Jeanine, pills, 21pcs

$90.0

Active ingredient:	Dienogest, Ethinylestradiol
Dosage form:	Drage
Indications for use:	Contraception

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Categories: Contraceptive, Medication, Obstetrics, gynecology

Description
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Composition

of 1 tablet contains:

Active ingredient:

ethinyl estradiol 0.03 mg,

dienogest 2 mg,

excipients:

lactose monohydrate;

potato starch;

gelatin;

talc;

magnesium stearate;

sucrose;

dextrose (glucose syrup);

macrogol 35000;

calcium carbonate;

povidone K 25;

titanium dioxide (E 171);

Carnauba wax

Pharmacological action

Pharmacodynamics

The contraceptive effect of Zhanin is carried out through various complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, as a result of which it becomes impermeable to spermatozoa.

When used correctly, the Pearl index (a measure that reflects the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If you skip pills or use them incorrectly, the Pearl index may increase.

The progestogenic component of Zhanin-dienogest-has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of HDL).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, the intensity and duration of bleeding decreases, and as a result, the risk of iron deficiency anemia decreases. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

Pharmacokinetics

Dienogest

Absorption. When taken orally, dienogest is rapidly and completely absorbed, and its serum cmax of 51 ng / ml is reached in approximately 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) and corticoid-binding globulin (CSG). About 10% of the total concentration in the blood serum is found in free form; about 90% is non-specifically associated with serum albumin. Induction of SHBS synthesis by ethinylestradiol does not affect the binding of dienogest to serum albumin.

Metabolism. Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 l/h.

Output. T_1/2 from plasma is about 8.5-10.8 h. In unchanged form, it is excreted in the urine in a small amount; in the form of metabolites — by the kidneys and through the gastrointestinal tract in a ratio of about 3: 1 with T_1/2 — 14.4 h.

Equilibrium concentration. The pharmacokinetics of dienogest are not affected by the level of SHBPS in the blood serum. As a result of daily use of the drug, the level of the substance in the serum increases approximately 1.5 times.

Ethinyl Estradiol

Absorption. After oral use, ethinyl estradiol is rapidly and completely absorbed. _Cmax in blood serum, equal to approximately 67 ng / ml, is reached in 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in an average oral bioavailability of about 44%.

Distribution. Ethinyl estradiol binds almost completely (approximately 98%), although not specifically, to albumin. Ethinyl estradiol induces the synthesis of SHBPS. The apparent volume of distribution of ethinyl estradiol is 2.8-8.6 l / kg.

Metabolism. Ethinyl estradiol undergoes presystemic biotransformation both in the small intestine mucosa and in the liver. The main pathway of metabolism is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3-7 ml / min / kg.

Output. The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by T_1/2 of about 1 h, the second — T_1/2 of 10-20 h. It is not excreted unchanged from the body. Metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of 4: 6 with a T_1/2 of about 24 hours.

Equilibrium concentration. The equilibrium concentration is reached during the second half of the treatment cycle.

Indications

Hormonal contraception.

Use during pregnancy and lactation

Jeanine® is not prescribed during pregnancy and lactation.

If pregnancy is detected while taking Jeanine®, it should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were taken carelessly in early pregnancy.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is contraindicated during lactation. Small amounts of sex steroids and / or their metabolites can be excreted in milk.

Contraindications

Jeanine® should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be discontinued immediately. :

hypersensitivity to any component of the drug Jeanine®;

thrombosis (venous and arterial) and thromboembolism in the present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

state prior thrombosis (including transient ischemic attack, angina) at present or in history;

migraine with focal neurological symptoms in the present or in the anamnesis;

diabetes mellitus with vascular complications;

severe or multiple risk factors for venous or arterial thrombosis, including complicated lesions of valvular apparatus of the heart, atrial fibrillation, vascular diseases of the brain or coronary arteries of the heart;

uncontrolled hypertension;

major surgery with prolonged immobilization;

the Smoking age 35 years;

pancreatitis with severe hypertriglyceridemia now or in history;

liver failure and severe liver disease (up to normalization of liver tests);

liver tumor (benign or malignant) at present or in history;

identification of hormone-dependent cancers (including genitalia or mammary glands) or suspicion of them;

vaginal bleeding of unknown origin;

pregnancy or suspicion of it;

the breast-feeding period.

Side effects

From the digestive system: nausea, vomiting.

From the side of the reproductive system: changes in vaginal secretion.

From the endocrine system: engorgement, soreness of the mammary glands, secretion from them; changes in body weight, changes in libido.

From the central nervous system: decreased mood, headache, migraine.

Other services: chloasma, poor tolerance of contact lenses, fluid retention in the body, allergic reactions.

Interaction

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and / or reduced contraceptive reliability. The following types of interaction have been reported in the literature.

Effects on hepatic metabolism: the use of drugs that induce microsomal liver enzymes may lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort.

HIV proteases (e. g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e. g. nevirapine) and their combinations may also potentially affect hepatic metabolism.

Effects on hepatic circulation: Some antibiotics (such as penicillins and tetracycline) have been shown to reduce the hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

When prescribing any of the above drugs, a woman should additionally use a barrier method of contraception (for example, a condom).

Substances that affect the metabolism of combined hormonal contraceptives (enzyme inhibitors). Dienogest is a substrate of cytochrome P450 (CYP)3A4. Known CYP3A4 inhibitors, such as azole antifungal drugs (e. g. ketoconazole), cimetidine, verapamil, macrolides (e. g. erythromycin), diltiazem, antidepressants, and grapefruit juice, may increase plasma levels of dienogest.

When taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

When taking antibiotics (with the exception of rifampicin and griseofulvin) and for 7 days after their withdrawal, an additional barrier method of contraception should be used. If the period of using the barrier method of protection ends later than the tablets in the package, you need to move on to the next package without the usual break in taking pills.

Oral combination contraceptives may interfere with the metabolism of other drugs, leading to an increase (for example, cyclosporine). or a decrease (for example, lamotrigine) in their concentration in plasma and tissues.

How to take it, course of use and dosage

Inside, with a small amount of water, daily at approximately the same time of day, in the order indicated on the package. Take 1 tablet a day, continuously for 21 days.Taking the next package begins after a 7-day break in taking pills, during which withdrawal bleeding usually occurs. Bleeding usually begins on the 2nd-3rd day after taking the last tablet and may not end until the start of taking a new package.

Start taking Zhanina®:

– in the absence of taking any hormonal contraceptives in the previous month. Zhanin® 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 2nd-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 pills from the first package;

– when switching from other combined oral contraceptives (from a vaginal ring, transdermal patch). It is preferable to start taking Zhanina® on 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 drugs containing 21 tablets), or after taking the last inactive tablet (for drugs containing 28 tablets in a package). In the transition from vaginal ring, transdermal patch, it is preferable to begin receiving Jeanine® daily removal of the ring or the patch, but not later than the day when it should be introduced a new ring or apply a new patch;

when the transition from contraceptives containing only progestins (“mini-pill”, the injectable form, the implant), or a progestogen releasing intrauterine device (Mirena). A woman can switch from mini-pili to Jeanine® on any day (without a break), from an implant or intrauterine contraceptive with a progestogen-on the day of its removal, from an injectable form-from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills;

– after an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection;

– after childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking the drug on the 21st-28th day after delivery 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 pills. If the woman has already had sexual activity, pregnancy should be excluded before taking Zhanina® or it is necessary to wait for the first menstruation.

Taking missed pills. If the delay in taking the drug is less than 12 hours, the contraceptive protection is not reduced. A woman should take a tablet as soon as possible, the next one is taken at the usual time.

If the delay in taking pills is more than 12 hours, the contraceptive protection may be reduced. In this case, you can follow the following two basic rules::

– taking the drug should never be interrupted for more than 7 days;

– to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation,7 days of continuous tablet intake are required.

If the delay in taking pills is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), the following tips can be given.

The first week of taking the drug

, a woman should take the last missed tablet as soon as possible (even if this means 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) should be used for the next 7 days. If sexual intercourse took place during the week before skipping pills, it is necessary to take into account the probability of pregnancy. The more pills missed and the closer the break in the intake of active substances, the more likely pregnancy.

The second week of taking the drug

, a woman should take the last missed tablet as soon as possible (even if this means taking two tablets at the same time). The next tablet is taken at the usual time.

Provided that the woman took the pills correctly during 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 pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of reduced reliability is inevitable due to the upcoming break in taking pills.

A woman should strictly adhere to one of the following two options (if all pills were taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods):

1. A woman should take the last missed pill as soon as possible (even if it means taking two pills at the same time). The next tablet is taken at the usual time, until the pills from the current package run out. The next package should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but there may be spotting and breakthrough bleeding while taking pills.

2. A woman can also stop taking 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 missed taking pills and then during a break in taking pills she does not have withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations for vomiting and diarrhea

If a woman has had vomiting or diarrhea for up to 4 hours after taking active pills, the absorption may be incomplete, and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping taking pills.

Changing the day when your menstrual cycle starts

In order to delay the onset of menstruation, a woman should continue taking pills from the new package of Zhanina® immediately after taking all the pills from the previous one, without interruption in reception. Pills from this new package can be taken as long as the woman wants (until the package is finished). Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Zhanin® from a new pack after the usual 7-day break.

In order to move the day of the beginning of menstruation to another day of the week, a woman should be recommended to shorten the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding while taking the second package (as well as in the case when she would like to delay the onset of menstruation).

Additional information for special patient categories

Children and teenagers. Jeanine® is indicated only after the onset of menarche.

Elderly patients. Not applicable. Jeanine® is not indicated after menopause.

Patients with liver disorders. Jeanine® is contraindicated in women with severe liver disease until liver function returns to normal (see also section “Contraindications”).

Patients with renal impairment. Jeanine® has not been specifically studied in patients with renal impairment. The available data do not suggest a change in treatment in these patients.

Overdose

Symptoms: nausea, vomiting, small vaginal bleeding (in girls).

Treatment: conduct symptomatic therapy. There is no specific antidote.

Special instructions

If any of the conditions, diseases, and risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed on a case-by-case basis and discussed with the woman before she decides to start taking the drug. If any of these conditions, diseases, or risk factors increase in severity, severity, or first appearance, a woman should consult with her doctor, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these medications. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of the drug for 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk is present mainly during the first 3 months.

Overall risk of VTE in patients taking low-dose combined oral contraceptives (ethinyl estradiol content —

VTE, which manifests as deep vein thrombosis, or pulmonary embolism, can occur with any combination of oral contraceptives.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels (for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels) occurs. There is no consensus on the association between the occurrence of these events and the use of combined oral contraceptives.

Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower limb or along a vein in the leg, pain or discomfort in the leg only when standing upright or walking, local fever in the affected leg, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden coughing, including with hemoptysis; acute chest pain, which can increase with deep breathing; anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are non-specific and can be misinterpreted as signs of other more or less severe events (for example, 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, arm, or leg, especially on one side of the body; sudden confusion, problems with speech and understanding; sudden one – or two-way loss of vision; sudden gait disturbance, 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 include sudden pain, swelling and slight blueness of the extremities, and a sharp stomach.

Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or behind the sternum; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting, or dizziness; severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat. Arterial thromboembolism can be fatal. The risk of developing thrombosis (venous and/or arterial) and thromboembolism 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 of age).

If available:

– obesity (body mass index greater than 30 kg/m2);

– family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide whether to take combined oral contraceptives;

– prolonged immobilization, serious surgery, any foot surgery or extensive trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least 4 weeks before it) and not resume taking them for two weeks after the end of immobilization;

– dyslipoproteinemia;

– arterial hypertension;

– migraines;

– heart valve diseases;

– atrial fibrillation.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

The increased risk of developing thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders can also occur in patients with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraines during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be a reason for immediate discontinuation of these drugs.

Biochemical parameters that indicate 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 (anti-cardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, consider that adequate treatment of the 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 oral contraceptives (ethinyl estradiol content —

Tumors

The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of cervical cancer with prolonged use of combined oral contraceptives. However, the association with the use of combined oral contraceptives has not been proven. There are still contradictions about the extent to which these data are related to screening for cervical pathology or sexual behavior (more rarely, the use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women who used combined oral contraceptives (relative risk — 1.24). The increased risk gradually disappears within 10 years after discontinuation of these medications. Because breast cancer is rare in women under the age of 40, the increase in breast cancer diagnoses among women who are currently or have recently taken combined oral contraceptives is insignificant relative to the overall risk of this disease. Its association with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier breast cancer diagnosis in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are more likely to develop early-stage breast cancer than women who have never used them.

In rare cases, the use of combined oral contraceptives resulted in the development of liver tumors, which in some cases led to life-threatening intra-abdominal bleeding. If severe abdominal pain, enlarged liver, 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 combined oral contraceptives.

Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment for arterial hypertension should be initiated. The use of combined oral contraceptives 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 with combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis. There are also cases of Crohn’s disease and ulcerative colitis associated with the use of combined oral contraceptives.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Acute or chronic liver function disorders may require discontinuation of combined oral contraceptives until liver function indicators return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (ethinyl estradiol content —

Sometimes chloasma can develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid prolonged exposure to the sun and UV radiation while taking combined oral contraceptives.

Preclinical safety data sheet

Preclinical data obtained during standard studies for the detection of toxicity with multiple doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Laboratory tests

The use of combined oral contraceptives may affect the results of certain laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein levels, carbohydrate metabolism, and coagulation and fibrinolysis parameters. Changes usually do not exceed the limits of normal values.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced in the following cases:: when skipping pills, vomiting and diarrhea, or as a result of a drug interaction.

Effects on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should only be evaluated after an adjustment period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignancies or pregnancy.

Some women may not develop withdrawal bleeding during the pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or there are no consecutive withdrawal bleeds, pregnancy should be excluded before continuing the drug.

Medical examinations

Before starting or resuming taking Jeanine®, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical examination (including blood pressure measurement, heart rate, body mass index determination) and gynecological examination, including breast examination and cytological examination of scrapings from the cervix (Pap test), and exclude pregnancy. The scope of additional examinations and the frequency of follow-up examinations are determined individually. Usually, control examinations should be carried out at least once a year.

A woman should be warned that drugs such as Jeanine® do not protect against HIV infection (AIDS) and other sexually transmitted diseases.