It halotestin inhibits gonadotropic pituitary function, inhibits follicular development and prevent ovulation process. The contraceptive effect is also enhanced by increasing the viscosity of halotestin cervical secretions and reduce the susceptibility of the endometrium to the blastocyst. Pearl (0.90) The index reflects the frequency of pregnancy in 100 women over 12 months of application of the chosen method of contraception.
Pregnancy rate does not depend on age, race, but increases in women weighing over 90 kg.
Halotestin concentrations norelgestromina and ethinyl estradiol in the blood plasma reaches steady-state values 48 hours after application of the transdermal patch Evra ® and up 0.8 ng / ml and 50 pg / ml, respectively. With long-term use of the transdermal patch Evra ® equilibrium concentration (C ss ) and area under the curve “concentration-time» (AUC) increase somewhat. At different temperatures and physical exertion are no significant changes in C ss and AUC norelgestromina and AUC of ethinyl estradiol increased somewhat during exercise, whereas the C ss remains unchanged. Targets are the C ss norelgestromina and ethinyl estradiol are maintained for 10 days of application of the patch transdermal Evra ® , those. Clinical efficacy of transdermal patch can be maintained even if a woman will hold its regular replacement of 2 full days after the scheduled seven-day period. The distribution Norelgestromin and norgestrel (serum metabolite norelgestromina) have a high (> 97%) of plasma protein binding. Norelgestromin binds to albumin, norgestrel binds preferentially to globulins, sex hormone binding. Ethinylestradiol has a high degree of binding to plasma albumin. Biotransformation Norelgestromin metabolized in the liver to form metabolite norgestrel, and various hydroxylated and conjugated metabolites. Ethinyl estradiol is metabolized to various hydroxylated compounds and their glucuronide and sulfate conjugates. Progestogens and estrogens inhibit many enzymes of the cytochrome P-450 (including CYP 3A4, CYP 2C19) in human liver microsomes. Elimination average half-life norelgestromina and ethinyl estradiol is about 28, and 17 hr, respectively. Metabolites norelgestromina and ethinyl estradiol are eliminated by the kidneys and the bowel. The influence of age, body weight and body surface area values of the C ss and AUC of ethinyl estradiol and norelgestromina slightly decreased with increasing age, body weight or body surface area.
Contraception for women.
Evra transdermal patch ® is contraindicated in women with the following conditions:
- thrombosis (arterial and venous) and thromboembolism currently or history (including thrombosis, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disease);
- state prior thrombosis (including transient ischemic attack, angina) currently or history;
- hereditary predisposition for venous or arterial thrombosis, including Activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein deficit S, hyperhomocysteinemia, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant), etc .;
- multiple or severe venous or arterial thrombosis risk factors, including complicated lesions valvular, subacute bacterial endocarditis, atrial fibrillation, cerebrovascular disease, or coronary artery disease, uncontrolled hypertension, smoking at the age of 35 years, hereditary dislipoproteinemia, three-dimensional surgical interference with prolonged immobilisation, obesity (body mass index over 30 kg / m 2 , calculated as the ratio of weight in kilograms to the square of the height in meters);
- diabetes with vascular disease;
- migraine with focal neurological symptoms;
- confirmed or suspected breast cancer;
- diagnosed (including history) estrogen-dependent cancers (such as cancer of the endometrium) or are suspected;
- vaginal bleeding of unknown etiology;
- cholestatic jaundice during pregnancy or jaundice while using hormonal contraceptives before;
- acute or chronic liver disease with impaired liver function;
- benign or malignant liver tumors;
- postpartum period (4 weeks);
- known or suspected pregnancy;
- Hypersensitivity to the drug;
- age 18 years.
– venous or arterial thromboembolism in siblings or parents at a relatively young age,
– thrombophlebitis of superficial veins and varicose veins;
– controlled hypertension;
– severe migraine without focal neurological symptoms;
– diabetes without vascular complications;
– existing (or history), severe depression;
– existing (or history) gallstone disease;
– chronic idiopathic jaundice;
– cholestatic jaundice, a family history (eg syndromes rotor, Dubin-Johnson);
– acute impairment of liver function during the previous pregnancy or previous the use of sex hormones,
– systemic lupus erythematosus;
– ulcerative colitis
– Crohn’s disease;
– hemolytic uremic syndrome
– Sydenham’s chorea;
– herpes during pregnancy;
– multiple sclerosis;
– uterine fibroids and endometriosis;
– the presence of relatives of the first line of kinship with breast cancer.
Use during pregnancy and lactation.
Evra transdermal patch ® is contraindicated during pregnancy and lactation.
Dosing and Administration
cutaneous To achieve maximum contraceptive effect women have used the patch transdermal Evra ® in strict accordance with the instructions. The instructions concerning the beginning of the patch transdermal Evra ® , shown below in the section “How to start the use of the patch transdermal Evra ® “. At the same time, you can only use one patch transdermal Evra ® . Each used patch transdermal Evra ® is removed and immediately replaced with a new one the same day of the week ( “day replacement”) on the 8th and the 15th days of the cycle of the drug (2nd and 3rd week ). Evra transdermal patch® can be changed at any time to replace the day. During the 4th week, from 22 th to 28 th day of the cycle, a transdermal patch Evra ® is not used. A new contraceptive cycle begins on the next day after the end of the 4th week; next transdermal patch Evra ® should be pasted, even if the bleeding menstrualnopodobnoe “cancellation” has not been or is not over. Under no circumstances should a break in wearing the transdermal patch Evra ® should not be more than 7 days, otherwise it increases the risk of pregnancy. In such situations, for 7 days at the same time you need to use a barrier method of contraception, since the risk of ovulation increases with each day of exceeding the recommended length of time, free from the use of a transdermal patch Evra ® . In the case of sexual intercourse during this period increased the probability of conception is very high.
patch transdermal Evra ® should stick to a clean, dry, intact and healthy skin of the buttocks, abdomen, outer surface of the upper arm or upper body with minimal body hair, in areas where it will not come into contact with a tight-fitting clothing.
In order to avoid possible irritation every next transdermal patch Evra ® is necessary to stick to a different area of the skin, it can be done within the same anatomical region. Unacceptable use transdermal patch on the breast.
The patch transdermal Evra ® should be tightly pressed to the edges of good contact with the skin. To avoid reducing the adhesive properties of the patch transdermal Evra ® should not be applied make-up, creams, lotions, powders and other local resources to those areas of the skin where it is glued or be bonded.
A woman should daily inspect patch transdermal Evra ® in order to be confident in his firmly secured.
The used transdermal patch must be carefully disposed of in accordance with the recommendations.
Since the used transdermal patch contains significant amounts of active ingredients, it must be disposed of carefully. For this special adhesive film is separated from the outside of the bag. Place the used transdermal patch in the sachet so that its adhesive side facing the painted area on the bag, and lightly pressed for sealing. Sealed packet is discarded. The used transdermal patch should not be thrown in the toilet or down the drain.
How to start the use of the transdermal patch Evra ® If during the previous menstrual cycle has not applied the hormonal contraceptive Contraception using the transdermal patch Evra ® begin on the first day of menstruation. Glued to the skin of a transdermal patch Evra ® and use it throughout the week (7 days). Day of bonding the first transdermal patch Evra ® (1 day / day of the beginning) specifies the following days replacement. Replacing Day will fall on the same day each week (8 th and 15 th days of the cycle). On the 22 th day of transdermal patch cycle is removed, and from 22 th to 28 th day of the cycle woman is not using the transdermal patch Evra ® . The next day is the first day of a new contraceptive cycle. If a woman begins to use a transdermal patch Evra ® is not the first day of menstruation, it is necessary to simultaneously use a barrier method of contraception during the first 7 days of the first contraceptive cycle.
If a woman goes to a combined oral contraceptive drug on the use of transdermal patch Evra ®
patch transdermal Evra ® should stick to the skin on the first day of bleeding menstrualnopodobnoe “cancel”, which began after the discontinuation of the combined oral contraceptive. Menstrualnopodobnoe If bleeding does not start within 5 days after receiving the contraceptive pill, it is necessary to exclude pregnancy before starting the use of the transdermal patch Evra ® . If the application of Evra ® starts after the first day of bleeding menstrualnopodobnoe, within 7 days you must simultaneously use barrier methods of contraception. If, after taking the last contraceptive pill has been more than 7 days, then the woman may have ovulated and therefore she should consult a doctor before starting to apply the patch Evra transdermal ® . Sexual intercourse during this prolonged period, receiving free contraceptive tablets may lead to pregnancy.
If a woman goes to the contraceptive pills containing progestogen only, the use of the patch transdermal Evra ®
She can any day to move from the use of a preparation containing only a progestogen (the day of implant removal, on the day when the next injection should be done), but for the first 7 days of treatment with transdermal patch Evra ® should use a barrier method for enhancing effectiveness.
After an abortion or miscarriage
After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin applying transdermal patch Evra ® . If a woman begins to apply the patch Evra transdermal ® immediately after an abortion or miscarriage, to resort to an additional method of contraception is not required. A woman should know that ovulation may occur within 10 days after an abortion or miscarriage.
After an abortion or miscarriage in the 20th week of pregnancy or later, use the patch transdermal Evra ® can begin on the 21st day after an abortion or miscarriage or on the first day the first ensuing menstruation (whichever comes first).
women are not breastfeeding her baby can start applying the patch Evra transdermal ® no earlier than 4 weeks after giving birth. If a woman begins to apply the patch Evra transdermal ® later, during the first 7 days it must additionally use a barrier method of contraception. If there was a sexual contact, it is necessary to exclude pregnancy before starting the use of the transdermal patch Evra ® , or the woman has to wait for the first menstrual period.
At full or partial peeling off transdermal patch Evra ®
If transdermal patch Evra ® is fully or partially come off, then the blood flows insufficient number of its active ingredients.
Even with partial peeling off transdermal patch Evra ®
- less than during the day (up to 24 hours) should be re-glue patch transdermal Evra ® in the same place or immediately replace it with a new transdermal patch Evra ® . Additional contraception is not required. Next transdermal patch Evra ® is necessary to stick to a regular “day of replacement.”
- more than during the day (24 hours or more), and if the woman does not know exactly when the patch Evra transdermal ® partially or completely come off: possible pregnancy. The woman should immediately start a new cycle, a new patch transdermal gluing Evra ® and consider this day the first day of contraceptive cycle. Barrier methods of contraception should be used at the same time only during the first 7 days of the new cycle.
Do not attempt to re-glue patch transdermal Evra ® , if it has lost its adhesive properties; instead, you must immediately stick the new patch transdermal Evra ® . You can not apply additional adhesive tape or bandage to keep the transdermal patch in place Evra ® .
If you skipped the next day replacement transdermal patch Evra ®
At the beginning of any contraceptive cycle (Week 1 / Day 1):
If the increased risk of pregnancy a woman should first stick the patch Evra transdermal ® a new cycle immediately as soon as you remember about it. This day is considered the new “1st day” and counted the new “day of replacement.” Barrier methods of contraception should be used concurrently for the first 7 days of the new cycle. In the case of sexual intercourse during the extended period of time without the use of contraception can occur conception. In the middle of the cycle (Week 2 / Day 8 or Week 3/15-Day):
- from the date of replacement have been one or two days (48 hours): the woman should immediately stick the new patch transdermal Evra ® . Next transdermal patch Evra ® is necessary to stick to a regular “day of replacement.” If during the 7 days preceding the first skipped day of transdermal patch attachment Evra ® , a woman properly applied transdermal patch Evra ® , no additional contraceptive protection is needed;
- It has passed since the replacement of more than two days (48 hours or more): there is an increased risk of pregnancy. Women should stop the current contraceptive cycle and immediately start a new 4-week cycle, pasted a new patch transdermal Evra ® . This day is considered the new “1st day” and counted the new “day of replacement.” Barrier contraception must be used simultaneously for the first 7 days of the new cycle;
- at the end of the cycle (Week 4 / Day 22): If the transdermal patch Evra ® is not removed at the beginning of the 4th week (22-day), then it should be removed as soon as possible. Another contraceptive cycle must begin at the normal “day replacement,” which is the next day after the 28th day. Additional contraception is not required.
Changing the date of replacement
if a woman finds it necessary to replace the transfer date, the current cycle should be completed. Removing third transdermal patch Evra ® should be made in an ordinary day replacement. During the week, free applications, a woman may choose a new day replacement, gluing the first transdermal patch Evra ® the next cycle on the chosen day. Period, free from the use of a transdermal patch Evra ® , in any case should not exceed 7 days. The shorter the period, the greater the likelihood that a woman will not be another menstrualnopodobnoe bleeding, and during the next cycle contraceptive may occur acyclic abundant or scanty bleeding.