Klimonorm - combined anti-menopausal agent.
Release form and composition
Drug form of Klimonorm - dragee of two kinds. Available in blisters of 21 pcs. (9 pieces of yellow color and 12 pieces of brown color), in a pack of 1 or 3 blisters.
The composition of the dragee yellow:
- Active ingredient: estradiol valerate - 2 mg;
- Auxiliary components: carnauba wax, purified water, dextrose, calcium carbonate, gelatin, potato starch, magnesium stearate, magnesium carbonate basic, macrogol 35 000, lactose monohydrate, povidone K25, titanium dioxide, sucrose, talc, iron yellow oxide.
The composition of dragee brown:
- Active ingredients: estradiol valerate - 2 mg, levonorgestrel - 150 mcg;
- Auxiliary components: gelatin, carnauba wax, purified water, dextrose, lactose monohydrate, potato starch, magnesium hydroxycarbonate basic, macrogol 35 000, magnesium stearate, povidone C25, calcium carbonate, sucrose, titanium dioxide, talc, dyes iron brown oxide and iron oxide red.
Indications for use
- Hormone replacement therapy (HRT) for depressive conditions, involutional changes of the skin and urinary tract in the menopausal period, for menopausal disorders, and for symptoms of estrogen deficiency due to primary ovarian dysfunction in women with an unresolved uterus, sterilization, hypogonadism, or natural menopause;
- Treatment of primary and secondary amenorrhea;
- Prevention of postmenopausal osteoporosis;
- Normalization of irregular menstrual cycles.
- Vaginal bleeding of unknown origin;
- Breast cancer or suspicion of it;
- The presence or suspicion of a hormone-dependent precancerous disease or a hormone-dependent malignant tumor;
- Severe liver disease;
- Benign and malignant tumors of the liver, including a history of;
- Severe hypertriglyceridemia;
- Deep vein thrombosis in the acute stage, venous thromboembolism at present or in history;
- Acute arterial thrombosis or arterial thromboembolism (myocardial infarction, stroke);
- Hypersensitivity to the drug.
If any of the conditions / diseases described above occurs during HRT, taking Klimonorm should be stopped immediately.
Patients diagnosed with arterial hypertension, diabetes mellitus, uterine myoma, endometriosis, congenital hyperbilirubinemia (Dubin-Johnson, Gilbert or Rotor syndromes), cholestatic jaundice or cholestatic itch during a previous pregnancy should be under special observation during the treatment period.
Dosing and Administration
The drug should be taken orally, swallowing pills whole, washed down with a small amount of water. The time of day when the patient begins to receive Klimonorm does not matter, but in the future it is necessary to adhere to this time.
Women whose menstruation continues, treatment begins on the 5th day of the menstrual cycle. With very rare menstruation and amenorrhea, as well as in postmenopausal, you can start taking the drug on any day (provided that pregnancy is excluded).
Each package is designed for 21 days. During the first 9 days take 1 tablet of yellow color, the next 12 days - 1 tablet of brown color. Then they make a 7-day break, during which menstrual-like bleeding begins (usually starts 2-3 days after taking the last bean). The day after the break, begin a new packaging. In this case, the reception of the first dragee should coincide with the day of reception of the first dragee from the previous package.
In the case of skipping the next reception, take the drug should be within the next 12-24 hours. If treatment is interrupted for a longer time, there is a possibility of vaginal bleeding.
- The reproductive system: a change in the frequency and intensity of uterine bleeding, intermenstrual bleeding (usually weakened with continued therapy), dysmenorrhea, breakthrough bleeding, changes in vaginal discharge, change in libido, a state similar to the premenstrual syndrome, breast enlargement, and pain or
- Cardiovascular system: sometimes - increased blood pressure, venous thrombosis, thromboembolism, heart palpitations;
- The digestive system: bloating, dyspepsia, nausea, abdominal pain, vomiting, relapse of cholestatic jaundice;
- Metabolism: change in body weight, edema;
- Central nervous system: sometimes - dizziness, headache, migraine, fatigue, anxiety or depressive symptoms;
- Dermatological reactions: sometimes - itching, rash, erythema nodosum, chloasma;
- Other: visual impairment, intolerance to contact lenses, muscle cramps, allergic reactions.
When conducting acute toxicity studies, there were no risks of acute side effects from taking the dose, many times exceeding the daily therapeutic. Overdose symptoms: nausea and / or vomiting, vaginal bleeding. There is no specific antidote for Klimonorm, symptomatic treatment.
Before starting or resuming hormone replacement therapy, women are referred for a thorough general medical and gynecological examination (including cytological examination of the cervical mucus and examination of the mammary glands), and also exclude pregnancy. Control examinations are recommended and periodically during treatment.
Klimonorm is not intended for contraception. If necessary, non-hormonal methods should be used (with the exception of temperature and calendar methods). If pregnancy is suspected, taking the drug should be suspended until pregnancy is excluded.
HRT increases the mammographic density of the mammary glands, with the result that it can have a negative effect on the x-ray diagnosis of breast cancer.
If you experience pain in the upper abdomen, signs of intraperitoneal bleeding or enlarged liver during differential diagnosis, you should consider the likelihood of a liver tumor.
If you suspect a thrombotic disorder, the drug should be immediately discontinued. HRT should also be discontinued if cholestatic jaundice or cholestatic pruritus recurs.
It has been reliably established that estrogens increase the lithogenicity of bile. In some cases, the use of estrogen may develop cholelithiasis.
Immediately stop taking Climonorm is necessary when the first migraine-like, unusually strong and frequent headaches or other symptoms that may be precursors of cerebral thrombotic stroke appear.
Special observation is required for women with moderately elevated levels of thyroglobulin in the blood, since HRT can cause its further increase, which increases the likelihood of developing acute pancreatitis.
In some cases ZTG can lead to undesirable manifestations of stimulation by estrogen, for example, to pathological uterine bleeding. For this reason, with the appearance of frequent or persistent bleeding, additional examination of the endometrium should be performed. With the recurrence of endometriosis, treatment is stopped.
If the treatment with Klimonorm irregular menstrual cycles does not give results, it is necessary to exclude diseases of an organic nature.
Under the influence of estrogen may increase uterine fibroids in size, in this case, the drug should be canceled.
There are cases of the development of chloasma in women undergoing HRT, especially with a history of chloasma in pregnant women. Patients who are prone to this disease are advised to avoid UV radiation and prolonged exposure to the sun during the application period.
The following diseases can occur or worsen during HRT: systemic lupus erythematosus, otosclerosis, minor chorea, bronchial asthma, benign breast tumor, migraine, epilepsy, porphyria. Although the relationship of their development with the use of estrogen-containing drugs has not been proven, in the presence of these conditions, special medical supervision is required.
Sex steroids can influence the results of some laboratory tests: on the biochemical indicators of liver, kidney, adrenal and thyroid gland function, on coagulation, fibrinolysis and carbohydrate metabolism, on plasma containing transport proteins (lipid and lipoprotein fractions, corticosteroid binding globulin).
Before the appointment of HRT should be discontinued hormonal contraceptives. If necessary, they are replaced by non-hormonal drugs.
Prolonged use of drugs that induce the induction of liver enzymes can lead to an increase in the clearance of sex hormones and a decrease in their clinical efficacy. A similar property was found in rifampicin, carbamazepine, primidone, barbiturates and hydantoins, it is assumed in felbamate, topiramate, griseofulvin and oxcarbazepine. It should be borne in mind that the maximum induction of enzymes is usually observed no earlier than 2-3 weeks and may persist for 4 more weeks after discontinuation of the drug.
Some antibiotics (including tetracyclines and penicillins) can reduce estradiol levels.
Medicinal substances that substantially conjugate (for example, paracetamol) can increase the bioavailability of estradiol.
HRT affects glucose tolerance, so you may need to adjust the dose of insulin or oral hypoglycemic agents.
Excessive consumption of alcohol during HRT may cause an increase in the content of estradiol in the blood.
Terms and conditions of storage
Store at room temperature out of the reach of children.
Shelf life - 5 years.