Evra tdts 150mkg + 20mkg 24ch package. N3
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Active ingredients
Norethisterone + Ethinyl Estradiol
Composition
In 1 transdermal therapeutic system, excretion within 24 hours: norelgestromin 6 mg 203 mcg; ethinyl estradiol 600 mcg 33.9 mcg.
Pharmacological effect
Contraceptive agent for transdermal use. It inhibits the gonadotropic function of the pituitary gland, inhibits the development of the follicle and interferes with the process of ovulation. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl Index - 0.90. The frequency of pregnancy does not depend on such factors as age, race, and increases in women with a body weight of more than 90 kg.
Pharmacokinetics
The absorption and distribution of Css norelgestromine and ethinyl estradiol in serum is reached 48 hours after the application of TTC Evra and is 0.8 ng / ml and 50 pg / ml, respectively. With prolonged use of TTC, Evra Css and AUC increase slightly. Under various temperature conditions and physical activity, there were no significant changes in Css and AUC of norelgestromin, and AUC of ethinyl estradiol slightly increased with physical activity, while Css remained unchanged. The clinical efficacy of TTC can be maintained even if the woman conducts another replacement of TTC 2 full days later than the scheduled seven day period. Norelgestromin and norgestrel (serum metabolite of norelgestromin) have a high degree (more than 97%) of binding to serum proteins. Norelgestromin binds to albumin, norgestrel binds predominantly to the globulins that bind the sex hormones. Ethinyl estradiol has a high degree of binding to serum albumin. Metabolism Norelgestromin is metabolized in the liver, with the formation of the metabolite norgestrel, as well as various hydroxylated and conjugated metabolites. Ethinyl estradiol is metabolized to various hydroxylated compounds and their glucuronide and sulfate conjugates. Progestogens and estrogens inhibit many microsomal liver enzymes of the cytochrome P450 system (includingCYP3A4, CYP2C19). Introduction The average T1 / 2 of norelgestromine and ethinyl estradiol is about 28 h and 17 h, respectively. The metabolites of norelgestromine and ethinyl estradiol are excreted in the urine and feces. Pharmacokinetics in special clinical situations The Css and AUC values of norelgestromin and ethinyl estradiol decrease slightly with increasing age, body weight, or body surface area.
Indications
Contraception in women.
Contraindications
Venous thrombosis including in history (including deep vein thrombosis, pulmonary thromboembolism); - arterial thrombosis, incl. history (including acute cerebrovascular accident, myocardial infarction, retinal artery thrombosis) or precursors of thrombosis (including angina pectoris or a transient attack of ischemia); - presence of serious or multiple risk factors for arterial thrombosis: severe hypertension (more than 160/100 mm Hg) .), diabetes mellitus with vascular lesion; - hereditary dyslipoproteinemia; - hereditary predisposition to venous or arterial thrombosis (for example, resistance of activated protein C, lack of anti rhombin III, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies against cardiolipin, lupus anticoagulant); - migraine with aura; - confirmed or suspected breast cancer; - endometrial cancer and confirmed or suspected estrogen-dependent tumors; liver carcinoma; - genital bleeding; - postmenopausal period; - age up to 18 years; - postpartum period (4 weeks); - lactation period; - hypersensitivity to the components of the drug. nenie on the breast, as well as erythematous, irritated or damaged skin.
Precautionary measures
Caution should be used when giving a family history of venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age; with prolonged immobilization; obesity (body mass index of more than 30 kg / m2, calculated as the ratio of body weight in kilograms to the square of height in meters); thrombophlebitis of superficial veins and varicose veins; dyslipoproteinemia; hypertension; lesions of the valvular apparatus of the heart; atrial fibrillation; diabetes; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease; ulcerative colitis; abnormal liver function; hypertriglyceridemia (includingfamily history); acute liver dysfunction during a previous pregnancy or previous use of sex hormones; in violation of the menstrual cycle; impaired renal function. Caution should be used for abnormal liver function; acute liver dysfunction during a previous pregnancy or previous use of sex hormones. Caution should be used in case of kidney dysfunction.
Use during pregnancy and lactation
The drug Evra is contraindicated during pregnancy and lactation.
Dosage and administration
The patient should be informed that in order to achieve the maximum contraceptive effect, it is necessary to strictly follow the instructions on the use of Evr TTC. Only one TTC can be used at a time. Each used TTC is removed and immediately replaced with a new one on the same day of the week (replacement day) on the 8th and 15th days of the menstrual cycle (2nd and 3rd week). TTC can be changed at any time of the day of replacement. During the 4th week, from the 22nd to the 28th day of the cycle, TTC is not used. A new contraceptive cycle begins the day after the end of the 4th week; The following TTS should be stuck, even if the menstruation was not or it has not ended. Under no circumstances should the break in the application of TTC Evra be longer than 7 days, otherwise the risk of pregnancy will increase. In such situations, for 7 days it is necessary to simultaneously use a barrier method of contraception, since The risk of ovulation increases with each day that the recommended duration of the period, free from the use of TTC, is exceeded. In the case of sexual intercourse during such an extended period, the probability of conception is very high. The beginning of the use of TTC Evra. If during the previous menstrual cycle, the woman did not use the hormonal contraceptive contraception using TTC Evra start on the first day of menstruation. One TTC Evra is glued to the skin and is used all week (7 days). The day of sticking the first TTS Evra (1st day / start day) determines the next days of replacement. The replacement day will be on the same day of each week (8th and 15th days of the cycle). On the 22nd day of the cycle, the TTC is removed, and from the 22nd to the 28th day of the cycle, the woman does not use the ETC TTC.The next day is considered the first day of the new contraceptive cycle. If a woman starts using TTC Evra not from the first day of the cycle, then you should use barrier methods of contraception at the same time for the first 7 days of the first contraceptive cycle. menstruation, which began after discontinuation of the combined oral contraceptive. If menstruation does not begin within 5 days after taking the contraceptive pill, then pregnancy should be excluded before starting using TTC Evra. If Evra starts using after 1 day of menstruation, then you should use barrier methods of contraception simultaneously within 7 days. the last contraceptive pill has passed for more than 7 days, then a woman may experience ovulation, and therefore she should consult a doctor before starting to use TTC Evra. Sexual intercourse during this extended period free from taking contraceptive pills can lead to pregnancy. If a woman switches from using drugs containing only progestogen, Eura Woman can use TTC to use a drug containing only progestogen on any day (on the day of removal implant, on the day when the next injection should be given), but during the first 7 days of using the Evra TTC, a barrier method should be used to enhance the contraceptive effect ekta.Posle vykidysha.Posle abortion or abortion or miscarriage before the 20th week of pregnancy, you can immediately begin to use TTS Evra. If a woman begins to apply TTC Evra immediately after an abortion or miscarriage, then additional methods of contraception are not required. A woman should know that ovulation can occur within 10 days after an abortion or miscarriage. After an abortion or miscarriage in the 20th week of pregnancy or later, using the TTC Evra can be started on the 21st day after the abortion or miscarriage, or on the 1st day of the first menstruation. After childbirth. Women who are not breastfeeding should start using TTC Evra no earlier than 4 weeks after delivery.If a woman begins to use TTC Evra later, then during the first 7 days she should additionally use a barrier method of contraception. If sexual intercourse has taken place, it is necessary to exclude pregnancy before starting using TTC Evra, or a woman should wait for the first menstruation. When completely uncoupling TTC Evra, if TTC Evra is completely or partially peeled off, then insufficient amount of its active ingredients is released. if the TTS Evra is partially unstuck for less than a day (up to 24 hours): you should re-glue the TTC of Evra to the same place or immediately replace it with a new TTC of Evra. Additional contraceptives are not required. The following TTC Evra needs to be glued on a normal replacement day. If it is partially peeled off for more than a day (24 hours or more), and if the woman does not know exactly when TTC Evra is partially or fully peeled off, pregnancy may occur. A woman should immediately begin a new cycle, sticking a new TTC Evra and consider this day as the first day of the contraceptive cycle. Barrier contraceptive methods should be used at the same time only in the first 7 days of the new cycle. One should not try to re-glue TTC Evra if she has lost her adhesive properties; instead, you must immediately glue the new TTC Evra. Additional adhesive tapes or bandages should not be used to keep TTC Evra in place. If the next days of replacing TTC EvraV are missed, at the beginning of any contraceptive cycle (1st week / 1st day): if there is an increased risk of pregnancy, the first TTS of Evra should stick as soon as he remembers it. This day is considered a new 1st day and a new replacement day is counted. Non-hormonal contraception should be simultaneously applied during the first 7 days of a new cycle. In the case of sexual intercourse during such an extended period, without conception of TTC Evra, conception may occur. In the middle of the cycle (2nd week / 8th day or 3rd week / 15th day): - if 1 or 2 days (up to 48 hours): a woman should immediately stick a new TTS. The following TTC must be glued on the normal replacement day. If during the 7 days preceding the first missed day of TTC attachment, the use of TTC was correct, then additional contraception is not required; —If more than 2 days have passed since the replacement (48 hours or more): there is an increased risk of pregnancy.A woman should stop the current contraceptive cycle and immediately start a new 4-week cycle by pasting a new ETC TTC. This day is considered a new 1st day and a new replacement day is counted. Barrier contraception should be applied simultaneously during the first 7 days of the cycle; —At the end of the cycle (4th week / 22nd day): if the TTC is not removed at the beginning of the 4th week (22nd day), then it should be removed as fast as possible. The next contraceptive cycle should begin on a regular replacement day, which is the day after the 28th day. Additional contraception is not required. Changing the day of replacement In order to postpone menstruation for one cycle, a woman must glue a new TTC Evra at the beginning of the 4th week (22nd day), thereby skipping the period free from using TTC Evra. There may be intermenstrual bleeding or spotting. After 6 consecutive weeks of TTS use, there should be a 7-day interval free from TTS use. After the end of this interval, regular use of the drug is resumed. If the woman wants to change the replacement day on the day appointed for that during the week, she should complete the current cycle by removing the third ETC TTC; A woman can choose a new replacement day by sticking the first TTS of Evra of the next cycle on the selected day. In no case should the period free from using TTC Evra be more than 7 days. The shorter this period, the higher the likelihood that a woman will not have a regular menstruation, and during the next contraceptive cycle, intermenstrual bleeding or spotting may occur. Method of application: TTC Evra should be pasted on clean, dry, intact and healthy skin of the buttocks, abdomen, the outer surface of the upper part of the shoulder or the upper part of the body with minimal hair growth, in areas where it will not come into contact with tight clothing. In order to avoid possible irritation, every next TT Evra is necessary to stick to the other area of the skin, it can be done within the same anatomic oblasti.TTS Evra should be tightly pressed to the edges well in contact with the skin. To prevent the adhesion properties of TTS Evra from declining, you should not apply make-up, creams, lotions, powders and other local products on those skin areas where it is glued or will be glued. A woman should inspect TTS Evra on a daily basis in order to be sure of its firm attachment. TTC must be disposed of carefully in accordance with the instructions.
Side effects
On the part of the central nervous system and peripheral nervous system: dizziness, migraine, paresthesia, hypesthesia, convulsions, tremor, emotional lability, depression, anxiety, insomnia, drowsiness. Cardiovascular system: increased blood pressure, palpitations, edema, varicose veins. On the part of the digestive system: gingivitis, anorexia or increased appetite, gastritis, gastroenteritis, dyspepsia, abdominal pain, vomiting, diarrhea, flatulence, constipation, hemorrhoids. On the part of the respiratory system: infections of the upper respiratory tract tei, dyspnea, bronchial asthma. From the reproductive system: pain during intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, breast enlargement, menstrual disorders (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation, which is not due to childbirth, ovarian dysfunction, mastitis, breast fibroadenomas, ovarian cysts. From the urinary system: urinary tract infections. From the musculoskeletal system: m muscle cramps, myalgia, arthralgia, ostalgia (including back pain, pain in the lower extremities), tendinosis (tendon changes), muscle weakness. Dermatological reactions: pruritus, urticaria, skin rash, contact dermatitis, bullous rash, acne, discoloration of the skin, eczema, increased sweating, alopecia, photosensitization , dry skin. On the part of the organ of vision: conjunctivitis, visual impairment. On the side of metabolism: weight gain, hypertriglyceridemia, hypercholesterolemia. Others: flu-like syndrome, feeling tired, allergic reactions, chest pain, asthenic Syndrome, syncope, anemia, abscesses, lymphadenopathy. Rarely (with a frequency of more than 0.01% to less than 0.1%): hypertonus or hypotonia of muscles, impaired coordination of movements, dysphonia, hemiplegia, neuralgia, stupor, increased libido, depersonalization, apathy , paranoia, benign breast tumors, cervical cancer in situ, perineal pain, ulceration of the genitals, atrophy of the mammary glands, lowering blood pressure, enanthema, dry mouth or increased salivation, colitis, pain during urination, hyperprolactinemia, melanosis, pigmentation disorders chlo azma, xerophthalmia, weight loss or obesity, inflammation of the subcutaneous tissue, alcohol intolerance, cholecystitis, cholelithiasis, abnormal liver function, purpura, flushing, thrombosis (includingdeep vein thrombosis, pulmonary thrombosis), thrombophlebitis of the superficial veins, pain in the veins, pulmonary embolism.
Overdose
Symptoms: nausea, vomiting, vaginal bleeding. Treatment: no specific antidote. TTC should be removed and symptomatic therapy should be performed.
Interaction with other drugs
Hydantoins, barbiturates, primidone, carbamazepine and rifampicin, as well as oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil, and phenylbutazone, can cause an acceleration of the metabolism of sex hormones, which can lead to interfunctional bleeding or failure, and ineffectiveness will not work. of pregnancy. The mechanism of interaction of these drugs and the active ingredients of TTC Evra is based on the ability of the above listed drugs to induce liver enzymes, with the participation of which the sex hormones are metabolized. The maximum induction of enzymes is usually achieved no earlier than 2-3 weeks, and can last for at least 4 weeks after discontinuation of the corresponding drug. Receiving herbal preparations containing Hypericum perforatum concomitantly with St. John's wort can lead to a loss of the contraceptive effect. Women who have taken these herbal remedies may experience intermenstrual bleeding and unwanted pregnancy. This is due to the fact that St. John's wort induces enzymes that metabolize sex hormones. Inducing effect may persist for 2 weeks. after the abolition of a herbal preparation containing St. John's wort. Holed up. Antibiotics may cause a loss of the contraceptive effect, (including ampicillin and tetracyclines). A study of the pharmacokinetic interaction showed that oral administration of tetracycline hydrochloride 3 days before and for 7 days while using TTC Evra does not have a significant effect on the pharmacokinetics of norelgestromin or ethinyl estradiol.
special instructions
There is no clinical evidence that the transdermal contraceptive system is safer than oral contraceptives in any aspect. Before starting or resuming the use of Evra TTC, you must collect a detailed medical history (including family history) and exclude pregnancy.Blood pressure should be measured and a physical examination should be carried out taking into account contraindications and warnings. If you suspect a hereditary predisposition to venous thromboembolism (if venous thromboembolism occurred in a brother, sister or parents at a relatively young age), a woman should be sent for consultation to a specialist before to decide on the use of hormonal contraception. The risk of vascular complications is increased in women with thrombophlebitis of superficial veins and varicose veins, as well as in obesity ( body mass index of more than 30 kg / m2. When prolonged immobilization, after extensive surgery on the lower limbs or severe injury, it is recommended to stop using hormonal contraceptives (during a planned operation it should be done 4 weeks before it) and resume hormonal contraception no earlier than 2 weeks after complete remobilization. Some epidemiological studies have revealed an increased risk of cervical cancer in women who have been using combined oral contraceptives for a long time. Women taking combined oral contraceptives may have liver tumors that may cause life-threatening intra-abdominal bleeding. In the case of women who use TTC Evra, severe pain in the upper abdomen, liver enlargement or symptoms of intra-abdominal bleeding, differential diagnosis should be made to rule out a possible liver tumor. Women with hypertriglyceridemia or this family history may have an increased risk of pancreatitis. in case of use of combined hormonal contraceptives. When pharmacologically uncontrolled arterial hypertension occurs in women during combination therapy th e preparation of hormonal contraceptives should be discontinued. The use of Evra’s TTC can be resumed after normalization of blood pressure. It has been reported that the following diseases may occur or worsen when oral administration of combined hormonal contraceptives is present, but there is no convincing evidence of their connection with the use of combined oral contraceptives.These include: jaundice and / or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic erythematosus; hemolytic uremic syndrome; Chorea Sydenham; gestational herpes associated with otosclerosis hearing loss. Hormonal contraceptives can affect some endocrine parameters, liver function markers and blood components: - concentrations of prothrombin and coagulation factors VII, VIII, IX and X increase; reduced levels of antithrombin III; decreases the level of protein S; increased norepinephrine-induced platelet aggregation - increases the concentration of thyroxine-binding globulin, which causes an increase in the concentration of total thyroid hormone, which is measured by iodine content associated with protein, T4 content (determined using chromatography or radioimmunoassay); binding of free T3 to an ion-exchange resin decreases, as evidenced by an increase in the concentration of thyroxin-binding globulin, the concentration of free T4 does not change. Serum concentration of other binding proteins can be increased; concentrations of globulins that bind sex hormones increase, which leads to an increase in concentrations of total circulating endogenous sex hormones. However, the concentrations of free or biologically active sex steroids are reduced or remain unchanged. Women who use Evra TTC may slightly increase concentrations of HDL-C, total cholesterol, LDL-C and LD-C, while the ratio of LDL / C-HDL may remain unchanged. Hormonal contraceptives may cause a decrease in serum folate concentrations. This can have potentially clinically significant consequences if a woman has a pregnancy shortly after discontinuing a hormonal contraceptive. Currently, all women are advised to take folic acid during and after hormonal contraception. Combined hormonal contraceptives can affect peripheral insulin resistance and glucose tolerance, but there is no evidence of the need to change the regimen of diabetes mellitus while using combined hormonal contraceptives.At the same time, patients with diabetes mellitus should be carefully monitored, especially at the early stage of using TTC Evra. There were reports of worsening endogenous depression, epilepsy, Crohn's disease and ulcerative colitis in women taking combined oral contraceptives. Women who have skin hyperpigmentation Persons during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while wearing the Evra TTC. Often, such hyperpigmentation is not completely reversible. Women should be informed that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Women taking medications that induce microsomal enzymes (hydantoins, barbiturates, primidone, carbamazepine , rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil, and phenylbutazone) and antibiotics (with the exception of tetracyclines) should temporarily use a barrier method of contraception until Completion to the use of TTC Evra or choose a different method of contraception. The barrier method should be applied during the course of treatment with the above preparations, as well as within 28 days after discontinuation of the inducers of microsomal enzymes and within 7 days after discontinuation of antibiotics. If the period for taking concomitant drugs exceeds the 3-week cycle of using Eur's TTC, then the new contraceptive cycle should be started immediately after the previous one, that is, without the usual period free from the use of TTC. Women who receive long-term therapy with drugs that induce hepatic enzymes should choose another method of contraception. When prescribed with Evra TTC, drugs that are metabolized by CYP3A4, CYP2C19 isoenzymes, especially those with a narrow therapeutic index (eg, cyclosporin), should be excluded significant interaction. When using any combined hormonal contraceptives, the menstrual cycle may be disrupted (spotting or intermenstrual bleeding), especially in the first months of use of these funds.The duration of the adaptation period is about three cycles. If during the use of the ETS TTS in accordance with the recommendations, the persistence of intermenstrual bleeding is observed or such bleeding occurs after the previous regular cycles, then other reasons than the use of TTC should be taken into account. It should be borne in mind the possibility of non-hormonal causes of menstrual irregularities and, if necessary, to conduct an adequate diagnostic examination to exclude organic disease or pregnancy. In some women in the period, free from the use of TTC Evra menstruation may not occur. If a woman violated the instructions for use in the period preceding the first failed menstruation, or if she did not have two menstruations after interruptions in the use of TTC, then pregnancy should be eliminated before continuing to use TTC of Evra. oligomenorrhea, especially if they are present before the start of hormonal contraception. If the TTC Evra application causes skin irritation, then a new TTC can be glued to another area to life and wearing it until the next day of replacement. In women weighing 90 kg or more, the effectiveness of contraception can be reduced. If symptoms of liver dysfunction occur, the use of combined hormonal contraceptives should be stopped until the markers of the liver function normalize. , which occurred during a previous pregnancy or prior use of sex hormones, combined hormonal contraceptives must be canceled. and the effectiveness of TTS Evra set only for women aged 18 to 45 years.