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Active ingredients
Dienogest + Ethinyl Estradiol
Release form
Pills
Composition
Ethinyl estradiol 30 mcg; dienogest 2 mg; Excipients: lactose monohydrate - 57.17 mg, corn starch - 12 mg, povidone 30LP - 3 mg, sodium starch glycolate - 5 mg, magnesium stearate - 800 mcg; MS (hypromellose - 48%, hydroxypropylcellulose - 12%, talc - 20%, hydrogenated seed oil of cotton - 5%, titanium dioxide - 15%) - 9 mg.
Pharmacological effect
Low-dose monophasic oral combination estrogen-progestin contraceptive drug. The action of the drug Bonade is based on the combined action of various factors, the most important of which is the suppression of ovulation and the increase in the viscosity of the cervix uterus. Dienogest also has a beneficial effect on the lipid profile, increasing HDL content. In women taking combined oral contraceptives (COCs), the cycle becomes more regular, less frequent painful menstruation, decreases the intensity and duration of bleeding.
Pharmacokinetics
Dienogest; Absorption; After oral administration dienogest is quickly and almost completely absorbed. Cmax in the blood plasma (51 ng / ml) is achieved 2.4 ± 1.4 h after administration of the drug. Bioavailability in combination with ethinyl estradiol is about 96%; Distribution; Dienogest binds to serum albumin (90%) and does not bind to specific transport proteins, the sex hormone-binding globulin (HSPG), and the corticosteroid-binding globulin (CGC). Any effect on the physiological transport of endogenous steroids is unlikely. An ethinyl estradiol-induced increase in the concentration of SHBG does not affect the binding of dieneogest to serum proteins. Equilibrium concentration. Concentration of SHBG does not affect the pharmacokinetics of dienogest. After taking the daily dose, the drug concentration in plasma increases by about 1-5 times, and Css is reached in about 4 days.; Metabolism; Dienogest is metabolized mainly by hydroxylation, but also by hydrogenation, conjugation and aromatization with the formation of inactive metabolites; ; Total clearance after a single dose is 3.6 l / h; T1 / 2 dienogest is 8.5-10.8 h.A minor amount of dienogest is excreted by the kidneys unchanged. Metabolites are excreted by the kidneys and with bile in a ratio of 3: 1. The T1 / 2 metabolite is 14.4 hours; Ethinyl estradiol; Absorption; After oral administration, ethinyl estradiol is rapidly and completely absorbed. Cmax in plasma (67 ng / ml) is reached within 1.5-4 hours. During absorption and "first pass" through the liver, ethinyl estradiol is metabolized, resulting in an average oral bioavailability of 44%; Distribution; Ethinyl estradiol is almost completely ( 98%), although not specifically, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. Recorded Vd ethinyl estradiol is 2.8-8.6 l / kg.; Equilibrium concentration. Css is reached during the second half of the treatment cycle, when the levels of the drug in serum become 2 times higher than the individual dose.; Metabolism; Ethinyl estradiol undergoes systemic conjugation both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation, followed by conjugation with glucuronic and / or sulfuric acid.; Elimination; The metabolic clearance from blood plasma is 2.3-7 ml / min / kg. The concentration of ethinyl estradiol in plasma decreases, and the decrease is biphasic in nature: the first phrase is characterized by T1 / 2 about 1 h, the second - 10-20 hours; unchanged is not displayed. Ethinyl estradiol metabolites are excreted by the kidneys and liver in a ratio of 4: 6, with T1 / 2 about 24 hours.
Indications
- contraception ;; - treatment of mild to moderate severity in women who need contraception, with the ineffectiveness of other treatment methods (topical treatment or use of systemic antibiotics).
Contraindications
Bonade is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions develops for the first time against the background of its use, the drug should be immediately canceled: - thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary thromboembolism, heart attack) myocardium) ;; - conditions that precede thrombosis (including angina pectoris) at present or in history ;; - cerebrovascular disease: stroke, transient ischemic attacks now and in history ;; - multiple or expressed risk factors for venous or arterial New thrombosis, includingcomplicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries of the heart, severe dyslipoproteinemia; uncontrolled arterial hypertension, serious surgical intervention, prolonged immobilization, surgery on the lower extremities and pelvic organs, neurosurgical interventions, smoking after the age of 35 ;; Leiden factor 5), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, the presence of antibodies to phospholipids, (anticardio lipin, lupus anticoagulant)) ;; - migraine with focal neurological symptoms now or in history ;; - diabetes mellitus with vascular complications ;; - pancreatitis with severe hypertriglyceridemia in the present or in history; severe liver disease and severe disease (until normalization of liver enzymes), including Rotor's and Dubin-Johnson's syndromes ;; - liver tumors (benign or malignant) currently or in history ;; - identified hormone-dependent malignant neoplasms (including genitals or mammary glands) or suspicion of them ;; - bleeding from vagina of unclear genesis ;; - pregnancy or suspicion of it ;; - lactation period (breastfeeding) ;; - hypersensitivity to any component of the drug Bonade ;; - galactose intolerance, lactase deficiency or glucose-galactose mala adsorption (the drug contains lactose) ;; - obesity (BMI over 30 kg / m2) ;; - extensive injury.; The drug Bonade is not intended for use in men.; With caution; You should carefully weigh the potential risk and the expected benefits of using KOC in each in case of the following diseases / conditions and risk factors: - risk factors for thrombosis and thromboembolism: smoking; obesity (BMI less than 30 kg / m2); dyslipoproteinemia, arterial hypertension; migraine without focal neurological symptoms; uncomplicated valvular heart disease; genetic predisposition to thrombosis (thrombosis,myocardial infarction or cerebral circulation at a young age in someone from the next of kin) ;; - other diseases in which there may be violations of the peripheral circulation: diabetes mellitus; oncological diseases, SLE; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of the superficial veins ;; - hereditary angioedema ;; - hypertriglyceridemia ;; - diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (eg, jaundice, cholestasis, gall bladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Chorea Sydenham) ;; - postpartum period.
Dosage and administration
The drug Bonade taken orally on 1 tab./day, not chewed and squeezed with a small amount of water at the same time every day. Tablets are taken for 21 days without a break according to the scheme indicated on the blister. Each blister contains 21 pills. Each tablet is labeled with the day of the week in which it should be taken. Over the next 7 days do not take pills. During this period, menstrual bleeding should begin (withdrawal bleeding). It usually begins 2-3 days after taking the last pill of the drug Bonade. After a 7-day break, on the 8th day, start taking the pills from the new package (if the package contains 21 pills) or blisters (if the package contains 63 pills) , even if the bleeding has not stopped yet. This means that a woman will always start a new package (blister) on the same day of the week and that every month the withdrawal will bleed approximately on the same day of the month. How to start taking the drug Bonade; or hormonal contraceptives in the previous month, the use of the drug Bonade should begin on the 1st day of the natural menstrual cycle (that is, on the 1st day of menstrual bleeding). Take a pill labeled with the appropriate day of the week. For example, if menstruation begins on Friday, take a pill labeled with letters denoting Friday. Then, continue to take the pills on the following days in the prescribed manner.It is also permissible to begin use from 2-5 days of the cycle, but in this case it is recommended to additionally apply a barrier method of contraception (condom) during the first 7 days of using the pills from the first package (blister) .; When switching from other COCs, the contraceptive vaginal ring or contraceptive patch you can start taking the drug Bonade the next day after taking the last pill from the previous package of COC (ie, without interruption in the reception). If the previous package also contained inactive pills (without active substance), you can begin to use the drug Bonade the next day after taking the last active tablet. You can also start the application later, but in no case no later than the next day, after the usual interruption in use (a break of 7 days for preparations containing 21 pills) or after taking the last inactive tablet (for preparations containing 28 pills per pack) .; In case of using a contraceptive patch or a contraceptive vaginal ring, taking the drug Bonade should be started on the day of their removal, but no later than the day when a new ring is to be inserted or a new patch is stuck.; When switching from oral contraction tivov containing only progestin ( "mini-pill"), you can stop taking the "mini-pill" any day and start applying Bonade preparation for the next day, at the same time. During the first 7 days of pill use, you must also use an additional barrier method of contraception. When switching from an injection contraceptive, implant or intrauterine contraceptive device (intrauterine device) that releases the gestagen, you should start using the drug Bonade on the day when the next injection should be given or on the day of removal of the implant or intrauterine contraceptive. During the first 7 days of pill use, you must also use an additional barrier method of contraception.; Immediately after birth, the doctor may recommend waiting until the end of the first normal menstrual cycle before starting the use of the drug Bonade. Sometimes, according to the recommendation of the doctor, you can start using the drug earlier.; After a miscarriage or abortion in the first trimester of pregnancy, you should consult with your doctor.It is usually recommended to start using the drug immediately.; Taking the missed pills; If the delay in taking the next pill is less than 12 hours, the contraceptive effect of the drug Bonade remains. The patient should take a pill as soon as she remembers. The following pill should be taken at the usual time. If the delay in taking the pills is more than 12 hours, contraceptive protection can be reduced. The more pills are missed in a row, and the closer this pass is to the beginning of reception or to the end of reception, the higher the risk of pregnancy. In this regard, you can be guided by the following rules:; consult with your doctor ;; - if you miss 1 tablet in the first week of the drug, you should take the missed pill as soon as possible, as soon as the patient remembers (even if it means taking two pills at the same time). The following pill should be taken at the usual time. You must additionally use a barrier method of contraception over the next 7 days. If sexual intercourse was within a week before the pill was missed, the likelihood of pregnancy should be considered. You should immediately consult with your doctor ;; - if 1 tablet is missed during the second week of taking the drug, you should take the missed pill as soon as possible as soon as the patient remembers (even if it means taking 2 pills at the same time). The following pill should be taken at the usual time. If a woman took the pills correctly for 7 days preceding the first missed pill, the contraceptive effect of the drug Bonade is maintained, and the woman does not need to use additional contraceptive measures. Otherwise, as well as skipping 2 or more pills, it is necessary to additionally use barrier methods of contraception for 7 days; There is no need to use additional contraceptive methods if the woman adheres to either of the following two options:; 1.You should take the missed pill as soon as possible, as soon as the patient remembers (even if it means taking 2 pills at the same time). The following pill should be taken at the usual time. The next package (blister) should be started immediately after taking the pills from the current package (blister), so there will be no break between the packages (blisters). Bleeding "cancellation" is unlikely until the pills from the second package (blister) run out, but there may be spotting or breakthrough uterine bleeding on the days of taking the drug; 2. You should stop using the pills from the current package (blister), take a break for 7 days or less (including the day you miss the tablet) and then start taking the pills from the new package (blister) .; No expected menstrual-like bleeding after a break in the use of pills may mean that woman is pregnant. In this case, a woman needs to consult with a doctor before she starts using pills from a new package (blister). Guided by these rules, a woman can always start using pills from the next package (blister) on the day of the week she usually does. ; In situations where it is recommended to stop taking the drug Bonade, or when its reliability can be reduced, you should refrain from sex or use non-hormonal contraceptive methods (for example, a condom or other bar ernye methods). Do not use rhythmic or temperature methods. These methods may be unreliable, because taking COCs leads to changes in basal temperature and cervical mucus.; Stopping the drug; You can stop taking the drug Bonade at any time. In case of termination of use due to the desire to become pregnant, it is usually recommended to wait until the first normal menstruation and only after that try to become pregnant. With this method, it is easier to establish the date of birth.; Recommendations in case of gastrointestinal disorders; In the event of vomiting or diarrhea, the active ingredients of the drug Bonade may not be completely absorbed. If vomiting lasts 3–4 hours after taking a contraceptive pill, the result may be the same as skipping a pill.You should do as recommended when you skip taking the pill. In the case of severe diarrhea, consult your doctor.; Delay the onset of menstrual bleeding; You can delay the onset of menstrual bleeding if you start taking pills from the following package (if the package contains 21 pills) or blisters (if the package contains 63 pills) immediately after the end of the current package (blister). You can take the pills as long as necessary, or until the pills in the package (blister) run out. If it is necessary for withdrawal bleeding to begin, you should stop taking the pills. During the application of the pills of the drug Bonade, abundant or spotting may appear from the new package (blister). The use of pills from the next package (blister) should begin after the usual 7-day interval.; Change the day of the onset of menstrual bleeding; If a woman takes the pills, strictly following all the recommendations, menstrual-like bleeding occurs on approximately the same days every 4 weeks. If it is necessary to change these days, one should shorten (but in no case extend) the next interval without taking pills. For example, bleeding begins on Fridays, but it is necessary that it starts on Tuesdays (3 days earlier), then you should start using pills from a new package (blister) 3 days earlier than usual. If the interval without taking the pill is too short, the bleeding may not occur at all at this interval. However, during the use of pills from a new package (blister), abundant or spotting may appear.; Special groups of patients; For children and adolescents, Bonade is indicated only after menarche.; Elderly patients: Bonade is not indicated after menopause.; contraindicated in women with severe liver disease until liver function levels return to normal.; Bonade has not been specifically studied in women with impaired renal function. The available data do not imply a change in the dosage regimen in these patients.