Climonorm - instructions for use, reviews, analogs and forms of release (pills or tablets) of a hormonal drug for the treatment of menopause, osteoporosis and hormone replacement therapy in women. Composition

In this article, you can read the instructions for using the drug Climonorm. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of the Clinonorm in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Clinonorm with available structural analogues. Use for the treatment of menopause, osteoporosis and hormone replacement therapy in adults, children, as well as during pregnancy and lactation. Composition of the hormonal drug.

Climonorm - an antimycotic combined preparation containing estrogen and progestogen.

Estradiol valerate (estrogen) in the human body is converted to natural 17beta-estradiol.

The addition of the heroin levonorgestrel for 12 days of each cycle prevents the development of hyperplasia and endometrial cancer.

Due to the composition and the cyclical regimen of the Climonorm administration (taking only estrogen for 9 days, then - combining estrogen and progestogen for 12 days and then - 7-day break), women with an unrefined uterus are given a regular menstrual cycle.

Estradiol replenishes the estrogen deficiency in the female body after the onset of menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as hot flashes, increased sweating, sleep disturbances, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, decreased libido, muscular and joint pain); involution of the skin and mucous membranes, especially the mucosal genitourinary system (urinary incontinence, dryness and irritation of the vaginal mucosa, tenderness in sexual intercourse).

Estradiol prevents bone loss caused by estrogen deficiency. This is mainly due to the suppression of osteoclast function and the shift of the bone remodeling process towards bone formation. It has been proven that prolonged use of hormone replacement therapy (HRT) reduces the risk of fractures of peripheral bones in women after menopause. With the abolition of HRT, the rate of bone mass reduction is comparable to that characteristic for the period immediately after menopause. It is not proven that using HRT, it is possible to achieve bone mass recovery to the pre-menopausal level.

HRT also has a beneficial effect on the content of collagen in the skin, on its density, and can also slow the process of wrinkle formation.

Admission of the Clononurma helps to lower the level of total cholesterol, LDL and to increase HDL, as a result, significantly increases the ratio of HDL / LDL, as well as to increase the level of TG.

It is believed that among women in postmenopausal women with HRT decreases the incidence of colon cancer. The mechanism of action is still unclear.

Composition

Estradiol valerate + levonorgestrel + excipients.

Pharmacokinetics

After ingestion of estradiol valerate is quickly and completely absorbed from the digestive tract. After entering the body, it is rapidly metabolized with the formation of 17β-estradiol and estrone, which are further subjected to standard metabolic transformations. After oral administration, the bioavailability of estradiol is about 30%. After ingestion, levonorgestrel is rapidly and almost completely absorbed from the digestive tract. 93-95% of levonorgestrel binds to albumin and sex hormone binding globulin (GSHG).

Estradiol is excreted in the form of metabolites, mainly with urine (90%) and to a lesser extent - with bile.

Metabolites of levonorgestrel are excreted in urine and bile, mainly in the form of sulfates and glucuronides.

Indications

• hormone replacement therapy (HRT) in menopausal disorders, involuntary changes in the skin and genitourinary tract, depressive conditions in menopause, as well as symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization, or primary ovarian dysfunction in women with undevelopedthe uterus;
• prevention of postmenopausal osteoporosis;
• normalization of irregular menstrual cycles;
• treatment of primary or secondary amenorrhea.

Forms of release

Dragee is two kinds of yellow and brown colors (9 + 12) (sometimes mistakenly called pills).

Instructions for use and reception scheme

If the menstrual cycle is maintained, treatment should begin on day 5 of the menstrual cycle (1 day of menstrual bleeding corresponds to the 1st day of the menstrual cycle).

With amenorrhea or very rare menstruation, and also in postmenopause, you can start taking the drug at any time, provided that pregnancy is excluded.

Each package is designed for a 21-day reception.

Every day during the first 9 days one yellow pellet is taken, and then for 12 days - one brown pellet daily. After 21 days of taking the drug, a 7-day break in taking the drug follows, during which menstrual bleeding occurs, caused by cancellation of the drug (usually 2-3 days after taking the last pills).

After a 7-day break in taking the drug, they begin a new package of the Climonorma, taking the first pills on the same day of the week as the first pills from the previous package.

Dragee swallowed whole, squeezed a small amount of liquid.The time of day when a woman takes the drug does not matter, however, if she starts taking the pills at any particular time, she should stick to this time and on. If the woman forgot to take the pills, she can take it within the next 12-24 hours. If the treatment is interrupted for a longer time, vaginal bleeding may occur.

Side effect

• changes in the frequency and intensity of uterine bleeding;
• breakthrough bleeding;
• intermenstrual bloody discharge (usually weakened during therapy);
• dysmenorrhea;
• changes in vaginal discharge;
• a condition similar to premenstrual syndrome;
• tenderness, tension and / or enlargement of the mammary glands;
• changes in libido;
• dyspepsia;
• bloating;
• nausea, vomiting;
• abdominal pain;
• relapse of cholestatic jaundice;
• headache;
• migraine;
• dizziness;
• anxiety or depressive symptoms;
• increased fatigue;
• cardiopalmus;
• increased blood pressure;
• venous thrombosis and thromboembolism;
• edema;
• changes in body weight (anorexia or obesity);
• skin rash;
• itching;
• Chloasma;
• erythema nodosum;
• muscle cramps;
• visual impairment;
• intolerance to contact lenses;
• allergic reactions.

Contraindications

• pregnancy;
• lactation;
• vaginal bleeding of unknown origin;
• confirmed or suspected diagnosis of breast cancer;
• confirmed or suspected diagnosis of hormone-dependent precancerous disease or hormone-dependent malignant tumor;
• liver tumors presently or in history (benign or malignant);
• severe liver disease;
• Acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);
• deep vein thrombosis in the acute stage, thromboembolism now or in the anamnesis;
• severe hypertriglyceridemia;
• hypersensitivity to the components of the drug.

If any of the conditions listed above occur during HRT, the drug should be discontinued immediately.

Application in pregnancy and lactation

HRT is not performed during pregnancy and lactation.

Large-scale epidemiological studies of steroid hormones used for contraception or HRT have not revealed an increased risk of developing congenital defects in children,born in women who took these hormones before pregnancy, as well as the teratogenic effects of hormones when they are accidentally taken in the early stages of pregnancy.

A small amount of sex hormones can be excreted in the mother's milk.

Use in children

Children are not used.

special instructions

The clinonorm is not used for contraception.

Before starting or resuming HRT, a woman should undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. In addition, violations of the blood coagulation system should be avoided. Periodically, follow-up examinations should be conducted.

If it is necessary to use contraception, non-hormonal methods should be used (with the exception of calendar and temperature methods). If you suspect a pregnancy, you should stop taking the pills until your pregnancy is excluded.

In the presence or deterioration of any of the following conditions or risk factors, the relationship between individual risk and benefit of treatment should be assessed before starting or continuing HRT.

Venous thromboembolism

In a number of controlled randomized, as well as epidemiological studies, an increased relative risk of venous thromboembolism (VTE) in the background of HRT, i.e. deep vein thrombosis or pulmonary embolism. Therefore, in the appointment of HRT to women with risk factors for VTE, the risk-benefit ratio should be carefully weighed and discussed with the patient.

Risk factors for VTE development include individual and family history (the presence of VTE in close relatives at a relatively young age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The question of the possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE may temporarily increase with prolonged immobilization, extensive planned and traumatological operations or massive trauma. Depending on the cause or duration of immobilization, it should be decided whether to temporarily discontinue HRT.

It should immediately stop treatment if symptoms of thrombotic disorders occur or if they are suspected.

Arterial thromboembolism

In randomized controlled trials with prolonged use of combined conjugated estrogens and medroxyprogesterone acetate, no evidence of a positive effect on the cardiovascular system was obtained. In large-scale clinical trials of this compound, a possible increase in the risk of coronary disease in the first year of use was identified. An increased risk of stroke was also detected. To date, long-term, randomized, controlled trials have not been conducted with other HRT medications in order to detect a positive effect on morbidity and mortality related to the cardiovascular system. Therefore, it is not known whether this increased risk extends to preparations for HRT containing other types of estrogens and progestogens.

Endometrial cancer

With prolonged monotherapy with estrogens, the risk of developing hyperplasia or endometrial carcinoma increases. Studies have confirmed that the addition of gestagens reduces the risk of hyperplasia and endometrial cancer.

Mammary cancer

According to clinical trials and observational studies, an increase in the relative risk of breast cancer in women receiving HRT for several years has been found. This may be due to earlier diagnosis, the biological effect of HRT, or a combination of both. The relative risk increases with the duration of treatment (by 2.3% when applied throughout the year), possibly further increasing with the combination of estrogens with progestogens. This increase is comparable to the increase in the risk of breast cancer in women with every year of the delay of natural menopause (by 2.8% per year of delay), as well as with obesity and alcohol abuse. The increased risk gradually decreases to the usual level during the first 5 years after discontinuation of HRT.

According to research data, breast cancer detected in women receiving HRT is usually more differentiated than in women who do not receive HRT.

HRT increases the mammographic density of the mammary glands, which in some cases may have a negative impact on the radiographic detection of breast cancer.

Liver tumors

Against the background of the use of sex steroids, which include means for HRT, in rare cases benign, and even more rarely - malignant tumors of the liver. In some cases, these tumors resulted in life-threatening intraperitoneal bleeding. With pain in the upper abdomen, enlarged liver, or signs of intraperitoneal bleeding in differential diagnosis, the probability of a liver tumor should be taken into account.

Cholelithiasis

It is known that estrogens increase the lithogenicity of bile. Some women are predisposed to the development of cholelithiasis in treatment with estrogen.

Other states

Treatment should be discontinued immediately at the first appearance of migraine or frequent and unusually severe headaches, as well as the appearance of other symptoms - possible precursors of thrombotic stroke brain.

The relationship between HRT and the development of clinically significant arterial hypertension has not been established. In women receiving HRT, a slight increase in blood pressure has been reported, a clinically significant increase is rarely noted.However, in some cases, with the development of a clinically significant hypertension with the use of HRT, the abolition of HRT can be considered.

With mild violations of liver function, incl. for various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, a doctor's observation is necessary, as well as periodic studies of liver function. With worsening of liver function parameters HRT should be abolished.

In case of recurrence of cholestatic jaundice or cholestatic pruritus observed for the first time during pregnancy or previous treatment with sex steroid hormones, HRT should be discontinued immediately.

Special monitoring of women with moderately elevated TG levels is necessary. In such cases, the use of HRT may cause a further increase in the level of TG in the blood, which increases the risk of developing acute pancreatitis.

Although HRT may affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the treatment regimen for diabetic patients with HRT. Nevertheless, patients with diabetes mellitus are required to be monitored for HRT.

In some patients, HRT may cause unwanted estrogen stimulation, such as abnormal uterine bleeding. Frequent or persistent abnormal uterine bleeding against the background of treatment is an indication for endometrial research.

If treatment of irregular menstrual cycles does not give results, a survey should be conducted to eliminate the organic disease.

Under the influence of estrogens, an increase in the size of uterine fibroids is possible. In this case, treatment should be discontinued.

It is recommended to stop treatment with the development of recurrence of endometriosis in the background of HRT.

If you suspect a prolactinoma before starting treatment, you should exclude this disease.

In some cases, there may be a chloasma, especially in women with a history of pregnant women with chloasma. During HRT, women with a tendency to develop chloasma should avoid prolonged exposure to sunlight or UV radiation.

The following diseases and conditions can occur or worsen in the presence of HRT: epilepsy, benign breast tumor, bronchial asthma, migraine, porphyria, otosclerosis, systemic lupus erythematosus, small chorea.Although the relationship of these diseases and conditions with HRT has not been proven, such patients should be under the supervision of a doctor when carrying out HRT.

Influence on the results of laboratory studies

Reception of sex steroids can affect the biochemical parameters of the function of the liver, thyroid, adrenal and kidney, for the transport of plasma proteins such as corticosteroid-binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis.

Impact on the ability to drive vehicles and manage mechanisms

Does not affect.

Drug Interactions

At the beginning of HRT, it is necessary to stop the use of hormonal contraceptives. If necessary, the patient should recommend non-hormonal contraceptives.

Long-term treatment with drugs that induce the induction of liver enzymes (for example, some anticonvulsants and antimicrobials) can increase the clearance of sex hormones and reduce their clinical effectiveness. A similar property of inducing liver enzymes was found in hydantoins, barbiturates, primidon, Carbamazepine and rifampicin,the presence of this feature is also assumed in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes is usually observed not earlier than 2-3 weeks, but then it can persist for at least 4 weeks after discontinuation of the drug.

In rare cases, along with the concomitant use of certain antibiotics (for example, a group of penicillins and tetracyclines), a decrease in the level of estradiol was observed.

Substances that are highly conjugated (for example, paracetamol) can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system during absorption.

Due to the effect of HRT on glucose tolerance, in some cases, the need for oral hypoglycemic agents or insulin may change.

Excessive consumption of alcohol during HRT may lead to an increase in the content of estradiol in the blood.

Analogues of the drug Climonorm

The Clinonorm does not have structural analogs for the active substance. The drug contains a unique combination of hormones.

Analogues on the pharmacological group (estrogens, gestagens and their analogs):

• Agesta;
• Byzanne;
• Ginepristone;
• Gynodian Depot;
• Jess;
• Jess Plus;
• Diane 35;
• The Divigel;
• Divina;
• Dimia;
• Duphaston;
• Evra;
• Janine;
• Zoeli;
• Clira;
• Climadinone;
• Climara;
• Klimen;
• Klimodien;
• Cliogest;
• Clostilbite;
• Krajonon;
• Levonorgestrel;
• Lindineth;
• Logest;
• Midian;
• Microlus;
• Miropristone;
• Mifegin;
• Mifepristone;
• NovaRing;
• Novinet;
• Non Ovlon;
• Norkolut;
• Norplant;
• Ovestin;
• Pencrofton;
• Postinor;
• Prim is Nor;
• Provera;
• Progesterone;
• Proginova;
• Projest;
• Regulon;
• Silhouettes;
• Sinestrol;
• Tamoxifen;
• Triogynal;
• Utrozhestan;
• Femoden;
• Femoston;
• Cycle;
• Charozette;
• Escapel;
• Estriol;
• Estrogele;
• Yarina;
• Yarina Plus.

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