Klomed

General characteristics. Structure:

Active ingredient: 50 mg of clomifene of citrate.

Excipients: magnesium stearate, Kollidon CL (кросповидон), Ludipresso (lactose, povidone, кросповидон).

Pharmacological properties:

Pharmacodynamics. Clomifene – anti-oestrogenic drug of nonsteroid structure. The mechanism of action is explained by ability to contact specifically receptors of estrogen in a hypothalamus and ovaries. In small doses drug strengthens secretion of gonadotropic hormones (prolactin, follicle-stimulating and luteinizing hormones) and stimulates an ovulation. At low contents in an organism of endogenous estrogen clomifene renders moderate oestrogenic effect, at the high level of estrogen – anti-oestrogenic action. In high doses drug slows down secretion of gonadotrophins. Has no gestagenny and androgenic activity.

Pharmacokinetics. At use inside it is well absorbed from a GIT. It is metabolized in a liver. It is excreted generally with bile, is exposed to enterogepatichesky recirculation; out of an organism it is brought with a stake. The elimination half-life makes 5-7 days.

Indications to use:

- Stimulation of an ovulation at anovulatory cycles and the related  infertility;

- disturbance of an ovulation at the central hypothalamic insufficiency;

- secondary amenorrhea of various genesis, oligomenorrhea, post-contraceptive amenorrhea;

- galactorrhoea of not tumoral origin;

- syndrome of Shteyna-Leventalya;

- Kiari-Frommel's syndrome;

- oligospermatism.

Route of administration and doses:

The dose of drug is registered individually according to reactivity of ovaries of the patient. At cyclic bleeding it is recommended to begin treatment for the 5th day of a cycle.

Scheme I: 50 milligrams/days within 5 days during which reaction of ovaries should be controlled clinical and laboratory trials. The ovulation usually comes between 11 and 15 days of a cycle.

The scheme II should be applied if the scheme I was unsuccessful. It is necessary to appoint a daily dose of 100 milligrams within 5 days, since 5th day of the following cycle. If it is not enough to cause an ovulation, the same course (100 milligrams) can be repeated. In case of the proceeding anovulation, after a 3-month break a 3-month course can be in addition conducted. After that further treatment is not recommended. The general dose during a cycle should not exceed 750 milligrams.

At a post-contraceptive amenorrhea it is necessary to apply clomifene in a dose of 50 milligrams/days daily, the 5-day period of treatment is usually successful even at treatment according to the scheme I.

At an oligospermatism drug should be used in a dose of 50 milligrams daily within 6 weeks under systematic control of a spermogram.

Features of use:

Before an initiation of treatment it is necessary to conduct careful gynecologic examination. Treatment begin when the general maintenance of a gonadotrophin in urine normal or below normal level, the condition of ovaries at a palpation is normal, a functional condition of a thyroid gland and adrenal glands within norm. In case of insufficiency of an ovulation prior to use of drug according to the scheme it is necessary to exclude or cure all other possible forms of infertility.

At the increased ovaries or cystous changes treatment should be stopped until the size of ovaries does not return to norm. In these cases treatment can be continued, but it is necessary to appoint drug in lower doses or to lower the treatment period. During performing therapy at such patients it is necessary to control a condition of ovaries.

During treatment it is recommended to control function of a liver.

In case of approach of pregnancy after performing treatment clomifene recommends purpose of progesterone for the purpose of prevention of development of insufficiency of function of a yellow body.

Clomifene is emitted in maternal milk. During feeding by a breast drug can be used only after careful assessment of a ratio of advantage and risk.

As in an initiation of treatment temporary vision disorders arise clomifene, it is not recommended to be engaged in driving of vehicles and other potentially dangerous types of activity.

Side effects:

From TsNS and organs of sight: dizziness, headache, depression, fatigue, hypererethism, sleep disorder, passing vision disorder.

From a GIT: nausea, vomiting, diarrhea, meteorism.

From urinogenital system: cystous increase in ovaries, dysmenorrhea, pollakiuria, polyuria, polycarpous pregnancy.

Allergic reactions: seldom – urticaria, allergic dermatitis.

Others: inflows, increase in body weight, tromboembolic episodes, a hair loss, pain in the field of chest glands, testicles, a hyperthermia.

Interaction with other medicines:

Gonadotrophins exponentiate effect of clomifene.

Contraindications:

- Hypersensitivity to drug components;

- pregnancy;

- the expressed abnormal liver functions;

- oothecoma;

- organic diseases of TsNS;

- uterine bleedings of not clear genesis;

- malignant and high-quality new growths of generative organs.

Overdose:

Symptoms: nausea, vomiting, feeling of heat, vision disorder, hypertrophy of ovaries, abdominal pains.

Treatment: symptomatic therapy.

Storage conditions:

To store at a temperature of 15-25 °C, in dry, protected from light and the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets of 50 mg. On 10 or 20 tablets in the blister. On 1, 2 or 3 blisters together with the application instruction in a pack. On 5, 15, 25, 50, 100, 500 tablets in packages. On 5, 15, 25, 50, 100 tablets in bottles.