The contraceptive buy halotestin effect Jeanine performed by complementary mechanisms, the most important of which are inhibition of ovulation and changes in cervical mucus viscosity, causing it becomes impenetrable to sperm.When used properly, Pearl index (an indicator of the number of pregnancies in 100 women taking contraceptive during the year) is less than 1. When skipping pills or incorrect use Pearl Index may increase.Jeanine progestogens component – dienogest – has anti-androgenic activity, as confirmed by the results of several clinical studies. Furthermore, dienogest improves blood lipid profile (increases the amount of high density lipoprotein).In women receiving combined oral contraceptives, menstrual cycle becomes more regular, more rarely observed painful menstruation, decreases the intensity and duration of bleeding, thus reducing the risk of iron deficiency anemia. Furthermore, there is evidence of reducing the risk of endometrial cancer and ovarian cancer.
Absorption. When taken orally dienogest is rapidly and completely absorbed, its maximum serum concentration equal to 51 ng / ml, is reached in about 2.5 hours. The bioavailability is approximately 96%.
Distribution. Dienogest bound to albumin serum, and is not associated with binding globulin sex steroids (SHBG) and corticoid-binding globulin (CBG). The free form is about 10% of the total serum concentration; about 90% – non-specifically bound to serum albumin. Induction of synthesis of SHBG ethinylestradiol not affect the binding to serum protein dienogest.
Metabolism. Dienogest almost completely metabolized. Clearance of serum after a single dose of about 3.6 l / h.
. Elimination half-life is about 8,5-10,8 h A small number in unchanged form excreted by the kidneys as metabolites (half-life – 14.4 hours.) Which are excreted by the kidneys and the gastrointestinal tract in a ratio of about 3.: 1.
The equilibrium concentration . Pharmacokinetics dienogest not affect SHBG levels in serum. As a result, the drug substance daily serum increased about 1.5 times.
Absorption . After oral administration, ethinylestradiol is rapidly and completely absorbed. Maximum serum concentration equal to approximately 67 pg / ml, achieved after 1.5-4 hours. During the suction and the first passage through the liver is metabolized ethinylestradiol, whereby its oral bioavailability averages about 44%.
Distribution . Ethinyl estradiol is almost full (about 98%), while non-specifically binds to albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8 – 8.6 l / kg.
Metabolism . Ethinylestradiol undergoes conjugation presistemna as mucosa of the small intestine and in the liver. The main pathway – aromatic hydroxylation. The rate of plasma clearance of 2.3 – 7 ml / min / kg. Excretion. The decrease in serum concentration of ethinyl estradiol is biphasic; The first phase is characterized by a half-life of about 1 hour, the second – 10-20 hours. In an unmodified form of the organism is not displayed. Ethinylestradiol metabolites are excreted in the urine and bile in a ratio of 4: 6. With a half-life of about 24 hours . The equilibrium concentration of the equilibrium concentration is achieved during the second half of the treatment cycle.
Janine should not be applied if any of the conditions / diseases listed below. If any of these conditions develop for the first time on his patients receiving the drug should be immediately repealed.
· Thrombosis (venous and arterial) and thromboembolism present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
· Conditions prior thrombosis (including transient ischemic attack, angina pectoris) now or in history.
· Migraine with focal neurological symptoms in the present or in history.
· Diabetes mellitus with vascular complications.
· Multiple or severe venous or arterial thrombosis risk factors, including complicated lesions valvular atrial fibrillation, cerebrovascular disease, or coronary arteries; uncontrolled hypertension, major surgery with prolonged immobilization, smoking at the age of 35 years.
· Pancreatitis with severe hypertriglyceridemia now or in history.
· Liver failure and severe liver disease (liver function tests before normalization).
· Liver tumors (benign or malignant) now or in history.
· Identified hormone malignancies (including genital or mammary glands) or are suspected.
· Vaginal bleeding of unknown origin.
· Pregnancy or suspicion of it.
· The period of lactation.
· Hypersensitivity to any component of the drug Janine.
You should carefully weigh the potential risks and expected benefits of the use of combined oral contraceptives in each individual case in the presence of the following diseases / conditions and risk factors:
· Risk factors for thrombosis and thromboembolism: smoking; obesity; dislipoproteinemia, hypertension; migraine; valvular disease; prolonged immobilization, major surgery, major trauma; a genetic predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin)
· Other diseases in which may occur peripheral circulatory disorders: diabetes; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn’s disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins
· Hereditary Angioedema
· Liver disease
· Diseases caused or aggravated first time during pregnancy, or on the background of the previous use of sex hormones (eg, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes gestationis, Sydenham’s chorea)
Pregnancy and lactation
Janine is not appointed during pregnancy and lactation.
If pregnancy is detected during the reception of Janine drug, the drug should be immediately abolished. However, extensive epidemiological studies have revealed no increased risk of defects in children born to women treated with hormones before pregnancy, or teratogenic effects when sex hormones were taken inadvertently in early pregnancy.
Admission combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is contraindicated during lactation. A small amount of sex steroids and / or their metabolites may be derived from milk.
Dosing and Administration
Drops should be taken orally in the order indicated on the package, every day at about the same time, with a little water. Take one tablet a day continuously for 21 days. Receiving the next pack is started after a 7-day break in taking pills, during which withdrawal bleeding usually occurs. Bleeding usually begins 2-3 days after the last pellet and can not end before receiving the pills from a new package.
How to start taking Jeanine
· If you do not receive any hormonal contraceptive use in the preceding month.
Janine Reception begins on the first day of the menstrual cycle (ie the first day of menstrual bleeding). Shall start receiving 2-5 days 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 tablet-taking from the first package.
· When switching from other combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, transdermal patch).
Preferably start accepting Janine the next day after taking the last active pills from the previous package, but in any case not later than the day after the usual 7-day interval (for formulations containing 21 tablet) or after the last inactive tablets (for formulations containing 28 tablets per pack). In the transition from a vaginal ring, transdermal patch preferably start taking Jeanine day remove the ring or patch, but not later than the day when it should be inserted a new ring or pasted a new patch.
· When switching from contraceptives containing only progestin ( “mini-pill”, an injectable form, implant) or releasing progestogen IUD (Mirena).
A woman can go to the mini-pill to Jeanine any day (without a break), with the implant or intrauterine device with progestin – the date of its removal from the injection mold – the day when the next injection should have to be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of tablet-taking.
· After an abortion in the first trimester of pregnancy.
A woman may start taking the drug immediately. Subject to this condition the woman does not need additional contraceptive protection.
· After delivery or abortion in the second trimester of pregnancy.
It is recommended to start taking the drug on day 21-28 after delivery or abortion in the second trimester of pregnancy. If the reception is started later, you must use an additional barrier method of contraception during the first 7 days of tablet-taking. However, if a woman has been sexually active, before you start taking Jeanine pregnancy should be excluded or must wait for the first menstrual period.
Admission missed pills
If the delay in receiving the drug was less than 12 hours , contraceptive protection is not reduced. The woman should take pills as soon as possible, should be taken at the usual time.
If the delay in taking pills made more than 12 hours , contraceptive protection may be reduced. It is possible to be guided by the following two basic rules:
· The drug should never be interrupted for more than 7 days.
· 7 days continuous administration of pills required to achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation.
Accordingly, these tips may be given if the delay in receiving a dragee was 12 hours (the interval since last receiving pellets over 36 hours):
· The first week of taking the drug
The woman should take the last missed pills as soon as possible, as soon as you remember (even if this means taking two pills at once). Next take the pills at the usual time. Additionally, it should be used a barrier method of contraception (such as a condom) for the next 7 days. If intercourse took place during the week before skipping pills, you need to take into account the chance of pregnancy. The more pills missed and the closer they are to a break in the reception of active substances, the greater the likelihood of pregnancy.
· The second week of taking the drug
The woman should take the last missed pills as soon as possible, as soon as you remember (even if it needs to take two pills at the same time). Next take the pills at the usual time.
Provided that the woman has taken pills correctly in the 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as skipping of two or more must be added dragees barrier methods (such as condoms) for 7 days.
· The third week of taking the drug
The risk of reduced reliability is imminent because of the forthcoming break in taking pills.
A woman should strictly adhere to one of the two following options. Moreover, if during the 7 days preceding the first missed pills, all the pills are taken correctly, there is no need to use additional contraceptive methods.
1. The woman should take the last missed pills as soon as possible, as soon as you remember (even if this means taking two pills at once). Next take the pills at the usual time until the end of the current package of pills. The next pack should be started immediately. Withdrawal bleeding is unlikely until the end of the second pack, but may experience spotting and breakthrough bleeding during the tablet-taking.
2. The woman may also interrupt the reception of pills from the current package. Then she should take a break for 7 days, including the day of skipping pills, and then start taking a new package.
If a woman misses pills, and then during a break in taking pills she had no withdrawal bleeding, pregnancy must be excluded.
Recommendations in case of vomiting and diarrhea
If a woman has had vomiting or diarrhea within 4 hours after taking the active pills, absorption may not be complete and should be additional contraceptive measures are taken. In these cases, you should be guided by the recommendations by skipping pills.
Changing the date of the beginning of the menstrual cycle
In order to delay the onset of menstruation, the woman should continue taking pills from a new package Jeanine immediately after taking all the pills from the previous one, without a break in the reception. Drops of this new packaging may be taken for as long as the woman wants (as long as the packaging is not finished). Against the background of the drug from the second package, women may experience spotting or breakthrough uterine bleeding. Resume Jeanine reception from a new package follows the usual 7-day break.
In order to move the first day of menstruation to another day of the week, the woman should be reduced the next break in taking pills for as many days, as much as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, will be spotting and breakthrough bleeding while taking second pack (just as when she wanted to delay the onset of menses).
Additional information for special categories of patients
Children and adolescents
The drug Jeanine shown only after menarche.
Not applicable. The drug Jeanine not shown after menopause.
Patients with disorders of the liver
Jeanine drug is contraindicated in women with severe liver disease as long as liver function tests have not come back to normal. See. Also “Contraindications”.
Patients with disorders of the kidney
The drug Jeanine not specifically studied in patients with disorders of the kidneys. Available data do not suggest changes in the treatment of such patients