Jeanine®
If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using Janine should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. If any of these conditions, diseases or risk factors worsen, intensify or manifest for the first time, a woman should consult her doctor, who may decide whether to discontinue the drug.
— Diseases of the cardiovascular system
There is epidemiological evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) when taking COCs. These diseases are rarely observed.
The risk of developing VTE is greatest in the first year of taking such drugs. An increased risk is present after initial use of a COC or resumption of use of the same or a different COC (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients indicate that this increased risk is predominantly present during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (<0.05 mg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth.
VTE can be life-threatening or lead to death (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of all COCs.
It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis: unilateral swelling of the lower extremity or swelling along a vein in the lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, local increase in temperature in the affected lower extremity, redness or discoloration of the skin of the lower extremity.
Symptoms of pulmonary embolism: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensation in the face or limbs, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the limbs, “acute” abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal.
In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in the risk of blood clots may be higher than with a simple summation of factors. In this case, taking the drug Zhanin® is contraindicated (see section “Contraindications”).
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
— obesity (body mass index 30 kg/m2 or more);
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Zhanine®;
- prolonged immobilization, extensive surgery, any operation on the lower extremities or major trauma. In these cases, taking the drug Zhanin® must be stopped (in the case of a planned operation, at least four weeks before it) and not resumed for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of venous thromboembolism, especially in the presence of other risk factors;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during use of the drug Zhanin® (which may precede cerebrovascular disorders) is grounds for immediate discontinuation of this drug.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose COCs (<0.05 mg ethinyl estradiol).
— Tumors
The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer (BC) diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. 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 who are currently or recently taking COCs is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in the risk of developing breast cancer may be due not only to earlier diagnosis of breast cancer, but also to the biological effect of sex hormones or a combination of these two factors. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.
In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.
— Other states
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs.
Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of arterial hypertension should be initiated. The drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of worsening the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during the use of COCs have also been described.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in diabetic patients using low-dose COCs (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma while taking Zhanine® should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Preclinical safety data
Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.
Laboratory tests
Taking the drug Zhanin® may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the concentration of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond normal values.
Reduced efficiency
The effectiveness of Zhanine® may be reduced in the following cases: missed pills, gastrointestinal disorders or as a result of drug interactions.
Frequency and severity of menstrual-like bleeding
While taking the drug Zhanine®, irregular bleeding may occur (“spotting” spotting and/or “breakthrough” uterine bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
No regular menstrual bleeding
Some women may not develop bleeding during a break in taking pills. “Contraindications” and “With caution”;
— Local compaction in the mammary gland;
- Concomitant use of other medications (see also “Interaction with other medications”);
- If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least four weeks before the proposed operation);
- Unusually heavy bleeding from the vagina;
- Missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;
— Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).
You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.
Compound
The active ingredients in Janine include 2 mg of dienogest and 30 mcg of ethinyl estradiol .
In addition to these substances, the tablets contain lactose in the form of monohydrate, potato starch, magnesium stearate, talc, and gelatin. The shell is made using sucrose, dextrose, macrogol 35000, calcium carbonate , polyvidone, titanium dioxide, carnauba wax.
Reviews about Janine
Reviews about Janine on the forums are quite varied. For the most part, they are positive, since the drug is well tolerated by women, is easy to use, and copes well with its main task.
In addition, patients and doctors in reviews of Janine note that the drug, in addition to contraception, has a number of other positive side effects: it helps with acne, normalizes the menstrual cycle, and reduces the intensity and pain of bleeding. In women who stop taking Zhanine tablets due to a desire to become pregnant, pregnancy after discontinuation of the drug often occurs within the first 2-3 cycles.
Due to the drug's ability to stabilize hormonal levels and suppress foci of pathological growth of the endometrium , it is often effective for fibroids and endometriosis (usually in situations where the disease is not too advanced).
However, there are also negative reviews about the drug, which are associated either with the lack of results in the treatment of endometriosis , or with side effects that significantly worsen the woman’s quality of life. Experts are inclined to believe that such phenomena can occur if the product was selected without taking into account contraindications for use, or is simply not suitable for a particular woman.
Analyzing doctors' reviews of Zhanine birth control pills, we can conclude that experts speak positively about this drug. Such a high rating is due to the fact that, being a low-dose drug, the latter has a pronounced contraceptive effect, helps restore hormonal imbalances and has a positive effect on the general condition of a woman.
Use with alcohol
In the instructions for the drug, the manufacturer does not give any recommendations regarding the possibility of using Janine tablets with alcoholic beverages.
The recommended dose of alcohol for a woman taking oral contraceptives is 20 grams of ethanol (a glass of wine).
However, please remember that:
- the reaction of different organisms to the same dose of alcohol may differ;
- hormonal drugs are an additional burden for the liver , which is responsible for the breakdown of ethyl alcohol (i.e., with an overdose of alcohol, the consequences can be quite serious both for the liver and for the body as a whole);
- with increased activity of liver enzymes due to an overdose of alcohol, the breakdown and elimination of substances contained in the drug are significantly accelerated (i.e., the contraceptive effect may be reduced);
- An overdose of alcohol, accompanied by vomiting, leads to the fact that the active substances of the tablets do not have time to be absorbed from the gastrointestinal tract, and as a result, the effectiveness of the drug decreases.
According to doctors, you should wait at least 3 hours between taking pills and alcoholic drinks.
Side effects of Janine
The most common side effects of taking estrogen-progestin oral contraceptives are:
- an increase in the size and tension of the mammary glands, their soreness, as well as the appearance of discharge from them;
- bloody discharge from the genital tract of varying intensity (can be spotting or have the character of breakthrough bleeding);
- headaches (migraine attacks are also possible);
- mood lability;
- change in libido ;
- deterioration of tolerance to contact lenses;
- visual impairment;
- abdominal pain;
- nausea;
- skin rashes;
- vomit;
- changes in the nature of vaginal discharge;
- nodular (nodous) or erythema multiforme ;
- cholestatic jaundice;
- generalized itching;
- weight fluctuations;
- fluid retention;
- allergic reactions.
Sometimes side effects of Zhanine are expressed in the form of increased plasma concentrations of triglycerides , diarrhea , increased fatigue, decreased tolerance to carbohydrates, chloasma (the risk of focal hyperpigmentation is especially high in women who chloasma during pregnancy).
Like other combined hormonal contraceptives for oral use, Janine can cause thrombosis or thromboembolism .
Pharmacodynamics and pharmacokinetics
The action of the pill is aimed at inhibiting the secretion of gonadotropic pituitary hormones, inhibiting the maturation of follicles and suppressing ovulation . With the use of the drug, the viscosity of the mucus filling the cervical canal increases, which creates obstacles for the penetration of sperm into the uterine cavity.
Taking Janine pills is accompanied by normalization of the menstrual cycle , a decrease in the pain of menstruation and the intensity of discharge, thereby significantly reducing the risk of developing anemia .
Dienogest , the progestin component of the drug, is a derivative of nortestosterone . Clinical studies of the use of this substance in patients with acne have established its pronounced antiandrogenic activity. In addition, dienogest is characterized by the ability to increase the concentration of high-density drugs in the blood.
After p/os administration of 1 tablet, dienogest is quickly and completely absorbed from the gastrointestinal tract . Plasma concentration reaches a maximum after 2 hours 30 minutes. The absolute bioavailability indicator is at the level of 96% (and this value remains the same in combination with the estrogenic component of Janine tablets).
About 1/10 of the administered dose of dienogest remains in the plasma in free form, the remaining 90% is nonspecifically bound to albumin . The substance does not bind to specific transport proteins. And this is precisely the reason that it does not displace cortisol and testosterone from their connections with CSG and SHBG, respectively.
The effect of the first passage is negligible. The resulting metabolic products are inactive.
The half-life of dienogest with a single dose is about 9 hours, with multiple doses - about 10. After oral administration, a little more than 85% of the dose is eliminated within 6 days (about half during the first day).
After p/os administration, ethinyl estradiol is quickly and completely absorbed from the digestive tract; the maximum plasma concentration is achieved in the next 1.5-4 hours after taking one tablet.
The substance is subject to the first passage effect, which accounts for its low bioavailability (this figure usually does not exceed 44%).
In free form, about 1.5% ethinyl estradiol , approximately 98.5% of the substance is bound to albumin . Ethinyl estradiol enhances the biosynthesis of CSG and SHBG without binding to these transport proteins .
After taking one tablet, the half-life of ethinyl estradiol is 10 hours. After three cycles of using the drug, it increases to 15 hours.
From 30 to 50% of metabolic products are excreted in the urine, about 30-40% are excreted in the intestinal contents.
During pregnancy
In the course of epidemiological studies, it was found that Janine does not increase the risk of teratogenic effects in a child whose mother took birth control pills before pregnancy or, unknowingly, in the first weeks.
However, during pregnancy, taking the drug is contraindicated.
Since combined hormonal drugs are characterized by the ability to suppress lactation and affect the composition of breast milk, nursing women are advised to refrain from taking them.
If you are planning a child, you should stop using birth control pills. Doctors advise trying to get pregnant from the beginning of a new cycle. Pregnancy usually occurs fairly quickly after taking the pills.
Analogs
Level 4 ATC code matches:
Ovidon
Rigevidon
Non-Ovlon
Mercilon
Yarina Plus
Yarina
Miniziston 20 fem
Novinet
Microgynon
Lindineth
Cyclo-Proginova
Regulon
Logest
Midiana
Belara
Femoden
Jess Plus
Jess
Zoely
Generics: Zhenetten , Diecyclen , Siluet , Bonade .
Analogues of Zhanin by mechanism of action: Belara , Yarina , Dailla , Midiana , Jess , Logest , Evra , Lindinet 30 , Mercilon , Marvelon , Egestrenol , Femoden , Oralcon , Dimia .
Janine or Silhouette - which is better?
The drugs Zhanine and Silhouette are structural analogues, that is, they contain identical substances in the same dosage as active components, they have the same mechanism of action, indications and contraindications.
The products are produced by different companies and have a significant difference in price; Silhouette is about half the price of its counterpart.
Which is better: Claira or Janine?
The basis of the drug Qlaira is dienogest and estradiol valerate of 17β-estradiol produced by the human body ). Each package contains 5 types of tablets, which differ in the composition of the active ingredients and their concentration.
The ethinyl estradiol contained in the Janine dragee exhibits greater metabolic stability in contrast to the estrogenic component of Qlaira , however, it also has a more pronounced effect on the liver .
The mechanism of action of Qlaira is due to the ability of its active components to suppress ovulation and change the properties of cervical mucus. In addition, the drug reduces pain and intensity of bleeding during menstruation , prevents the development of iron deficiency anemia , and reduces the risk of developing ovarian and endometrial cancer .
Which is better: Janine or Diana 35?
Diane-35 is a combination of cyproterone (2 mg) and ethinyl estradiol (35 mcg). If Zhanine is prescribed primarily to prevent pregnancy in women with endometriosis , then the use of Diane-35 is advisable for contraception in women with pronounced signs of androgenization .
Janine or Visanne - which is better?
The drug Visanne of micronized dienogest as an active component . The drug is intended for the treatment of endometriosis. To achieve a therapeutic effect, the tablets are taken for six months.
The main indication for use of the drug Zhanine is contraception (in particular contraception in women with endometriosis ).
According to doctors and patients who were treated with both drugs, treatment of endometriosis with Janine is not always as effective as treatment with Visanne. In addition, the latter is often better tolerated and causes fewer side effects.
When wondering which drug to choose, you should remember that each woman’s body is individual, in addition, in each specific case, the indications for use may differ. In this regard, a specialist must prescribe this or that remedy.
Contraindications
Contraindications to the use of birth control pills are:
- thrombosis of veins and arteries (including a history; including PE, DVT, myocardial infarction , cerebrovascular disorders );
- conditions preceding thrombosis (including a history; for example, angina pectoris attacks of focal or cerebral disorders associated with cerebral circulation
- diabetes mellitus occurring with vascular complications ;
- severe and/or multiple factors that increase the risk of thrombosis of veins or arteries ;
- severe forms of liver disease (including a history; taking the drug is allowed only if the liver test results are normal);
- liver tumors;
- malignant diseases of the mammary glands or reproductive organs (as well as suspicion of them) caused by an imbalance of hormones
- vaginal bleeding of unspecified etiology;
- established or suspected pregnancy ;
- hypersensitivity to substances contained in the tablets.
Interaction
The simultaneous use of Zhanine birth control pills with drugs that induce microsomal enzymes of liver cells (including barbiturates , hydantoins , Rifampicin , Carbamazepine , Primidon and, probably, Topiramate , Griseofulvin , Felbamate ), provokes an increase in the clearance of dienogest and ethinyl estradiol , which may cause a decrease in contraceptive effect.
As a rule, the maximum activity of liver enzymes is observed 2-3 weeks after the start of treatment with these drugs, however, it can be observed over the next 4 weeks after completion of the course.
When Zhanine is used in combination with ampicillin and tetracycline of ethinyl estradiol decreases .
It should be remembered that women who take any of the above-mentioned drugs for a short course should additionally use barrier contraceptives throughout the entire period of treatment and for 7 days after its completion.
If a woman is undergoing treatment with Rifampicin , the need to use additional contraceptive measures continues for a full 4 weeks after its completion. If concomitant therapy is started at the end of taking a package of hormonal tablets, the next one should be started without taking the usual break.
