The contraceptive Yasmin is a modern medicinal product, designed to prevent pregnancy and normalize the menstrual cycle in women aged 18 to 40 years. The drug is recommended to be taken cyclically, since already from the first dose significant changes begin to occur in the cervix.
Yasmin birth control pills contain 2 active substances: ethinyl estradiol and drospirenone, which act on the egg and slow down the ovulation process. Tablets weighing 3 mg are covered with a white shell. One blister is enough for 3 weeks.
A hormonal agent of directed action instantly affects the microflora of the cervix. Due to the reaction of the uterine mucus and the main components of the drug, the work of the glands that produce the cervical secret slows down. The cervix, deprived of the necessary amount of nutrients and mucus, becomes difficult for the movement of spermatozoa. The effect of the drug is 87% effective, contraception has a positive effect on the hormonal background of a woman. The drospirenone included in the composition is useful for patients suffering from hormonal imbalance, up to the neuropsychic form.
Yasmin contraceptive is prescribed in several cases:
Hormonal contraception is also effective for excessive breast engorgement.
Yasmin contraceptive instructions for use: the medication is taken once a day, 1 tablet strictly at the same time. If you miss or violate the dose of the drug, negative consequences for the body are possible. After 21 days, you need to take a 7-day break, after which repeat the standard dosage. During the break, blood discharge begins - a normal reaction of the body. Contraception restores a regular menstrual cycle.
Taking pills may be contraindicated if the patient has the following diseases:
The first days after taking the contraceptive, bleeding opens - pseudomenstruation. When taking the drug Yasmin, the cycle lasts normally, without complications and abdominal pain. Often this medication is taken to control the menstrual cycle, in particular, to reduce pain. You should not stop taking the drug after the onset of bleeding in order to avoid serious complications in the uterus. Among the negative side effects are the following:
Yasmin contraceptive pills are a monophasic type of contraceptive, so you should consult a gynecologist before use. Irregular bleeding in the first weeks of use is normal and will stabilize over time.
Birth control pills NovinetA modern drug designed to prevent pregnancy and normalize the menstrual cycle in women aged 18 to 40 years. The drug is recommended to be taken cyclically, since already from the first dose significant changes begin to occur in the cervix.
A hormonal agent of directed action instantly affects the microflora of the cervix. Due to the reaction of the uterine mucus and the main components of the drug, the work of the glands that produce the cervical secret slows down. The cervix, deprived of the necessary amount of nutrients and mucus, becomes difficult for the movement of spermatozoa. The effect of the drug is 87% effective, contraception has a positive effect on the hormonal background of a woman. The drospirenone included in the composition is useful for patients suffering from hormonal imbalance, up to the neuropsychic form.
Yasmin contraceptive is prescribed in several cases: prevention of unwanted pregnancy; failure in the menstrual cycle; acne; puffiness.
Hormonal contraception is also effective for excessive breast engorgement.
Yasmin tablets are taken once a day, 1 tablet strictly at the same time. If you miss or violate the dose of the drug, negative consequences for the body are possible. After 21 days, you need to take a 7-day break, after which repeat the standard dosage. During the break, blood discharge begins - a normal reaction of the body. Contraception restores a regular menstrual cycle.
The first days after taking the contraceptive Yasmin, bleeding opens - pseudomenstruation. When taking the drug Yasmin, the cycle lasts normally, without complications and abdominal pain. Often this medication is taken to control the menstrual cycle, in particular, to reduce pain. You should not stop taking the drug after the onset of bleeding in order to avoid serious complications in the uterus. Among the negative side effects are the following: dizziness; nausea; vomit; stomach ache; shortness of breath; a strong expectorant cough with the presence of blood (it is recommended to immediately call an ambulance); insomnia; allergic reactions.
Taking Yasmin tablets may be contraindicated if the patient has the following diseases: allergy to the components of the drug; breast cancer; diabetes; renal and liver failure; pregnancy; ischemia of the heart; high blood pressure.
Yasmin - tablet - 3 mg coated with a white shell. One blister is enough for 3 weeks.
Yasmin birth control pills contain 2 active substances: ethinyl estradiol and drospirenone, which act on the egg and slow down the ovulation process.
Yasmin contraceptive pills are a monophasic type of contraceptive, so you should consult a gynecologist before use. Irregular bleeding in the first weeks of use is normal and will stabilize over time.
The description on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult your doctor and read the annotation approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the dose and methods of its use.
03.04.2004, 04:26
I found very few reviews about them on other sites. Here they are, and I quote in part:
1. I have been taking contraceptives for 3 years, first Orthocyclen, then Mercilon, and then Yasmin (by the way, Italy produces it, at least the Israeli version). Never had any side effects. But the difference, of course, is felt. Yasmin is beyond competition. No pain, no PMS, the "red days of the calendar" have become shorter and there is less discharge. (sorry for the details). And most importantly - Yasmin does not contain progesterone, which is exactly the factor that increases the risk of blood clots.
Diana tablets (and some others, I don’t know the names) are reliably known that they can lead to the formation of nodules in the chest, this has been scientifically proven.
Of course, before taking the pills, you need to do blood tests, and then at least once a year.
2. Tell me, does anyone take the new "Yasmin" tablets? They seem to have appeared on sale a year ago, but here in Italy - only two months. I heard a lot of positive things about them: it loses weight, and water does not linger, and there is practically no PMS ... Today I visited my gynecologist and asked about them. The doctor told me that in addition to all of the above, they also reduce the feeling of hunger and there are even fewer hormones in them. Everything is fine with the tests, so I was discharged. As I start a new package - I'll tell you about the "miracle"!
And another question - where can I buy them in Moscow and how much do they cost?
03.04.2004, 18:05
You found few reviews because in Russia they go under the name Janine, but they are the same. I took - no side effects, very satisfied.
wild Orchid
03.04.2004, 19:45
Are they even better (if you can compare) Logest? Are there less hormones? I took Logest, and now after the spiral they advised me again Logest or Janine, so I don’t know which ones to choose ...
03.04.2004, 20:15
If this is Jeanine, as they wrote above, then I can say that the pills are super! I lost so much weight on them after giving birth that now I weigh like I was 16 :-), I can’t even believe it. however, the instructions say that you should not smoke while taking the pills, because the risk of blood clots increases. So it still exists.
03.04.2004, 21:29
If we are talking about Janine, then I will subscribe :) I have been 100% satisfied for a year. Not a single complaint and side effect :)
03.04.2004, 22:57
Are you absolutely sure of this? It's just that I found an article about Yasmin two years ago about the fact that this is a new OK and its advantage is that they do not get fat from it. Here is the link http://www.medinfo.ru/news/worldnews/world-19-04-2002-4.php3 Jeanine is new OK? And in English, the name of Jeanine is JEANINE (found on the site).
03.04.2004, 23:13
Do they sell it in Moscow by prescription or freely?
04.04.2004, 00:53
and for this month, what are the feelings about side effects, fullness, etc.?
I just found here info about what in Russian Yasmin is called Yarina (???) http://www.doctor-sex.ru/enciklop/ginekolog/kontracepc.html
In Russian pharmacies, neither Russian nor English name did not find. :-(
04.04.2004, 07:51
about fullness, because I have gained weight for a long time, but it seems that it has not increased :-). Side effects, too, I can’t say for sure, because. I had been ill with colds for a whole month and felt terrible, but I can’t say from what. Yes, plus I have a lot of other medicines. My gynecologist was very complimentary. I can't really say anything right now. Ask in a couple of months :-).
04.04.2004, 10:53
Free.
04.04.2004, 16:22
I've never taken pills, I'm a little afraid to tell
04.04.2004, 16:36
Are you in the states? Did the doctor tell you anything about a break when taking OK? I read in one source that it is necessary in tech. take a two-month break for a year, in another that take a year and then take a break, all Russian gynecologists unanimously say that breaks are needed. My doctor says no breaks are needed. And I took it for 5 months, maybe I’ll take a break of 2 months, and in Russia I’ll already try the much-praised Zhanin. Here in thought...
04.04.2004, 16:48
Nothing good for me personally. I take it because I suspect endometriosis, otherwise I would not do it. True, I tried only one pill, but there were enough side effects, one of which - I started to gain weight. :-(I haven’t heard anything bad about Janine yet, maybe I’ll switch to them. My American doctor says that I need to try different ones to find those that suit me. But I need to try every OK for 3 or more months, because all these side effects after 3 Months allegedly go away.So you can look for suitable OK for years.There are sites that describe the positive effects of OK, for example http://www.doctor-sex.ru/enciklop/ginekolog/kontracepc.But after reading the annotation to any OK, you can see that the side effects The effects from them are dozens of times more positive.So without the need, I would no-no.All IMHO.
Drospirenone; Ethinyl Estradiol
Provided in section Therapeutic indications Yasmin 21 Yasmin 21 Therapeutic indications in the instructions for the medicine Yasmin 21
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Coated tablets
contraception;
contraception and treatment of moderate acne (acne vulgaris);
contraception and treatment of severe premenstrual syndrome (PMS).
Contraception (prevention of unwanted pregnancy).
Provided in section Dosage and administration Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Dosage and administration in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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Film-coated tablets; Tablets
Coated tablets
How to take Jess ®
Reception mode "24+4"
inside. The tablets should be taken in the order indicated by the arrows on the package, at about the same time every day, with a little water. Tablets are taken without interruption in admission. One tablet per day should be taken consecutively for 28 days. Taking tablets from each subsequent package should be started the next day after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after the start of the white inactive tablets and may not end before the start of the next pack of tablets. Pills from a new pack should always be started on the same day of the week, and withdrawal bleeding will occur on about the same days each month.
Flexible reception mode
A flexible regimen for taking the drug Jess ® can only be used if there is a Click dispenser (click) and flex cartridges. Take one tablet at the same time every day with a small amount of liquid.
The tablets should be taken continuously for at least 24 days. Between the 25th and 120th day of using the drug Jess ®, at the discretion of the patient, a 4-day break in taking the tablets can be made. The break in taking the tablets should not exceed 4 days. A 4-day break in taking the tablets must be taken no later than 120 days of continuous taking the tablets. After each 4-day break in taking the tablets, a new cycle begins with a minimum duration of 24 days and a maximum duration of 120 days. As a rule, withdrawal bleeding develops during the 4-day break in taking the pills, but may not end until the next pill is due. If spotting/bleeding from the vagina appears for 3 consecutive days between the 25th and 120th day, it is recommended to take a 4-day break from taking the tablets. This will reduce the total number of bleeding days.
Brief instruction manual dispenser Click (Clyk)
Read carefully before and during operation detailed instructions for the operation of the dispenser.
general description dispenser Click (click)(see fig. 1).
Picture 1.
Side keys. The area to press to receive the pill.
Flex cartridge eject button. Pressing this button ejects the flex cartridge.
Pill dispensing area. The part of the dispenser where the dispensed tablets appear.
Pill time indicator. Shows the time of taking the pill.
Display. Displays the main screen and menu items.
OK button. Pressing the button confirms an action, such as starting a 4-day pill break and changing the reminder tone.
Most important features
Activating a new dispenser: The flex cartridge (containing 30 tablets) should be removed from the packaging and immediately inserted into the dispenser. Insert the narrow end of the flex-cartridge into the dispenser so that the dispenser window (as well as the tablets in the flex-cartridge) is clearly visible (see Fig. 2). The flex cartridge must be fully inserted.
Figure 2. Preparing to use the Click dispenser (Clyk).
The dispenser will automatically record the time the first pill was dispensed, setting that time as the time of taking. Thus, a woman must be sure that:
That she unpacks and inserts the flex cartridge on the day she plans to start taking her pills;
That the time of issuing the first tablet will be convenient for daily tablet intake. Every 24 hours, a signal will appear on the dispenser display about the time to take the next tablet.
Pill extraction
With one hand, simultaneously press both side keys to remove the tablet, which will be received by the other hand.
Replacing the Flex Cartridge
In normal use, the flex cartridge can only be removed if it is empty, in other cases, follow the detailed operating instructions for the Click dispenser. (Clyk).. An empty flex cartridge is ejected by pressing the flex cartridge eject button. The dispenser saves all information about the current cycle, and a new filled flex cartridge should be inserted according to the instructions above. Before starting and during use, you should carefully read the detailed operating instructions for the Click dispenser. (Clyk). enclosed in the package with the drug.
How to start taking the drug Jess ®
In the absence of taking any hormonal contraceptive drugs in the previous month. Jess ® should be started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding), in which case additional contraceptive measures are not required. It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package. The tablets should then be taken in the order indicated for the 24+4 or flexible regimen.
When switching from other combined contraceptive preparations (COC, vaginal ring or transdermal patch). It is preferable to start taking Jess ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Taking the drug Jess ® should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is pasted.
When switching from contraceptive preparations containing only gestagens (mini-pili, injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive. A woman can switch from a mini-pill to Jess ® any day (without a break); from an implant or intrauterine contraceptive with a progestogen - on the day of its removal; with an injectable contraceptive - on the day when the next injection should be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, the woman does not need additional contraceptive measures.
After an abortion in the second trimester of pregnancy or childbirth. The drug can be started on the 21-28th day after a spontaneous or medical abortion or after childbirth, in the absence of breastfeeding. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual intercourse has already taken place, pregnancy should be excluded before taking the drug Jess ® or it is necessary to wait for the first menstruation.
Stopping the drug Jess ®. You can stop taking the drug at any time. If a woman is not planning a pregnancy or pregnancy is contraindicated because she is taking medications that are potentially harmful to the fetus, other methods of contraception should be discussed with her doctor. If a woman is planning a pregnancy, it is recommended to stop taking the drug and wait for natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the gestational age and time of birth.
Instructions for handling the packaging of the drug Jess ® for the "24 + 4" intake regimen
A blister is glued into the Jess ® package, which contains 24 active hormone-containing light pink tablets and 4 inactive white, hormone-free tablets (last row). The package also contains a self-adhesive appointment calendar, consisting of 7 self-adhesive strips with the names of the days of the week marked on them. You need to select the strip where the first day of the week is indicated on which you plan to start taking the pills. For example, if a woman starts taking the pills on Wednesday, you should use a strip that starts with "Wed." (See Fig. 3).
Figure 3
The strip is glued along the top of the package so that the designation of the first day is above the tablet to which the arrow with the inscription "Start" is directed (Fig. 4).
Figure 4
This way it will be clear on which day of the week each tablet should be taken (Fig. 5).
Figure 5
Taking missed pills. Missing inactive white tablets can be ignored. However, they should be discarded so as not to accidentally prolong the period of taking inactive tablets. The following recommendations apply only to skipping active light pink tablets:
If the delay in taking the drug was less than 24 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next pill at the usual time;
If the delay in taking the tablets was more than 24 hours, contraceptive protection may be reduced. The more pills missed, and the closer the missed pills are to the inactive pill phase when using the 24+4 regimen or to the pill-free period on the background of a flexible regimen, the higher the likelihood of pregnancy.
In this case, you can be guided by the following basic rules:
Taking the drug should never be interrupted for more than 7 days (it is necessary to pay attention to the fact that the recommended interval for taking inactive white tablets is 4 days for the "24 + 4" dosing regimen, and for the flexible dosing regimen, the interval WITHOUT taking the tablets should not exceed 4 days);
To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.
Dispenser Click (click) allows you to control pill intake and warns a woman about the need to use an additional method of contraception.
A warning symbol (exclamation mark) appears on the display when you miss a pill or if you take pills irregularly for more than 7 days in a row. This symbol disappears after 7 days of continuous dispensing of tablets by the dispenser. If you miss taking more than one tablet, it is recommended to consult a doctor. In the case of the reception mode "24 + 4", as well as in the flexible mode, if the information from the dispenser Click (click) is not available or there are doubts about its reliability, it is necessary to adhere to following recommendations:
When skipping during the 1st to 7th day of taking the tablets. The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered;
When skipping from the 8th to the 14th day of taking the tablets in the "24 + 4" regimen or when skipping during the 8th to 24th day of taking the tablets in the flexible regimen. The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. Provided that the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, and if you miss two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days, and with a flexible regimen, barrier methods of contraception should be used until the continuous period of taking pills reaches 7 days;
When skipping from the 15th to the 24th day of taking the pills with the "24 + 4" intake regimen or when skipping during the 25th to the 120th day of taking the pills with the flexible regimen. The risk of reduced reliability is inevitable due to the approaching period of inactive white pills in the case of a 24+4 dosing regimen or a pill-free period with a flexible dosing regimen. You must strictly adhere to one of the two following options. In this case, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, the woman must use the first of the following regimens and additionally use a barrier method of contraception (eg, a condom) for 7 days.
1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). For the 24+4 regimen: take the following tablets at the usual time until the active light pink tablets in the package run out. 4 inactive white tablets should be discarded and immediately start taking the tablets from the next package. Withdrawal bleeding is unlikely until the active light pink tablets in the second pack have run out, but spotting and/or breakthrough bleeding may occur while taking the tablets. In the case of a flexible regimen, at least 7 tablets should be taken without interruption in admission. (1 tab. daily).
2. For the 24+4 regimen: the woman can also stop taking active light pink tablets from the current package. Then she should take a break of no more than 4 days, including the days of skipping pills, and then start taking the drug from a new package. If a woman missed taking the active light pink pills and no withdrawal bleeding occurred while taking the inactive white pills, pregnancy should be ruled out. For a flexible dosing regimen, a woman can also take a 4-day pill break, including a day of missing a pill, to induce withdrawal bleeding, and then start a new cycle of taking the drug. If a woman misses a pill and does not experience withdrawal bleeding in the next pill-free period, the possibility of pregnancy should be considered.
Recommendations for gastrointestinal disorders. In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken. If within 3-4 hours after taking the active light pink tablet there was vomiting or diarrhea, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the start of her period to another day of the week, an additional active light pink tablet should be taken.
How to change the timing of withdrawal bleeding or delay the onset of withdrawal bleeding while on the 24+4 regimen. To delay the onset of withdrawal bleeding, the woman should continue taking the tablets from the next package of Jess ®, skipping the inactive white tablets from the current package. Thus, the cycle can be extended as desired for any period until the active light pink tablets from the second package run out, i.e. about 3 weeks later than usual. If you plan to start the next cycle earlier, at any time you need to stop taking the active light pink tablets from the second package, discard the remaining active light pink tablets and start taking the white inactive tablets (maximum within 4 days), and then start taking the tablets from new packaging. In this case, about 2-3 days after taking the last light pink tablet from the previous package, withdrawal bleeding should begin. While taking the drug from the second package, a woman may experience spotting and / or breakthrough uterine bleeding. Regular intake of the drug Jess ® is then resumed after the end of the period of taking inactive white tablets. To reschedule the onset of withdrawal bleeding to another day of the week, the woman should shorten her next inactive white tablet period by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have spotting and/or breakthrough bleeding while taking the pills from the second pack.
Use in special categories of patients
Children and teenagers. The drug Jess ® is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
Elderly patients. Not applicable. The drug Jess ® is not indicated after the onset of menopause.
Patients with impaired liver function. Jess® is contraindicated in women with severe liver disease until liver function tests return to normal (see also "Contraindications" and "Pharmacodynamics").
Patients with impaired renal function. The drug Jess ® is contraindicated in women with severe renal insufficiency or acute renal failure (see also "Contraindications" and "Pharmacodynamics").
inside, in the order indicated on the package, every day at about the same time, with a small amount of water.
Take one tablet per day continuously for 21 days. Taking the tablets from the next package begins after a 7-day break, during which menstrual-like bleeding (withdrawal bleeding) usually develops. As a rule, it begins on the 2-3rd day after taking the last pill and may not end before taking the pills from the new package.
How to start taking Yarina ®
In the absence of taking any hormonal contraceptives in the previous month
Reception Yarina ® begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
When switching from other combined oral contraceptives, vaginal ring or contraceptive patch
It is preferable to start taking Yarina ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing containing 28 tablets per pack). Yarina ® should be started on the day the vaginal ring or patch is removed, but no later than the day a new ring is to be inserted or a new patch is pasted.
When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena)
You can switch from mini-pill to Yarina ® on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After an abortion in the first trimester of pregnancy
You can start taking the drug immediately, on the day of the abortion. If this condition is met, the woman does not need additional contraception.
After childbirth or abortion in the second trimester of pregnancy
You should start taking the drug no earlier than 21-28 days after childbirth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Yarina ®, or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the tablets was more than 12 hours, contraceptive protection is reduced. The more pills missed, and the closer the missed pill is to a 7-day pill break, the greater the chance of pregnancy.
In this case, you can be guided by the following two basic rules:
The drug should never be interrupted for more than 7 days;
To achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation, 7 days of continuous tablet intake are required.
Accordingly, the following advice can be given if the delay in taking the tablets is more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours).
First week of taking the drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the possibility of pregnancy should be taken into account.
Second week of taking the drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Provided that the woman has taken her pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the drug
The risk of pregnancy increases due to the upcoming break in taking the pills. A woman must strictly adhere to one of the two options below. At the same time, if within 7 days preceding the first missed tablet, all tablets were taken correctly, there is no need to use additional contraceptive methods.
1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next pills are taken at the usual time until the pills from the current package run out. Taking the tablets from the next package should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.
2. You can stop taking the pills from the current pack, thus starting a 7-day break (including the day you missed the pills), and then start taking the pills from the new pack.
If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.
In the event of vomiting or diarrhea up to 4 hours after taking the tablets, absorption may not be complete and additional precautions should be taken to prevent unwanted pregnancy. In such cases, you should be guided by the above recommendations when skipping tablets.
Changing the day of onset of menstrual bleeding
In order to delay the onset of menstrual-like bleeding, it is necessary to continue taking the tablets from the new Yarina ® package without a 7-day break. Tablets from a new package can be taken for as long as necessary, incl. until the pills from the package run out. Against the background of taking the drug from the second package, spotting from the vagina or breakthrough uterine bleeding is possible. Resume taking Yarina ® from the next package should be after the usual 7-day break.
In order to move the day of the onset of menstrual bleeding to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the greater the risk that she will not have withdrawal bleeding and will experience spotting and breakthrough bleeding during the second pack (just as she would like to delay the onset of menstrual bleeding).
Children and teenagers. The drug Yasmin 21 is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
Elderly patients. Not applicable. Yasmin 21 ® is not indicated after menopause.
Yasmin 21 ® is contraindicated in women with severe liver disease until liver function tests return to normal (see also "Contraindications" and "Pharmacokinetics").
Yasmin 21 ® is contraindicated in women with severe renal insufficiency or acute renal failure (see also "Contraindications" and "Pharmacokinetics").
Provided in section Contraindications Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Contraindications in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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Film-coated tablets; Tablets
Coated tablets
The drug Jess ® is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time while taking the drug, the drug should be immediately discontinued.
hypersensitivity to any of the components of the drug Jess ® ;
thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders;
identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant);
Availability high risk venous or arterial thrombosis (see "Special Instructions");
liver failure and severe liver disease (before normalization of liver function tests);
severe renal failure, acute renal failure;
adrenal insufficiency;
identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them .;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose monohydrate);
breastfeeding period.
CAREFULLY
If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case:
risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident in young age one of the next of kin; obesity; dyslipoproteinemia, arterial hypertension; migraine; heart valve disease; cardiac arrhythmias, prolonged immobilization, major surgery, extensive trauma;
diseases in which there may be violations of peripheral circulation: diabetes; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and non-specific ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins;
hypertriglyceridemia;
liver disease;
diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea).
Yasmin 21 ® should not be used in the presence of any of the conditions/diseases listed below:
thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;
conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
migraine with focal neurological symptoms at present or in history;
diabetes mellitus with vascular complications;
multiple or pronounced risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35;
pancreatitis with severe hypertriglyceridemia at present or in history;
liver failure and severe liver disease (before normalization of liver tests);
liver tumors (benign or malignant) at present or in history;
severe and / or acute renal failure;
identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them;
bleeding from the vagina of unknown origin;
pregnancy or suspicion of it;
the period of breastfeeding;
hypersensitivity to any of the components of the drug Yasmin 21 ® .
If any of these conditions develop for the first time while taking Yarina ® , the drug should be immediately discontinued.
CAREFULLY
The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases / conditions and risk factors:
risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, prolonged immobilization, major surgery, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in whom - or from the next of kin);
other diseases that may cause peripheral circulatory disorders (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia), phlebitis of superficial veins;
hereditary angioedema;
hypertriglyceridemia;
liver disease;
diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea);
postpartum period.
Provided in section Side effects Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Side effects in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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The following most common adverse reactions were reported in women using Jess ® in the 24 + 4 regimen for Contraception and Contraception and Treatment of Moderate Acne (acne vulgaris)»: nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin. These adverse reactions occurred in more than 3% of women. In patients using the drug Jess ® for the indication "Contraception and treatment of severe premenstrual syndrome", the following most common adverse reactions were reported (in more than 10% of women): nausea, pain in the mammary glands, irregular uterine bleeding. Serious adverse reactions are arterial and venous thromboembolism, and for the "flexible" regimen of the drug, breast cancer and focal nodular hyperplasia of the liver are additionally noted. Below is the frequency adverse reactions reported in the course of clinical trials of Jess ® for the "24 + 4" regimen for the indications "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)"(N=3565), according to the indication "Contraception and treatment of severe premenstrual syndrome" (N=289), as well as a flexible regimen for taking the drug Jess ® (N=2738). Within each group, allocated depending on the frequency of occurrence of adverse reactions, those are presented in order of decreasing severity. By frequency, they are divided into developing often (≥1 / 100 and<1/10); нечасто (≥1/1000 и <1/100) и редко (≥1/10000 и <1/1000).
For additional adverse reactions identified only in the course of post-registration observations, and for which it was not possible to estimate the frequency of occurrence, it was indicated “frequency unknown”.
The frequency of adverse reactions in clinical studies of the drug Jess ® (mode "24 + 4" and "flexible" regimen *)
From the blood and lymphatic system: rarely - anemia, thrombocythemia.
From the immune system: rarely - an allergic reaction; frequency unknown - hypersensitivity.
From the side of metabolism and nutrition: rarely - increased appetite, anorexia, hyperkalemia, hyponatremia.
Mental disorders: often - emotional lability, depression, decreased libido; infrequently - nervousness, drowsiness; rarely - anorgasmia, insomnia.
From the nervous system: often - headache; infrequently - dizziness, paresthesia; rarely - vertigo, tremor.
From the side of the organ of vision: rarely - conjunctivitis, dryness of the mucous membrane of the eyes.
From the side of the heart: rarely - tachycardia.
From the vascular side: often - migraine; infrequently - varicose veins, increased blood pressure; rarely - phlebitis, epistaxis, syncope, venous thromboembolism (VTE), arterial thromboembolism (ATE).
From the gastrointestinal tract: often - nausea; infrequently - abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhea; rarely - bloating, a feeling of heaviness in the abdomen, hiatal hernia, oral candidiasis, constipation, dry mouth.
From the side of the liver and biliary tract: rarely - biliary dyskinesia, cholecystitis.
From the skin and subcutaneous tissues: infrequently - acne, itching, rash; rarely - chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis, skin nodule; frequency unknown - erythema multiforme.
From the side of the musculoskeletal and connective tissue: infrequently - back pain, pain in the limbs, muscle cramps.
From the genitals and mammary gland: often - pain in the mammary glands, metrorrhagia **, absence of menstrual bleeding; infrequently - vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic masses in the breast, spotting / bleeding from the genital tract **, discharge from the genital tract, hot flushes, vaginitis, painful menstrual-like bleeding, scanty menstrual-like bleeding, heavy menstrual-like bleeding, dryness of the vaginal mucosa, abnormal Pap test results; rarely - dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast hyperplasia, neoplasm in the mammary gland, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.
General disorders and disorders at the injection site: infrequently - asthenia, increased sweating, edema (generalized edema, peripheral edema, swelling of the face); rarely - malaise
Laboratory and instrumental data: infrequently - weight gain; rarely - weight loss.
*In cases where adverse reactions occurred with different frequencies during the use of the 24 + 4 regimen and the flexible regimen, the highest frequency is indicated
** The frequency of irregular bleeding decreases as the duration of taking Jess® increases.
For more information on VTE and ATE, migraine, breast cancer and focal nodular hyperplasia of the liver, see also "Contraindications" and "Special Instructions".
Additional Information
Listed below are adverse reactions with a very rare occurrence or delayed symptoms, which are believed to be associated with taking drugs from the COC group (see also "Contraindications" and "Special Instructions").
Tumors
The frequency of diagnosing breast cancer in women taking COCs is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking COCs is insignificant in relation to the overall risk of this disease;
Other states
Erythema nodosum, erythema multiforme (flexible regimen only);
Women with hypertriglyceridemia (increased risk of pancreatitis while taking COCs);
Increased blood pressure;
Conditions that develop or worsen while taking COCs, but their relationship has not been proven: jaundice and / or itching associated with cholestasis; cholelithiasmin 21; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis;
Liver dysfunction;
Change in glucose tolerance or effect on insulin resistance;
Chloasma;
Interaction. The interaction of COCs with other drugs (enzyme inducers) can lead to breakthrough bleeding and / or reduced contraceptive effectiveness (see "Interactions").
The most commonly reported adverse reactions to Yasmin 21® are nausea and breast pain. They occurred in more than 6% of women using this drug.
Serious adverse reactions are arterial and venous thromboembolism.
The table below shows the frequency of adverse reactions. reported in clinical trials with Yasmin 21® (N=4897). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided into frequent (≥1/100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных реакций, выявленных только в процессе постмаркетинговых исследований, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота неизвестна» (см. табл. 1).
Table 1
Adverse events in clinical trials were codified using MedDRA (Medical Dictionary of Regulatory Activity 12.1). Various MedDRA terms representing the same symptom have been grouped together and presented as a single adverse reaction to avoid diluting or blurring the true effect.
* - Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on very rare.
Venous or arterial thromboembolism includes the following entities: peripheral deep vein occlusion, thrombosis and pulmonary embolism/occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not defined as haemorrhagic.
For venous and arterial thromboembolism, migraine, see also "Contraindications" and "Special Instructions".
Additional Information
Listed below are adverse reactions with a very rare occurrence or with delayed symptoms, which are believed to be associated with the use of drugs from the group of combined oral contraceptives (see also "Contraindications" and "Special Instructions").
Tumors:
The frequency of diagnosing breast cancer in women taking combined oral contraceptives is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant in relation to the overall risk of this disease.
Tumors of the liver (benign and malignant).
Other states:
erythema nodosum;
Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);
Increased blood pressure;
Conditions that develop or worsen while taking combined oral contraceptives, but their relationship with the drug has not been proven (jaundice and / or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea ; herpes of pregnancy; hearing loss associated with otosclerosis);
In women with hereditary angioedema, estrogen use may cause or exacerbate symptoms;
Liver dysfunction;
Impaired glucose tolerance or effect on insulin resistance;
Crohn's disease, ulcerative colitis;
Chloasma;
Hypersensitivity (including symptoms such as rash, urticaria).
Interaction. The interaction of combined oral contraceptives with other drugs (inducers of microsomal liver enzymes, some antibiotics) can lead to breakthrough bleeding and / or a decrease in contraceptive efficacy (see "Interaction").
Provided in section Overdose Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Overdose in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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Symptoms(identified based on the total experience with oral contraceptives): nausea, vomiting, spotting or metrorrhagia.
Treatment: symptomatic. There is no specific antidote.
Serious violations in case of overdose have not been reported.
Provided in section Pharmacodynamics Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Pharmacodynamics in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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Jess ® is a combined hormonal contraceptive with antimineralocorticoid and antiandrogenic effects. The contraceptive effect of COCs is based on the interaction of various factors, the most important of which include the suppression of ovulation and changes in the properties of the secretion of the cervix, as a result of which it becomes less permeable to spermatozoa. When used correctly, the Pearl Index (number of pregnancies per 100 women per year) is less than 1. If pills are missed or used incorrectly, the Pearl Index may increase. In women taking COCs, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of COCs reduces the risk of developing endometrial cancer and ovarian cancer. Drospirenone contained in Jess ® has an antimineralocorticoid effect. Prevents weight gain and the appearance of edema associated with estrogen-induced fluid retention, which ensures good tolerability of the drug. Drospirenone has a positive effect on PMS.
The clinical efficacy of Jess ® in relieving symptoms of severe PMS, such as severe psycho-emotional disorders, breast engorgement, headache, muscle and joint pain, weight gain and other symptoms associated with the menstrual cycle, has been shown. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (blackheads), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body. Drospirenone does not have androgenic, estrogenic, corticosteroids and antiglucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone.
In combination with ethinylestradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in HDL. The drug Jess ® can be used both in the usual mode (reception mode "24 + 4": within 24 days of taking active tablets, then within 4 days - taking inactive tablets), and in a flexible mode.
The adaptable extended regimen (flexible regimen) of taking the drug Jess ® is based on the previously approved regimen for taking the drug "24 + 4" and lies in the fact that the active tablets of the drug can be taken daily continuously for up to 120 days. Thus, the continuous period of taking active tablets can be 24-120 days, and the duration of the break in taking the tablets should not exceed 4 days. A flexible regimen is possible only if there is a Clyk dispenser and flex-cartridges that allow you to comply with the regimen of taking the drug (see "Method of administration and doses"). The results of a multicenter comparative open randomized study in parallel groups showed that the flexible regimen of taking the drug Jess ®, aimed at achieving the maximum duration of intervals without bleeding up to 120 days, reduced the total number of days of menstruation per year from 66 (reception mode "24 + 4") up to 41 days ("flexible" mode of admission).
Yasmin 21 ® is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.
The contraceptive effect of Yarina ® is mainly carried out by suppressing ovulation and increasing the viscosity of cervical mucus.
The incidence of venous thromboembolism (VTE) in women with or without risk factors for VTE using ethinylestradiol/drospirenone-containing oral contraceptives at a dose of 0.03 mg/3 mg is the same as in women using levonorgestrel-containing combined oral contraceptives or other combined oral contraceptives . This was confirmed in a prospective controlled database study comparing women using oral contraceptives at a dose of 0.03 mg ethinylestradiol/3 mg drospirenone with women using other combined oral contraceptives. Data analysis revealed the same risk of VTE among the sample.
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstrual bleeding is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.
Drospirenone contained in Yarin ® has an antimineralocorticoid effect and is able to prevent weight gain and other symptoms (eg edema) associated with estrogen-dependent fluid retention. Drospirenone also has antiandrogenic activity and helps reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to the action of natural progesterone produced by the female body. This should be considered when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne (acne) and seborrhea. When used correctly, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or use them incorrectly, the Pearl index may increase.
Provided in section Pharmacokinetics Yasmin 21 information is based on data from another drug with exactly the same composition as the drug Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to clarify the information in the section Pharmacokinetics in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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Drospirenone
Absorption
When taken orally, it is rapidly and almost completely absorbed. After a single oral administration, Cmax of drospirenone in serum, equal to about 38 ng / ml, is reached after about 1-2 hours. Bioavailability ranges from 76 to 85%. Compared with the intake of the substance on an empty stomach, food intake does not affect the bioavailability of drospirenone.
Distribution
After oral administration, a two-phase decrease in the level of the drug in serum is observed, with T 1/2 (1.6 ± 0.7) and (27 ± 7.5) h, respectively. It binds to serum albumin and does not bind to SHBG) or corticosteroid-binding globulin (CBG). Only 3-5% of the total serum concentration of the substance is present as a free steroid. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent V d is (3.7±1.2) l/kg.
Metabolism
After oral administration, it is metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the cytochrome P450CYP3A4 isoenzyme.
Excretion from the body
The rate of metabolic clearance of drospirenone in serum is (1.5 ± 0.2) ml / min / kg. It is excreted unchanged only in trace amounts. Drospirenone metabolites are excreted in faeces and urine in a ratio of approximately 1.2:1.4. T 1/2 in the excretion of metabolites with urine and feces is approximately 40 hours.
During cyclic treatment, the equilibrium C min of drospirenone in serum is reached between the 7th and 14th days of treatment and is approximately 70 ng / ml. There was an increase in serum concentration by about 2-3 times (due to cumulation), which was due to the ratio of T 1/2 in the terminal phase and the dosing interval. A further increase in the concentration of drospirenone in the blood plasma is observed between the 1st and 6th cycles of administration, after which no increase in concentration is observed.
Special populations of patients
Impact of kidney failure: Serum C ss of drospirenone in women with mild renal insufficiency (Cl creatinine = 50-80 ml / min) were comparable to those in women with normal renal function (Cl creatinine> 80 ml / min). In women with moderate renal insufficiency (Cl creatinine = 30-50 ml / min), the serum level of drospirenone was on average 37% higher than in women with normal renal function. Treatment was well tolerated in all groups. Drospirenone did not have a clinically significant effect on serum potassium concentration. The pharmacokinetics of drospirenone in severe renal insufficiency has not been studied.
Impact of liver failure: Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.
Ethinylestradiol
Absorption
After oral administration, it is rapidly and completely absorbed. C max in blood plasma after a single oral administration is achieved after 1-2 hours and is about 88-100 pg / ml. Absolute bioavailability as a result of presystemic conjugation and first passage metabolism is approximately 60%. Concomitant food intake reduces the bioavailability of ethinylestradiol in approximately 25% of the examined, while in other subjects such changes were not observed.
Distribution
The concentration of etigylestradiol in serum decreases biphasically, the terminal phase is characterized by T 1/2 of approximately 24 hours. It is very largely, but not specifically, associated with serum albumin (about 98.5%) and causes an increase in plasma concentrations of SHBG. The apparent V d is about 5 l/kg.
Metabolism
Ethinylestradiol undergoes presystemic conjugation in the mucosa of the small intestine and liver. Ethinylestradiol and its oxidative metabolites are primarily conjugated to glucuronides or sulfate. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg.
Excretion from the body
Ethinylestradiol is practically not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T 1/2 of metabolites is approximately 24 hours.
The state of C ss is achieved during the second half of the treatment cycle, and the concentration of ethinyl estradiol in the blood plasma increases by about 1.5-2.3 times.
Preclinical safety data
Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex steroids may promote the growth of certain hormone-dependent tissues and tumors.
Drospirenone
When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration C max drospirenone in serum, equal to 37 ng / ml, is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Eating does not affect the bioavailability of drospirenone.
Drospirenone binds to serum albumin (0.5-0.7%) and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). In the free form is only 3-5% of the total concentration in the blood serum. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins.
After oral administration, drospirenone is completely metabolized.
Most of the plasma metabolites are represented by acidic forms of drospirenone, which are formed without the involvement of cytochrome P450.
The concentration of drospirenone in plasma decreases in 2 phases. Drospirenone is not excreted unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines in a ratio of approximately 1.2-1.4. T 1/2 for excretion of metabolites with urine and faeces is approximately 40 hours.
During cyclic treatment, the maximum equilibrium concentration of drospirenone in serum is reached in the second half of the cycle.
A further increase in the serum concentration of drosperinone is observed after 1-6 cycles of administration, after which no increase in concentration is observed.
Additional information for special categories of patients
Patients with liver disorders. In women with moderate hepatic impairment (Child-Pugh class B), AUC is comparable to that in healthy women with similar Cmax values in the absorption and distribution phases. T 1/2 drospirenone in patients with moderate hepatic impairment was 1.8 times higher than in healthy volunteers with preserved liver function.
In patients with moderate hepatic impairment, a 50% decrease in drospirenone clearance was noted compared with women with intact liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. When diabetes mellitus is detected and concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma has not been established.
It should be concluded that drospirenone is well tolerated in women with mild to moderate hepatic impairment (Child-Pugh class B).
Patients with kidney disorders. The concentration of drospirenone in blood plasma upon reaching the equilibrium state was comparable in women with mild renal impairment (Cl creatinine - 50-80 ml / min) and in women with preserved kidney function (Cl creatinine -> 80 ml / min). However, in women with moderate renal impairment (Cl creatinine - 30-50 ml / min), the average plasma concentration of drospirenone was 37% higher than in patients with preserved renal function. Drospirenone was well tolerated by all groups of patients. There was no change in the concentration of potassium in the blood plasma when using drospirenone.
Ethinylestradiol
After oral administration, ethinylestradiol is rapidly and completely absorbed. C max in plasma, equal to approximately 54-100 pg / ml, is reached in 1-2 hours. During absorption and the first passage through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability, on average, about 45%.
Ethinyl estradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHBG.
Ethinylestradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation.
The decrease in the concentration of ethinylestradiol in the blood plasma is biphasic. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6 with a T 1/2 of about 24 hours.
Interaction in the instructions for the drug Yasmin 21 directly from the package or from the pharmacist in the pharmacy.
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The influence of other drugs on the drug Jess ®
Interaction with drugs that induce microsomal enzymes is possible, as a result of which the clearance of sex hormones may increase, which, in turn, may lead to breakthrough uterine bleeding and / or a decrease in the contraceptive effect. Women who receive treatment with such drugs in addition to the drug Jess are recommended to use a barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their withdrawal. If the period of use of the barrier method of contraception ends later than the active tablets in the Jess ® package, you should start taking the Jess ® tablets from a new package without interrupting the active tablets.
Substances that increase the clearance of the drug Jess ® (weaken the effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.
Substances with different effects on the clearance of the drug Jess ®. When used together with Jess ®, many inhibitors of HIV proteases or hepatitis C virus and NNRTIs can either increase or decrease the concentration of estrogens or progestins in the blood plasma. In some cases, this effect may be clinically significant.
Substances that reduce the clearance of COCs (enzyme inhibitors). Strong and moderate CYP3A4 inhibitors such as azole antimycotics (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltYasmin 21em, and grapefruit juice may increase plasma concentrations of estrogen or progestin, or both.
It was shown that etoricoxib at doses of 60 and 120 mg / day, when taken together with COCs containing 0.035 mg of ethinylestradiol, increases the concentration of ethinylestradiol in blood plasma by 1.4 and 1.6 times, respectively.
The effect of the drug Jess ® on other drugs
COCs can interfere with the metabolism of other drugs, leading to an increase (eg cyclosporine) or a decrease (eg lamotrigine) in plasma and tissue concentrations. In vitro drospirenone is able to weakly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
in vivo in female volunteers taking omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of 3 mg drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely.
In vitro ethinylestradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, and an irreversible inhibitor of CYP3A4/5, CYP2C8 and CYP2J2. In clinical studies, the administration of a hormonal contraceptive containing ethinylestradiol did not lead to any increase or only a slight increase in plasma concentrations of CYP3A4 substrates (eg midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (eg theophylline) or moderately (eg melatonin and tizanidine).
Other forms of interaction
In patients with intact renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Jess ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug (see "Special Instructions").
Interactions of oral contraceptives with other drugs may lead to breakthrough bleeding and/or reduced contraceptive reliability. Women taking these drugs should temporarily use barrier methods in addition to Yasmin 21 ® , or choose another method of contraception.
The following interactions have been reported in the literature.
Influence on hepatic metabolism. The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or reduce the reliability of contraception. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.
HIV protease inhibitors(eg ritonavir) and non-nucleoside reverse transcriptase inhibitors(eg nevirapine) and their combinations also have the potential to affect hepatic metabolism.
Effects on enterohepatic circulation. According to separate studies, some antibiotics (eg penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.
During the reception drugs that affect microsomal enzymes, and within 28 days after their cancellation, you should additionally use a barrier method of contraception.
During the reception antibiotics(such as penicillins and tetracyclines) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking the tablets from the next package of Yarina ® without the usual break in taking the tablets.
The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the influence of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.
Oral combined contraceptives can interfere with the metabolism of other drugs, resulting in an increase (eg cyclosporine) or decrease (eg lamotrigine) in plasma and tissue concentrations.
Based on interaction studies in vitro, as well as research in vivo on female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drug substances is unlikely.
There is a theoretical possibility of increasing the serum potassium level in women receiving Yarina ® simultaneously with other drugs that can increase the serum potassium level. These drugs include angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentrations compared with placebo.
