Evra - instructions for use, reviews, analogs and form of contraceptive patch of a contraceptive in adults and during pregnancy (consequences of use)

In this article, you can read the instructions for using the drug Evra. Presented are reviews of visitors to the site - consumers of this medication, as well as the opinions of physicians specialists on the use of Eur in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Eur in the presence of existing structural analogs. Use as a contraceptive in adults, as well as the consequences of use in pregnancy and lactation.

Evra - Contraceptive for transdermal (through the skin) applications. Oppresses the gonadotropic function of the pituitary gland, suppresses the development of the follicle and prevents 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 blastocyst. The Pearl Index is 0.90.

The frequency of pregnancy does not depend on such factors as age, race and is increased in women with a body weight of more than 90 kg.

Pharmacokinetics

Norelgestromine 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. Metabolites of noregestromine and ethinylestradiol are excreted in urine and feces.

Indications

• contraception in women.

Forms of release

Plaster for contraception or transdermal therapeutic system (TTC) 203 μg + 33,9 μg / day.

Instructions for use and use

The patient should be informed that in order to achieve the maximum contraceptive effect, it is necessary to strictly follow the instructions for the application of the Eurasian TTC. At the same time, only one TTC can be used.

Each used TTS is removed and immediately replaced with a new one on the same day of the week (the "day of replacement") on the 8th and 15th days of the menstrual cycle (2nd and 3rd week). TTS can be changed at any time of day of replacement. During the 4th week, from the 22nd to the 28th day of the cycle, the TTC is not used. The new contraceptive cycle begins the day after the end of the 4th week; the next TTS should be glued, even if the menstruation was not or it did not end.

Under no circumstances should a break in the application of the TTC Eur should be more than 7 days, otherwise the risk of pregnancy increases. In such situations for 7 days it is necessary to use the barrier method of contraception at the same time. the risk of ovulation increases every day exceeding the recommended duration of the period free from the use of TTS. In the case of sexual intercourse during such an increased period, the probability of conception is very high.

Beginning of the application of TTC Evra

If during the previous menstrual cycle the woman did not use the hormonal contraceptive

Contraception with the help of TTS Evra begins on the first day of menstruation.Glue one TTS Evra to the skin and use it all week (7 days). The day of gluing the first TTC of Eur (1st day / day of the beginning) determines the subsequent days of replacement. Day replacement will occur on the same day each week (8th and 15th days of the cycle). On the 22nd day of the cycle, the TTS is removed, and from the 22nd to the 28th day of the cycle the woman does not use the TTC of Evra. The next day is considered the first day of a new contraceptive cycle. If a woman starts using the TTC of Eur on the first day of the cycle, then the barrier methods of contraception should be used simultaneously during the first 7 days of the first contraceptive cycle.

If a woman goes from using a combined oral contraceptive to using the TTC Evra

TTS Evra should be glued to the skin on the first day of menstruation, which began after the termination of taking a combined oral contraceptive. If menstruation does not begin within 5 days after taking the contraceptive pill, then you must exclude pregnancy before starting the use of the Eurasian TTC.

If the application of Evra begins after the first day of menstruation, then within 7 days it is necessary to use barrier methods of contraception at the same time.

If, after taking the last contraceptive pill, more than 7 days have passed, the woman may have ovulation, and therefore she should consult a doctor before starting to use the TTC of Eur. Sexual intercourse during this extended period, free from taking contraceptive pills, can lead to the onset of pregnancy.

If a woman passes from the use of drugs containing only progestogen, to use the TTC Evra

A woman can switch from using a progestogen only (on the day of removal of the implant, on the day the next injection is to be made), but within the first 7 days of using the TTS, a barrier method should be used to enhance the contraceptive effect.

After an abortion or miscarriage

After abortion or miscarriage before the 20th week of pregnancy, you can immediately begin using the TTC Evra. If a woman begins to use the TTS Evra immediately after an abortion or a miscarriage, then additional methods of contraception are not required. A woman should know that ovulation can occur within 10 days after an abortion or a miscarriage.After an abortion or miscarriage at the 20th week of pregnancy or later, the use of the TTS Eur can begin on the 21st day after the abortion or miscarriage, or on the 1st day of the first menstrual period.

After childbirth

Women who are not breastfeeding should begin using the TTS of Eur not earlier than 4 weeks after giving birth. If a woman starts to use the TTS of Eur later, then within the first 7 days she must additionally use the barrier method of contraception. If there was sexual intercourse, it is necessary to exclude pregnancy before starting the application of TTC Eur, or a woman should wait for the first menstruation.

When full or partial tapping of the TTC Evra

If the TTC Evra has completely or partially peeled off, then an insufficient amount of its active ingredients is supplied to the blood.

Even with a partial peeling off of the TTS Eur in less than a day (up to 24 hours): re-paste the TTC Eur on the same place or immediately replace it with a new TTC Eur. No additional contraceptives are required. The next TTC Eur should be glued to the usual "replacement day".

At partial peeling more than a day (24 hours and longer), and also if a woman does not know exactly when the TTC Evra partially or completely peeled off - pregnancy may occur.A woman should immediately begin a new cycle, pasting a new TTC of Eur and consider this day as the first day of the contraceptive cycle. Barrier methods of contraception should be applied simultaneously only in the first 7 days of a new cycle.

Do not try to re-glue the TTC of Eur, if it has lost its adhesive properties; Instead, it is necessary to immediately glue a new TTS Evra. Do not use additional adhesive tapes or bandages to hold in place the TTC Eur.

If you missed the regular days of replacing the TTC Evra

At the beginning of any contraceptive cycle (week 1 / day 1): at an increased risk of pregnancy, a woman should glue the first TTS of the new cycle of Eur as soon as she remembers it. This day is considered a new "1st day" and a new "day of replacement" is counted. Non-hormonal contraception should be applied simultaneously during the first 7 days of a new cycle. In the case of sexual intercourse during such an elongated period without the use of the TTS of Eur, conception may occur.

In the middle of the cycle (2nd week / 8th day or 3rd week / 15th day):

• if one or two days (up to 48 hours) have passed since the day of replacement: a woman should immediately glue a new TTS.The next TTC should be glued to the usual "replacement day". If the TTS application was correct within 7 days preceding the first missed TTS attachment day, additional contraception is not required;
• if more than 2 days (48 hours or more) have passed since the day of replacement: there is an increased risk of pregnancy. The woman should stop the current contraceptive cycle and immediately begin a new 4-week cycle, pasting the new TTC of Eur. This day is considered a new "1st day" and a new "day of replacement" is counted. Barrier contraception should be applied simultaneously during the first 7 days of the new cycle;
• at the end of the cycle (week 4 / day 22): if the TTC is not deleted at the beginning of the 4th week (22nd day), then it should be removed as soon as possible. The next contraceptive cycle should begin on the usual "replacement day", which is the next day after the 28th day. Additional contraception is not required.

Change day of replacement

In order to postpone menstruation for one cycle, a woman should glue a new TTS of Eur at the beginning of the 4th week (22nd day), thus missing a period free from the use of the TTC of Eur. Intermenstrual bleeding or spotting may occur.After 6 consecutive weeks of TTS use, there should be a 7-day interval free from the use of TTS. After the end of this interval, regular use of the drug is resumed.

If, at the appointed day for a week, free from the application, the woman wants to change the day of replacement, she must complete the current cycle by removing the third TTC of Eur; a woman can choose a new day of replacement, pasting the first TTC of the Eur of the next cycle on the selected day. A period free from the use of the TTC of Eur, in no case shall be more than 7 days. The shorter this period, the higher the probability that a woman will not have another menstrual period, and during the next contraceptive cycle, intermenstrual bleeding or spotting may occur.

Mode of application

TTS Evra should be applied to clean, dry, intact and healthy skin of the buttocks, abdomen, outer surface of the upper part of the shoulder or the upper part of the trunk with minimal hair, in areas where it will not come into contact with tight clothing.

In order to avoid possible irritation, every next TTS of the Eur should be glued to another area of ​​the skin, this can be done within the same anatomical area.

TTS Eur should be pressed tightly, so that its edges are in good contact with the skin. To prevent the decrease in the adhesive properties of the TTC Eur, makeup, creams, lotions, powders and other local remedies can not be applied to those areas of the skin where it is glued or glued.

A woman should examine the TTC of Eur every day in order to be sure of her strong attachment.

Used TTS should be disposed of carefully in accordance with the instructions.

Side effect

• dizziness;
• migraine;
• paresthesia, hypoesthesia;
• convulsions;
• tremor;
• depression, anxiety;
• insomnia, drowsiness;
• increased blood pressure, palpitations;
• edematous syndrome, varicose veins;
• gingivitis;
• anorexia or increased appetite;
• gastritis, gastroenteritis;
• dyspepsia, abdominal pain;
• vomiting;
• diarrhea, flatulence, constipation;
• pain during intercourse (dyspareunia);
• vaginitis;
• dysmenorrhea;
• decreased libido;
• increased mammary glands;
• disorders of the menstrual cycle (including intermenstrual bleeding, hypermenorrhea);
• lactation, which does not occur in connection with childbirth;
• ovarian failure;
• ovarian cysts;
• muscle cramps;
• Myalgia, arthralgia, Ostalgia (incl.pain in the back, pain in the lower limbs);
• muscle weakness;
• skin itching, urticaria, skin rash, contact dermatitis;
• eczema;
• dry skin;
• conjunctivitis, disorders;
• influenza-like syndrome;
• feeling tired;
• chest pain.

Contraindications

• venous thrombosis incl. in the anamnesis (including a deep vein thrombosis, pulmonary thromboembolism);
• arterial thrombosis, incl. a history (including cerebrovascular accident, myocardial infarction, thrombosis of retinal artery) or precursors thrombosis (including angina, or transient ischemic attack);
• the presence of severe or multiple risk factor of arterial thrombosis: severe hypertension (over 160/100 mmHg), diabetes with vascular lesion;
• hereditary dyslipoproteinemia;
• a genetic predisposition to venous or arterial thrombosis (e.g. activated protein C resistance, antithrombin 3 deficiency, protein C deficiency, protein deficit S, 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;
• adenoma and carcinoma of the liver;
• genital bleeding;
• postmenopausal period;
• age to 18 years;
• postpartum period (4 weeks);
• lactation period;
• hypersensitivity to the components of the drug.

The use of mammary glands on the area, as well as on hyperemic, irritated or damaged skin areas is unacceptable.

Application in pregnancy and lactation

The drug Evra is contraindicated in pregnancy and lactation.

In case of pregnancy, the drug should be immediately canceled. Negative effects on the fetus during the study of pregnant women taking the contraceptive were not noted.

special instructions

There is no clinical evidence that the transdermal contraceptive system is safer in any aspect than oral contraceptives.

Before starting or resuming the use of the TTS, you need to collect a detailed medical history (including a family history) and exclude pregnancy. It is necessary to measure BP and conduct a physical examination 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 referred for advice to a specialist before deciding whether to use hormonal contraception.

The risk of vascular complications is increased in women with thrombophlebitis of superficial veins and with varicose veins, and also with obesity (body mass index more than 30 kg / m2).

With prolonged immobilization, after extensive operation on the lower extremities or severe trauma, it is recommended to stop the use of hormonal contraceptives (in the case of a planned operation, it should be done 4 weeks before) and resume hormonal contraception no earlier than 2 weeks later. after complete remobilization.

Some epidemiological studies have revealed an increased risk of cervical cancer in women who have long been using combined oral contraceptives.

If there is pharmacologically uncontrolled hypertension in women during the use of combined hormonal contraceptives, the drug should be discarded.The use of TTS Eur can be resumed after normalization of blood pressure.

Combined hormonal contraceptives can affect the resistance of peripheral tissues to insulin and glucose tolerance, but there is no evidence of a need to change the regimen of diabetes therapy during the use of combined hormonal contraceptives. At the same time, the condition of patients suffering from diabetes mellitus should be closely monitored, especially at an early stage of the use of the Eurasian TTC.

An exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis in women taking combined oral contraceptives has been reported.

Women who have experienced hyperpigmentation of the facial skin during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while wearing the TTC Eur. 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.

When using any combination hormonal contraceptives, the menstrual cycle may be disturbed (smearingor intermenstrual bleeding), especially in the first months of use of these funds. The duration of the adaptation period is about three cycles.

In some women, menstruation may not occur during a period free from the use of the TTS. If a woman violated the instructions for use in the period preceding the first failed menstruation, or if she did not have two menstruation after interruptions in the use of TTS, then pregnancy should be excluded before continuing to use the TTC Eura.

In some women, the abolition of hormonal contraceptives can trigger the onset of amenorrhea or oligomenorrhoea, especially if they are present before hormonal contraception begins.

In women with a body weight of 90 kg or more, the effectiveness of contraception can be reduced.

The safety and efficacy of the TTC Evra are established only for women between 18 and 45 years of age.

Overdose

When an overdose occurs: nausea, vomiting, vaginal bleeding.

Treatment: there is no specific antidote. It is necessary to remove TTS and conduct symptomatic therapy.

Drug Interactions

Hydantoins, barbiturates, primidon, 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 be the cause of intermenstrual bleeding or ineffectiveness of hormonal contraception, that is, the onset of an unwanted pregnancy. The mechanism of interaction of these drugs and active ingredients of TTS Evra is based on the ability of the above drugs to induce hepatic enzymes, with the participation of which sex hormones are metabolized. The maximum induction of enzymes is usually achieved no earlier than in 2-3 weeks, and can persist for at least 4 weeks after the withdrawal of the drug.

The intake of herbal preparations containing Hypericum perforatum (Hypericum perforatum) concurrently with the use of the TTS of Eur can lead to a loss of contraceptive effect. Women taking such herbal remedies may experience intermenstrual bleeding and an unwanted pregnancy. This is due to the fact that St. John's wort is inducing enzymes that metabolize sex hormones. The induction effect can persist for 2 weeks. after the cancellation of a herbal preparation containing St. John's Wort.

Loss of contraceptive effect can cause antibiotics, (including ampicillin and tetracyclines). A study of pharmacokinetic interaction showed that oral administration of Tetracycline hydrochloride 3 days before and for 7 days during the use of TTS Eur, did not have a significant effect on the pharmacokinetics of noregstromine or ethinylestradiol.

Analogues of contraceptive plaster Evra

Structural analogs for the active substance, the patch of Evra does not.

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