Klostilbegit tablets 50mg, No. 10

• anovulatory infertility (induction of ovulation);

• amenorrhea (disgonadotropic form), secondary amenorrhea, post-contraceptive amenorrhea;

• Stein-Leventhal syndrome (polycystic ovary syndrome);

• oligomenorrhea;

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

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

• androgen deficiency;

• in men: oligospermia.

Inside.

In infertility, the dose and duration of treatment depends 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 with early ovulation or the duration of the follicular phase less than 12 days). For amenorrhea, treatment can be started any day.

Scheme I. At 50 mg per day for 5 days with simultaneous monitoring of the reaction of the ovaries using clinical and laboratory studies. Ovulation usually occurs between the 11th and 15th day of the cycle. If such treatment does not lead to ovulation, scheme II should be applied.

Scheme II. From the 5th day of the next cycle, 100 mg per day for 5 days. If at this time ovulation is not observed, the same scheme should be repeated again (100 mg per day). In case of failure, the drug should be interrupted for 3 months, and then the treatment should be repeated within 3 months. If the second course is ineffective, subsequent drug treatment is ineffective. The total amount of the drug taken during each course should not exceed 750 mg.

In polycystic ovary disease, due to the tendency to hyperstimulation, treatment should be started with a dose of 50 mg per day.

In the absence of menstruation due to prolonged use of contraceptives, 50 mg per day should be prescribed; a 5-day course of treatment is usually effective already at the first attempt.

Men are prescribed 50 mg 1-2 times a day for 6 weeks (systematic monitoring of spermogram is required).

Active ingredient: clomiphene citrate - 50 mg
Excipients: gelatin 2 mg, magnesium stearate 2 mg, stearic acid 2 mg, talc 5 mg, potato starch 39 mg and lactose monohydrate 100 mg.

• Hypersensitivity to any ingredient in the drug;

• hepatic and / or renal failure;

• pregnancy and lactation;

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

• swelling or hypofunction of the pituitary gland;

• dysfunction of the thyroid or adrenal glands;

• metrorrhagia of unknown etiology;

• long-term or recently developed visual impairment;

• genital neoplasms;

• endometriosis;

• ovarian failure against the background of hyperprolactinemia;

• galactose intolerance, lactase deficiency or glucose malabsorption (since each tablet contains 100 mg of lactose).

Pharmacological properties

Pharmacodynamics

Antiestrogen of non-steroidal structure, the action of which is due to specific binding to estrogen receptors of the ovaries and pituitary gland. With a low content of estrogen in the body, it exhibits a moderate estrogenic effect, with a high content - an antiestrogenic effect. In small doses, it enhances the secretion of gonadotropins (prolactin, FSH and LH), stimulates ovulation; in large doses inhibits the secretion of gonadotropins. Does not possess gestagenic and androgenic activity.

Pharmacokinetics:

When taken orally, it is well absorbed from the gastrointestinal tract. It is metabolized in the liver. Undergoes enterohepatic recirculation. T1 / 2 - 5-7 days.
It is excreted mainly in the bile.

Pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

Side effect

From the digestive system:
nausea, vomiting;
rarely: gastralgia, flatulence, diarrhea, acute abdominal syndrome.
From the nervous system: headache, dizziness, drowsiness;
rarely: slowing down of the speed of mental and motor reactions, increased excitability, depression, insomnia.
Sense organs: visual impairment (impaired perception of light, double vision, blurred contours, photophobia, etc.).
On the part of the genitourinary system: increased urination, breast thickening, lower abdominal pain, dysmenorrhea, abnormal uterine bleeding, an increase in the size of the ovary (including cystic);
rarely: vaginal dryness, polyuria, menorrhagia.
Allergic reactions:
rarely - rash, urticaria, allergic dermatitis, vasomotor disorders.
Others:
rarely: increased appetite, increase or decrease in body weight, alopecia, breast tenderness, flushing of the face.
When treated with clomiphene, the likelihood of multiple pregnancies, ectopic pregnancy, endometriosis, and the growth of existing uterine fibroids increases.
Hot flushes observed during the course of treatment stop after the end of the drug intake.
Cystic enlargement of the ovaries may also occur, especially with Stein-Leventhal syndrome. In these cases, the size of the ovaries can reach 4-8 cm. In this case, you should monitor the body temperature and stop treatment as soon as it becomes biphasic.

Overdose

Symptoms: nausea, vomiting, vasomotor phenomena, flushes of blood to the face, visual disturbances (decreased visual acuity, flashes, scotoma), enlarged ovaries and pain in the pelvic and abdominal organs.
Treatment: in addition to removing the active substance in case of overdose, only supportive therapy can be used. There is no data on the possibility of elimination of clomiphene by dialysis.

Interaction with other medicinal products

Compatible with preparations of gonadotropic hormones.

special instructions

It is recommended to check liver function before taking the drug.

A thorough gynecological examination should be carried out before using this drug. The use of this drug is indicated in cases where the total level of gonadotropin in the urine is below the lower limit of the norm or at the normal level, palpation of the ovaries does not reveal abnormalities, and the functions of the thyroid gland and adrenal glands are normal.

If the egg does not mature, all other possible causes of infertility should be ruled out or treated before using this drug. If an enlargement of the ovaries or their cystic transformation is detected, the use of the drug is not allowed until the ovaries return to normal size. In the future, you should reduce the dose or duration of treatment.

In the course of treatment, it is necessary to constantly monitor the gynecologist, control the function of the ovaries, vaginal examinations, observe the phenomenon of the 'pupil'.

Often, during the course of treatment, it is difficult to determine the moment of ovulation, and also the insufficiency of the corpus luteum is often observed. Therefore, after conception, it is recommended to begin prophylactic administration of progesterone.

Increases the likelihood of developing multiple pregnancies.

Each tablet contains 100 mg of lactose, so the drug is not recommended for patients with galactose intolerance, lactase deficiency or glucose malabsorption.

Ability to drive cars
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, since the drug can cause visual impairment.