4 pcs. in a blister).
Composition of 1 active tablet:
    active ingredients: drospirenone - 3 mg, ethinylestradiol - 0.02 mg;
    auxiliary components: polysorbate-80, pregelatinized corn starch, povidone-K30, croscarmellose sodium, lactose monohydrate, magnesium stearate;
    shell composition: pink opadry II (macrogol-3350, talc, partially hydrolyzed polyvinyl alcohol, titanium dioxide, iron dye black oxide, iron dye red oxide, iron dye yellow oxide).
Composition of 1 placebo tablet:
    core: povidone-K30, magnesium stearate, anhydrous lactose;
    shell: opadry II white (titanium dioxide, talc, macrogol-3350, partially hydrolyzed polyvinyl alcohol).

Pharmacodynamics

Vidora micro is a microdosing combined monophasic hormonal contraceptive drug that contains ethinyl estradiol (a synthetic analogue of the female sex hormone estradiol) and drospirenone (a synthetic hormone with a pharmacological profile similar to natural progesterone). The contraceptive properties of the drug are based on the interaction of various factors, the most important of which are inhibition of ovulation and an increase in the viscosity of the cervical secretion, as a result of which it becomes impenetrable for spermatozoa.
With the correct use of Vidora, the Pearl micro index (an indicator that reflects the number of pregnancies in 100 women who use a contraceptive drug during the year) is less than one. If the dosing regimen is violated (in case of missing tablets or improper use), the Pearl index value may increase.
Drospirenone in a therapeutic dose also has an antiandrogenic and unexpressed antimineralocorticoid effect. Deprived of estrogenic, antiglucocorticoid and glucocorticoid activity, the substance has a pharmacological profile similar to that of natural progesterone. Drospirenone has antiandrogenic activity, helps to reduce the production of secretion of the sebaceous glands and improve the severity of clinical symptoms in women with acne (acne vulgaris). This factor should be taken into account when choosing a contraceptive drug, especially for patients with hormone-dependent fluid retention, as well as for acne and seborrhea.
In combination with ethinyl estradiol, drospirenone demonstrates an improvement in the lipid profile and an increase in the concentration of HDL (high density lipoprotein).
The action of Vidora micro is aimed at regulating menstrual bleeding, which is one of the risk factors for the occurrence of iron deficiency anemia, this is expressed in a decrease in their volume and a decrease in the severity of pain. There is also evidence that the use of COCs (combined oral contraceptives) decreases the likelihood of developing ovarian and endometrial cancer.

Pharmacokinetics

Ethinylestradiol

After oral administration, the substance is absorbed quickly and almost completely. After a single dose, Cmax (maximum concentration) is 88-100 ng / ml, Tmax (time to reach the maximum concentration) - from 1 to 2 hours. The substance is metabolized during absorption and the first passage through the liver. When taken orally, the absolute bioavailability is 60%. Against the background of concomitant food intake, bioavailability decreases in about 25% of cases.
This hormone binds to plasma proteins at about 98.5%. It induces the synthesis of SHBG (sex hormone binding globulin) in the liver. The apparent Vd (volume of distribution) of ethinylestradiol is approximately 5 l / kg.
Css (equilibrium concentration) is achieved during the second half of the Vidora micro intake cycle.
A small amount of ethinyl estradiol passes into breast milk (0.02% of the dose).
Approximately 50-60% of the substance in the mucous membrane of the small intestine and liver undergoes presystemic conjugation (first-pass effect). The main metabolic pathway is aromatic hydroxylation, which results in the formation of hydroxylated and methylated metabolites, both free and in the form of conjugates with sulfuric and / or glucuronic acids. Part of ethinyl estradiol conjugated with glucuronic acid is reabsorbed in the intestine after elimination with bile (intestinal-hepatic recirculation).
Ethinylestradiol is metabolized in full and is practically not excreted unchanged. The rate of metabolic clearance from blood plasma is 5 ml / min / kg. Excretion of metabolites of the substance is carried out through the intestines and kidneys in a ratio of 6 ÷ 4, T1 / 2 (half-life) - about 24 hours.

Drospirenone

After oral administration, the substance is absorbed quickly and almost completely. After a single dose of Cmax in the blood plasma is approximately 35 ng / ml, the value of Tmax in the blood plasma is from 1 to 2 hours. Bioavailability is in the range of 76–85%, food intake has no effect on it.
Drospirenone binds to blood plasma albumin. This hormone does not bind to SHBG and KSG (corticosteroid binding globulin). The concentration of free drospirenone is no more than 3-5% of the dose received. The 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 of a substance in blood plasma is reached between 7 and 14 days of therapy and is approximately 60 ng / ml. A subsequent increase in concentration is observed approximately between 1 and 6 cycles of taking Vidora micro. There is no further increase in concentration.
Drospirenone metabolism occurs in the liver, while the cytochrome P450 system is practically not involved in the process. Plasma metabolites are mainly represented by acidic forms of drospirenone, which are formed as a result of rupture of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate. The substance is metabolized almost in full.
The metabolic clearance rate of drospirenone is 1.5 ± 0.2 ml / min / kg. Metabolites are excreted by the kidneys and through the intestines in a ratio of 1.4 ÷ 1.2. T1 / 2 metabolites - approximately 40 hours.
With moderate renal failure (in women with creatinine clearance of 30-50 ml / min), the plasma concentration of drospirenone in the blood is higher than in women with no renal dysfunction, by an average of 37%.
Pharmacokinetic parameters for moderate liver dysfunction (class B on the Child-Pugh scale):
    AUC (area under the concentration-time curve): comparable values ​​with the corresponding indicator in healthy women with similar Cmax values ​​in the phases of absorption and distribution;
    T1 / 2: the value of the indicator is 1.8 times higher than in women with no hepatic dysfunction;
    clearance of drospirenone: reduced by about 50%.
In severe hepatic impairment, the pharmacokinetic parameters of drospirenone have not been studied.

Indications for use

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

Contraindications

Absolute:
    migraine with focal neurological symptoms, including a history of;
    vaginal bleeding of unknown origin;
    identified hormone-dependent malignant diseases (of any organ) or suspicion of them;
    diabetes mellitus with diabetic angiopathy;
    pancreatitis with severe hypertriglyceridemia, in history including;
    severe or acute renal failure;
    liver tumors (including benign), currently or in history;
    liver failure and severe liver disease (within 3 months after normalization of liver function tests);
    hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
    conditions preceding thrombosis (including transient ischemic attacks, angina pectoris and atrial fibrillation), including a history of;
    venous and arterial thrombosis (including deep vein thrombosis, cerebrovascular disorders, pulmonary embolism, myocardial infarction), including a history of;
    predisposition to venous or arterial thrombosis (hereditary or acquired), such as protein C or protein S deficiency, hyperhomocysteinemia, the presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant), antithrombin III deficiency, resistance to activated protein C (APC);
    the presence of pronounced or multiple risk factors for venous or arterial thrombosis, including uncontrolled arterial hypertension, diseases of the cerebral or coronary arteries, atrial fibrillation, complicated lesions of the valvular apparatus of the heart, obesity with a body mass index (BMI) of more than 30 kg / m2, smoking over the age of 35, extensive trauma, volumetric surgery or operations on the lower extremities, prolonged immobilization;
    pregnancy or suspicion of it;
    lactation period;
    hypersensitivity to any component of Vidora micro.
Relative (Vidora micro can be prescribed by a doctor after assessing possible risks and should be used under close supervision of the patient's condition):
    hereditary angioedema;
    mild to moderate liver disease;
    hypertriglyceridemia;
    diseases that may be accompanied by peripheral circulatory disorders: sickle cell anemia, systemic lupus erythematosus, ulcerative colitis, hemolytic uremic syndrome, phlebitis of superficial veins, Crohn's disease, diabetes mellitus without vascular disorders;
    diseases that first appeared or worsened during pregnancy or during the period of previous use of sex hormones, for example, porphyria, chloasma, cholelithiasis, Sydenham's chorea, otosclerosis with hearing impairment, jaundice and / or pruritus associated with cholestasis, herpes during a previous pregnancy, postpartum period;
    the presence of a risk factor for the development of thrombosis and thromboembolism: uncomplicated valvular heart disease, migraine without focal neurological symptoms, controlled arterial hypertension, dyslipoproteinemia, thrombosis and thromboembolism in a family history (cerebrovascular accident, thrombosis or myocardial infarction at a young age relatives), smoking, age over 35 in nonsmoking women, obesity with a BMI of less than 30 kg / m2.

Vidora micro, instructions for use: method and dosage

Vidora micro tablets should be taken orally: swallow whole (do not chew) and drink plenty of water.
Take 1 tablet 1 time per day, preferably at the same time of day, in the order indicated on the blister, for 28 days: first active tablets (21 or 24 depending on the form of the drug), then placebo (7 or 4 respectively).
During the period of taking placebo (inactive) tablets (white), menstrual bleeding occurs. It begins, as a rule, 2-3 days after taking the last active pill and can continue even after the start of taking the drug from a new package. Vidora micro is designed for a 28-day course and does not imply a break in taking between tablets from different packages, that is, after the end of the drug from the current package, you need to start a new one the next day.
The choice in favor of one of the two forms of the drug Vidora micro (21 active tablets + 7 placebos or 24 active tablets + 4 placebos) should be made by the doctor, based on the individual characteristics of the woman and the duration of the follicular phase of her menstrual cycle.
The rules for starting a contraceptive, depending on various circumstances:
    lack of hormonal contraception in the previous month: optimally - on the first day of the menstrual cycle (bleeding), possibly on days 2–5, but within 7 days an additional barrier method of contraception will be required;
    switching from another combined oral contraceptive (COC): optimally - the next day after the last intake of an active pill / pill, but not later than the next day after the usual 7-day break (for contraceptives containing 21 pills / pills), or on the next day after the last intake of an inactive tablet / dragee (for contraceptives containing 28 tablets / dragee);
    switching from another combined hormonal contraceptive (transdermal patch, vaginal ring): on the day the patch or ring is removed, but no later than the day when a new patch should be glued or a new ring inserted;
    transition from hormonal contraceptives containing only progestogen (injectable forms, intrauterine systems with controlled release of progestogen, subcutaneous implants, "mini-pills"): injectable forms - on the day when the next injection is necessary, implant or intrauterine system - on the day of them removal, "mini-drank" - any day without interruption. In all described cases, it is necessary to additionally use a barrier contraceptive method within the first 7 days;
    abortion in the first trimester of pregnancy: immediately (then additional contraception is not necessary);
    abortion in the second trimester, childbirth (in the absence of breastfeeding): on days 21-28. It is possible later, but then during the first 7 days additional barrier protection is required.
Vidora micro, containing 21 active and 7 placebo tablets, and Vidora micro, containing 24 active and 4 placebo tablets, are not therapeutically identical, since the cyclic (course) dose of active substances is different. For this reason, when switching from one mode of use of the drug to another, it is necessary to adhere to the recommendations for switching to Vidora micro from another COC.

Taking missed inactive pills

In this case, no action is required. Missed pills can be thrown away to avoid unintentionally extending the placebo period.

Taking missed active pills

If the delay is less than 12 hours, the effectiveness of Vidora micro does not decrease. You should take the missed pill as soon as possible, and then take the drug as usual.
If the delay is more than 12 hours, the contraceptive protection of the drug is reduced. The more tablets are missed in a row, the higher the likelihood of pregnancy.
For such situations, various recommendations are offered, depending on which week of the cycle the Vidora micro reception was missed:
    in the first week: you should take the pill as soon as possible, even if you have to take 2 pills at the same time, then adhere to the usual regimen. For the next 7 days, you must use barrier contraceptives. If, during the 7 days preceding the missed pill, there was sexual intercourse, the likelihood of pregnancy cannot be ruled out;
    in the second week: you should take the pill as soon as possible, even if you have to take 2 pills at the same time, then adhere to the usual regimen. If during the 7 days preceding the missed pill, the drug was taken correctly, there is no need to use additional contraceptive measures. If there were violations or the missed amount was 2 or more tablets, barrier contraceptives should be additionally used within a week;
    in the third and fourth weeks: you should take the pill as soon as possible, even if you have to take 2 pills at the same time (but no more), then continue to take the active pills as usual. The inactive pills must be thrown away and the active pills must be taken from the new package immediately, that is, without interruption. During the next week, it is additionally necessary to use barrier contraceptives.

Change in the day of the onset of menstrual bleeding

    in order to postpone the onset of menstruation to another day of the week, it is necessary to shorten the duration of taking inactive tablets by the desired number of days (the shorter the interval, the higher the likelihood of no withdrawal bleeding and the likelihood of breakthrough bleeding or spotting while taking the drug from the next package);
    in order to postpone the onset of bleeding, it is necessary to continue taking the active tablets from the next package, skipping the placebo tablets from the current package. It is possible to extend the cycle in this way for any period of time, but no more than until the end of the active tablets from the second package (during the period of taking Vidora micro from the second package, breakthrough uterine bleeding or spotting may occur).

Selected recommendations

In severe gastrointestinal disorders, the absorption of the active substances of the Vidora micro preparation is impaired. If after taking an active tablet within 4 hours there was diarrhea or vomiting, you must follow the recommendations from the section "Taking the missed active tablets".
If a woman does not want to postpone the onset of withdrawal bleeding to another day of the week, a pill from a different package should be taken as an additional one.

Side effects

    infectious and parasitic diseases: infrequently - candidiasis, herpes simplex;
    from the side of metabolism: infrequently - increased appetite, weight gain;
    from the immune system: infrequently - allergic reactions (including angioedema); rarely - bronchial asthma;
    from the nervous system: often - headache; infrequently - drowsiness, nervousness, dizziness, paresthesia;
    on the part of the psyche: infrequently - emotional lability; rarely, depression;
    from the respiratory system: infrequently - pharyngitis;
    on the part of the cardiovascular system: infrequently - a decrease or increase in blood pressure, tachycardia, extrasystole, varicose veins of the lower extremities, pulmonary embolism; rarely - venous or arterial thromboembolism (thrombosis, thrombosis and thromboembolism / pulmonary vascular occlusion, peripheral deep vein occlusion, thromboembolism, stroke, heart attack / myocardial infarction / cerebral infarction);
    from the musculoskeletal system: infrequently - neck pain, muscle cramps;
    from the digestive system: often - abdominal pain; infrequently - constipation / diarrhea, vomiting, nausea, gastroenteritis;
    from the urinary system: infrequently - cystitis;
    on the part of the skin and subcutaneous tissues: often - acne; infrequently - dry skin, rash, itching, seborrhea, alopecia; rarely - erythema nodosum, erythema multiforme;
    from the senses: infrequently - visual impairment; rarely - hearing loss;
    from the reproductive system and mammary glands: often - vaginal discharge, painful menstrual bleeding, acyclic uterine bleeding, metrorrhagia, increased sensitivity of the mammary glands, pain and enlargement of the mammary glands; infrequently - vulvovaginal candidiasis, profuse menstrual bleeding, absence of menstrual bleeding, pelvic pain, candidiasis, decreased libido, dryness of the vaginal mucosa, hot flashes, colpitis, ovarian cysts, fibrocystic changes in the mammary gland, neoplasms of the mammary glands, discharge mammary glands, pathological changes in the Pap smear;
    general reactions: infrequently - thirst, asthenia, increased sweating, edema.
Very rarely, the following side effects occur, which, presumably, may be associated with the use of COCs:
    pancreatitis in women with hypertriglyceridemia;
    liver tumors, including malignant;
    impaired liver function;
    Crohn's disease, ulcerative colitis;
    chloasma;
    changes in glucose tolerance and the development of insulin resistance;
    mammary cancer.
The relationship between the development of the following conditions / diseases with COC intake has not been reliably established: hemolytic uremic syndrome, cholelithiasis, cholestatic jaundice and / or pruritus (associated with cholestasis), Sydenham's chorea, epilepsy, porphyria, systemic lupus erythematosus, uterine myoma, herpes during pregnancy ...
Women with hereditary angioedema may develop edema or worsen its symptoms.

Overdose

The main symptoms are vomiting, nausea, metrorrhagia, or spotting bleeding from the vagina.
Therapy: symptomatic.
There is no specific antidote.

Special instructions

Before prescribing Vidora micro, pregnancy should be excluded, it is recommended to undergo a gynecological and general medical examination, including a cytological examination of the cervix and an examination of the mammary glands. It is also necessary to exclude violations from the blood coagulation system. Women who receive the drug for a long time should undergo preventive control examinations at least once every six months.
Every woman should be warned that Vidora micro does not protect against any sexually transmitted infections.
A woman should stop taking a contraceptive and urgently consult a doctor if symptoms of venous or arterial thrombosis develop, which include:
    one-sided pain in the lower extremities and / or swelling;
    sudden cough or shortness of breath;
    sudden severe chest pain, including radiating to the left arm;
    any unusual, severe, prolonged headache;
    dizziness;
    loss of consciousness or fainting, including with an epileptic seizure;
    diplopia;
    sudden partial or complete loss of vision;
    aphasia or slurred speech;
    weakness or very significant loss of sensitivity that suddenly appears in one part of the body or on one side;
    symptom complex "acute abdomen";
    movement disorders.
In the case of a planned surgical operation, Vidora micro should be canceled 4 weeks in advance. Reception can be resumed only 2 weeks after the end of immobilization.
Women prone to chloasma should avoid exposure to ultraviolet radiation and prolonged exposure to the sun while taking the contraceptive.
Drospirenone increases the concentration of renin and aldosterone in the blood plasma, may worsen the course of endogenous depression and epilepsy.
Vidora micro can affect the biochemical parameters of kidney, adrenal, liver and thyroid function, blood clotting, fibrinolysis and carbohydrate metabolism, the amount of plasma transport proteins (corticosteroid-binding globulin, lipid / lipoprotein fractions).
The use of Vidora micro as a contraceptive can be especially useful for women with seborrhea, acne (acne) and hormone-dependent fluid retention.
During the period of COC use, irregular bleeding may occur (spotting spotting or breakthrough bleeding), especially in the first few months of use, and therefore it makes sense to assess the condition only after 3-4 months of contraception. If irregular bleeding recurs or develops for the first time after several regular cycles, the woman should undergo a thorough examination to rule out pregnancy and malignant neoplasms.

Influence on the ability to drive vehicles and complex mechanisms

Vidora micro does not affect psychomotor and cognitive functions.

Application during pregnancy and lactation

Vidora micro is not prescribed during pregnancy / lactation.
If pregnancy is detected while taking the drug, it is immediately canceled. An increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects in cases where Vidora micro was taken in the early stages of pregnancy through negligence, have not been identified.
COCs can reduce the amount of breast milk and affect its composition, therefore, it is not recommended to use Vidora micro until breastfeeding is stopped.

Childhood use

You can take Vidora micro only after the onset of menarche.

With impaired renal function

In severe or acute renal failure, Vidora micro is contraindicated.

For violations of liver function

Contraindication:
    severe liver disease (until the normalization of functional liver function tests);
    benign / malignant liver tumors, including a burdened history.

Use in the elderly

After the onset of menopause, Vidora micro is not prescribed.

Drug interactions

A decrease in the contraceptive effectiveness of Vidora micro is possible with prolonged simultaneous use of microsomal liver enzymes, such as drugs containing St. John's wort, barbiturates, griseofulvin, primidone, rifabutin, oxcarbazepine, phenytoin, felbamate, rifampicin, carbamazepine, topiramate.
Inhibitors of HIV protease (eg ritonavir), non-nucleoside reverse transcriptase inhibitors (nevirapine), and combinations thereof, are thought to have an effect on hepatic metabolism.
In connection with the above, while taking medications that can affect the induction of microsomal liver enzymes, and within 28 days after their cancellation, you should additionally use barrier contraceptives. If the inducers need to be continued after taking the last active Vidora micro tablet, you should skip taking the placebo tablets and start a new package.
Penicillin / tetracycline antibiotics reduce the contraceptive effectiveness of Vidora micro. During their intake and within 7 days after cancellation, additional barrier contraception should be used.
Vidora micro can affect the metabolism of other drugs, as a result of which both a decrease (lamotrigine) and an increase (cyclosporine) of their concentration in blood plasma and tissues are possible.
It is assumed that COCs can increase the concentration of potassium in the blood with the simultaneous use of the following drugs: aldosterone antagonists, potassium-sparing diuretics, angiotensin II receptor antagonists, angiotensin-converting enzyme inhibitors, some nonsteroidal anti-inflammatory drugs (for example, indomethacin).

Terms and conditions of storage

Keep out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life is 3 years.

Reviews about Vidora micro

Reviews about Vidora micro are different. Many women were satisfied with the effect of the drug. They did not develop any side effects, including weight gain and mood swings. In other cases, it is reported that the use of the drug was abandoned due to the occurrence of pronounced adverse reactions.

Terms of sell

You can buy Vidora Micro without a prescription from a doctor.