Instructions for use CLIMODIEN

Pharmacological properties of the drug Climodien

Climodien contains estradiol valerate, which is a prodrug of 17β-estradiol, and a synthetic progestogen, dienogest. The inclusion of estradiol in the drug provides hormone replacement therapy (HRT) after the onset of the menopausal period, as well as effective treatment of psycho-vegetative symptoms of menopause: hot flashes, episodes of increased sweating, sleep disturbances, nervousness, irritability, dizziness, headache, degenerative changes in the skin and mucous membranes genitourinary system, namely urinary incontinence, dryness and irritation of the vaginal mucosa, dyspareunia. The inclusion of dienogest in a continuous therapy regimen prevents the development of endometrial hyperplasia and leads to its atrophy, as well as a decrease in the severity and, in many cases, a further cessation of vaginal bleeding. After 3 months of therapy, menstrual bleeding stopped in approximately 67% of women, and after 12 months - in 85%. The results of clinical studies show that when using the drug Climodien, the total level of cholesterol and LDL decreases, and the level of HDL increases, as a result of which the HDL/LDL ratio increases significantly. It is believed that estrogens have a direct effect on the vascular system. During the use of the drug Climodien, the level of marker substances in the urine associated with the vasodilatory effect increases. Estradiol inhibits postmenopausal bone loss caused by estrogen deficiency. Long-term HRT has been shown to reduce the risk of distal bone fractures in postmenopausal women, mainly due to inhibition of osteoclast function, which promotes the formation of new bone tissue during the process of bone remodeling. This effect of Climodien was demonstrated by measuring specific bone markers such as ALP, pyridinoline and deoxypyridinoline compounds. The results of clinical studies involving women with sleep disorders caused by postmenopausal syndrome prove that the use of Climoden improves the quality of sleep. Based on observational data using a combination of conjugated equine estrogens with medroxyprogesterone acetate, it is assumed that the incidence of colon cancer in women receiving HRT is reduced. In a study with conjugated equine estrogens monotherapy, no reduction in this risk was observed; It is unknown whether these findings apply to other HRT medications. Dienogest, considered the only nortestosterone derivative with antiandrogenic properties, has a pronounced progestogenic effect. This in vivo may be explained by its high serum concentration after oral administration; 10% of the substance in the blood is present in the form of unbound free steroid. The mechanism of action of dienogest does not involve inhibition of cytochrome P450 in vitro , therefore dienogest is not expected to interact with other drugs at this level. The toxicity profile of estradiol and estradiol valerate has been well studied. There is no preclinical data to supplement the information provided in the instructions regarding the safety of estradiol valerate. Data from preclinical studies based on the results of standard studies of safety, toxicity with single and repeated use of genotoxicity, reproductive toxicity and carcinogenicity of the drug were not identified. Estradiol valerate Estradiol valerate is rapidly and completely absorbed. During absorption and first passage through the liver, the steroid ester is broken down into estradiol and valeric acid. Estradiol is further metabolized into estrone, estriol and estrone sulfate. After oral administration of estradiol valerate, only about 3% of estradiol is bioavailable. Eating food does not affect the bioavailability of estradiol. Within 60 minutes after taking the tablet, the concentration of estradiol in the serum increases rapidly and reaches an average value (approximately 18 pg/ml). After this, the concentration of the steroid in the blood serum slowly increases to a maximum, which is about 30 pg/ml, and is reached approximately 8 hours after taking the tablet. Estradiol binds to albumin and sex steroid binding globulin (SGBS). Only 1–1.5% of the total serum estradiol concentration exists in an unbound state, and 30–40% is bound to sex steroid binding globulin. After breaking the ester bond of exogenously administered estradiol valerate, the metabolism of the substance occurs in the same way as endogenous estradiol. Estradiol is primarily metabolized in the liver, but also outside it (eg in the intestines, kidneys, skeletal muscles and target organs). During metabolism, estrone, estriol, catecholestrogens and conjugates of these compounds with sulfuric and glucuronic acids are formed. Within 24 hours after a single oral dose of estradiol valerate, serum estradiol levels decrease to 10 pkg/ml. The half-life until the terminal phase cannot be accurately determined. Estradiol metabolites are excreted from the body in the form of sulfates and glucuronides in the urine. After repeated use, serum estradiol levels are more than 3 times higher (compared to a single dose). On average, the concentration of estradiol ranges from 40 pg/ml (minimum) to 90 pg/ml (maximum). After completion of therapy with Climodien, the levels of estradiol and estrone observed at the beginning of treatment are achieved over the next 2–3 days. Dienogest After oral administration, dienogest is rapidly and completely absorbed. The maximum serum concentration is reached within 1 hour after a single oral dose and is approximately 54 pg/ml. The absolute bioavailability of dienogest after oral administration exceeds 90%. Dienogest binds to albumin and does not bind to SHBG or corticoid-binding globulin (CBG). Only 10% of the total dienogest serum concentration is in the form of free steroid, and 90% is nonspecifically bound to albumin. Dienogest is completely metabolized primarily by hydroxylation, but also by hydrogenation, conjugation and the formation of aromatic compounds to form inactive metabolites. The clearance of metabolites from serum is approximately 0.85 ml/min/kg. Serum dienogest levels decrease biphasically. The final phase is characterized by a half-life of about 11 hours. Dienogest is not excreted unchanged. Metabolites are excreted mainly by the kidneys. The pharmacokinetics of dienogest does not depend on the level of SHB. When taken daily, the concentration of the substance in the serum increases by 1.3 times, reaching a steady state during the first half of the treatment cycle.

Use of the drug Climodien

If a woman is not taking estrogens or switching to Climodien after using another combination drug for continuous use, then treatment can be started at any time. Patients starting to take Climodien after using a cyclic combination drug for HRT should begin taking it after the end of the current cycle of therapy. Doses Take one tablet daily. Method of use Each package is designed for 28 days of treatment. Treatment is carried out continuously, that is, the next package of tablets begins immediately after the end of the previous one. The tablets should be taken without chewing with a small amount of liquid. It is advisable to maintain a constant time of day for taking. Missed pills A missed pill should be taken as soon as possible. If you are more than 24 hours late in taking the pill, you should not take an additional pill. If you miss several tablets, bleeding may occur. Nature of bleeding: Climodien can be used in women no earlier than one year after the onset of menopause, that is, no earlier than one year after the last menstrual bleeding. When taking the drug during perimenopause, there is a high risk of irregular breakthrough bleeding due to possible cyclic hormonal activity of the ovaries. HRT ensures that there are no cyclic bleedings, but they may occur during the first few cycles of using the drug. Bleeding may be unexpected in nature, but it is unlikely that its intensity will be excessive. Patients should be warned about this and explained that bleeding decreases significantly and usually stops completely over time. If severe bleeding is prolonged or if bleeding or spotting becomes unbearable, discontinuation of therapy or switching to cyclic HRT should be considered.

Note!

Description of the drug Climodien table. p/o No. 28 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Contraindications to the use of the drug Climodien

HRT should not be started for any of the following conditions. If any of these conditions occur during HRT, use of the drug should be discontinued immediately. During pregnancy and breastfeeding. Vaginal bleeding of unknown etiology. Diagnosed or suspected breast cancer. Diagnosed precancerous conditions or malignant tumors dependent on sex steroids, or suspicion of their presence. Current or history of liver tumors (benign or malignant). Severe liver diseases. Arterial thromboembolism in the acute stage (for example, myocardial infarction, stroke). Exacerbation of deep vein thrombosis, current thromboembolic disorders or a history of such diseases. Severe form of hypertriglyceridemia. Hypersensitivity to the active substances or to any of the auxiliary components of the drug.

special instructions

Climodien is not a contraceptive or fertility aid. If necessary, non-hormonal methods of contraception should be used, excluding calendar and temperature methods.

Before starting HRT, the specified conditions/risk factors should be taken into account when assessing the risk/benefit of treatment, taking into account the individual characteristics of the patient. The use of HRT should be stopped immediately if any of the contraindications are identified, as well as in the presence of the following conditions and diseases:

migraine-like or frequent and unusually severe headache that appears for the first time, or other symptoms that are likely prodromal signs of cerebral vascular occlusion;

recurrence of cholestatic jaundice or cholestatic pruritus first noted during pregnancy or previous use of sex steroids;

symptoms of thrombotic disorders or suspicion of their occurrence.

In the event of a relapse or exacerbation of any of the following diseases or risk factors, it is recommended to repeat an individual analysis of the balance of benefits and risks of therapy, taking into account the possible need to discontinue treatment.

Venous thromboembolism (VTE)

The results of epidemiological and randomized controlled studies suggest the likelihood of an increased risk of developing VTE, that is, deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with a risk factor for developing VTE, the risk-benefit ratio of treatment should be carefully weighed.

Generally recognized risk factors for the development of VTE include personal and family history (a case of VTE in a close relative at a relatively early age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE may temporarily increase with prolonged immobilization, after major elective or major surgery, or after severe trauma. The issue of temporary cessation of HRT should be decided depending on the nature of the surgical intervention and the duration

Product description certified by the manufacturer Bayer

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Side effects of the drug Climodien

In the table below, data on side effects is distributed by organs and systems. The frequency of adverse reactions is based on data from clinical studies, and a probable connection with therapy with Climodien has been established.

When using the drug Climodien, the following side effects may be noted, recorded as isolated reactions during clinical trials of drugs for HRT: fungal infections, increased appetite, inhibition of the activity of liver enzymes, an increase in the size of uterine fibroids. Very rarely, erythema nodosum, exudative erythema multiforme, chloasma and hemorrhagic dermatitis (vascular purpura) were noted in women using HRT.

Special instructions for the use of the drug Climodien

Climodien is not a contraceptive or fertility aid. If necessary, non-hormonal methods of contraception should be used, excluding calendar and temperature methods. Before starting HRT, the specified conditions/risk factors should be taken into account when assessing the risk/benefit of treatment, taking into account the individual characteristics of the patient. The use of HRT should be stopped immediately if any of the contraindications are identified, as well as in the presence of the following conditions and diseases:

• migraine-like or frequent and unusually severe headache that appears for the first time, or other symptoms that are likely prodromal signs of cerebral vascular occlusion;
• recurrence of cholestatic jaundice or cholestatic pruritus first noted during pregnancy or previous use of sex steroids;
• symptoms of thrombotic disorders or suspicion of their occurrence.

In the event of a relapse or exacerbation of any of the following diseases or risk factors, it is recommended to repeat an individual analysis of the balance of benefits and risks of therapy, taking into account the possible need to discontinue treatment. Venous thromboembolism (VTE) Epidemiological and randomized controlled studies suggest an increased risk of developing VTE, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with a risk factor for developing VTE, the risk-benefit ratio of treatment should be carefully weighed. Generally recognized risk factors for the development of VTE include personal and family history (a case of VTE in a close relative at a relatively early age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The possible role of varicose veins in the development of VTE remains controversial. The risk of VTE may temporarily increase with prolonged immobilization, after major elective or major surgery, or after severe trauma. The issue of temporary cessation of HRT should be decided depending on the nature of the surgical intervention and the duration of immobilization. Arterial thromboembolism The results of two large clinical studies using a combination of conjugated equine estrogens and medroxyprogesterone acetate (MPA) in a continuous regimen indicate a possible increase in the risk of developing coronary artery disease during the first year of use; with continued treatment, the risk remained stable. Another negative consequence identified during therapy is an increase in the risk of stroke by 30–40% with estrogen monotherapy or their use in combination with MPA. Gallstone disease Estrogens are known to increase the lithogenicity of bile. Some women are prone to gallbladder disease during estrogen treatment. Dementia Based on clinical studies with products containing conjugated equine estrogens, there is no evidence that hormonal use may increase the risk of developing dementia when treatment is initiated in women aged 65 years or older. The risk may be reduced if treatment is started early in menopause. Tumors Breast cancer Based on clinical studies and observations, an increased risk of developing breast cancer in women using HRT for several years has been shown. These facts may be associated with earlier diagnosis, the stimulating effect of HRT on pre-existing tumors and the combined influence of these factors. The overall relative risk of diagnosing breast cancer in more than 50 epidemiological studies conducted was generally between 1 and 2. The relative risk increases with duration of treatment and may be lower, or more likely unchanged, with estrogen monotherapy. A similar increase in the incidence of breast cancer is noted, for example, in women with a delay in the onset of natural menopause or with alcohol consumption or obesity. A few years after starting HRT therapy, the increase in risk is leveled out. It is noted that tumors identified in women using or recently using HRT are characterized by a higher degree of differentiation than tumors identified in women not using HRT. When using HRT, the density of images during mammographic examinations increases, which in some cases can complicate the diagnosis of breast diseases. Endometrial cancer Long-term estrogen monotherapy increases the risk of developing endometrial hyperplasia or carcinoma. Based on research results, it is believed that the appropriate inclusion of progestogens in the treatment regimen will eliminate this increased risk. Liver tumors After using hormonal drugs, including HRT, benign, and even less often, malignant liver tumors were noted in isolated cases. In isolated cases, these tumors caused life-threatening intra-abdominal bleeding. If there is pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, the differential diagnosis must take into account the likelihood of a liver tumor. Other conditions No general association has been established between the use of HRT and the development of clinical hypertension. A slight increase in blood pressure has been reported in women receiving HRT; a clinically significant increase in blood pressure has rarely been observed. However, if in some cases persistent clinically significant hypertension develops during HRT, the advisability of discontinuing HRT should be considered. For mild liver dysfunction, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, patients should be under close medical supervision with periodic determination of liver function. If liver function tests worsen, HRT should be discontinued. Women with moderately elevated TG levels require special monitoring. In such cases, the use of HRT may cause a further increase in TG levels, which threatens the risk of developing acute pancreatitis. Although HRT may affect peripheral insulin resistance and glucose tolerance, there is generally no need to change the therapeutic regimen for diabetic patients using HRT. However, women with diabetes should be under close medical supervision during HRT. Some patients may develop undesirable manifestations of estrogen stimulation during HRT, such as abnormal uterine bleeding. Frequent or constant bleeding during treatment is an indication for examination of the condition of the endometrium. Under the influence of estrogens, the size of uterine fibroids can increase. In this case, treatment should be stopped. It is recommended to discontinue treatment if recurrence of endometriosis is observed during therapy. If you suspect the presence of prolactinoma, before starting HRT, you should exclude the possibility of this disease. In some cases, chloasma may occur, especially in women with a history of chloasma during pregnancy. When taking a course of HRT, women predisposed to chloasma should avoid exposure to the sun or ultraviolet radiation. It has been found that the following conditions and diseases may occur or worsen when using HRT. Although it cannot be confidently stated that these changes are associated with HRT, patients taking HRT who have the following diseases should be closely monitored: epilepsy; benign diseases of the mammary glands; BA; migraine; porphyria; otosclerosis; systemic lupus erythematosus; chorea. Medical examination/consultation Before starting or resuming HRT, the patient's medical history and physical examination should be carefully reviewed, taking into account contraindications (see CONTRAINDICATIONS) and precautions (see SPECIAL INSTRUCTIONS), and such examinations should be repeated periodically. The frequency and nature of examinations should be based on existing standards of medical practice, taking into account the individual characteristics of the patient. As a rule, the pelvic organs are subject to examination, including standard cytological analysis of the cervix, examination of the abdominal cavity, mammary glands, and blood pressure measurement. During pregnancy and breastfeeding. HRT is not prescribed during pregnancy and breastfeeding. If pregnancy occurs during treatment with Climodien, its use should be discontinued immediately. Based on the results of studies, steroid therapy for the purpose of contraception and HRT or accidental use during early pregnancy has not revealed an increased risk of congenital malformations in newborns. Small amounts of sex hormones can be excreted in breast milk. Effect on the ability to drive vehicles and operate machinery: not noted.

Climen®

The drug Klimen® is not used for contraception.

If there are symptoms of estrogen deficiency due to the onset of natural menopause, HRT in a cyclic mode is carried out in women in the perimenopausal period (in women in the postmenopausal period, HRT in a continuous mode is indicated).

If contraception is necessary, non-hormonal methods should be used (with the exception of calendar and temperature methods). If you suspect pregnancy, you should stop taking the pills until pregnancy has been ruled out (see section "Pregnancy and lactation").

If any of the following conditions or risk factors are present or worsened, the balance of individual risk and benefit of treatment should be assessed before starting or continuing to take Climen®.

Prescribing Climen® to women who have several risk factors for thrombosis or a high degree of severity of one of the risk factors is contraindicated.

Venous thromboembolism

A number of controlled randomized as well as epidemiological studies have revealed an increased relative risk of developing venous thromboembolism (VTE) while taking the drug Klimen®, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing Climen® to women with risk factors for VTE, the risk-benefit ratio of treatment should be carefully weighed and discussed with the patient.

Risk factors for the development of VTE include individual and family history (the presence of VTE in first-degree relatives at a relatively young age may indicate a genetic predisposition), known predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S, hyperhomocysteinemia, antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant), as well as multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension, smoking over the age of 35 years, obesity with a body mass index >30 kg/m2. The risk of VTE also increases with age. The possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE may temporarily increase with prolonged immobilization, “major” elective and trauma surgeries, or major trauma. Depending on the cause or duration of immobilization, the question of the advisability of temporarily stopping taking the drug Climen should be decided.

Treatment should be stopped immediately if symptoms of thrombotic disorders appear or if their occurrence is suspected.

Arterial thromboembolism

Randomized controlled trials with long-term use of combined conjugated equine estrogens (CEE) and medroxyprogesterone acetate did not provide evidence of a beneficial effect on the cardiovascular system.

Large-scale clinical studies of this compound found a possible increase in the risk of coronary heart disease (CHD) in the first year of use, followed by a lack of benefit. One large clinical trial using CLE alone found a potential reduction in coronary heart disease (CHD) among women aged 50–59 years, but no overall benefit in the overall study population.

As a secondary outcome, two large clinical trials using CLE as monotherapy or in combination with MPA found a 30-40% increase in the risk of stroke. It is unknown whether this increased risk applies to other HRT products, in particular Climen®, containing other types of estrogens and progestogens, or to non-oral routes of administration.

Endometrial cancer

With long-term estrogen monotherapy, the risk of developing endometrial hyperplasia or cancer increases. Studies have confirmed that the addition of gestagens prevents the increased risk of endometrial hyperplasia and cancer.

Mammary cancer

According to clinical trials and observational studies, an increase in the relative risk of developing breast cancer in women using HRT drugs for several years was found. This may be due to earlier diagnosis, accelerated growth of an existing tumor during HRT, or a combination of both factors.

The relative risk increases with duration of use but may be absent or reduced with estrogen-only treatment. This increase is comparable to the increased risk of breast cancer in women with a later onset of natural menopause, as well as with obesity and alcohol abuse.

The increased risk gradually decreases to normal levels during the first few years after stopping use of HRT drugs, which include Clymen®. Suggestions regarding the increased risk of developing breast cancer are based on the results of more than 50 epidemiological studies.

There is a risk of breast cancer spreading beyond the breast.

Two large randomized trials of CLE alone or chronically combined with MPA yielded estimated risk ratios of 0.77 (95% confidence interval: 0.59–1.01) or 1.24 (95% confidence interval: 1. 01-1.54) after approximately 6 years of use of this combination. It is unknown whether this increased risk also applies to other HRT products, in particular Clymen®.

HRT drugs, which include Klimen®, increase the mammographic density of the mammary glands, which in some cases can have a negative effect on the X-ray detection of breast cancer.

Liver tumors

During the use of sex hormones, which also include drugs for HRT, in rare cases benign, and even more rarely, malignant liver tumors were observed. In some cases, these tumors have resulted in life-threatening intra-abdominal bleeding. If there is pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, the differential diagnosis should take into account the possibility of a liver tumor.

Cholelithiasis

It is known that estrogens increase the lithogenicity of bile. Some women are predisposed to developing gallstones when treated with estrogen.

Dementia

There is limited data showing an increased risk of dementia in women starting hormone replacement therapy aged 65 years or older. The risk may be reduced if HRT is started early in menopause, as has been observed in studies. It is not known whether this applies to other HRT drugs, which include Climen®.

Other states

Treatment should be stopped immediately if migraine-like or frequent and unusually severe headaches appear for the first time, as well as if other symptoms appear that are possible precursors of a thrombotic stroke of the brain.

The relationship between taking the drug Climen® and the development of clinically significant arterial hypertension has not been established. In women taking drugs for HRT, which include the drug Klimen®, a slight increase in blood pressure has been described; a clinically significant increase (over 140/90 mm Hg) is rarely observed. However, in some cases, if persistent clinically significant arterial hypertension develops while taking the drug Climen®, discontinuation of the drug may be considered.

For mild liver dysfunction, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, medical supervision is necessary, as well as periodic liver function tests. If liver function indicators deteriorate, Climen® should be discontinued.

In case of recurrence of cholestatic jaundice or cholestatic itching, which was observed for the first time during pregnancy or previous treatment with sex steroid hormones, you must immediately stop taking the drug Climen®.

Special monitoring is required for women with moderately elevated triglyceride concentrations. In such cases, the use of Klimen® may cause a further increase in the concentration of triglycerides in the blood, which increases the risk of acute pancreatitis.

Although taking the drug Klimen® may affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the treatment regimen of patients with diabetes when using the drug. However, women with diabetes mellitus should be monitored when using the drug Climen®.

Some patients under the influence of Climen® may develop undesirable manifestations of estrogen stimulation, for example, vaginal bleeding. Frequent or persistent vaginal bleeding during treatment is an indication for endometrial examination.

If treatment for irregular menstrual cycles does not produce results, an examination should be performed to exclude an organic disease.

Under the influence of estrogens, uterine fibroids may increase in size. In this case, treatment should be stopped.

It is recommended to discontinue treatment if a relapse of endometriosis develops while taking the drug Climen®.

If prolactinoma is detected, the patient should be under close medical supervision (including periodic determination of prolactin concentration).

In some cases, chloasma may occur, especially in women with a history of chloasma during pregnancy. While using the drug Klimen®, women with a tendency to develop chloasma should avoid prolonged exposure to the sun or ultraviolet radiation. The following conditions may occur or be aggravated while taking HRT medications, which include Climen®. Although their relationship with taking the drug Klimen® has not been proven, women with these conditions should be under medical supervision when using the drug Klimen®: epilepsy; benign breast diseases; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, chorea minor.

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

Additional Information

There is no data on the need for dose adjustment in women under 65 years of age. When using the drug Klimen® in women over 65 years of age, you should take into account the information presented in the “Special Instructions” section.

The use of Klimen® in women with impaired liver function has not been studied. The use of Klimen® in women with impaired renal function has not been studied. Available data indicate that there is no need for dose adjustment in such patients.

Medical examination and consultation

Before starting or resuming taking Climen®, you should familiarize yourself in detail with the patient's medical history and conduct a physical and gynecological examination. The frequency and nature of such examinations should be based on existing standards of medical practice with the necessary consideration of the individual characteristics of each patient (but not less than once every 6 months) and should include blood pressure measurement, assessment of the condition of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervical epithelium.

Impact on laboratory results

Taking sex hormones can affect the biochemical parameters of the liver, thyroid gland, adrenal glands and kidneys, the plasma content of transport proteins, such as corticosteroid binding globulin and lipid/lipoprotein fractions, indicators of carbohydrate metabolism, coagulation and fibrinolysis.

Drug interactions Climodien

The use of hormonal contraceptives should be discontinued at the start of HRT, and if necessary, non-hormonal methods of contraception should be recommended. Treatment with drugs that affect the activity of liver enzymes (for example, some anticonvulsants and antimicrobials) for a long time can increase the clearance of sex hormones and reduce their clinical effectiveness. Such liver enzyme inducing properties have been identified in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, and the presence of these properties can also be expected in oxcarbazepine, topiramate, felbamate and griseofulvin. Maximum induction of enzymes, as a rule, is observed no earlier than 2–3 weeks from the start of use and persists for 4 weeks after discontinuation of the drug. In isolated cases, during concomitant use of certain types of antibiotics (for example, penicillin and tetracycline groups), a decrease in estradiol levels was noted. Substances that form conjugates (eg paracetamol) can increase the bioavailability of estradiol by competitively inhibiting conjugation systems during adsorption. In some cases, the need for oral antidiabetic agents or insulin may change due to the effect of Climodien on glucose tolerance. in vitro studies showed that dienogest at standard concentrations does not inhibit isoenzymes of the cytochrome P450 system. Given this, drug interactions at this level are unlikely. Interaction with alcohol Excessive alcohol consumption during HRT may lead to increased plasma estradiol levels. Influence on laboratory test results. Taking sex steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, levels of transport proteins such as corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters coagulation and fibrinolysis.