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Active ingredients
Desogestrel + Ethinyl Estradiol
Release form
Pills
Composition
Active ingredient: ethinyl estradiol - 0, 020 mg, desogestrel - 0, 150 mg. Concentration of active ingredient (mg): 0, 17 mg
Pharmacological effect
Novynette is a contraceptive that contains synthetic follicular and luteal hormones. The action of Novynette is to slow down the maturation of the egg. Prior to the use of the drug, a general and gynecological examination should be performed to exclude diseases that pose a risk for the use of hormonal contraception. While taking the drug, you should regularly - every six months - undergo a medical examination. Contraceptive use has a number of advantages compared with other contraceptive methods: a reliable contraceptive method, after termination of which fertility is restored, the amount of bleeding during menstruation is reduced, and its duration is shortened, pain during menstruation decreases or can completely disappear, the use of contraceptive drugs reduces the possibility of anemia , infectious diseases of the pelvic organs, the probability of ectopic pregnancy, as well as diseases of the uterus, ovaries and olive glands.
Pharmacokinetics
Desogestrel Absorption: When taken orally, desogestrel is absorbed from the gastrointestinal tract (GIT) quickly and almost completely. Metabolized to 3-keto-desogestrel, which is the biologically active metabolite of desogestrel. The average maximum concentration in serum (Cmax) 2 ng / ml, is reached 1.5 hours (Tmax) after taking the pill. Bioavailability of the drug is 62-81%. The distribution in the body of 3-keto-desogestrel binds to plasma proteins, mainly albumin, and the sex hormone-binding globulin (SHBG). The volume of distribution is 1.5 l / kg. Metabolism: In addition to 3-keto-dezogestrel, which is formed in the liver and in the intestinal wall, other metabolites are formed: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (first phase metabolites). They do not possess pharmacological activity, and partially, by conjugation (the second phase of metabolization), are converted into polar metabolites (sulfates and glucuronates).Plasma clearance of about 2 ml / min per 1 kg of body weight. Excretion from the body: The average half-life of 3-keto-desogestrel is 30 hours. Metabolites are excreted by the kidneys and through the intestines (in the ratio 4: 6). Stable concentration is set to the second half of the cycle. At this time, the level of ketogestrel increases by 2-3 times. Ethinyl estradiol Absorption: Ethinyl estradiol is absorbed from the gastrointestinal tract quickly and completely. The average maximum concentration in serum (Cmax) is 80 pg / ml - in 1-2 hours (Tmax) after taking the pill. Bioavailability due to presystemic conjugation and first-pass effect is about 60%. Distribution in the body: Ethinyl estradiol is completely bound to plasma proteins, mainly albumin. The volume of distribution is 5 l / kg. Metabolism: Presystemic conjugation of ethinyl estradiol is significant. Passing through the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinyl estradiol and its conjugates of the first phase of metabolism (sulfates and glucuronides) are released into the bile and enter enterohepatic circulation. Plasma clearance of about 5 ml / min per 1 kg of body weight. Excretion from the body: The average half-life of ethinyl estradiol is about 24 hours. About 40% is excreted by the kidneys and about 60% through the intestines. Stable concentration is set to 3-4 days, while the level of ethinyl estradiol in serum is 30-40% higher than after a single dose
Indications
Cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including the lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including in AIDS patients, with organ transplantation) . The drug can be used to prevent cryptococcal infection in patients with AIDS, generalized candidiasis, including candidaemia, disseminated candidiasis, and other forms of invasive candidal infection (including infections of the peritoneum, endocardium, eyes, respiratory and urinary tract). Treatment can be carried out in patients with malignant neoplasms, patients in intensive care units, patients receiving cytotoxic or immunosuppressive agents, as well as in the presence of other factors predisposing to the development of candidiasis, candidiasis of the mucous membranes, including the oral cavity and pharynx (including atrophic oral candidiasis associated with wearing dentures), esophagus, non-invasive bronchopulmonary infections, candiduria, candidiasis of the skin.prevention of recurrent oropharyngeal candidiasis in AIDS patients, genital candidiasis: vaginal candidiasis (acute and chronic recurrent), prophylactic use to reduce the frequency of recurrences of vaginal candidiasis (3 or more episodes per year). Candida balanitis, prevention of fungal infections in patients with malignant tumors that are prone to such infections as a result of cytotoxic chemotherapy or radiation therapy, skin mycoses, including mycoses of the feet, body, inguinal region, pityrias, psoriasis, onychomycosis, and candidosis of the skin, deep endemic mycoses, coccidioidomycosis , paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.
Contraindications
Do not use combined oral contraceptives (CPC) for the conditions listed below. If such a situation arises for the first time while taking an oral contraceptive, its use should be stopped immediately. Established pregnancy or possible pregnancy. Moderate or severe hypertension. Hyperlipoproteinemia. Presence or indication of a history of venous thromboembolism (for example, deep vein thrombosis, pulmonary embolism). The presence or indication of a history of arterial thromboembolism (for example, myocardial infarction, cerebrovascular disorders), or a condition preceded by it (for example, angina pectoris, transient ischemic attack). The presence of severe or multiple risk factors for arterial or venous thrombosis (see section "Features of Use"). Hereditary or acquired susceptibility to arterial or venous thrombosis, such as resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). Diabetes with vascular complications. Pancreatitis at present or in history, accompanied by severe hypertriglyceridemia. Severe liver disease, cholestatic jaundice or hepatitis, including a history of (in the absence of normalization of liver tests and for 3 months after their normalization), jaundice during pregnancy in history, jaundice due to steroids, Rotor syndrome and Dubin syndrome - Johnson, hepatocellular tumors and porphyria. Cholelithiasis. Liver tumors, in t. Ch. A history of (benign or malignant).Detection or suspected estrogen-dependent tumors (for example, the genital organs of the mammary glands), endometrial hyperplasia. Bleeding from the vagina of unknown etiology. Migraine with focal neurological symptoms (see Section "Features of Use"). Systemic lupus erythematosus, in t. Ch. In history. Severe itching, herpes pregnant, the appearance or progression of otosclerosis in the period of a previous pregnancy or when taking steroids. Hypersensitivity to active substances or to any of the excipients
Precautionary measures
If any of the diseases / conditions / risk factors listed below are present, the benefits and the possible risk of taking ethinyl estradiol + desogestrel should be carefully weighed. This question should be discussed with the patient before the start of the drug. In the case of exacerbation of diseases, deterioration of the condition or the appearance of the first symptoms of the above-mentioned conditions or risk factors, the patient should immediately consult a doctor. The doctor decides on canceling the drug individually. Diseases of the heart and blood vessels6 In the course of epidemiological studies, it was found that there may be a link between the use of COCs and an increase in the risk of arterial and venous thrombosis and thromboembolism, such as myocardial infarction, stroke, deep vein thrombosis and PEH. These diseases are extremely rare. The use of any COC is associated with an increased risk of venous thromboembolism (VTE), manifested as deep vein thrombosis and / or pulmonary embolism. The risk is higher in the first year of admission than in women taking COCs for more than 1 year. When taking a combination of desogestrel and ethinyl estradiol, there is an increased (almost 2 times) risk of developing VTE in comparison with drugs containing levonorgestrel, norgestimate or norethisterone as a progestin component. Thrombosis is extremely rare in other blood vessels (for example, in the veins and arteries of the liver, mesentery, kidneys, brain, or retina). At the moment there is no unequivocal opinion on the possible role of varicose veins and superficial thrombophlebitis in the etiology of the development of VTE. If a hereditary predisposition to thromboembolic diseases is suspected, a woman should be referred for consultation to a specialist before making a decision about prescribing any hormonal contraceptives. Risk factors for venous and arterial thrombosis, thromboembolism.High risk factors for the development of venous thrombosis are: age over 35 years, air travel lasting more than 4 hours (especially if there are other risk factors), overweight (BMI> 30 kg / m2). The risk of complications increases with increasing BMI, it is especially important to take this into account in the presence of other risk factors. Prolonged immobilization, extended surgical interventions, neurosurgical operations, surgical interventions in the pelvic region or on the lower limbs, severe injury. With prolonged immobilization and the above surgical interventions, it is recommended to discontinue the use of a combination of ethinyl estradiol + desogestrel, with planned surgical interventions no later than 4 weeks before the operation, and not to resume reception within 2 weeks after full rehabilitation. To prevent unwanted pregnancy should use other methods of contraception. If the combination has not been stopped in advance, then antithrombotic therapy is indicated in this case. The presence of family history of thromboembolic disease (venous thrombosis / thromboembolism in brothers, sisters or parents at a young age). Other conditions / diseases associated with the development of venous thrombosis (cancer, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell anemia). The risk of developing VTE is increased both during the initial use of KOK and when KOC is resumed after a break of 4 weeks or more. The development of VTE can be fatal in 1-2% of cases. Symptoms of VTE (deep vein thrombosis and pulmonary embolism) Symptoms of deep vein thrombosis may include: unilateral edema of the leg, including the feet, or along the affected vein; pain in the leg or soreness when touched to the leg, which can be felt, incl. only when standing or walking; sensation of heat in a sore limb, redness or discoloration of the skin of the leg. Symptoms of pulmonary thromboembolism: a sudden attack of difficulty breathing or rapid breathing of unknown etiology; a sudden attack of cough, which may be accompanied by hemoptysis; severe chest pain; feeling very weak or dizzy; fast or irregular heart rhythm. Some of these symptoms (for example, difficulty breathing, coughing) are non-specific, which may make diagnosis difficult.It is possible to make a diagnosis of a more common or less dangerous disease (for example, an infectious disease of the respiratory tract). Other signs of vessel occlusion are sudden pain, swelling and blue limb. In case of occlusion of the eye vessel, the symptoms can vary from a painless blurred vision, which can progress to complete loss of vision. Sometimes a complete loss of vision may occur suddenly. Epidemiological studies have identified a link between the use of COCs and an increased risk of arterial thrombosis (myocardial infarction) or cerebral circulatory disorders (for example, transient ischemic attack, stroke). Arterial thromboembolism can be fatal. High risk factors for arterial thrombosis are: age over 35 years, smoking. Women taking COCs are recommended to refrain from smoking. Smokers over the age of 35 should not take COCs. Arterial hypertension, overweight (BMI> 30 kg / m2). The risk of complications increases with increasing BMI, it is especially important to take into account in the presence of other risk factors, the presence of thromboembolic diseases in the family history (arterial thrombosis / thromboembolism in brothers, sisters or parents at a young age), migraine. The increase in the frequency and intensity of migraine when taking COCs (which may be a sign of cerebrovascular disorders) is a reason to cancel the combination of ethinyl estradiol + desogestrel. Other conditions / diseases associated with vascular adverse events (diabetes mellitus, hyperhomocysteinemia, valvular heart disease and atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus). Symptoms of arterial thromboembolism: Symptoms of disorders of cerebral circulation: sudden numbness or weakness of the facial muscles, arms or legs, affecting one side or part of the body; sudden gait disturbance, dizziness, imbalance or coordination of movement; sudden confusion, impaired speech or understanding; sudden visual impairment in one or both eyes; sudden severe or prolonged headache of unknown etiology; loss of consciousness or weakness, with or without cramps.Temporary symptoms may indicate the development of a transient ischemic attack. Symptoms of myocardial infarction: pain, discomfort, a feeling of pressure, heaviness or fullness in the chest; pain in the arm or below the sternum; unpleasant sensation (discomfort), giving to the back, jaw, throat, arm, in the stomach; a feeling of fullness in the stomach, indigestion or feeling of suffocation; sweating, nausea, vomiting, or dizziness; severe tiredness, anxiety, or difficulty breathing; fast or irregular heart rhythm. The risk of thromboembolic complications increases with a combination of several risk factors for the development of these complications. Biochemical indicators that may indicate hereditary or acquired susceptibility to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, anti-phospholipid antibodies (antibodies to cardiolipins, lashes, lashes, and they are laspantic, and they are laspantic, they are laspantic, they are deficient in lacunae, lupus, and they are inadequate. Tumors: The most important risk factor for cervical cancer is the persistence of human papillomavirus (HPV infection). Some epidemiological studies have noted an increase in the risk of cervical cancer in women who receive long-term COCs, but so far there are controversies about the extent to which these data are influenced by a combination of various factors, such as cervical screening and sexual behavior, including more rare use of barrier contraceptive methods, or their relationship. There is evidence that there is a slight increase in the relative risk (1.24) of breast cancer in women using COCs. Raise
Use during pregnancy and lactation
Since the active ingredients pass into the mother's milk and can reduce the amount of milk produced, the use of the drug during breastfeeding is not recommended.
Dosage and administration
Inside Taking the pills starts from the first day of the menstrual cycle and take 1 tablet per day for 21 days, if possible at the same time of day. After taking the last tablet out of the package, a 7-day break is taken during which menstrual-like bleeding occurs as a result of discontinuation of the drug.The next day after a 7-day break (four weeks after taking the first pill, on the same day of the week), taking the drug from the next package, which also contains 21 pills, is resumed, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. When complying with the rules of admission, the contraceptive effect is maintained for the duration of the 7-day break. The first dose of the drug. The first pill should be taken from the first day of the menstrual cycle. In this case, you do not need to use additional methods of contraception. Taking the pills can be started from 2-5 days of menstruation, but in this case, in the first cycle of using the drug, additional methods of contraception should be used in the first 7 days of taking the pills. If more than 5 days have passed after the onset of menstruation, the start of taking the drug should be postponed until the next menstruation. Taking the drug after childbirth. Non-breastfeeding women can start taking pills no earlier than 21 days after delivery, after consulting with a doctor. In this case, there is no need to use other methods of contraception. If you have already had sexual contact after giving birth, then you should wait until the first menstruation with the pill. If the decision is made to take the drug later than 21 days after delivery, then in the first 7 days you need to use additional methods of contraception. Taking the drug after an abortion. After an abortion, in the absence of contraindications, it is necessary to begin taking pills from the first day, and in this case there is no need to use additional methods of contraception. Transfer from another oral contraceptive. Taking Novynette after using another hormonal oral contraceptive containing 30 µg of ethinyl estradiol, according to the 21-day regimen: It is recommended to take the first Novynette pill the next day after completing the course of the previous preparation. You do not need to withstand a 7-day break or wait for the onset of menstruation. No need to use additional methods of contraception. When switching to Novynette from a preparation containing 28 pills, the next day after the pills in the package are finished, begin a new package of Novynette.The transition to Novynette after the use of oral hormonal preparations containing only progestogen (the so-called "mini-pile"): The first pill Novynette must be taken on the first day of the cycle. No need to use additional methods of contraception. If menstruation does not occur when taking a mini-drink, then after excluding pregnancy, you can begin taking Novynette on any day of the cycle, but in this case, additional contraceptive methods should be used in the first 7 days. In the above cases, the use of the following non-hormonal methods is recommended as an additional method of contraception: the use of a cervical cap with a spermicidal gel, a condom, or abstinence from sexual contact. The use of the calendar method in these cases is not recommended. Postponement of the menstrual cycle. If there is a need to postpone menstruation, it is necessary to continue taking pills from a new package, without a 7-day break, in the usual way. With the postponement of menstruation, breakthrough or spot bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular intake Novynette can be restored after the usual 7-day break. Missed pills. If a woman forgot to take a pill in a timely manner, and after skipping no more than 12 hours have passed, you just need to take a forgotten pill, and then continue taking it at your usual time. If more than 12 hours have passed between taking the pills, this is considered to be skipping the pill, the contraceptive reliability in this cycle is not guaranteed and the use of additional methods of contraception is recommended. If you skip one pill in the first or second week of the cycle, you need to take 2 pills on the next day and then continue taking it regularly using additional contraceptive methods until the end of the cycle. When you skip a pill in the third week of the cycle, you must take a forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimal dose of estrogen, the risk of ovulation or bleeding increases when you skip a pill and therefore it is recommended to use additional methods of contraception. What to do with vomiting or diarrhea? If after taking the drug appears vomiting or diarrhea, then the absorption of the drug may be defective.If the symptoms stopped within 12 hours, then you need to take another pill extra. After that, you should continue taking the pills in the usual way. If symptoms continue for more than 12 hours, then additional contraceptive methods should be used during vomiting or diarrhea and for the next 7 days.
Side effects
Side effects, the appearance of which requires immediate discontinuation of the drug: arterial hypertension, hemolytic-uremic syndrome, porphyria, hearing loss due to otosclerosis. Rarely encountered: arterial and venous thromboembolism (including t. Myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary thromboembolism). exacerbation of reactive systemic lupus erythematosus. Very rare: arterial or venous thromboembolism of the liver, mesenteric, renal, retinal arteries and veins. Chorea Sydenham (passing after the abolition of the drug). Other Side effects, less severe, but more common. The feasibility of continuing the use of the drug is decided individually after consultation with the doctor, based on the ratio polzarisk. Reproductive system: acyclic bleeding, bleeding from the vagina, amenorrhea after discontinuation of the drug, a change in the state of vaginal mucus, the development of inflammatory processes of the vagina (eg: candidiasis). Mammary glands: tension, pain, increase in mammary glands, galactorrhea. Gastrointestinal and hepato-biliary system: nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice or itching associated with cholestasis, cholelithiasis. Skin: nodular exudative erythema, rash, chloasma. Central nervous system: headache, migraine, mood changes, depressive states. Metabolic disorders: fluid retention in the body, change (increase) in body weight, decrease in carbohydrate tolerance. Eyes: increased sensitivity of the cornea when wearing contact lenses. Other: allergic reactions
Overdose
Symptoms: nausea, vomiting, in girls - bleeding from the vagina. Treatment: in the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, the treatment is symptomatic.
Interaction with other drugs
Some medications (antiepileptic, antibiotics, sedatives, laxatives) can reduce the effectiveness of Novynette. If you have diabetes, then you may need to increase the dose of insulin or an antidiabetic. You should inform your doctor or pharmacist about drugs you have recently or recently taken.
special instructions
If any of these conditions appear while taking the drug, stop taking the drug and contact your doctor. Before laboratory testing of blood, inform your doctor about taking a contraceptive, because the drug may change some laboratory parameters. During the application of pills, on the skin, especially on the face, some women may appear brownish-yellow spots. If you have seen this during pregnancy or when using other drugs containing hormones, the appearance of these spots can also be observed while taking Novynette. If the likelihood of this is high, avoid sun and ultraviolet rays. If menstruation does not occur, it is necessary to exclude pregnancy with a pregnancy test, the result of which the use of pills does not affect. If you took the pills as directed, you did not have vomiting, and you do not take other medicines, then the probability of pregnancy is minimal. Continue to use the pills, as opposed to contact your doctor. Novynette, like other hormonal contraceptives, does not protect against AIDS and other sexually transmitted diseases. The drug does not affect the ability to drive a car or the ability to drive cars with an increased risk of injury.