Klostilbegit

Klostilbegit – drug with anti-oestrogenic action.

Form of release and structure

Klostilbegit release in the form of tablets: white, grayish-white or yellow-white color, flat, round, with a facet, with a text of "CLO" on one of the parties, without or almost inodorous (on 10 pieces in blisters or brown glass bottles with a polyethylene cover, the shock-absorber accordion and control of the first opening, on 1 blister or bank in a cardboard pack).

Is a part of 1 tablet:

• Active agent: clomifene citrate – 50 mg;
• Auxiliary components: gelatin – 2 mg, magnesium stearate – 2 mg, stearic acid – 2 mg, talc – 5 mg, potato starch – 39 mg, monohydrate of lactose – 100 mg.

Indications to use

• Amenorrhea (in a disgonadotropny form);
• Anovulatory infertility (induction of an ovulation);
• Post-contraceptive amenorrhea;
• Secondary amenorrhea;
• Syndrome of a long puerperal amenorrhea galactorrhoea (Kiari-Frommel's syndrome);
• Syndrome of a polycystosis of ovaries (syndrome of Shteyna-Leventalya);
• Galactorrhoea (at a hypophysis tumor);
• Oligomenorrhea;
• Androgenic insufficiency;
• Oligospermatism (at men).

Contraindications

• Renal and/or liver failure;
• Oothecoma (except a syndrome of a polycystosis of ovaries);
• Functional disturbances of a thyroid gland and adrenal glands;
• Hypofunction or tumor of a hypophysis;
• Vision disorders (recently developed or it is long existing);
• Metrorrhagia of not clear etiology;
• New growths of generative organs;
• Insufficiency of function of ovaries against the background of a giperprolaktinemiya;
• Endometriosis;
• Intolerance of a galactose, malabsorption of glucose or lactose intolerance;
• Pregnancy and lactation (breastfeeding);
• Hypersensitivity to drug components.

Route of administration and dosage

At treatment of infertility the dose and duration of a medical course are defined by sensitivity to Klostilbegit's action of ovaries.

It is recommended to begin treatment to women with a regular menstrual cycle for the fifth day of a cycle or for the third day of a cycle lasting follicular phase less than 12 days or an early ovulation. At an amenorrhea therapy can be begun in any day.

At first Klostilbegit apply according to the following scheme: for 5 days on 50 mg a day with simultaneous control of reaction of ovaries by means of laboratory and clinical trials. As a rule, the ovulation comes between 11 and 15 days of a cycle.

If therapy does not lead to an ovulation, drug is used according to the second scheme: for 5 days, since 5 in the afternoon the following cycle, accepts 100 mg of Klostilbegit a day. If at this time the ovulation does not occur, the same scheme needs to be repeated once again. At the proceeding anovulation it is necessary to take a three-months break in administration of drug, and then within the next 3 months to repeat therapy. At inefficiency of a repeated course further use of Klostilbegit is not effective. As much as possible during each course it is possible to accept 750 mg of drug.

The initial daily dose of drug at a syndrome of a polycystosis of ovaries makes 50 mg (because of a tendency to hyper stimulation).

At a post-contraceptive amenorrhea of Klostilbegit accept daily 50 mg. In most cases carrying out a five-day course of the first described scheme of treatment is successful.

According to indications to men drug is appointed by 1-2 times a day on 50 mg. Therapy duration – 6 weeks (under systematic control of a spermogram).

Side effects

During Klostilbegit's use development of the following side effects is possible (> 1% – often; <1% – is rare):

• Endocrine system: a dysmenorrhea, consolidation of mammary glands, pathological uterine bleeding, increase in the sizes of an ovary (including cystous); seldom – morbidity in the field of chest glands. During therapy the probability of developing of endometriosis, an extrauterine pregnancy, polycarpous pregnancy, growth of the available uterus fibroma increases. Also perhaps cystous increase in ovaries, in particular at a syndrome of Shteyna-Leventalya (the size of ovaries can reach 4-8 cm). In this case it is necessary to watch the body temperature and as soon as it becomes two-phase, to interrupt therapy;
• Central nervous system: headache, drowsiness, dizziness; seldom – delay of motor and mental reactions, a depression, a hyperexcitability, sleeplessness;
• Alimentary system: vomiting, nausea; seldom – a syndrome of an acute abdomen, a meteorism, a gastralgia, diarrhea, increase in appetite;
• Reproductive system: dryness of a vagina, pain in the bottom of a stomach;
• Urinary system: polyuria, increase of an urination;
• Sense bodys: vision disorders (including blurring of contours, doubling, light perception disturbance, a photophobia);
• Metabolism: seldom – reduction or increase in body weight;
• Allergic reactions: seldom – allergic dermatitis, rash, vasculomotor frustration, a small tortoiseshell;
• Dermatological reactions: seldom – an alopecia;
• Others: the feeling of rush of blood to the person which is followed by feeling of heat (passes after the end of therapy).

Special instructions

Before therapy it is recommended to conduct a research of function of a liver, and also careful gynecologic inspection. Treatment should be begun when the summary contents of a gonadotrophin in urine below the lower bound of norm or normal, functions of adrenal glands and a thyroid gland meet standard, the condition of ovaries at a palpation is normal.

In the absence of an ovulation prior to Klostilbegit's use it is necessary to cure or exclude all other possible forms of infertility.

At increase in ovaries during treatment or emergence of cystous changes, administration of drug needs to be interrupted until the size of ovaries does not return to norm. Further therapy can be resumed, but at the same time to lower Klostilbegit's dose or to reduce course duration.

During use of drug the constant observation of the gynecologist including control of function of ovaries, vaginal examonations, observation of a phenomenon of "pupil" is necessary. In many cases it is difficult to define the ovulation moment, insufficiency of a yellow body is also quite often observed. Therefore it is recommended to carry out after conception preventive therapy by progesterone.

Klostilbegit increases probability of development of polycarpous pregnancy.

Each tablet contains 100 mg of lactose therefore drug should not be accepted to patients with a lactose intolerance, intolerance of a galactose or malabsorption of glucose.

As Klostilbegit can lead to a vision disorder, patients during therapy need to be careful at control of motor transport and performance of other types of the works demanding high concentration of attention and bystry psychomotor reactions.

Medicinal interaction

Klostilbegit it is possible to accept along with drugs of gonadotropic hormones.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 5 years.