Gonadotropin chorionic - instructions for use, dose, side effects, contraindications

Gonadotropin is a chorionic human (hCG) - gonadotropic hormone, which is produced by the placenta during pregnancy, then in unchanged the form is excreted by the kidneys. To obtain the drug it is extracted from the urine and purified. It is necessary for normal growth and maturation of gametes in women and men, as well as for the production of sex hormones.

Has gonadotropic action, follicle-stimulating and luteinizing. Luteinizing activity predominates over follicle-stimulating activity. Stimulates the development of genital organs and secondary sexual characteristics. Among women the drug causes ovulation and stimulates the synthesis of estrogens (estradiol) and progesterone. In men - stimulates spermatogenesis, production of testosterone and dihydrotestosterone.

Pharmacokinetics:

After intramuscular injection is well absorbed. The half-life is 8 hours. The maximum concentration of hCG in the blood plasma is reached in 4-12 hours. The half-life of gonadotropin chorionic is 29-30 hours, in the case of daily intramuscular injections, cumulation of the drug may occur. Gonadotropin chorionic is excreted by the kidneys. About 10-20% of the administered dose is found in the urine unchanged, the main part is excreted as fragments of the β-chain.

Indications:

Among women:

ovarian dysfunction (anovulatory), amenorrhea;

- maintaining the phase of the yellow body;

In men and boys:

hypogonadotropic hypogonadism;

- delay in puberty due to deficiency of the gonadotropic function of the pituitary gland;

- cryptorchidism, not due to anatomical obstruction;

- Insufficiency of spermatogenesis, oligo-asthenospermia, azoospermia;

- when carrying out a differential diagnostic test of anarchism and cryptorchidism in boys;

- when carrying out the Leydig functional test for evaluation of testicular function at hypogonadotropic hypogonadism before the onset of long-term stimulating treatment.

Contraindications:

- Hypersensitivity to hCG or to any component of the drug;

- hormone-dependent malignant tumors of genital organs and breast cancer at the present time or suspected of them (ovarian cancer, breast cancer, cancer uterus in women and prostate cancer, breast carcinoma in men);

- organic lesions of the central nervous system (CNS) (tumors of the pituitary gland, hypothalamus);

- deep vein thrombophlebitis;

- hypothyroidism;

- adrenal insufficiency;

hyperprolactinemia;

- children's age till 3 years;

In boys (optional):

premature puberty;

In men (in addition):

- Infertility, not associated with hypogonadotropic hypogonadism;

In women (in addition):

- wrong formation of genital organs, incompatible with pregnancy;

- a fibrous tumor of the uterus, which is incompatible with pregnancy;

- primary failure of the ovaries;

- Infertility, not associated with anovulation (eg, tubal or cervical genesis);

- bleeding or spotting from the vagina of an unclear etiology;

- Pregnancy and the period of breastfeeding.

Carefully:

Persons with risk factors for thrombosis (personal or family history, severe obesity (body mass index> 30 kg / m²) or thrombophilia).

In men and boys: from latent or overt heart failure, impaired renal function, arterial hypertension, epilepsy or migraine (or in the presence of these conditions in the anamnesis); in pre-pubertal boys; in patients with bronchial asthma.

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:

Application of the drug Gonadotropin chorionic during pregnancy and breastfeeding is contraindicated.

Dosing and Administration:

After the addition of the solvent to the lyophilizate, the reconstituted solution gonadotropin chorionic is administered intramuscularly, slowly. The prepared solution is not subject to storage, since further preservation of the sterility of the solution is not guaranteed. These dosages are the treatment should be adjusted by the doctor individually, depending on the necessary response to the administration of the drug.

Among women:

- with anovulatory cycles gonadotropin chorionic appoint from 10-12 days of the menstrual cycle to 3000 ME 2-3 times with an interval of 2-3 days or 1500 ME 6-7 times every other day;

- to maintain the phase of the yellow body can be done from two to three repeated injections of the drug at a dose of 1500 ME up to 5000 ME each for 9 days after ovulation or embryo transfer (for example, on days 3, 6 and 9 after induction of ovulation).

In men and boys:

- with hypogonadotropic hypogonadism - 1000-2000 ME drug 2-3 times a week. In case of infertility, a combination of gonadotropin chorionic with an additional preparation containing follitropin (follicle-stimulating hormone), 2-3 times a week is possible. The course of treatment should last at least 3 months, when you can expect any improvement in spermatogenesis. During this treatment, it is necessary to suspend the substitution testosterone therapy.When the improvement of spermatogenesis is achieved, in order to maintain it, in some cases isolated application of gonadotropin chorionic is sufficient;

- with a delay in puberty due to insufficient gonadotrophic function of the pituitary - 1500 ME 2-3 times a week. The course of treatment - at least 6 months;

- with cryptorchidism, not due to anatomical obstruction: at the age from 3 to 6 years - 500-1000 IU twice a week for 6 weeks; at the age of over 6 years - 1500 ME twice a week for 6 weeks. The course of treatment, if necessary, can be repeated;

- in case of insufficiency of spermatogenesis, oligoasthenospermia, azoospermia, 500 ME in combination with menotropin (75 ME follicle-stimulating hormone + 75 ME luteinizing hormone) daily, or 2000 ME every 5 days in combination with menotropin (150 ME follicle stimulating hormone + 150 ME luteinizing hormone) 3 times a week for 3 months. In the absence of response to treatment, a 2000 ME 2-3 times a week with menotropin (150 ME follicle-stimulating hormone +150 ME luteinizing hormone) 3 times a week for 3-12 months. When the improvement of spermatogenesis is achieved, subsequent therapy can be performed only in a number of casessupporting doses of gonadotropin chorionic;

- for the purpose of differential diagnosis of cryptorchidism and anarchism in boys Gonadotropin chorionic is administered intramuscularly once in a dose of 100 IU / kg, serum testosterone concentration is determined before the test and 72-96 hours after the injection of the drug. In the case of anarchism, the test will be negative, indicating a lack of testicular tissue, in the case of cryptorchidism, even if only one testicle is present, positive (5-10-fold increase in testosterone concentration). If the test is weakly positive, a search for a gonad (ultrasound examination of the abdominal cavity or laparoscopy) is necessary, since there is a high risk of malignancy.

Side effects:

Immune system disorders: In rare cases, a generalized rash or fever may occur.

General disorders and disorders at the place of administration: when applying gonadotropin chorionic can occur reactions at the injection site, for example, bruising, pain, redness, swelling and itching. In some cases, allergic reactions have been reported,most of which were manifested as pain and / or rash at the injection site; increased fatigue.

Among women:

Disorders from the metabolism and nutrition: edema.

Disorders of the psyche: irritability, anxiety, depression.

Impaired nervous system: headache, dizziness.

In men and boys:

Disorders from the endocrine system: premature puberty.

Disturbances from the skin and subcutaneous tissues: acne.

Violations of the genitals and the breast: treatment gonadotropin chorionic sporadically can cause gynecomastia; hyperplasia of the prostate, enlargement of the penis, increased sensitivity of the nipples of the mammary glands in men, an increase in the testicles in the inguinal canal with cryptorchidism.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Gonadotropin chorionic is characterized by extremely low toxicity.

Among women against the background of an overdose, there may be a syndrome of ovarian hyperstimulation (OSS).

Depending on the degree of severity (based on clinical and laboratory symptoms), several types of CHD are distinguished:

Heaviness	Symptoms
СГЯ of an easy degree	Abdominal discomfort. Pain in abdomen of low intensity. The size of the ovaries is usually <8 cm *.
СГЯ of an average degree	Soreness of mammary glands. Pain in the abdomen of medium intensity. Nausea and / or vomiting. Diarrhea. Ultrasonic signs of ascites. A small or medium increase in ovarian cysts. The size of the ovaries is usually 8-12 cm *.
OSS of a severe degree	Weight gain. In rare cases, thromboembolism. Clinical signs of ascites (sometimes hydrothorax). Oliguria. Hemoconcentration, hematocrit> 45%. Hypoproteinemia. Large cysts of the ovaries (prone to rupture). The size of the ovaries is usually> 12 cm *.

* The size of the ovaries may not correlate with the severity of the OHSS in the cycles of assisted reproductive technologies (ART) in connection with the puncture of the follicles.

Principles treatment of CHD:

Easy degree:

bed rest; abundant drinking of mineral water; observation of the patient's condition.

Medium and severe degree (only in a hospital):

- monitoring the function of the cardiovascular system (CVS), respiratory system, liver, kidney, electrolyte and water balance (diuresis, weight dynamics, abdominal circumference changes);

- control of hematocrit level;

- Crystalloid solutions intravenously drip (to restore and maintain the volume of circulating blood (BCC));

- colloidal solutions intravenously drip - 1,5-3 l / day (with preservation hemoconcentration) and oliguria stand;

- hemodialysis (with the development of renal failure);

- corticosteroid, anti-prostaglandin, antihistamines (to reduce the permeability of capillaries);

- with thromboembolism - low molecular weight heparins (Fraxiparin, Clexane); plasmapheresis - 1-4 sessions with an interval of 1-2 days (improvement of the rheological properties of blood, normalization of the acid-base state (CBS) and gas composition of the blood, reduction in the size of the ovaries);

- Paracentesis and transvaginal puncture of the abdominal cavity with ascites. Hospitalization in a hospital is necessary for the development of PCOS of medium and severe severity.

Men and boys possibly the development of gynecomastia; the boys may change their behavior,similar to those observed during the first phase of puberty; degeneration of the sexual glands (with unreasonably long-term use in cryptorchidism), atrophy of the seminiferous tubules (due to inhibition of follicle-stimulating hormone (FSH) production as a result of stimulation of the production of androgens and estrogens); decrease in the number of spermatozoa in the ejaculate (when the drug is abused in men).

Long-term use of the drug may lead to increased side effects.

Interaction:

It is necessary to avoid joint use of the drug Gonadotropin chorionic with high doses of glucocorticosteroids.

No other interactions with drugs were noted.

Special instructions:

The use of gonadotropin increases the risk of venous or arterial thromboembolism, so it is necessary to evaluate the benefits of in vitro fertilization therapy for patients at risk. It should also be noted that pregnancy itself is also accompanied by an increased risk of thrombosis.

Increases the likelihood of multiple pregnancies. During treatment with the drug and within 10 days after discontinuation of treatment, the drug Gonadotropin chorionic can influence the values of immunological tests for the concentration of hCG in blood plasma and urine, which can lead to a false positive result of the pregnancy test.

Treatment of male patients with chorionic gonadotropin leads to an increase in the production of androgens, so patients at risk must be under strict medical supervision, since exacerbation of the disease or relapse can sometimes result from increased production of androgens.

HCG promotes premature closure of the epiphyses or premature puberty. It is necessarygto control the development of the skeleton.

In men The drug is ineffective with a high content of follicle-stimulating hormone.

Unreasonably long-term use of the drug in cryptorchidism, especially if surgical intervention is shown, can lead to degeneration of the sex glands.

Prolonged administration can lead to the formation of antibodies to the drug.

Effect on the ability to drive transp. cf. and fur:

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Lyophilizate for solution for intramuscular injection, 500 ME, 1000 ME and 1500 ME.

Packaging:

In the bottles of the glass tube.

5 bottles of the drug in a contoured cell pack of a polyvinylchloride film complete with 5 ampoules of 1 ml of solvent (sodium chloride, injection for 9 mg / ml) in a contiguous cell pack of polyvinyl chloride film together with instructions for use of the preparation and solvent, scarifier or with a knife amputated in a pack of cardboard.

When packing ampoules with incisions, rings and break points, scarifiers or ampoule knives do not.

Storage conditions:

In the dark place at a temperature of no higher than 20 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002469

Date of registration:04.05.2012 / 10.11.2014

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Representation: & nbspMOSCOW ENDOCRINE FACTORY FGUP MOSCOW ENDOCRINE FACTORY FGUP Russia

Information update date: & nbsp04.05.2017

Illustrated instructions

Instructions

Gonadotropin chorionic (Gonadotrophin chorionic)