Clostilbegit for women - composition and indications for use. Clostilbegit for women - composition and indications for use Clostilbegit indications for use

Antiestrogenic drug of nonsteroidal structure.
Preparation: CLOSTILBEGIT®
The active substance of the drug: clomifene
ATX encoding: G03GB02
CFG: Stimulator of gonadotropin production
Registration number: P No. 014432/01
Date of registration: 29.12.06
The owner of the reg. Award: EGIS PHARMACEUTICALS Plc (Hungary)

Release form Klostilbegit, drug packaging and composition.

Tablets are white, yellowish white or grayish white, round, flat, chamfered, engraved with "CLO" on one side, odorless or almost odorless.
1 tab.
clomiphene citrate
50 mg

Excipients: gelatin, magnesium stearate, stearic acid, talc, potato starch, lactose monohydrate.

10 pieces. - dark glass bottles (1) - packs of cardboard.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Clostilbegit

Antiestrogenic drug of nonsteroidal structure. The mechanism of action is due to specific binding to estrogen receptors in the ovaries and pituitary gland. At a low content of estrogen in the body, it exhibits a moderate estrogenic effect, at a high content - an antiestrogenic effect. In small doses, it enhances the secretion of gonadotropins (prolactin, FSH and LH), stimulates ovulation; in high doses inhibits the secretion of gonadotropins. It has no gestagenic and androgenic activity.

Pharmacokinetics of the drug.

Suction

After oral administration, clomiphene is well absorbed from the gastrointestinal tract.

Distribution

Due to the strong binding to plasma proteins, the drug is slowly eliminated from the plasma. Clomiphene and its metabolites undergo enterohepatic recirculation and accumulate in adipose tissue.

Metabolism

Clomiphene is metabolized in the liver to form metabolites with antiestrogenic activity.

breeding

T1 / 2 clomiphene is 5-7 days.

It is excreted mainly with bile.

Indications for use:

Anovulatory infertility (ovulation induction);

Amenorrhea (dysgonadotropic form);

Secondary amenorrhea;

Postcontraceptive amenorrhea;

Stein-Leventhal syndrome (polycystic ovary syndrome);

Oligomenorrhea;

Galactorrhea (against the background of a pituitary tumor);

Chiari-Frommel syndrome (syndrome of prolonged postpartum amenorrhea-galactorrhea);

Androgen deficiency;

In men: oligospermia.

Dosage and method of application of the drug.

In case of infertility, the dose and duration of treatment depend on the sensitivity (response to the drug) of the ovaries.

Patients with a regular menstrual cycle are advised to start treatment on the 5th day of the cycle (or on the 3rd day of the cycle if ovulation is early or the duration of the follicular phase is less than 12 days). With amenorrhea, treatment can be started any day.

Scheme I: 50 mg/day for 5 days while monitoring the ovarian response using clinical and laboratory studies. Ovulation usually occurs between days 11 and 15 of the cycle. If such treatment does not lead to ovulation, then regimen II should be used.

Scheme II: from the 5th day of the next cycle, 100 mg / day is prescribed for 5 days. If ovulation is not observed at this time, then the same scheme should be repeated again (100 mg / day). In case of ongoing anovulation, the drug should be interrupted for 3 months, and then the treatment should be repeated for 3 months. With the ineffectiveness of the second course, subsequent treatment with the drug is also not effective. The maximum total dose of the drug taken during each course is 750 mg.

With polycystic ovaries, due to the tendency to hyperstimulation, the initial dose of the drug is 50 mg / day.

With postcontraceptive amenorrhea, the drug should be administered at a dose of 50 mg / day daily. As a rule, when using regimen I, a five-day course of treatment is successful.

For men, in accordance with the indications, the drug is prescribed 50 mg 1-2 times / day for 6 weeks under the systematic control of spermogram.

Side effects of Clostilbegit:

Determining the frequency of side effects: often -> 1%; rarely -< 1%.

From the digestive system: nausea, vomiting; rarely - gastralgia, flatulence, diarrhea, acute abdomen syndrome, increased appetite.

From the side of the central nervous system: headache, dizziness, drowsiness; rarely - a slowdown in mental and motor reactions, irritability, depression, insomnia.

From the senses: visual impairment (including impaired perception of light, double vision, blurred contours, photophobia).

From the urinary system: increased urination, polyuria.

From the reproductive system: pain in the lower abdomen, vaginal dryness.

From the endocrine system: compaction of the mammary glands, dysmenorrhea, pathological uterine bleeding, an increase in the size of the ovary (including cystic); rarely - soreness in the region of the mammary glands.

When treated with clomiphene, the likelihood of multiple pregnancy, ectopic pregnancy, endometriosis, and the growth of existing uterine fibroids increases.

Perhaps cystic enlargement of the ovaries, especially with Stein-Leventhal syndrome. In these cases, the size of the ovaries can reach 4-8 cm. In this case, body temperature should be monitored and treatment should be stopped as soon as it becomes biphasic.

Dermatological reactions: rarely - alopecia.

From the side of metabolism: rarely - an increase or decrease in body weight.

Allergic reactions: rarely - rash, urticaria, allergic dermatitis, vasomotor disorders.

Other: sensations of a rush of blood to the face with a feeling of heat (stop after the end of the drug).

Contraindications to the drug:

Liver and / or renal failure;

Ovarian cyst (with the exception of polycystic ovary syndrome);

Tumor or hypofunction of the pituitary gland;

Thyroid dysfunction;

Adrenal dysfunction;

Metrorrhagia of unknown etiology;

Long-term or recent visual impairment;

Neoplasms of the genital organs;

endometriosis;

Insufficiency of ovarian function against the background of hyperprolactinemia;

Pregnancy;

lactation (breastfeeding);

Galactose intolerance, lactase deficiency or glucose malabsorption;

Hypersensitivity to the components of the drug.

Use during pregnancy and lactation.

Use during pregnancy and during breastfeeding is contraindicated.

Special instructions for the use of Klostilbegit.

Before starting treatment, a thorough gynecological examination should be carried out. Treatment begins when the total content of gonadotropin in the urine is normal or below the lower limit of normal, the condition of the ovaries on palpation is normal, the functions of the thyroid gland and adrenal glands correspond to the norm.

In the absence of ovulation before the start of the drug, all other possible forms of infertility should be excluded or cured.

If ovarian enlargement or cystic changes occur while taking the drug, treatment should be discontinued until the size of the ovaries returns to normal. In the future, the reception can be resumed, but at the same time reduce the dose of the drug or the duration of treatment.

In the process of treatment, constant monitoring by a gynecologist is necessary, ovarian function should be monitored, vaginal examinations should be carried out, and the “pupil” phenomenon should be observed. It is often difficult to determine the moment of ovulation during the course of treatment, and corpus luteum insufficiency is also often observed. Therefore, after conception, prophylactic treatment with progesterone is recommended.

The drug is contraindicated in patients with galactose intolerance, lactase deficiency or glucose malabsorption, because. each tablet contains 100 mg lactose.

Influence on the ability to drive vehicles and control mechanisms

Since the drug can cause visual impairment, during the period of treatment, patients should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug overdose:

Symptoms: nausea, vomiting, vasomotor reactions, feelings of flushing to the face, visual disturbances (decreased visual acuity, flashes, scotoma), enlargement of the ovaries and pain in the pelvic organs and in the abdomen.

Treatment: measures aimed at removing clomiphene from the body; maintenance therapy. Data on the possibility of removing clomiphene during dialysis are not available.

Interaction of Clostilbegit with other drugs.

Compatible with preparations of gonadotropic hormones.

Conditions of sale in pharmacies.

The drug is dispensed by prescription.

Terms of the storage conditions of the drug Klostilbegit.

The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C. Shelf life - 5 years.

Infertility of one of the spouses is a common problem faced by couples who want to have a baby. However, modern medicine is actively developing in this direction, offering patients many drugs that can correct the situation. One of them was the drug "Klostilbegit" for men. Reviews and results of admission, as well as instructions for using this medication will be discussed in this article.

Indications for use

It is worth noting that most often the drug is prescribed to women, not men. It is used in the absence of ovulation, since the action of the drug is aimed at stimulating this process. The medicine also helps with amenorrhea, that is, with a prolonged absence of menstruation for several cycles. It can also be used for rare periods, the interval between which exceeds 35-40 days. The benefits of the drug for women have been proven by many studies, but not everyone knows that it can also be effectively used to treat male infertility.

As a rule, it is prescribed when oligospermia is detected, that is, with an insufficient amount of ejaculate in a patient. "Klostilbegit" for men with long-term use stimulates the production of sperm in sufficient quantities for conception. In addition, this drug is an antiestrogen, so it is also used by bodybuilders who want to keep their physical shape in good condition. However, it is not recommended to choose it without consulting a specialist, because improper medication can subsequently result in problems with sexual function and hormones.

Release form and composition

The drug is produced by the Hungarian pharmaceutical company EGIS. Its main active ingredient is its content in 1 tablet is 50 mg. The composition of the drug includes many auxiliary components, among which it is worth highlighting lactose monohydrate, stearic acid, talc, potato starch and gelatin.

Produced "Klostilbegit" for men and women in white tablets. They may also have a slight grayish or yellowish tint. They are round and flat, in the middle they have a dividing chamfer. To distinguish the original from fakes, make sure that the tablet is engraved with CLO. The drug has no pronounced smell and taste. You can buy "Klostilbegit" in a pharmacy by prescription. It is sold in cartons or glass bottles, and the tablets themselves are stored in aluminum foil blisters.

Contraindications for use

Most often, "Klostilbegit" is prescribed for men when planning a pregnancy. However, the drug is not suitable for all patients, as it has a number of contraindications. Therefore, before taking the medicine, it is important to consult with your doctor so as not to aggravate the existing problems. This tool should not be used by people with the following restrictions:

hypersensitivity to the components of the drug, usually to lactose;
suspicious neoplasms of the genital organs;
with chronic and acute visual impairment;
any disorders of the thyroid gland and adrenal glands;
hypofunction or tumor of the pituitary gland;
chronic liver or kidney failure;
pregnancy and lactation;
ovarian cyst, metrorrhagia or endometriosis in women.

How to take medicine correctly?

To achieve an effective result, the drug "Klostilbegit" instruction for men recommends taking only under the supervision of a specialist. They usually drink the medicine in a course, the duration of which is 5-6 weeks. While taking the medication, regular spermograms are performed to monitor changes in the patient's fertility level. As a rule, it is necessary to use the drug in the morning and in the evening. Men should take one 50 mg tablet at a time. However, if the disease is mild, the doctor may reduce the dosage to one dose per day. You need to drink a tablet with a small amount of clean water, it is not recommended to chew the medication.

In the absence of visible effectiveness from taking the drug, the doctor may extend the course. However, the total dose taken during the week should not exceed more than 750 mg. Before starting the medication, it is recommended to undergo a complete examination, as well as check the liver.

Possible side effects

It is necessary to use "Klostilbegit" for men when planning with caution, as it is a strong hormonal agent that has many side effects. They are quite rare, but you need to know about them. If you begin to notice the appearance of unpleasant symptoms after starting the medication, then consult a doctor to adjust the course or completely stop the drug. As a rule, patients complain of the following side effects:

regular sensations of a rush to the blood of the face and a feeling of heat - disappear after stopping the intake;
the appearance of drowsiness, headaches and dizziness, insomnia, increased irritability and symptoms of depression appear less frequently;
increased appetite, combined with constant nausea and urge to vomit;
flatulence and diarrhea;
violation of the perception of light, including hypersensitivity, mild myopia and photophobia;
increased urine production resulting in frequent urination;
pain and soreness of the mammary glands, uterine bleeding - in women;
complete or partial baldness - in men;
various allergic reactions: rash, redness, itching on the skin;
unreasonable decrease or increase in body weight.

Consequences of an overdose

The first signs of an overdose of Clostilbegit for men appear after a single dose of 250 mg of the drug. The patient begins to feel increasing pain in the lower abdomen, then nausea appears, flowing into vomiting, which does not bring relief. Patients complain of flushing to the face and blurred vision. Its severity decreases, outbreaks and scotomas (blind areas) appear.

If you suspect an overdose, you should immediately seek help from specialists. As a rule, they begin to carry out measures aimed at removing the drug from the body. When severe symptoms appear, supportive therapy is also carried out. After treatment, the signs of intoxication completely disappear. However, it is not recommended to drive a car for several days after rehabilitation, as there is a high probability of residual manifestations of visual impairment.

"Klostilbegit" for men: the results of admission

The effectiveness of taking the drug in oligospermia has been proven in practice. With regular use of the drug for 5-6 weeks, there is a significant improvement in spermogram data. According to studies, in 98% of patients, the number of spermatozoa increased, and the time of their activity also increased significantly. However, patients who drank "Klostilbegit" for men also note that their immunity has noticeably decreased, so they recommend drinking the drug at the same time as vitamins. About 40% of patients also noted the appearance of excess weight associated with a violation of the level of hormones in the body.

"Klostilbegit" for men: reviews

Before starting treatment, many people seek to find out reviews about the drug that the doctor prescribed for them. "Klostilbegit" is an effective remedy that is popular with patients suffering from infertility. Among the advantages of the drug, its affordable price is noted (about 500-800 rubles per pack). When using the medicine, you do not need to take into account meals and time of day, which patients also like. Thanks to him, spermatozoa accumulate in the semen, which increases the likelihood of conception. In addition, after treatment with this drug, the chance of multiple pregnancy increases. According to men, its main drawback is a sharp deterioration in spermogram after stopping the intake.

Thus, the drug "Klostilbegit" for men can be called effective. Reviews and results of admission confirm the quality of this medicine. However, it brings benefits one-time, not curing oligospermia to the end. To permanently get rid of the disease, you need to choose another remedy.

To stimulate ovulation, in particular tubal infertility and. In addition, a side effect of Clostilbegit is a change in pH and thickening of the cervical (cervical) mucus, which interferes with the advancement of spermatozoa. That is why pregnancy during stimulation with Clomid comes, as a rule, not directly in cycles with Clomiphene, but in the interval between courses or after several courses of taking the drug, when the viscosity and pH are restored. Reviews about the drug Clomiphene or Klostilbegit fully confirm this.

With polycystic ovary syndrome, clostilbegit is one of the main drugs that help restore ovulation. However, restoring ovulation, clomiphene may slightly increase the viscosity of cervical mucus. In most cases, this additional action is not critical, and pregnancy occurs. The additional appointment of duphaston precisely at the time of ovulation further worsens the patency of the cervix for spermatozoa.

In no case do not start taking Clomiphene without a doctor's prescription and do not increase the dosage on your own! Firstly, it depends on the dose of the drug whether it will stimulate ovulation or suppress it, and secondly, hyperstimulation threatens the formation of cysts and your possible pregnancy will be postponed indefinitely. It is also not recommended to conduct more than 6 courses of ovarian stimulation in a lifetime. The price of an unskilled approach to stimulation is your health. The effect of the drug persists for several years, and the supply of eggs in the female body is limited, and after hyperstimulation, ovarian hyperfunction occurs, which threatens with ovarian exhaustion and early menopause. Ovarian hyperfunction is deliberately achieved with IVF stimulation and this is the main side effect of the long-awaited pregnancy, which persists for many years.

With the correct selection of the dosage of Clostilbegit during stimulation (IVF does not count), the consequences are minimized and, as a rule, the second and subsequent pregnancy occurs without problems, and early menopause does not threaten.

They write that Clostilbegit and Clomiphene have a pronounced antiestrogenic effect, but this is not so. An estrogenic or antiestrogenic effect will manifest itself, it entirely depends on the dosage and, with the right dosage, the drug will not adversely affect the growth of the endometrium.

Support for the second phase of the menstrual cycle after stimulation with Clomiphene is usually carried out by Duphaston or Utrozhestan. In order to prevent the development of insufficiency of the corpus luteum function after treatment with Clostilbegit, it is recommended to carry out prophylactic treatment with progesterone Duphaston or Utrozhestan after conception. Clostilbegit is used only with the constant supervision of a gynecologist.

After taking the drug, you need to check and, if necessary, restore liver function, otherwise severe toxicosis and late gestosis during pregnancy may occur.

Stimulator of gonadotropin production

Active substance

Clomiphene citrate (clomifene)

Release form, composition and packaging

Tablets white, yellowish white or grayish white, round, flat, chamfered, engraved with "CLO" on one side; odorless or nearly odorless.

Excipients: gelatin - 2 mg, magnesium stearate - 2 mg, stearic acid - 2 mg, talc - 5 mg, potato starch - 39 mg, lactose monohydrate - 100 mg.

10 pieces. - PVC/PVDC/aluminum foil blisters (1) - cardboard packs.
10 pieces. - brown glass bottles with a PE cap, with a first opening control and an accordion shock absorber (1) - packs of cardboard.

pharmachologic effect

Pharmacokinetics

Suction

After oral administration, it is well absorbed from the gastrointestinal tract.

Metabolism

Clomiphene is metabolized in the liver. It undergoes enterohepatic recirculation.

breeding

T 1/2 clomiphene is 5-7 days. It is excreted mainly with bile.

Indications

- anovulatory infertility (ovulation induction);

- amenorrhea (dysgonadotropic form);

- secondary amenorrhea;

- postcontraceptive amenorrhea;

- Stein-Leventhal syndrome (polycystic ovary syndrome);

- oligomenorrhea;

- galactorrhea (against the background of a pituitary tumor);

- Chiari-Frommel syndrome (syndrome of prolonged postpartum amenorrhea-galactorrhea);

- androgen deficiency;

- in men: oligospermia.

Contraindications

- ovarian cyst (with the exception of polycystic ovary syndrome);

- tumor or hypofunction of the pituitary gland;

- dysfunction of the thyroid gland;

- dysfunction of the adrenal glands;

- metrorrhagia of unknown etiology;

- long-term or recently developed visual impairment;

- neoplasms of the genital organs;

- endometriosis;

- insufficiency of ovarian function against the background of hyperprolactinemia;

- pregnancy;

- lactation (breastfeeding);

- intolerance to galactose, lactase deficiency or malabsorption;

- Hypersensitivity to the components of the drug.

Dosage

At infertility the dose and duration of the course of treatment depend on the sensitivity (response to the drug) of the ovaries.

Patients with regular menstrual cycle 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 or the duration of the follicular phase is less than 12 days). At amenorrhea treatment can be started any day.

Scheme I: 50 mg / day for 5 days while monitoring the ovarian response using clinical and laboratory studies. Ovulation usually occurs between days 11 and 15 of the cycle. If such treatment does not lead to ovulation, then regimen II should be used.

Scheme II: from the 5th day of the next cycle, 100 mg / day is prescribed for 5 days. If ovulation is not observed at this time, then the same scheme should be repeated again (100 mg / day). In case of ongoing anovulation, the drug should be interrupted for 3 months, and then the treatment should be repeated for 3 months. With the ineffectiveness of the second course, subsequent treatment with the drug is also not effective. The maximum total dose of the drug taken during each course is 750 mg.

At polycystic ovarian syndrome, due to the tendency to hyperstimulation, the initial dose of the drug is 50 mg / day.

At postcontraceptive amenorrhea the drug should be prescribed at a dose of 50 mg / day daily. As a rule, when using regimen I, a five-day course of treatment is successful.

men in accordance with the indications, the drug is prescribed 50 mg 1-2 times / day for 6 weeks under the systematic control of spermogram.

Side effects

Determining the frequency of side effects: often -> 1%; rarely -< 1%.

From the digestive system: nausea, vomiting; rarely - gastralgia, flatulence, diarrhea, acute abdomen syndrome, increased appetite.

Increases the likelihood of multiple pregnancy.

The drug is contraindicated in patients with galactose intolerance, lactase deficiency or glucose malabsorption, because. each tablet contains 100 mg lactose.

Influence on the ability to drive vehicles and control mechanisms

Pregnancy and lactation

Use during pregnancy and during breastfeeding is contraindicated.

For impaired renal function

Contraindicated in renal failure.

For impaired liver function

Contraindicated in liver failure.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C. Shelf life - 5 years.