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1 tablet contains:active ingredients: drospirenone 3 mg, ethinyl estradiol 0.03 mgexcipients: lactose monohydrate 60 mg, corn starch 12.77 mg, silicon dioxide colloid 0.8 mg, hypromellose-2910 1.6 mg, talc 1.2 mg, magnesium stearate 0.6 mgfilm coat: opadry II yellow 31F82689 2.4 mg (hypromellose-2910 33%, lactose monohydrate 28%, titanium dioxide (E171) 22.5%, macrogol-6000 10%, talc 5%, iron dye oxide yellow (E172) 1.5%).
Pharmacotherapeutic group:Combined contraceptive (estrogen + progestogen)ATH:G.03.A.A.12 Drospirenone and ethinyl estradiol
The drug Delsia is a low-dose combined monophasic oral hormonal contraceptive drug containing ethinyl estradiol and drospirenone. The contraceptive effect of the drug Delsia is mainly carried out by suppressing ovulation, increasing the viscosity of the cervical secretions and changing the endometrium.If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women using the contraceptive drug during the year) is less than 1. If you skip the pills or misuse, the Pearl index may increase.In women taking combined oral contraceptives (COCs), the menstrual cycle becomes more regular, painful menstruation is less common, the intensity of menstrual-like bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of. which reduces the risk of endometrial cancer and ovarian cancer.Drospirenone contained in the drug Delsia, has anti-mineralocorticoid action and prevents the increase in body weight and peripheral edema associated with estrogen-dependent fluid retention.Drospirenone also has anti-androgenic activity and helps reduce acne, oily skin and hair. This action of drospirenone is similar to the action of natural progesterone, produced in the female body. This should be considered when choosing a contraceptive drug, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea.
AbsorptionWhen ingested, drospirenone is rapidly and almost completely absorbed. After a single dose, the maximum concentration (C max) of drospirenone in the blood plasma, equal to 38 ng / ml, is reached in 1-2 hours. Food intake does not affect bioavailability, which ranges from 76 to 85%.DistributionDrospirenone binds to plasma albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CAG). Only 3-5% of the total concentration of a substance in the blood plasma is present as a free hormone. 95-97% of the substance is non-specifically bound to plasma albumin. An ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to plasma proteins. The average apparent volume of distribution is 3.7 ± 1.2 l / kg.MetabolismAfter oral administration, drospirenone is completely metabolized. Most plasma metabolites are acidic forms of drospirenone.Drospirenone is also a substrate for oxidative metabolism catalyzed by the CYP3A4 isoenzyme. The rate of metabolic clearance of drospirenone from blood plasma is 1.5 ± 0.2 ml / min / kg.RemovalThe concentration of drospirenone in plasma decreases in two phases. The second, final phase has a half-life (T1 / 2) of about 31 hours. In unchanged form, drospirenone is excreted in trace amounts. Its metabolites are excreted through the gastrointestinal tract and the kidneys in a ratio of about 1.2: 1.4. The half-life of the metabolites of drospirenone is approximately 40 hours.Equilibrium concentrationThe concentration of SHBG does not affect the pharmacokinetics of drospirenone. During the intake cycle of the drug, the concentration of drospirenone in plasma increases by 2-3 times, the equilibrium concentration is reached after 8 days of taking the drug.If kidney damageStudies have shown that the concentration of drospirenone in the blood plasma of women with mild renal dysfunction (creatinine clearance (CK) - 50-80 ml / min) when reaching equilibrium and in women with intact kidney function (CK - more than 80 ml / min) is comparable . However, in women with moderate renal impairment (CC - 30–50 ml / min), the average concentration of drospirenone in the blood plasma was 37% higher than in patients with intact kidney function. No marked changes in the concentration of potassium in the blood plasma when using drospirenone.In violation of the liverIn women with moderate hepatic impairment (Child-Pugh class B), the area under the concentration-time curve (AUC) is comparable to that in healthy women with similar Cmax values in the absorption and distribution phases. T1 / 2 of drospirenone in patients with moderate liver dysfunction was 1.8 times higher than in healthy volunteers.In patients with moderate hepatic impairment, there was a decrease in the clearance of drospirenone by approximately 50% compared with healthy women, and there were no differences in plasma potassium concentrations in the studied groups. When diabetes mellitus is detected and the concomitant use of spironolactone (both states are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma has not been established. Thus, we can conclude that the tolerability of drospirenone in women with mild and moderate liver dysfunction is good (class B on the Child-Pugh scale).EthnicityThe effect of ethnicity (a study was conducted on a cohort of women of the Caucasian race and Japanese women) on the pharmacokinetics parameters of drospirenone and ethinyl estradiol has not been established.Ethinyl Estradiol
AbsorptionAfter ingestion, ethinyl estradiol is rapidly and completely absorbed. Cmax - 100 mg / ml is achieved within 1-2 hours. During absorption and "first pass" through the liver, ethinyl estradiol is metabolized. as a result, its oral bioavailability averages about 45% with high inter-individual variability - from 20 to 65%. Simultaneous food intake in some cases is accompanied by a decrease in the bioavailability of ethinyl estradiol by 25%.DistributionEthinyl estradiol is nonspecific but firmly bound to plasma albumin (about 98%) and induces a rise in plasma concentration of SHBG. The estimated volume of distribution is 5 l / kg.MetabolismEthinyl estradiol undergoes significant primary metabolism in the intestine and liver. Ethinyl estradiol and its oxidative metabolites are primarily conjugated to glucuronides or sulfate. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg.RemovalThe decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic the first phase is characterized by a half-life of about 1 hour, the second - 20 hours. Ethinyl estradiol is practically not displayed unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine at a ratio of 4: 6. The half-life of metabolites is approximately 24 hours.Equilibrium concentrationThe equilibrium state is reached in the second half of the drug intake cycle, when the concentration of ethinyl estradiol in the blood plasma increases by 40-110% compared with the use of a single dose.
- Thrombosis (venous and arterial) at the present time or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders)- conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris) now or in history:- identified predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia. antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant)- migraine with focal neurological symptoms at present or in history- diabetes mellitus with diabetic angiopathy- multiple or severe risk factors for venous or arterial thrombosis (including complicated valvular heart disease, atrial fibrillation, vascular disease of the brain or coronary arteries uncontrolled arterial hypertension, prolonged immobilization, volume surgery, surgery on the lower extremities, in the pelvic region, neurosurgical operations, extensive injuries, smoking after the age of 35, obesity with a body mass index of more than 30 kg / m2 severe dislipoprotei emiya flight lasting more than 4 hours)- pancreatitis with severe hypertriglyceridemia now or in history- liver failure and severe liver disease (until normalization of liver function tests and within three months after the return of these indicators to normal)- liver tumors (benign or malignant) now or in history- severe renal failure and / or acute renal failure:- identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them:- bleeding from the vagina of unknown origin- pregnancy or suspicion of it- breastfeeding period- hypersensitivity to the drug- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.In the event of the first detection or development of any of the above diseases / conditions or risk factors during the use of the drug, the administration of the drug Delsia should be immediately stopped.Carefully
The ratio of the potential risk and the expected benefit of using the drug Delsia in each individual case should be assessed with the following diseases / conditions and risk factors:- Risk factors for thrombosis and thromboembolism: smoking, obesity with a body mass index of less than 30 kg / m2, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis, uncomplicated valvular heart disease, hereditary predisposition to thrombosis, uncomplicated heart disease, hereditary predisposition to thrombosis cerebral circulation at a young age in one of the closest relatives), age over 35 years in non-smoking women- other diseases in which disorders of the peripheral circulation can be observed: diabetes mellitus without diabetic angiopathy, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohns disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins- hereditary angioedema- hypertriglyceridemia- liver disease, not related to contraindications (see. "Contraindications")- Diseases that first arose 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 impairment of hearing, porphyria, herpes during a previous pregnancy, Chorea Sydengam, chloasma) - postpartum period.
Tablets should be taken orally in the order indicated on the packaging, every day at about the same time, with a small amount of water. You should take 1 tablet continuously for 21 days. Taking the pills from the next pack begins after a 7-day break, during which menstrual-like bleeding is usually observed ("withdrawal" bleeding). As a rule, it starts 2-3 days after taking the last pill and may not end before taking the pills from a new pack.Start taking the drug Delsia. In the absence of taking any hormonal contraceptive drugs in the previous month, administration of the drug Delsia starts on the 1st day of the menstrual cycle (that is, on the 1st day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.Switch from other combined hormonal contraceptive drugs (COC, vaginal ring or transdermal patch). It is preferable to start taking the drug Delsia the next day after taking the last pill containing hormones, but in no case no later than the next day after the usual 7-day break (for drugs containing 21 pills) or after taking the last pill from the previous package (for drugs containing 28 tablets). Dalsia should be taken on the day of removal of the vaginal ring or patch, but no later than the day when a new patch is to be inserted or a new patch is stuck.Transfer from contraceptives containing progestogens only ("mini-pili", injection forms, implant or intrauterine system (IUD) with controlled release of progestogen). You can switch from “mini-drank” to the drug Delsia on any day (without a break), from the implant or IUD - on the day of their removal, from the injection contraceptive - on the day when the next injection should be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.After abortion in the first trimester of pregnancy. You can start taking the drug immediately - on the day of the abortion. Subject to this condition, the woman does not need additional methods of contraception.After childbirth or termination of pregnancy in the II trimester. It is recommended to start taking the drug at 21-28 days after birth (in the absence of breastfeeding) or abortion in the II trimester. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already lived sexually, before starting the drug Delsia pregnancy should be excluded or you must wait for the first menstruation.Acceptance of missed pills. If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. A woman should take a pill as soon as possible, the next pill is taken at the usual time.If the delay in taking the drug was more than 12 hours. Contraceptive protection can be reduced. The more pills missed and the closer the pass to the 7-day break in taking pills, the greater the likelihood of pregnancy.In this case, you can follow the following two basic rules:- The drug should never be interrupted for more than 7 days- to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of tablets.Accordingly, if the delay in taking the pills was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours), the following can be recommended:The first week of taking the drug. You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used within the next 7 days. If sexual intercourse took place during the week before the pill was missed, the likelihood of pregnancy should be considered.The second week of taking the drug. You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The next pill is taken at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping 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 pregnancy increases due to the upcoming break in taking pills. A woman should strictly adhere to one of the following two options. Moreover, if within the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) within 7 days.1. You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The following tablets are taken at the usual time until the tablets in the current packaging run out. The next package should start immediately without a break. Bleeding "cancellation" is unlikely until the tablets in the second pack run out, but there may be "spotting" spotting and "breakthrough" bleeding while taking the pills.2. You can also stop taking the pills from the current package, thus starting the 7-day break (including the day you miss the pills), and then start taking the pills from the new package.If a woman misses taking pills, and then during a break in reception she has no "withdrawal" bleeding, it is necessary to exclude pregnancy.Recommendations in case of disorders of the gastrointestinal tract (GIT). In the event of severe gastrointestinal disorders (vomiting, diarrhea), absorption may be incomplete, therefore additional contraceptive methods should be used. If vomiting occurs within 4 hours after taking the pill, you should follow the recommendations when skipping pills.Change the day of the onset of menstrual bleeding. In order to delay the onset of menstrual bleeding, it is necessary to continue taking the pills from the new Delsia package without a 7-day break. Tablets from the new package can be taken as long as necessary, including until the package is finished. On the background of taking the drug from the second package, "spotting" bleeding from the vagina or "breakthrough" uterine bleeding is possible. Resume regular use of the drug Delsia from the next package should be after the usual 7-day break. In order to transfer the onset of menstrual bleeding to another day of the week, a woman should shorten the closest interruption in taking the pills for the desired number of days. The shorter the interval, the higher the risk that she will not have "withdrawal" bleeding, and in the future there will be "spotting" discharge and "breakthrough" bleeding while taking the tablets from the second package (as well as when she would like to delay the onset of menstrual bleeding).
Use in children. The efficacy and safety of the drug as a contraceptive studied in women of reproductive age. The use of the drug before the onset of menarche is not shown. 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 in women over 18 years of age. The available data do not suggest dose adjustment in this age group.Use in old age. After menopause, the use of the drug Delsia is not shown.Use in violation of the liver. The use of the drug is contraindicated in the presence of currently severe liver disease (until normalization of functional liver tests and within three months after the return of these indicators to normal).Use in violation of renal function. Use of the drug is contraindicated in acute renal failure and severe renal failure.
The use of the drug Delsia is contraindicated during pregnancy. If pregnancy is detected while taking the drug Delsia, the drug should be stopped immediately. Conducted epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or a teratogenic effect in cases where sex hormones were taken carelessly in the early stages of pregnancy. Experimental studies on animals have shown the adverse effects of the drug during pregnancy and lactation in animals. Based on these data, we can not exclude the possibility of adverse effects of the drug on the fetus or newborn in humans.Available data on the results of taking the drug Delsia during pregnancy is limited, which does not allow to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and newborn. There are currently no significant epidemiological data available.Breastfeeding period
The use of the drug Delsia is contraindicated during breastfeeding. KOK can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding stops. A small amount of sex hormones and / or their metabolites can pass into breast milk.
The following adverse reactions have been reported while using the combination of drospirenone and ethinyl estradiol.On the part of the immune system: rarely - hypersensitivity reactions, asthma.Mental disorders: often - depressive mood infrequently - increased libido, decreased libido.On the part of the nervous system: often - a headache.From the organ of hearing: rarely - hearing loss.Since the cardiovascular system: often - migraine infrequently - hypertension, hypotension rarely, venous or arterial thromboembolism.On the part of the digestive system: often - nausea infrequently - vomiting, diarrhea.From the skin and subcutaneous tissues: infrequently - acne, eczema, itching, alopecia rarely, erythema nodosum, erythema multiforme.On the part of the genitals and mammary gland: menstrual disorders, intermenstrual bleeding, breast tenderness, vaginal discharge, vulvovaginal candidiasis infrequently - an increase in the mammary glands, vaginitis rarely - discharge from the mammary glands.Other: infrequently - weight gain, weight loss, fluid retention.The following are the side reactions with a very rare occurrence or delayed symptoms, which are believed to be associated with taking drugs from the oral group of oral contraceptives:- venous thromboembolic disorders- arterial thromboembolic disorders- hypertension- liver tumors- conditions developing or worsening while taking combined oral contraceptives, but their relationship with the drug is not proven: Crohn's disease, ulcerative colitis, epilepsy, porphyria, systemic lupus erythematosus, pregnant herpes, Sydenhem's chorea, hemolytic-uremic syndrome, jaundice and / or itching associated with cholestasis- chloasma- acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until the liver functions back to normal- in women with hereditary angioedema, estrogen administration may cause or aggravate its symptoms- the frequency of diagnosing breast cancer in women taking combined oral contraceptives is somewhat increased. Due to the fact that breast cancer is rarely observed in women under 40 years old, an increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant relative to the overall risk of this disease.
Before starting or resuming use of the drug, Delsia, you should familiarize yourself with the history of life, family history of the woman, conduct a thorough general medical (including blood pressure, heart rate, body mass index) and gynecological examination, including breast examination and cytological examination of scrapings from the cervix (Pap test), exclude pregnancy. The amount of additional research and the frequency of control examinations is determined individually. Usually, control examinations should be carried out at least 1 time in 6 months.A woman should be informed that Delsia does not protect against HIV infection (AIDS) and other sexually transmitted diseases.If any of the conditions, diseases, and risk factors listed below are present, then the potential risk and the expected benefits of using COC in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the drug. When weighting, amplification, or at the first manifestation of risk factors may require the abolition of 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, cerebrovascular disease. 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 COC or the resumption of the use of the same or different COCs (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 VTE in women taking low-dose COCs (containing less than 50 µg of ethinyl estradiol) is 2–3 times higher than in non-pregnant women who do not take COCs however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth. VTE can be fatal (1-2% of cases).According to some reports, drugs containing drospirenone have a higher risk of thromboembolic complications compared with drugs containing levonorgestrel, norgestimate or norethisterone.VTE, which is manifested in the form of deep vein thrombosis or pulmonary thromboembolism (PE), can develop with the use of any COCs.Thrombosis of other blood vessels, such as the hepatic, mesenteric, renal, cerebral veins and retinal arteries or vessels, is extremely rare with COCs. There is no consensus regarding the relationship between the occurrence of these events and the use of KOC. Symptoms of deep vein thrombosis (DVT) include: one-sided swelling of the lower limb or along the vein on 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 change in the color of the skin of the lower limb .The symptoms of pulmonary embolism are as follows: difficulty breathing or rapid breathing sudden cough, incl. with hemoptysis acute pain in the chest, which may increase 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 may be misinterpreted as symptoms of other more or less serious 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, limbs, 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 slight blueing of the extremities, acute abdomen.Symptoms of myocardial infarction include: pain the discomfort a feeling of pressure, heaviness, a feeling of constriction or fullness in the chest, in the hand or behind the sternum discomfort in the left half of the chest radiating to the back, cheekbone, larynx, arm, epigastric region cold sweat, nausea, vomiting, dizziness, severe weakness, anxiety, shortness of breath feeling of rapid or irregular heartbeat.Arterial thromboembolism can be life threatening or fatal.In women with a combination of several risk factors for arterial and venous thrombosis and thromboembolism or a high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the total value of the existing risk factors increases. In this case, taking the drug Delsia is contraindicated (see section "Contraindications").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 of more than 30 kg / m2)- family history (for example, thrombosis or thromboembolism in first-line relatives 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 COCs- long-term immobilization, serious surgery on the lower limbs, in the pelvic region, neurosurgical operations or extensive trauma. In these situations, it is necessary to discontinue use of the COC (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. Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE. especially with other risk factors- severe 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, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), and sickle cell anemia.An increase in the frequency and severity of migraine attacks during the application of COCs (which may precede cerebrovascular disorders) is a reason for the immediate cessation of these drugs.Biochemical indices indicating hereditary or acquired susceptibility to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia. antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin. lupus anticoagulant).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 (containing less than 50 μg of ethinyl estradiol).TumorsThe 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 COCs. However, the connection with the reception of the COC is not proven. Conflicting data remain on the extent to which these data are associated with screening for the identification of cervical pathology or sexual behavior (more rare use of barrier methods of contraception).There is also evidence of a reduction in the risk of endometrial and ovarian cancer when taking COCs.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 COCs 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 old, an increase in the number of breast cancer diagnoses in women who are taking COCs now or who have recently taken it is insignificant relative to the overall risk of this disease. The relationship between the development of breast cancer and COC is not proven. The observed increase in risk may also be due to careful observation and earlier diagnosis of breast cancer in women using COCs. Women who have ever applied COC. earlier stages of breast cancer are detected than in women who have never used them.In rare cases, the development of benign, and in extremely rare cases, malignant tumors of the liver, which in some cases led to life-threatening intra-abdominal bleeding, were observed against the background of COCs. In the event of 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 concentration of potassium in women with mild to moderate renal insufficiency. Theoretically, there is a risk of hyperkalemia in women with impaired renal function and the initial concentration of potassium in the blood plasma at the level of the upper limit of normal or on the background of medication, leading to a delay of potassium in the body.Women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking COCs. Although a slight increase in blood pressure has been reported in many women taking COCs, clinically significant hypertension has been rarely observed. However, if a persistent, clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of hypertension should be initiated. Receiving COC 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 during both pregnancy and COC. but their association with COC is not proven: jaundice and / or pruritus associated with cholestasis the formation of gallstones: porphyria SLE: hemolytic uremic syndrome Sydenham's chorea: herpes during pregnancy hearing loss associated with otosclerosis. Also described are cases of Crohn's disease or ulcerative colitis associated with COC use.With the use of the drug may develop chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking COCs should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.In acute or chronic liver dysfunction, it may be necessary to discontinue the drug until the liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during the previous administration of sex hormones, requires discontinuation of COC.Although COCs may affect insulin resistance and glucose tolerance, there is no need to change the dosage regimen of hypoglycemic agents in women with diabetes who use low-dose COCs (containing less than 50 µg of ethinyl estradiol). However, women with diabetes mellitus need careful control of the concentration of glucose in the blood during the use of the drug.Reduced efficiency
The effectiveness of COCs can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions.Effect on the menstrual cycle
Irregular (acyclic) bleeding ("spotting" bleeding or "breakthrough" bleeding) may occur on the background of COC use, especially during the first months of use. Therefore, any irregular bleeding should be assessed only 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 neoplasms or pregnancy.Some women may not develop "withdrawal" bleeding during a break in the pill. If the COC was taken as directed, then pregnancy is unlikely. However, if prior to this, the COC was administered irregularly, or if there are no two “withdrawal” bleeding in a row, then pregnancy should be excluded before continuing to take the drug.Impact on laboratory test scores
Admission of COCs can influence the results of some laboratory tests, including indicators of liver function, kidney, thyroid gland, adrenal glands, concentration of transport proteins in plasma, carbohydrate metabolism, coagulation parameters and fibrinolysis. Changes usually do not go beyond the normal range. Drospirenone increases the concentration of renin and aldosterone in the blood plasma, which is associated with its antimineralocorticoid effect.Impact on the ability to drive trans. Wed and fur .:
No effects on the ability to drive vehicles and mechanisms have been identified.
The interaction of COCs with other drugs can lead to "breakthrough" bleeding and / or a decrease in contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to the drug Delsia or choose another method of contraception.Interactions leading to a decrease in the effectiveness of the drug Delsia
Effect on hepatic metabolism. The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which, in turn, can lead to "breakthrough" bleeding or decrease the reliability of contraception. Such drugs include phenytoin, barbiturates, primidone. carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.When combined with the drug Delsia, many HIV protease and hepatitis C virus inhibitors, as well as non-nucleoside reverse transcriptase inhibitors, can either increase or decrease the concentration of estrogen or gestagen in the blood plasma. In some cases, this effect may be clinically significant.During the taking of drugs that affect the microsomal liver enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be additionally used.Effects on enterohepatic recirculation. Some antibiotics (for example, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol.During the reception of antibiotics (such as penicillins and tetracyclines) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of use of the barrier method of protection ends later than the tablets in the package, you need to proceed to taking the pills from the next package of the drug Delsia without the usual interruption in taking the pills.Other interactions
Strong and moderate inhibitors of CYP3A4. such as azole antimycotics (for example, itraconazole, voriconazole, fluconazole), verapamil. macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen or progestin, or both.It was shown that etoricoxib in doses of 60 and 120 mg / day when taken in conjunction with COC containing 0.035 mg of ethinyl estradiol. increases the concentration of ethinyl estradiol in the blood plasma by 1.4 and 1.6 times, respectively.In vitro, drospirenone is able to weakly or moderately inhibit cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.Based on in vivo interaction studies in female volunteers who took omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of 3 mg of drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely. In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical studies, prescribing a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only led to a slight increase in plasma concentrations of CYP3A4 substrates (for example, midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (for example, theophylline ) or moderately (for example, melatonin and tizanidine).COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue concentrations.There is a theoretical possibility of increasing the concentration of potassium in the blood plasma of women who receive the drug Delsia along with other drugs that can increase the concentration of potassium in the blood plasma. These drugs include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies studying the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between the concentration of potassium in the blood plasma in comparison with placebo. However, in women taking drugs that increase the concentration of potassium in the blood plasma, it is recommended to determine this indicator during the first cycle of the drug Delsia.Despite the fact that taking COCs affects insulin resistance and glucose tolerance, dose adjustment of hypoglycemic drugs while taking COCs is not required.
No serious violations in overdose were reported. Based on a generalized experience with COCs, symptoms that may occur during an overdose: nausea, vomiting, vaginal bloody discharge or metrorrhagia.Treatment: conduct symptomatic therapy. There is no specific antidote.Shelf life - 2 years.Storage conditions
At a temperature not higher than 25 ° С.Keep out of the reach of children.Terms of sell
You can buy Delsia without a prescription.'
|The purpose of the medication||Contraception|