Clostilbegyt Clomifenе tablets 50mg №10

Clostilbegyt Clomifenе tablets 50mg №10

Product Code: 5406
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Composition

active substance:1 tablet contains 50 mg clomiphene citrate;

excipients:lactose, potato starch, talcum powder, magnesium stearate, stearic acid, gelatin.

The

Dosage form

Pills.

basic physico-chemical properties:round, flat tablets with chamfer, engraved "CLO" on the one hand, white, yellowish-white or grayish-white without or almost odorless.

The

drug description

ovulation Stimulants, synthetic. ATC code G03G B02.

The

Pharmacological properties

Pharmacodynamics.

Clomiphene is a non-steroidal anti-estrogene structure that stimulates ovulation. The mechanism of action is explained by the ability to communicate specifically with estrogen receptors in the hypothalamus and ovaries. In small doses, increases the secretion of gonadotropins (prolactin, FSH and LH) stimulates ovulation. In high doses, inhibits the secretion of gonadotropins. Does not show gestagenic and androgenic activity.

Pharmacokinetics.

after use, completely absorbed from the digestive tract. Metabolized in the liver. Excreted mainly in the bile is subject to enterohepatic recirculation and is excreted mainly in the faeces. The half-life period is 5-7 days.

Reading

treatment of ovulation disorders, including induction of ovulation in women with anovulatory cycle in order to become pregnant.

Secondary amenorrhea of various etiologies (including amenorrhea after contraceptive use). Stein-Leventhal Syndrome. Oligomenorrhea. Chiari-Frommel syndrome (prolonged postpartum amenorrhea-galactorrhea syndrome). Oligospermatism.

Contra

hypersensitivity to the active substance or to any other component of the drug. Liver disease or impaired function of the liver in history.

ovarian Cyst (except polycystic ovaries syndrome).

the Decrease in pituitary function.

Functional disorders of the thyroid or adrenal glands.

Uterine bleeding of unknown etiology.

a Hormone-dependent tumor.

blurred vision (recent or chronic disturbances of vision).

Pregnancy.

patients with ovarian dyskinesia, menopause or other conditions in which the drug may not be used.

The

Interaction with other medicinal products and other forms of interaction

is Not installed.

application Features

Before treatment, it is recommended to monitor liver function, hormonal status and gonadotropin levels in renal excretion, conduct a thorough gynecological examination. The use of the drug is recommended only in cases where the level of total gonadotropin of urine below the lower limit of normal or normal, when palpated ovaries normal in size and normal function of the thyroid gland and adrenal glands.

in the absence of ovulation, other possible causes of infertility should be excluded and corrected before starting clomiphene therapy. If there is an increase in ovarian or cystic transformation, the treatment is not allowed until the ovaries are normal in size. In the future, the dose or course of treatment should be reduced.

ovaries should be examined regularly during treatment.

during treatment klostilbegitit is very difficult to determine the time of ovulation and as a consequence, there is often insufficient output of the yellow body, so it is recommended to begin preventive treatment with progesterone after conception.

the Drug should be used under the constant supervision of a gynecologist!

Reservations.

a Good level of endogenous estrogen (based on the evaluation of vaginal smears, endometrial biopsy, the amount of estrogen in the urine, or endometrial bleeding caused by progesterone) provides a favorable prognosis for ovulation, while taking clostilbegit.

Low levels of estrogen, though clinically less favorable, does not preclude successful outcome of therapy. Therapy, clostilbegytis ineffective in patients with primary failure of the pituitary or ovaries. Therapy, clostilbegytcan not replace the specific treatment in other cases of ovulatory dysfunction, such as thyroid disease or adrenal.

hyperprolactinemia is another effective method of treatment. Clostilbegyt,is the first treatment for low weight related amenorrhoea, with infertility, and it does not depend on high levels of follicle stimulating hormone (FSH), which is observed at early menopause.

the ovarian hyperstimulation Syndrome (ohss).

the ovarian hyperstimulation syndrome was reported in patients treated with clomiphene to increase ovulation.

ovarian hyperstimulation Syndrome was observed after cyclic administration of clomiphene or when used in combination with gonadotropin.

it was Also reported the following syndromes that have been associated with the syndrome during therapy with klomifenom: exudative pericardit, anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema, ovarian haemorrhage, deep venous thrombosis, prokruchenny of the ovary and acute respiratory distress syndrome.

If the results of the concept will be to progress quickly, you may experience a severe form of the syndrome.

the Doctor may reduce the dose of the drug or prescribe it only for a short time.

Treatment should be carried out using minimally effective doses of the drug. It is not recommended to hold more than 6 courses.

Patients should be warned about the need to inform the doctor about the appearance of abdominal pain or pelvic, weight gain, discomfort after use of the drug. In case of pain in the lower abdomen during the reception of clomiphene, it is necessary to conduct a thorough examination of the patient and, if an increase in ovaries is detected, treatment should be stopped until the ovarian size is normalized. In such cases, the dose and duration of the drug during the next cycle should be reduced.

Some patients with ovarian polycystic syndrome are sensitive to gonadotropin, so they may be more sensitive to conventional doses of Clostilbegit.

Patients also complain of abdominal pain or pain in the pelvic region, discomfort, bloating after taking clomiphene should be examined in connection with the possible presence of cysts or other diseases.

most patients should be treated conservatively. The dose and/or duration of the next course of treatment should be reduced.

visual impairment.

Patients should be the prevention of the occurrence of eye problems such as blurred vision or other symptoms such as spots or flashes (absolute scotoma) which arise during or shortly after cessation of treatment with Clostilbegyt.

visual impairment is usually the opposite; however, cases of prolonged visual impairment have been reported even after treatment was discontinued.

visual impairment may be irreversible, especially when used in high doses or with prolonged treatment.

the Nature of visual impairment did not understand. But if the patient has any symptoms, treatment should be stopped and a thorough examination by an ophthalmologist. 

Patients should be warned about these symptoms and that in this case, do not drive or operate machinery, especially when changing lighting.

In the case of visual impairments, re-Clostilbegyt does not assign.

Excipients.

Clostilbegitcontains lactose, so patients with hereditary galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this drug.

precautions.

Hypertriglyceridemia.

cases of hypertriglyceridemia were reported in post-marketing studies of clomiphene (see "Side effects"). The risk of hypertriglyceridemia can be associated with the adoption of the above recommended doses or with a longer course of treatment and with the existing hyperlipidemia or existing family history of the disease.

For these patients are assigned the monitoring of triglycerides in the blood plasma.

Multiple pregnancy.

there is a possibility of increasing the frequency of multiple pregnancy during therapy with Clostilbegit.

potential complications and risks should be discussed with the patient.

Ectopic pregnancy.

in the treatment of the drug increases the risk of ectopic pregnancy.

there were no reports of multiple pregnancies at the same time, including intrauterine and ectopic pregnancies.

uterine Fibroids.

care should be taken to treat patients with uterine fibroids due to a possible further increase in fibroids.

pregnancy Loss and congenital malformations.

The total rate of reported congenital abnormalities during pregnancy associated with taking the drug during pregnancy (before or after conception) during the studies was within the limits of what was reported in the published data for the population as a whole.

In literature appeared spontaneous were reported congenital anomalies as special cases such as a partial defect of the neural tube, which has been associated with ovulation, as a result of receiving clostilbegytbut this was not confirmed in human studies.

the Doctor should explain to patients the risks of pregnancy no matter how it went with the drug or naturally.

the Patient should also be informed of the great risks associated with pregnancy such as, age of partners, abortions in medical history, rhesus factor, menstrual cycle problems, infertility history (regardless of cause), heart disease, diabetes mellitus, the impact of infectious diseases such as rubella, as well as congenital family abnormalities and other risk factors that may be relevant to the patient for whom the possibility of using clomiphene is being considered. The purpose of the drug can be based on the assessment of the patient and after consultation with the geneticist.

ovarian Cancer.

there have been rare reports of ovarian cancer taking drugs to treat infertility: infertility is the main risk factor for the disease.

Epidemiological evidence suggests that prolonged use ofclostilbegitmay increase the risk of ovarian cancer. Therefore, do not exceed the duration of treatment.

after successful completion of treatment with Clostilbegit, the doctor may prescribe preventive treatment with progesterone.

the Drug should be used under the constant supervision of a gynecologist.

use during pregnancy or lactation.

the Purpose Clostilbegyt is contraindicated during pregnancy.

certain congenital malformations were observed After induction of ovulation with clomiphene, but their frequency did not exceed that in the usual population (<1%): congenital heart anomalies, down syndrome, foot deformity, intestinal abnormalities, hypospadias.

in order to avoid accidental administration of the drug at an early stage of pregnancy, it is necessary to use tests to determine ovulation before each course of treatment. And also do a pregnancy test also before each subsequent course of treatment.

Unknown, clomiphene penetrates into breast milk, but the drug may reduce lactation. Therefore, during breast-feeding it is used only after a thorough assessment of the risk-benefit ratio.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

temporary visual impairment may occur at the beginning of treatment, in which case it is not necessary to drive or operate machinery.

Method of application and doses

in case of infertility, the dose and duration of treatment depend on the sensitivity (ability to react) of the ovaries. In case of regular cyclic bleeding, it is recommended to start treatment on the 5th day of the cycle (or on the 3rd day of the cycle in case of early ovulation if the follicular phase is shorter than 12 days). In patients with amenorrhea treatment can be started at any period of the cycle.

I treatment regimen: a dose of 50 mg per day should be prescribed for 5 days under the control of ovarian reaction by clinical and laboratory studies. Ovulation usually occurs between the 11th and 15th days of the cycle. In case of absence of ovulation in response to given treatment, it is necessary to go to the treatment regimen II.

II treatment regimen: from the 5th day of the next cycle, prescribe 100 mg daily for 5 days. If ovulation does not occur at this time, the same treatment (100 mg per day) should be repeated again.

if there is no ovulation, take a three-month break and recommend another tricycle treatment. If not followed ovulation, repeat treatment is not recommended. The total dose of the drug for any one cycle should not exceed 750 mg.

With amenorrhea after contraceptive use dose is 50 mg per day for 5 days.

Children.Assignment Clostilbegyt is contraindicated in children.

Overdose

overdose Symptoms may include nausea, vomiting, vasomotor phenomena, disorders of sight (blurred vision, flashes, scotoma), increase of the ovaries, stomach pain.

In addition to the elimination of the active substance, overdose can only be used maintenance therapy.

there is no data on the effectiveness of dialysis to derive clomiphene.

Side effects

the nervous system: headache, dizziness, fatigue; exhaustion, convulsions, nervous tension, insomnia, syncope, cerebrovascular accident, cerebral thrombosis, neurological disorders, disorientation, and RosLada speech.

on the part of the organ of vision:visual disturbances (light sensitivity, Donna in the eyes, blurred contours, photophobia, flashes, scotoma) after image, cataract, optic neuritis scotoma, phosphene (flash), decreased visual acuity.

from the digestive tract:nausea, vomiting, "acute stomach", diarrhea, constipation, abdominal pain, bloating, pancreatitis.

from the digestive system: deviation from the norm of liver function, hepatitis, jaundice.

on the part of the cardiovascular system:tachycardia, palpitations.

From the urinary system: an increase in the frequency of urination.

on the part of the skin and subcutaneous tissue: allergic dermatitis, rashes, itching, blisters, Verso hair loss; multiformal erythema, ecchymosis, angioedema, alopecia, urticaria.

Metabolic disorders:increased or decreased body weight, increased appetite, hypertriglyceridemia.

on the part of the vascular system:vasomotor phenomena, the tides; thrombosis of cerebral vessels.

on the part of the reproductive system and mammary glands:pathological uterine bleeding, dysmenorrhea, ovarian enlargement, painful menstruation, pain and discomfort in the mammary glands; dry vaginal mucosa; ovarian hyperstimulation syndrome, the appearance or deterioration of manifestations of endometriosis, ectopic pregnancy. It was reported that the appearance of harmonic tumors or deterioration of their course, ovarian cancer. Intermenstrual spotting or menorrhagia.

Mental disorders: depression, paranoid psychosis.

the hot Flashes observed during treatment stop after the end of treatment. Cystic ovarian enlargement can also be observed, especially in Stein-Leventhal syndrome. In these cases, the ovaries can increase to 4-8 cm, so you need to check the body temperature, and when it becomes two-phase, should stop treatment. There is an increased chance of multiple pregnancy.

Pregnancy, postpartum and prenatal period:multiple pregnancy, both intrauterine and ectopic pregnancy; an ectopic pregnancy.

Neoplasms of benign, malignant neoplasm and uncertain etiology (including cysts and polyps):

tumors or tumors are dependent on the endocrine system; ovarian cancer.

from the immune system:allergic reactions.

Side effects are dose-dependent and often occur when applying high doses and with an extended course of treatment, as has been the case in studies.

in the treatment at the recommended doses, adverse reactions are not noticeable do not affect the treatment.

ovarian Enlargement.

when using the drug in recommended doses, an increase in ovaries is not often observed, although the size of the ovaries may increase when changing the cycle. Similarly, may increase the pain in the ovaries during the change cycle (mittelschmerz).

Also with increasing dose and prolonged course of treatment, the result of increased ovaries may occur cysts and lengthening of the luteal phase of the cycle.

there have been cases of abnormal ovarian enlargement. In this case, the majority conservative treatment is recommended for patients.

The

shelf Life

5 years.

storage Conditions

Store at a temperature not exceeding 25 ° C out of reach of children.

The

Packaging

10 tablets in a brown bottle; 1 bottle in a carton.

The

Category vacation

According to the recipe.

The

Manufacturer

ZAO Pharmaceutical factory EGIS.

location of the manufacturer and address of the place of business

9900, G.. Kormend, Matyas Kira St. 65, Hungary.

CLOSTILBEGYT 50 MG TABLETS

the Synthetic drug that stimulates ovulation. The active ingredient is clomiphene. It has a pronounced estrogenic effect, increases the secretion of gonadotropins (FSH, LG). Indicated for infertility associated with anovulation, while a primary, secondary, post-contraceptive amenorrhea, oligomenorrhea, galactorrhea (due to pituitary tumor), androgen insufficiency.

application Features

Before starting therapy, you need to make sure that there are no other factors that cause infertility. With an irregular menstrual cycle, treatment should begin on the fifth day of the cycle. Assigned to the 50 mg for 5 days. At the same time, ovarian response to stimulation is monitored.

if the desired effect is not achieved, the dose increases to 100 mg, the drug is taken for five days. Clostilbegit is intended for oral use. Tablets are chewed, washed down with plenty of liquid. You first need to undergo a full gynaecological examination.

Contraindications

The
  • ovarian Cysts, thyroid disease.
  • Neoplasms of the pelvic organs, endometriosis is diagnosed.

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