Klimonorm®

Brand Bayer Pharma AG

In stock 6 Items

Available since: 2019-09-19

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Clinical Pharmacology

Klimonorm has anti-menopausal effect.

Pharmacodynamics

Klimonorm®^® contains estrogen - estradiol valerate, which in the human body turns into natural 17β-estradiol. Also part of the drug Klimonorm^® includes progesterone derivative - levonorgestrel. The addition of levonorgestrel for 12 days of each cycle prevents the development of hyperplasia and endometrial cancer.

Due to the composition and cyclic regimen Klimonorm^® (reception of estrogen only for 9 days, then a combination of estrogen and progestogen for 12 days, and finally, a 7-day break), in women with an unremoved uterus, the menstrual cycle is established during regular use of the drug.

Estradiol restores estrogen deficiency in the female body after menopause and provides effective treatment of psycho-emotional and autonomic menopausal symptoms (such as "hot flashes", sweating, insomnia, irritability, irritability, palpitations, cardialgia, dizziness, headache, decreased libido, muscle and joint pain); involutions of the skin and mucous membranes, especially the mucous membranes of the urogenital system (urinary incontinence, dryness and irritation of the vaginal mucosa, pain during sexual intercourse); reduces the risk of cardiovascular disease. It inhibits proliferative processes in the endometrium and reduces the risk of developing endometrial cancer.

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 peripheral bone fractures in women after menopause. With the abolition of HRT, the rate of decrease in bone mass is comparable to the indicators characteristic of the period immediately after menopause. It is not proved that, using HRT, it is possible to achieve recovery of bone mass to the premenopausal level.

HRT also has a beneficial effect on the collagen content in the skin, as well as on its density, and can also slow down the formation of wrinkles.

Reception Klimonorm^® leads to a decrease in total cholesterol, low-density lipoprotein (LDL) and an increase in high-density lipoprotein (HDL), resulting in a significantly increased HDL / LDL ratio, as well as an increase in triglyceride levels.

Observational studies suggest that among postmenopausal women, the incidence of colon cancer is reduced when using HRT. The mechanism of action is still unclear.

Pharmacokinetics

Estradiol valerate and levonorgestrel are rapidly and well absorbed from the gastrointestinal tract. Estradiol valerate is rapidly metabolized to form highly active 17-beta-estradiol and estrone, which undergo further metabolic transformations. Estradiol valerate is excreted in the form of metabolites with urine (90%) and bile, levonorgestrel in the form of conjugates - with urine and bile.

Indications

Hormone replacement therapy in pre- and postmenopause, incl. after surgical removal of the ovaries;
menopausal syndrome (mental and autonomic symptoms) in peri-and postmenopause;
atrophy of the skin and mucous membranes (including urinary organs) in postmenopause;
signs of irritation of the bladder and urethra, urinary incontinence in a stressful situation (with atrophy of the sphincters of the bladder) in postmenopausal;
prevention of postmenopausal osteoporosis.

Composition

1 yellow bean contains:

Active substance: estradiol valerate 2 mg;

Excipients: iron oxide yellow, purified water, carnauba wax, dextrose (glucose), gelatin, calcium carbonate, potato starch, lactose monohydrate, magnesium basic carbonate, magnesium stearate, macrogol 35 000, povidone K25, sucrose, talc, titanium dioxide.

1 brown bean contains:

Active substance: estradiol valerate 2 mg, levonorgestrel 0.15 mg;

Excipients: iron oxide brown, iron oxide red, purified water, carnauba wax, dextrose (glucose), gelatin, calcium carbonate, potato starch, lactose monohydrate, magnesium hydroxycarbonate basic, magnesium stearate, macrogol 35 000, povidone K25, sucrose, talc, titanium dioxide .

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Dosage and Administration

Klimonorm taken orally, pills swallow whole, washed down with a small amount of liquid. The time of day when a woman takes Climonorm does not matter, however, if she started taking pills at any particular time, she should stick to that time and beyond. If a woman has forgotten to take pills, she can take it within the next 12-24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

If the patient continues to have menstruation, treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day of the menstrual cycle). Each package is designed for a 21-day reception. Every day, for the first 9 days, take one yellow dragee, and then, for 12 days, take one brown dragee daily. After a 21-day drug intake, there is a 7-day break in reception, during which menstrual-like bleeding occurs, caused by drug withdrawal (usually 2-3 days after taking the last bean).

After a 7-day break in taking the drug, they start new packaging of Climonorm, taking the first tablet on the same day of the week as the first tablet from the previous pack.

Adverse reactions

On the part of the digestive tract: During the first cycles of treatment, gastrointestinal disorders, nausea, and vomiting are possible.

From the genitourinary system: irregular, prolonged and prolonged vaginal bleeding.

On the part of the skin: pigmentation on the skin (chloasma), itching.

Other: breast tenderness, weakening of libido.

Contraindications

Hypersensitivity to components of Klimonorm;
severe dysfunction and liver tumors (including history);
congenital disorders of lipid metabolism;
thromboembolic processes (including in the anamnesis);
myocardial infarction;
acute cerebrovascular accident;
hormone-dependent tumors of the uterus, ovaries and mammary glands or suspicion of them;
endometriosis and pathological genital bleeding;
diabetes mellitus (severe), diabetic angiopathy;
idiopathic jaundice, pruritus, herpes, progressive otosclerosis during a previous pregnancy

Drug interactions

The activity is reduced by drugs that accelerate the biotransformation of steroid hormones: barbiturates, non-narcotic analgesics (phenylbutazone), antibiotics (rifampicin, ampicillin, tetracycline, griseofulvin), antiepileptic drugs (carbamazepine, phenytoin)

Pregnancy and Lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Special instructions

Klimonorm is not used for contraception.

Before starting or resuming HRT, a woman is recommended to undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded. Periodic control tests should be carried out.

If contraception is necessary, non-hormonal methods should be used (except for calendar and temperature methods). If a pregnancy is suspected, pills should be stopped until pregnancy is excluded.

If any of the following conditions or risk factors are present or worsening, before starting or continuing HRT, the ratio of the individual risk to the benefit of treatment should be evaluated.

Venous thromboembolism

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

Risk factors for VTE include an individual and family history (the presence of VTE in immediate 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 traumatic operations or massive injury. Depending on the cause or duration of immobilization, the question of whether to temporarily stop HRT should be decided.

Treatment should be discontinued immediately if symptoms of thrombotic disorders appear or if they are suspected.

Arterial thromboembolism

In the course of 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. So far, no other long-term randomized controlled trials have been conducted with other drugs for HRT 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 drugs for HRT containing other types of estrogen and progestogen.

Endometrial cancer

Long-term estrogen monotherapy increases the risk of endometrial hyperplasia or carcinoma. Studies have confirmed that adding progestogens reduces the risk of endometrial hyperplasia and cancer.

Mammary cancer

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

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

HRT increases the mammographic density of the mammary glands, which in some cases may have a negative effect on the x-ray detection of breast cancer.

Liver tumors

Against the background of the use of sex steroids, which include drugs for hormone replacement therapy, benign and, even more rarely, malignant tumors of the liver have been observed in rare cases. In some cases, these tumors led to life-threatening intraperitoneal bleeding. For pain in the upper abdomen, enlarged liver, or signs of intraperitoneal bleeding, a differential diagnosis should take into account the probability of having a liver tumor.

Cholelithiasis

It is known that estrogen increases the lithogenicity of bile. Some women are predisposed to the development of cholelithiasis with estrogen therapy.

Other states

Treatment should be discontinued immediately when migraine-like or frequent and unusually severe headaches appear for the first time, as well as when other symptoms appear — possible harbingers of a cerebral thrombotic stroke.

The relationship between HRT and the development of clinically severe arterial hypertension has not been established.In women receiving HRT, a slight increase in blood pressure has been described; a clinically significant increase is rarely observed. However, in some cases, with the development of persistent clinically significant arterial hypertension while receiving HRT, the withdrawal of HRT may be considered.

With mild abnormal liver function, including in various forms of hyperbilirubinemia, such as the Dubin-Johnson syndrome or Rotor syndrome, physician observation is necessary, as well as periodic studies of liver function. With a deterioration in liver function, HRT should be abolished.

When recurrent cholestatic jaundice or cholestatic pruritus, observed for the first time during pregnancy or previous treatment with sex steroid hormones, it is necessary to immediately stop HRT.

Special attention should be paid to women with moderately elevated TG levels. 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, it is usually not necessary to change the treatment regimen for diabetics during HRT. Nonetheless, patients with diabetes mellitus require monitoring during HRT.

In some patients, unwanted manifestations of estrogen stimulation, such as abnormal uterine bleeding, may develop under the influence of HRT. Frequent or persistent pathological uterine bleeding during treatment is an indication for endometrial research.

If the treatment of irregular menstrual cycles does not give results, an examination should be conducted to exclude diseases of an organic nature.

Under the influence of estrogen may increase the size of uterine fibroids. In this case, treatment should be discontinued.

It is recommended to stop treatment in case of endometriosis recurrence with HRT.

If you suspect the presence of prolactinomas before the start of treatment, this disease should be excluded.

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

The following diseases and conditions can occur or be aggravated against the background of HRT: epilepsy, benign mammary gland tumor, asthma, migraine, porphyria, otosclerosis, systemic lupus erythematosus, small chorea. Although the connection of these diseases and conditions with the conduct of HRT has not been proven, such patients should be monitored by a physician during HRT.

Impact on laboratory results

The use of sex steroids can affect the biochemical indicators of liver, thyroid, adrenal and kidney function, the plasma levels of transport proteins such as corticosteroid binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis.

Influence on ability to drive motor transport and control mechanisms

Does not affect.

Overdosage

Studies of acute toxicity did not reveal the risk of acute side effects from accidental use of the drug Klimonorm in an amount many times greater than the daily therapeutic dose.

Symptoms: nausea, vomiting, vaginal bleeding are possible.

Treatment:there is no specific antidote, symptomatic treatment.