Clomid

Active material: Klomyfen
When ATH: G03GB02
CCF: Stimulant products gonadotropins
ICD-10 codes (testimony): E28.2, N46, N64.3, N91, N97
When CSF: 15.07.06
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)

Pharmaceutical form, composition and packaging

Pills white, off-white, or grayish white color, round, flat, chamfered, Engraved “CLO” on one side, with little or no odor.

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

10 PC. – vials of dark glass (1) – packs cardboard.

Pharmacological action

Non-steroidal anti-estrogen drug structure. The mechanism of action is due to a specific binding to the estrogen receptors of the ovaries and pituitary gland. At low levels of estrogen in the body exhibits a moderate estrogenic effect, with a high content – antiestrogenic effects. In small doses, it increases the secretion of gonadotropins (prolactin, FSH and LH), It stimulates ovulation; at high doses inhibits the secretion of gonadotropins. Progestogens, and androgen activity is not.

Pharmacokinetics

Absorption

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

Distribution

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

Metabolism

Clomiphene is metabolized in the liver to produce metabolites, possess anti-estrogen activity.

Deduction

T_1/2 clomiphene is 5-7 days.

Write mainly in the bile.

Testimony

- Anovulatory infertility (ovulation induction);

- Amenorrhea (disgonadotropnaya form);

- Secondary amenorrhea;

- Postkontraceptivnaâ amenorrhoeic;

- Stein-Leventhal syndrome (polycystic ovary syndrome);

- Oligomenorrhea;

- Galactorrhea (against the backdrop of a pituitary tumor);

- Chiari syndrome, Frommelya (syndrome, prolonged postpartum amenorrhea-galactorrhea);

- Androgen deficiency;

- Men: oligospermatism.

Dosage regimen

At infertility the dose and duration of treatment depend on the sensitivity (drug reactions) ovary.

PATIENT with regular menstrual cycle it is recommended to start treatment on the 5 th day of the cycle (or 3rd day cycle at ovulation early follicular phase or duration less 12 days). When amenorrhea treatment can begin on any day.

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

Scheme II: from 5 the day of the next cycle appoint 100 mg / day for 5 days. If at this time there is no ovulation, it is necessary to repeat the same pattern (by 100 mg / day). In the case of continued anovulation the drug should be discontinued at 3 of the month, and then repeating treatments for 3 months. With the ineffectiveness of second-year follow-up treatment is not effective as a drug. The maximum total dose, accepted for each course, is 750 mg.

At polycystic ovary syndrome, the tendency to hyperstimulation, the initial dose is 50 mg / day.

At postkontraceptivnoj amenorrhoeic the drug should be administered at a dose of 50 mg / day. Usually, the application of the scheme I five-day course of treatment is successful.

Men according to the testimony of the drug is prescribed for 50 mg 1-2 times / day for 6 weeks of systematic control of semen.

Side effect

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

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

CNS: headache, dizziness, drowsiness; rarely – mental retardation and motor responses, hypererethism, depression, insomnia.

From the senses: visual impairment (incl. impaired perception of light, bifurcation, blurring contours, photophobia).

From the urinary system: increased urination, polyuria.

On the part of the reproductive system: abdominal pain, vaginal dryness.

On the part of the endocrine system: seal breast, dysmenorrhoea, abnormal uterine bleeding, increasing the size of the ovary (incl. cystic); rarely – pain in the breast.

In the treatment of clomiphene increases the likelihood of multiple pregnancies, ectopic pregnancy, endometriosis, growth of existing uterine fibroids.

Perhaps cystic ovarian enlargement, especially when Stein-Leventhal syndrome. In these cases, the size of the ovaries can reach 4-8 cm. It should monitor the temperature of the body and to stop treatment, as soon as it becomes a two-phase.

Dermatological reactions: rarely – alopecia.

Metabolism: rarely – increase or decrease in body weight.

Allergic reactions: rarely – rash, hives, atopic dermatitis, vasomotor disturbances.

Other: I feel a rush of blood to the face with a feeling of heat (terminated after ingestion).

Contraindications

- Liver and / or kidney failure;

- Ovarian cyst (except in polycystic ovary syndrome);

- A tumor of the pituitary gland, or hypothyroidism;

- Thyroid dysfunction;

- Dysfunction of the adrenal glands;

- Metrorrhagia of unknown etiology;

- Long-existing or newly developed visual impairment;

- Neoplasms of genital organs;

- Endometriosis;

- Failure of ovarian function on the background of hyperprolactinemia;

- Pregnancy;

- Lactation (breast-feeding);

- Galactose intolerance, lactase deficiency or glucose malabsorption;

- Hypersensitivity to the drug.

Pregnancy and lactation

Contraindicated use during pregnancy and lactation.

Cautions

Prior to administration of the drug is recommended to investigate the function of the liver.

Before treatment, a thorough gynecological examination. Treatment starts, when the total content of gonadotropin in urine is normal or below the lower limit of normal, the state of ovarian palpation OK, thyroid and adrenal glands are normal.

In the absence of ovulation to the start of the drug should be avoided or cured all other possible forms of infertility.

If you experience while taking the drug to increase ovarian cystic changes or treatment should be discontinued until, while the size of the ovaries will not return to normal. In the future, the reception can be resumed, but reduce the dose or duration of treatment.

In the course of treatment must be continued monitoring gynecologist, should monitor the function of the ovaries, carry out a vaginal examination, observe the phenomenon “pupil”. Often during the course of treatment is difficult to determine the time of ovulation, as it is often observed failure of the corpus luteum. So after conception is recommended that prophylactic treatment of progesterone.

The drug is contraindicated in patients with galactose intolerance, lactase deficiency or glucose malabsorption, tk. Each tablet contains 100 Lactose mg.

Effects on ability to drive vehicles and management mechanisms

Because the drug can cause blurred vision, During treatment, patients should be careful when driving and occupation of other potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, vasomotor reactions, I feel a rush of blood to the face, visual impairment (reduced visual acuity, Flash, scotoma), ovarian enlargement and pain in the pelvic and abdominal.

Treatment: measures, aimed at removing from the body of clomiphene; maintenance therapy. Data on the possible removal by dialysis clomiphene absent.

Drug Interactions

Compatible with drugs gonadotropins.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

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