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Drospirenone, Ethinyl Estradiol, Calcium Levomefolinate

Bayer Pharma AG
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2019-09-19
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Clinical Pharmacology

Jess Plus is a low-dose monophasic oral combined estrogen-progestin contraceptive drug, which includes active pills and auxiliary vitamin pills containing calcium levomefolat.

The contraceptive effect of the drug Jess Plus is mainly due to the suppression of ovulation and increasing the viscosity of cervical mucus.

In women taking combined oral contraceptives (COCs), the cycle becomes more regular, soreness, intensity and duration of menstrual bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduction in the risk of endometrial and ovarian cancer.

Drospirenone contained in the drug Plus Plus, has anti-mineralocorticoid action and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps reduce acne (acne), oily skin and hair. This effect of drospirenone is similar to the action of natural progesterone, produced in 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 and seborrhea. If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or misuse, the Pearl Index may increase.

The acidic form of calcium levomefolata, its structure is identical to the natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form contained in food. The average concentration in the blood plasma of people who do not use food enriched with folic acid is about 15 nmol / l.

Levomefolat, unlike folic acid, is a biologically active form of folate. Because of this, it is absorbed better than folic acid. Levomefolat is indicated to meet the increased need and provide the necessary folate content in the woman’s body during pregnancy and during breastfeeding. The introduction of calcium levomefolata in the oral contraceptive reduces the risk of developing a defect in the neural tube of the fetus if a woman unexpectedly becomes pregnant immediately after discontinuation of the use of contraception (or in very rare cases when using oral contraception).

Pharmacokinetics

Drospirenone

Absorption. When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration Cmax Drospirenone in the blood plasma, equal to 35 ng / ml, is achieved in 1–2 hours. Bioavailability varies from 76 to 85%. Compared with taking drospirenone on an empty stomach, eating does not affect its bioavailability.

Distribution. After oral administration, there is a two-phase decrease in serum level of the drug with T1/2 respectively (1.6 ± 0.7) h and (27.0 ± 7.5) h. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (GTC). Only 3-5% of the total concentration of the substance in the serum is present as a free hormone. An ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to plasma proteins. Average apparent vd makes (3,7 ± 1,2) l / kg.

Metabolism. After oral administration, drospirenone is extensively metabolized. Most plasma metabolites are represented by the acidic forms of drospirenone, which are formed without the involvement of the cytochrome P450 system. The isoenzyme of cytochrome P4503A4 participates to a minimum extent in the metabolism of drospirenone, drospirenone is able to reduce the concentration of the enzyme in the blood plasma and the activity of the cytochrome P4501A1, P4502С9 and P4502С19 isoenzymes in vitro.

Derivation. The rate of metabolic clearance of drospirenone in plasma is (1.5 ± 0.2) ml / min / kg. In unchanged form, drospirenone is excreted only in trace amounts. The metabolites of drospirenone are excreted through the gastrointestinal tract and kidneys in a ratio of approximately 1.2: 1.4. T1/2 for excretion of metabolites - about 40 hours.

Equilibrium concentration. During the first course of use of the drug Css Drospirenone in the blood plasma of about 60 ng / ml is achieved from the 7th to the 14th day of the drug. There was an increase in plasma concentration of drospirenone approximately 2-3 times (due to cumulation), which was determined by the ratio T1/2 in the terminal phase and dosing interval. A further increase in the concentration of drospirenone in plasma is noted after 1-6 courses of use of the drug, after which there is no increase in concentration.

Impaired renal function. Plasma concentration of drospirenone when reaching equilibrium was comparable in women with mild renal dysfunction (Cl creatinine - 50–80 ml / min) and in women with intact kidney function (Cl creatinine> 80 ml / min). However, in women with moderate renal dysfunction (creatinine Cl - 30–50 ml / min), the average concentration of drospirenone in the blood plasma was 37% higher than in patients with preserved renal function. No marked changes in the concentration of potassium in the blood plasma when using drospirenone.

Liver dysfunction. In women with moderate hepatic impairment (Child-Pugh grade B), AUC is comparable to that in healthy women with similar C values.max in the phases of absorption and distribution. T1/2 drospirenone in patients with moderate liver dysfunction was 1.8 times higher than in healthy volunteers with intact liver function.

In patients with moderately impaired liver function, there was a decrease in the clearance of drospirenone by about 50% compared with women with intact liver function, and there were no differences in plasma potassium concentrations in the studied groups. Changes in the concentration of potassium are not observed even in the case of a combination of factors predisposing to its increase (concomitant diabetes mellitus or treatment with spironolactone).

Ethinyl Estradiol

Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. Cmax - about 33 pg / ml - achieved within 1–2 hours. The drug is subjected to a first-pass metabolism in the liver, its bioavailability when taken orally is on average about 60%. Simultaneous food intake in some cases is accompanied by a decrease in the bioavailability of ethinyl estradiol by 25%.

Distribution. The concentration of ethinyl estradiol in the blood plasma decreases in 2 phases, T1/2 Ethinyl estradiol in the second phase is about 24 hours. Ethinyl estradiol has nonspecific but strong binding to plasma albumin (about 98.5%) and induces an increase in plasma concentration of SHBG. Estimated Vd makes about 5 l / kg.

Metabolism. Ethinyl estradiol undergoes presystemic conjugation in the liver and in the mucosa of the small intestine. The main metabolic pathway of ethinyl estradiol is aromatic hydroxylation with the formation of numerous metabolites that are in both bound and unbound state. The rate of elimination of ethinyl estradiol is about 5 ml / min / kg.

Derivation. Ethinyl estradiol is derived only as metabolites by the kidneys and through the gastrointestinal tract in the ratio 4: 6 with T1/2 about 24 hours

Equilibrium concentration. The equilibrium state is reached in the second half of the course of treatment, the concentration of ethinyl estradiol in the blood plasma increases approximately 1.4-2.1 times.

Ethnicity. The effect of ethnicity on pharmacokinetic parameters was studied in single and multiple dosing studies of drospirenone and ethinyl estradiol in healthy women of the European race, as well as in Japanese women. The effect of ethnicity on the pharmacokinetic parameters of drospirenone and ethinyl estradiol has not been established.

Calcium levomefolat

Absorption. After ingestion of calcium, levomefolat is rapidly absorbed and incorporated into the body folate pool. After a single ingestion of 0.451 mg of calcium levomefolata in 0.5–1.5 hours Cmax becomes 50 nmol / l higher than the initial concentration.

Distribution. Folate pharmacokinetics has a biphasic character: folate pool is determined with a fast and slow metabolism. A fast metabolized pool is likely to represent folate re-ingested, which is consistent with T1/2 calcium levomefolat, which is about 4-5 hours after a single dose of 0.451 mg. A slow metabolism pool reflects polyglutamate folate conversion, T1/2 which is about 100 days. Inbound folates and folates, going through the enterohepatic cycle, maintain a constant concentration of L-5-methyl-THF in the body.

L-5-methyl-THF represents the main form of folate in the body, in which they are delivered to peripheral tissues for participation in cellular folate metabolism.

Metabolism. L-5-methyl-THF is the main folate transported form in plasma. When comparing 0.451 mg of calcium levomefolata and 0.4 mg of folic acid, similar metabolic mechanisms were established for other significant folates. Folate coenzymes are involved in 3 major conjugated metabolic cycles in the cytoplasm of cells. These cycles are necessary for the synthesis of thymidine and purines, the precursors of deoxyribonucleic (DNA) and ribonucleic (RNA) acids, as well as for the synthesis of methionine from homocysteine ​​and the conversion of serine to glycine.

Derivation. L-5-methyl-THF is excreted by the kidneys unchanged and in the form of metabolites, as well as through the gastrointestinal tract.

Equilibrium concentration. The equilibrium state of L-5-methyl-THF in the blood plasma after ingestion of 0.451 mg of calcium levomefolata is reached in 8–16 weeks and depends on its initial concentration. In red blood cells Css is achieved at a later date due to the life span of red blood cells, which is about 120 days.

Indications

  • contraception, intended primarily for women with symptoms of hormone-dependent fluid retention in the body;
  • contraception and treatment of moderate acne(acne vulgaris);
  • contraception in women with folate deficiency;
  • contraception and treatment of severe premenstrual syndrome (PMS).

Composition

1 active combination tablet contains:
active substances: Drospirenone (micronized) 3 mg, ethinyl estradiol betadex clathrate, micronized (in terms of ethinyl estradiol) 0.02 mg, calcium levofefat (micronized) 0.451 mg;
Excipients: lactose monohydrate - 45.329 mg; MCC - 24.8 mg; croscarmellose sodium - 3.2 mg; hyprolosis (5 cp) - 1.6 mg; magnesium stearate - 1.6 mg
film cover: pink varnish - 2 mg or (alternatively): hypromellose (5 cP) - 1,0112 mg, macrogol 6000 - 0.2024 mg; talc - 0.2024 mg; titanium dioxide - 0.5580 mg; iron dye red oxide - 0.026 mg.

1 supplemental vitamin tablet contains:
active substance: calcium levomefolat (micronized) 0.451 mg,
Excipients: lactose monohydrate - 48.349 mg; MCC - 24.8 mg; croscarmellose sodium - 3.2 mg; hyprolosis (5 cp) - 1.6 mg; magnesium stearate - 1.6 mg,
film cover: light orange lacquer - 2 mg or (alternatively): hypromellose (5 cP) - 1,0112 mg, macrogol 6000 - 0.2024 mg; talc - 0.2024 mg; titanium dioxide - 0.5723 mg; iron dye yellow oxide - 0.0089 mg; iron dye red oxide - 0.0028 mg.

Drospirenone, Ethinyl Estradiol, Calcium Levomefolinate is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Jess plus Bayer Pharma AG Germany pills
Yarina Plus Bayer Pharma AG Germany pills

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Drospirenone, Ethinyl Estradiol, Calcium Levomefolinate

Dosage and Administration

Inside in the order indicated on the package, every day at approximately the same time, without chewing, with a small amount of water.

Take 1 tab. per day, continuously, for 28 days. Taking the pills from the next pack begins immediately after the end of the previous one.

Start taking the drug Jess A plus

Taking the drug jess Plus starts on the first day of the menstrual cycle (i.e., on the first day of the menstrual bleeding).

Recommendations in case of vomiting and diarrhea

In case of vomiting or diarrhea up to 4 hours after taking the pills, absorption may be incomplete, and additional measures should be taken to prevent unwanted pregnancy.

Use in certain patient groups

Children. Efficacy and safety of the drug Jess Plus as a contraceptive studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in post-pubertal age up to 18 years of age are similar to those of women over 18 years of age. The use of the drug before menarche is not shown.

Elderly patients. The drug Jess Plus does not apply after menopause.

Liver dysfunction. The drug is contraindicated for use in women with severely impaired liver function.

Impaired renal function. The drug is contraindicated for use in women with severe impaired renal function and in acute renal failure.

Adverse reactions

The most common adverse reactions reported in connection with the use of the drug Jes are as follows:

- nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified genesis (more than 3% of women using the drug according to the indications "Contraception" and "Contraception and treatment of the moderate form of acne / acne vulgaris /");

- nausea, pain in the mammary glands, irregular uterine bleeding (more than 10% of women using the drug for the indication of "Contraception and treatment of severe premenstrual syndrome").

Serious adverse reactions are arterial and venous thromboembolism. Below is the frequency of adverse reactions that were reported during clinical trials of drugs Jess and Plus Plus for "Contraception", as well as for "Contraception and treatment of the moderate form of acne (acne vulgaris)" (n = 3565) and "Contraception and treatment severe premenstrual syndrome "(n = 289) for the drug Jes. Within each group, selected depending on the frequency of occurrence, adverse reactions are presented in order of decreasing severity. The incidence of adverse events was classified as follows: frequent (≥1 / 100 and

From the side of the central nervous system: often - migraine.

Mental disorders: often - mood swings, depression / depressed mood; infrequently - decrease or loss of libido.

Since the cardiovascular system: rarely, venous or arterial thromboembolism (approximate frequency following epidemiological studies covering the group of combined oral contraceptives. Frequency bordered with very rare. The term includes the following nosological units: peripheral deep venous occlusion, thrombosis and embolism / pulmonary vascular occlusion, thrombosis of the deep veins, thrombosis and pulmonary vascular occlusion, thrombosis, pulmonary vascular occlusion, thrombosis, thrombosis and pulmonary vessels; and heart attack, myocardial infarction, cerebral infarction and hemorrhagic stroke).

From the digestive system: often nausea.

From the skin: frequency unknown erythema multiforme.

From the reproductive system and mammary glands: often - pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin.

Adverse events were classified using the MedDRA (Medical Regulatory Activity Dictionary) dictionary.Different MedDRA terms, reflecting the same symptom, were grouped together and presented as the only adverse reaction, in order to avoid weakening or blurring the true effect.

CAREFULLY

  • The potential risk and the expected benefit of using the drug Jess Plus in each individual case should be assessed with the following diseases / conditions and risk factors:
  • thrombosis risk factors and venous thromboembolism: smoking, obesity, dislipoproteinemia controlled hypertension, migraine without focal neurological symptoms, uncomplicated valvular disease, a genetic predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age, someone from the next relatives);
  • other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; hereditary angioedema;
  • hypertriglyceridemia;
  • liver disease, not related to contraindications;
  • diseases first arisen or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes of pregnant women, Sydenhamma chorea);
  • postpartum period.

Drug interactions

The interaction of oral contraceptives with other drugs can lead to breakthrough uterine bleeding and / or decrease the reliability of contraception.

The interactions leading to a decrease in the effectiveness of the drug Jes® A plus

Effect on hepatic metabolism. The use of drugs that induce liver microsomal enzymes, can lead to an increase in the clearance of sex hormones. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort. HIV protease inhibitors (for example, ritonavir) and non-nucleoside reverse transcriptase inhibitors (for example, nevirapine), and combinations thereof, also have the potential to affect liver metabolism.

Effect on enterohepatic recirculation. According to separate researches, some antibiotics (for example penicillins and tetracycline) can decrease enterohepatic recirculation of estrogen. thereby reducing the concentration of ethinyl estradiol.

During the taking of drugs that affect the microsomal liver enzymes, and within 28 days after their cancellation, a barrier method of contraception should be additionally used.

During the reception of antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their cancellation, a barrier method of contraception should be additionally used. If the period of use of the barrier method of contraception ends later than the hormone-containing pink pills in the package, you should skip taking the remaining auxiliary light-orange pills and start taking the drug Jes® Plus from the new package without interruption in taking the pills.

Interactions that reduce the effectiveness of calcium levomefolata

Effect on folate metabolism. Some medications reduce the concentration of folate in the blood or reduce the effectiveness of calcium levomefolata by inhibiting the enzyme dihydrofolate reductase (for example, methotrexate, trimethoprim, Sulfasalazinee and triamterene) or by reducing folate absorption (for example, cholestyramine) or by means of unknown mechanisms (for example, antiepileptic drugs, for example drugs, for example drugs (for example, cholestyramine, for example, anti-epileptic drugs, for example, anti-epileptic drugs). , phenobarbital, primidone and valproic acid).

Effect on the metabolism of CPC (enzyme inhibitors). The major metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of cytochrome P450 inhibitors on the metabolism of drospirenone is unlikely.

The effect of PDA or calcium levomefolata on the activity of other drugs

PDA can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.

Based on research interactions, as well as studies involving female volunteers who take omeprazole, simvastatin and midazolam as the substrates studied, it can be concluded that the effect of drospirenone in a dose of 3 mg on the metabolism of other drugs is unlikely.

Folates may alter the pharmacokinetics or pharmacodynamics of certain drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (mostly reversible, subject to an increase in the dose affecting the folate metabolism of the drug) of their therapeutic action. Appointment of folate during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.

Pregnancy and Lactation

Pregnancy

The drug is contraindicated during pregnancy. If pregnancy is detected while taking the drug Jess Plus, the drug should be immediately canceled. Data on the results of taking the drug Jess Plus during pregnancy is limited, and do not allow to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and the newborn child. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took COCs before pregnancy or are teratogenic in cases of COC carelessness in the early stages of pregnancy. No specific epidemiological studies have been conducted on Jess plus.

Lactation

The drug is contraindicated during lactation. Taking COCs can reduce the amount of breast milk and alter its composition, so their use is not recommended until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites may be excreted in milk, but there is no evidence of their negative impact on the health of the child.

Special instructions

If any of the conditions, diseases and risk factors listed below are presently present, the potential risk and the expected benefits of using the drug Jess should be carefully weighed.® Plus in each individual case and discuss it with a woman before she decides to start taking the drug of this drug.

Diseases of the cardiovascular system

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

The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs. Increased risk is present after the initial use of combined oral contraceptives or the resumption of the use of the same or different combined oral contraceptives (after a break between taking the drug in 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.

The overall risk of venous thromboembolism of VTE in patients taking low-dose combined oral contraceptives (<50 g="" of="" ethinyl="" estradiol="" is="" 2-3="" times="" higher="" than="" in="" non-pregnant="" patients="" who="" do="" not="" take="" pda="" however="" this="" risk="" remains="" lower="" compared="" to="" the="" vte="" during="" pregnancy="" and="" childbirth="" p="">

VTE can be life threatening or fatal (1-2% of cases).

VTE, which is manifested as deep vein thrombosis or pulmonary embolism, can occur with any combination oral contraceptive pill.

Thrombosis of other blood vessels, such as the hepatic, mesenteric, renal, cerebral veins and retinal arteries or vessels, is extremely rare with combined oral contraceptives. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.

Symptoms of deep vein thrombosis (DVT): one-sided swelling of the lower limb or along the vein of the lower limb, pain or discomfort in the lower limb only in a vertical position or when walking, local temperature increase in the affected lower limb, redness or discoloration of the skin on the lower limb.

Symptoms of pulmonary thromboembolism (pulmonary embolism): difficulty or rapid breathing; sudden cough, incl. with hemoptysis; acute chest pain, which may worsen with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are nonspecific and can be interpreted incorrectly as signs of other more or less severe events (for example, an infection of the respiratory tract).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke: sudden weakness or loss of sensitivity of the face, upper or lower extremities, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one or two-sided vision loss; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without epileptic seizures.

Other signs of vascular occlusion: sudden pain, swelling and weak blue in the limbs, acute abdomen.

Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, feeling of constriction or distension in the chest, in the 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 life threatening or fatal.

The risk of 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 old);

in the presence of:

- obesity (body mass index more than 30 kg / m2);

- family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age). In the case of hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Jes® A plus;

- prolonged immobilization, serious surgery, any operation on the lower limbs or extensive trauma. In these situations, it is advisable to stop using the drug.® Plus (in the case of the planned operation, at least four weeks before it) and not to resume reception within two weeks after the end of immobilization;

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- valvular heart disease;

- Atrial fibrillation.

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

You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can 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.

Increase in the frequency and severity of migraine while using the drug Jess® Plus (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of this drug.

The biochemical indices indicating hereditary or acquired susceptibility to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin III, lack of protein C, lack of protein S, anti-phospholipid antibodies (anti-cardiolipin antibodies, anti-antikoma, anti-antithrombin-III, anti-antithrombin III, anti-anthrax)

When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<50 g="" of="" ethinyl="" estradiol="" p="">

Tumors

The most important risk factor for cervical cancer is persistent HPV infection. There are reports of some increase in the risk of developing cervical cancer with prolonged use of CPC. However, the connection with the admission of the CCP is not proven. The possibility of the relationship of these data with screening for diseases of the cervix uterus and with the characteristics of sexual behavior (more rare use of barrier methods of contraception) is discussed.

A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women taking CPC at the present time (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely observed in women under 40 years of age, an increase in the number of breast cancer diagnoses in women who are currently taking or are taking CCP is insignificant relative to the overall risk of this disease. His connection with the reception of the CCP is not proven. The observed increase in risk may be the result of careful observation and earlier diagnosis of breast cancer in women using PDA. Women who have ever used CCP, are detected earlier stages of breast cancer than women who have never used them.

In rare cases, against the background of the use of PDA, the development of benign, and in extremely rare cases, malignant tumors of the liver, which in individual patients led to life-threatening intra-abdominal bleeding, was observed.

If you experience severe pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis.

Tumors can be life threatening or fatal.

Other states

Clinical studies have shown no effect of drospirenone on plasma potassium concentration in patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial concentration of potassium at the upper limit of the norm, the risk of hyperkalemia cannot be ruled out against the background of medication, leading to a delay of potassium in the body.

Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking PDA.

Despite the fact that a slight increase in blood pressure has been described in many women taking CPC, clinically significant increases were rarely observed. However, if while taking the drug Jess® Plus, a persistent, clinically significant increase in blood pressure is developing; this drug should be discontinued and treatment of hypertension should begin. 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 when taking PDA, but their relationship with taking PDA has not been proven: jaundice and / or pruritus associated with cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus: hemolytic-uremic syndrome; Chorea Sydenham; herpes pregnant; hearing loss associated with otosclerosis. Also described are cases of Crohn's disease and ulcerative colitis with PDA use.

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

Acute or chronic abnormal liver function may require discontinuation of the drug Jess® Plus, as long as liver function indicators do not return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous intake of sex hormones, requires discontinuation of the drug Jess® A plus.

Although KPC may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients who use the drug Jes® A plus. However, women with diabetes should be carefully monitored while taking this drug.

Chloasma can sometimes develop, especially in women with a history of pregnant chloasma. Women with a penchant for chloasma while taking the drug Jess® Plus should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Folate may mask vitamin B deficiency12.

Preclinical safety data

Preclinical data obtained in the course of standard studies to identify toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of particular risk to humans. Nevertheless, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.

The preclinical data obtained in the course of standard studies of calcium levomefolata to identify toxicity with repeated doses of the drug, as well as genotoxicity and toxicity for the reproductive system, do not indicate a particular risk to humans.

Laboratory tests

Taking the drug jess® Plus, it can affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, concentration of transport proteins in plasma, indicators of carbohydrate metabolism, blood coagulation parameters and fibrinolysis. Changes usually do not go beyond the normal range. Drospirenone increases plasma renin activity and aldosterone concentration, which is associated with its antimineralocorticoid effect.

There is a theoretical possibility of increasing the concentration of potassium in the blood plasma of women receiving the drug Jes® Plus, along with other drugs that can increase the content of potassium in the blood plasma. These drugs include angiotensin II receptor antagonists, potassium-saving diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between plasma potassium concentration compared with placebo.

Reduced efficiency

The effectiveness of the drug Jess® Plus can be reduced in the following cases: when skipping pills, vomiting and diarrhea, or as a result of drug interactions.

The frequency and severity of menstrual bleeding

On the background of taking the drug Jess® Plus, there may be irregular (acyclic) bleeding and vaginal bleeding (spotting or "breakthrough" uterine bleeding), especially during the first months of use. Therefore, the assessment of any irregular bleeding should be carried out after an adaptation period of approximately 3 cycles.

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

Some women may not develop "withdrawal" bleeding during a break in the pill. If the drug is jess® Plus was taken as recommended, it is unlikely that a woman is pregnant. However, with an irregular use of the drug Jess®Plus, and the absence of two consecutive bleeding "cancellation", the drug can not be continued until pregnancy is excluded.

Medical examinations

Before starting or resuming use of the drug, you should familiarize yourself with the history of life, family history of the woman, conduct a thorough physical examination (including measurement of blood pressure, heart rate, body mass index, breast examination), gynecological examination, cytological examination of the cervix (Pap test), exclude pregnancy. When you resume taking the drug Jess® Plus the amount of additional research and the frequency of control examinations is determined individually, but at least 1 time in 6 months.

It should warn the woman that the drug Jess® Plus does not protect against HIV infection and other sexually transmitted diseases.

Influence on ability to drive motor transport and control mechanisms

Cases of adverse effects of Jess have not been reported.® Plus the speed of psychomotor reactions; Research on the effect of the drug on the speed of psychomotor reactions has not been conducted.

Overdosage

Cases of drug overdose Jess Plus were not reported.

Symptoms: nausea, vomiting, spotting from the vagina, or metrorrhagia (more often in young women).

Treatment: there is no specific antidote, symptomatic treatment should be carried out. Calcium levomefolat and its metabolites are identical to folates, which are part of natural products, the daily consumption of which does not harm the body. Calcium levomefolata at a dose of 17 mg per day (the dose is 37 times higher than that contained in 1 table. Of the drug Jes Plus) for 12 weeks was well tolerated.

  • Brand name: Jes plus
  • Active ingredient: Drospirenone, Ethinyl Estradiol, Calcium Levomefolinate
  • Dosage form: Film Coated pills
  • Manufacturer: Bayer Pharma AG
  • Country of Origin: Germany

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