Klimonorm - Instructions For Use, Reviews, Drug Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Klimonorm

Klimonorm: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. For violations of liver function
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Klimonorm

ATX code: G03FB09

Active ingredient: levonorgestrel (Levonorgestrel) + estradiol (Estradiol)

Producer: Bayer Weimer GmbH & Co, KG (Germany)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 730 rubles.

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Klimonorm is a combined anti-climacteric agent.

Release form and composition

Dosage form - dragees of two types: yellow and brown, have a round shape (in blisters of 9 yellow and 12 brown dragees, in a cardboard box 1 or 3 blisters and instructions for the use of Klimonorm).

Content of active substances in 1 tablet:

• Yellow: estradiol valerate - 2 mg;
• Brown: estradiol valerate - 2 mg, levonorgestrel - 0.15 mg.

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

Additionally composed of:

• Yellow dragees: yellow iron oxide, basic magnesium carbonate;
• Brown dragees: iron oxide red, iron oxide brown, magnesium hydroxycarbonate basic.

Pharmacological properties

Pharmacodynamics

Klimonorm is a combined anti-climacteric drug, it includes:

• Estrogen - estradiol valerate, in the body it is converted into natural 17β-estradiol, the most active main female sex hormone;
• Levonorgestrel is a synthetic progestogen, a subclass of steroid female sex hormones, which prevents the occurrence of cancer and endometrial hyperplasia.

With regular intake in women with an unremoved uterus, the menstrual cycle is established, which is provided by the composition of Klimonorm and the cyclic regimen (9 days - only estrogen; 12 days - a combination of estrogen and gestagen; 7 days - a break).

Estradiol provides replenishment in the female body of estrogen deficiency after menopause and effective therapy of vegetative and psychoemotional climacteric symptoms (in the form of hot flashes, increased sweating, sleep disturbances, increased nervous excitability, irritability, cardialgia, palpitations, dizziness, headache, decreased libido muscle pain). Also, the action of the substance is directed to the treatment of involution of the mucous membranes and skin, in particular this applies to the mucous membranes of the genitourinary system (irritation and dryness of the vaginal mucosa, urinary incontinence, pain during sexual intercourse).

Estradiol helps to prevent bone loss caused by estrogen deficiency. This is mainly due to the suppression of osteoclast function and a shift in the process of bone remodeling in the direction of bone formation. There is evidence that long-term use of HRT (hormone replacement therapy) in women after menopause can reduce the likelihood of peripheral bone fractures. With the abolition of HRT, the rate of decrease in bone mass can be compared with the indicators that are characteristic of the period immediately after menopause. There is no evidence that bone mass can recover to premenopausal levels.

Also, HRT has a beneficial effect on the skin, including its density and collagen content in it, and helps to slow down the formation of wrinkles.

As a result of therapy, there is a decrease in the level of total cholesterol and LDL (low density lipoproteins) and an increase in HDL (high density lipoproteins), as a result, the HDL / LDL ratio significantly increases, and the level of TG (thyroglobulin) also increases.

There is an assumption that the use of HRT among postmenopausal women decreases the incidence of colon cancer (has an unclear mechanism of action).

Pharmacokinetics

After oral administration, estradiol valerate is rapidly and completely absorbed from the gastrointestinal tract. Then it is rapidly metabolized, with the formation of 17β-estradiol and estrone, further they undergo standard metabolic transformations. The bioavailability of estradiol is approximately 30%. C _max (maximum concentration) of estradiol in the blood plasma is achieved in 2-3 hours, the ratio of estrone-estradiol is 4 ÷ 1.

After oral administration, levonorgestrel is rapidly and almost completely absorbed from the gastrointestinal tract. The time to reach C _{max of} levonorgestrel in blood plasma is 1–2 hours.

93 to 95% of levonorgestrel binds to sex hormone binding globulin (SHBG) and albumin.

Excretion of estradiol occurs in the urine (about 90%) and bile (to a lesser extent) in the form of metabolites.

Excretion of levonorgestrel metabolites occurs in the bile and urine, mainly in the form of glucuronides and sulfates.

Indications for use

• Hormone replacement therapy of involutional changes in the skin and genitourinary tract, climacteric disorders and depressive conditions in the climacteric period, symptoms of estrogen deficiency against the background of sterilization, hypogonadism or natural menopause, as well as primary ovarian dysfunction in women with an unremoved uterus;
• Restoration of menstrual cycles with their irregularity;
• Treatment of amenorrhea (primary and secondary);
• Prevention of postmenopausal osteoporosis.

Contraindications

• Vaginal bleeding of unknown etiology;
• Breast cancer (diagnosed or suspected);
• The period of pregnancy and breastfeeding;
• Malignant hormone-dependent tumor or hormone-dependent precancerous disease with a presumptive or confirmed diagnosis;
• Severe liver disease;
• Benign or malignant liver tumors, including those indicated in the history;
• Severe hypertriglyceridemia;
• Exacerbation of deep vein thrombosis, thromboembolism, including in history;
• Acute arterial thrombosis, thromboembolism, including stroke, myocardial infarction;
• Hypersensitivity to the components of Klimonorm.

If these conditions appear during the treatment period, the drug should be immediately canceled.

It is recommended with caution to prescribe Klimonorm to patients with congenital hyperbilirubinemia (Gilbert, Rotor, Dabin-Johnson syndromes), cholestatic pruritus or cholestatic jaundice during pregnancy, arterial hypertension, endometriosis, diabetes mellitus, uterine myoma.

Klimonorm, instructions for use: method and dosage

Klimonorm is intended for oral administration, the pills are swallowed whole and washed down with a sufficient amount of liquid. To take the drug, a woman chooses a convenient time of day for her, which should be strictly adhered to for the entire period of treatment.

For patients with a preserved menstrual cycle, the first tablet should be taken on the 5th day of menstrual bleeding.

With very rare or no menstruation, treatment can be started at any time, provided that there is a confirmed absence of pregnancy.

Dosage of Klimonorm is 1 tablet 1 time per day, during the first 9 days, yellow tablets are taken, then 12 days - brown. After taking all 21 pills, a break should be taken for 7 days. On days 2-3 after discontinuation of the drug, menstrual bleeding occurs.

The first pills from a new package should be taken after a 7-day break on the same day of the week as from the previous package.

If you accidentally miss taking pills at the set time, a woman should try to take it as soon as possible (in the next 12-24 hours). With a longer interruption of therapy, vaginal bleeding may occur.

Side effects

The drug Klimonorm can cause the following side effects:

• On the part of the reproductive system: changes in libido, intensity and frequency of uterine bleeding, intermenstrual spotting, breakthrough bleeding (usually weakened during therapy), vaginal discharge, dysmenorrhea, feeling similar to premenstrual syndrome; enlargement and / or tension, soreness of the mammary glands;
• From the digestive system: abdominal pain, dyspepsia, nausea, bloating, vomiting, recurrence of cholestatic jaundice;
• From the nervous system: sometimes - increased fatigue, dizziness, headache, depressive symptoms, migraine, anxiety;
• From the side of the cardiovascular system: sometimes - increased blood pressure, heart palpitations, venous thrombosis, thromboembolism;
• From the side of metabolism: changes in body weight, edema;
• Dermatological reactions: sometimes - pruritus, skin rash, erythema nodosum, chloasma;
• Others: the development of allergic reactions, muscle cramps, intolerance to contact lenses, visual impairment.

Overdose

In case of accidental intake of the drug Klimonorm in an amount that is many times greater than the daily therapeutic dose, the risk of developing acute side effects has not been identified.

The main possible symptoms of an overdose: vomiting, nausea, vaginal bleeding.

Therapy: symptomatic. There is no specific antidote.

special instructions

Klimonorm cannot be used for contraception.

The prescription of the drug is made by the doctor on the basis of clinical indications, a thorough general medical, gynecological examination, the results of a study of the mammary glands and cervical mucus. In addition, the absence of pregnancy and blood clotting disorders should be confirmed.

The use of pills should be accompanied by periodic follow-up examinations.

During the period of treatment, a woman should use only non-hormonal contraceptive drugs. If pregnancy is suspected, it is necessary to stop therapy until it is excluded.

The use of Klimonorm is associated with the risk of developing venous thromboembolism, it increases with age. When prescribing a hormonal agent for patients with a genetic predisposition to deep vein thrombosis or pulmonary embolism, and for patients with severe obesity, it is necessary to weigh the ratio of the potential risk and the expected benefit of therapy.

In the case of prolonged immobilization during the period of treatment or when signs or suspicions appear indicating thrombotic disorders, it is recommended to stop using Klimonorm.

In the first year of use, the risk of coronary heart disease and stroke may increase.

With prolonged estrogen monotherapy, the risk of developing endometrial carcinoma or hyperplasia increases; when combined with the addition of gestagens, the likelihood of endometrial hyperplasia and cancer decreases.

The relationship between hormone therapy and the development of breast cancer is not clearly established. Research data indicate that in women taking hormonal drugs, it is more differentiated than in other patients.

Treatment increases breast density on mammography exams, which can negatively affect X-ray detection of breast cancer.

The increased risk of breast cancer is reduced to normal levels 5 years after hormone therapy ends.

Against the background of sex steroids, the development of benign or malignant liver tumors is possible.

Climonorm increases the lithogenicity of bile, which poses a threat to the development of gallstone disease.

Migraine headaches or frequent and very severe headaches can be symptoms of a thrombotic stroke of the brain, therefore, if they appear, you must stop taking the pills and consult a doctor.

In the case of the development of persistent severe arterial hypertension, it is recommended to consider the issue of canceling Klimonorm.

Regular observation of a physician requires the treatment of patients with impaired liver function, and if the liver function indicators deteriorate, hormone replacement therapy should be canceled.

If there is a recurrence of cholestatic jaundice or cholestatic pruritus, first observed during pregnancy or previous use of sex steroid hormones, treatment should be stopped immediately.

Climonorm increases the likelihood of developing acute pancreatitis in women with elevated triglyceride levels.

With frequent pathological uterine bleeding against the background of hormonal therapy, it is recommended to conduct a study of the endometrium.

With an increase in the size of uterine fibroids, the development of recurrence of endometriosis under the influence of estrogens, therapy should be discontinued.

For women prone to chloasma, or with a history of chloasma in pregnant women, prolonged exposure to the sun or ultraviolet radiation is contraindicated.

In the absence of a clinical effect in the treatment of irregular menstrual cycles, it is recommended to conduct additional examinations aimed at excluding diseases of an organic nature.

Hormone replacement therapy can cause the occurrence or aggravation of the following conditions and diseases: benign breast tumor, epilepsy, bronchial asthma, porphyria, migraine, otosclerosis, chorea minor, systemic lupus erythematosus.

While taking sex steroids, there is a change in the biochemical parameters of the adrenal glands, kidneys, liver and thyroid function, the content of transport proteins in the blood plasma (corticosteroid-binding globulin, lipid or lipoprotein fractions), indicators of fibrinolysis, coagulation, carbohydrate metabolism.

Influence on the ability to drive vehicles and complex mechanisms

Klimonorm does not affect the patient's ability to drive vehicles and mechanisms.

Application during pregnancy and lactation

Climonorm is not prescribed during pregnancy / lactation.

For violations of liver function

• liver tumors, including a burdened history, severe liver disease: therapy is contraindicated;
• cholestatic jaundice, cholestatic pruritus during pregnancy: Climonorm is prescribed with caution;
• mild violations of hepatic function, including against the background of various forms of hyperbilirubinemia, such as Rotor syndrome or Dubin-Johnson syndrome: medical supervision is shown, as well as periodic studies of liver function; in case of deterioration of hepatic function indicators, HRT should be canceled.

Drug interactions

Simultaneous use with hormonal contraceptives is contraindicated.

Long-term treatment with certain anticonvulsant or antimicrobial drugs that potentiate the induction of liver enzymes can increase the clearance of sex hormones and reduce their effect. Hydantoins, barbiturates, primidone, carbamazepine and rifampicin are characteristic of inducing liver enzymes; this feature is also suggested for griseofulvin, oxcarbazepine, felbamate and topiramate. Enzyme induction usually peaks after 2-3 weeks of taking the drug and remains stable for at least 4 weeks after discontinuation.

The simultaneous use of certain antibiotics, including the tetracycline and penicillin groups, in rare cases leads to a decrease in estradiol levels. Paracetamol and other substances that undergo conjugation to a large extent can increase the bioavailability of estradiol.

Climonorm affects glucose tolerance, when combined with oral hypoglycemic agents or insulin, their dose may need to be adjusted.

Drinking alcohol in large doses during hormone therapy can increase the level of estradiol in the blood.

Analogs

Klimonorm analogs are: Klimodien, Kliogest, Femoston.

Terms and conditions of storage

Store at room temperature out of reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Klimonorm

Reviews about Klimonorm are mostly positive. Patients and doctors indicate high efficacy and good tolerance of the drug.

Price for Klimonorm in pharmacies

The approximate price for Klimonorm (21 tablets) is 678–862 rubles.

Klimonorm: prices in online pharmacies

Drug name Price Pharmacy

Klimonorm dragee 21 pcs. 730 RUB Buy

Klimonorm dragee 21 pcs. 751 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!