Instruction for use: Somatropin (Somatropinum)

Chemical name

A single-chain polypeptide consisting of 191 amino acid residues (human growth hormone)

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Nosological classification (ICD-10)

D84.9 Immunodeficiency, unspecified

Pneumonia in immunodeficiency states, Autoimmune disease, Autoimmune diseases, Significant immunodeficiency, Immune Deficiency, Immunodeficiency, Immunodeficiency diseases, Immunodeficiency conditions due to surgical intervention, Immunocorrection for cancer, Immunomodulation, Infections in Patients with Weakened Immunity, Correction of immune deficiency, Correction of immunodeficiency states, Correction of weakened immunity, Correction of weakened immunity in immunodeficient states, Impaired immunity, Infringement of the immune status, Impaired immune system, Primary immunodeficiency, Maintenance of immunity, Reduction of protective forces, Decreased immunity, Decreased immunity for colds and infectious diseases, Decreased immune status, Reduced resistance to infectious diseases, Reduced resistance to infectious and catarrhal diseases, Reduced resistance of the body, Low immunity, Predisposition to colds, Acquired immunodeficiency, Radiation immunodeficiency, Development of immunodeficiency, The syndrome of immune dysfunction, Immunodeficiency Syndrome, Syndrome of primary immunodeficiency, Reduction of body defenses, Decreased immunity, Decreased body immune defense, Decreased local immunity, Decrease in the total body resistance, Reduction of cellular immunity, Reduced resistance to infections in children, Decreased body resistance, Reduced body resistance, Reduced immunity, The state of immunodeficiency, Stimulation of the processes of nonspecific immunity, Severe secondary selective immunodeficiency, Inhibition of immunity, Primary immunodeficiency states

E34.3 Low-growth [dwarfism], not elsewhere classified

Growth retardation, Growth retardation in children, Dwarfism, Nanism hypophyseal, Inadequate endogenous growth hormone, Growth Hormone Deficiency, Pituitary Nanism, Low height, Growth disorder, Disturbance of the growth process, Pituitary dwarfism, Disruption of endogenous hormone secretion with growth retardation, Growth disorders, Naniz disproportionate, Nanism associated with external factors

Q96 Turner Syndrome

Turner syndrome, Gonadal Dysgenesis, Mixed gonadal dysgenesis, Shereshevsky-Turner Syndrome

R62 Lack of expected normal physiological development

Genetic Disease, Delay in the child's physical development, Insufficient growth intensity, Growth lag

Characteristics

Sterile white or almost white lyophilized powder.

Pharmacology

Pharmacological action - anabolic, somatotropic, stimulating growth.

Stimulates the growth of the bones of the human skeleton, affecting the plates of the epiphysis of tubular bones, causes an increase in the number and size of cells of the muscles, liver, thymus, gonads, adrenals and thyroid gland. Activates the synthesis of chondroitin sulfate and collagen, increases the excretion of hydroxyproline, increases body weight.

Regulates protein metabolism - stimulates the transport of amino acids into the cell and protein synthesis. Reduces cholesterol, increases the number of triglycerides, reduces the volume of adipose tissue; Suppresses the release of insulin and causes hyperglycemia. Prevents the removal of liquid, nitrogen, sodium, potassium and phosphorus. The loss of calcium (acceleration of renal ejection) is compensated by its increased absorption in the digestive tract.

Indications

Disturbance of the growth process in children with insufficient endogenous growth hormone, chronic renal failure in children, accompanied by growth retardation, Shereshevsky-Turner syndrome, osteoporosis, immunodeficiency syndromes accompanied by weight loss.

Contraindications

Hypersensitivity, malignant neoplasms, epiphysic closure, pregnancy, breast-feeding.

pregnancy and lactation

The action category for fetus by FDA is C.

Side effects

Headache, increased intracranial pressure, accompanied by severe and frequent headaches, nausea, vomiting, visual impairment, suppression of thyroid function with development of symptoms of hypothyroidism, hyperglycemia, leukemia, epiphysis of the head of the femur, edematous syndrome; Local reactions - changes in fat tissue volume, pain and itching at the injection site.

Interaction

Glucocorticoids inhibit the stimulating effect of growth hormone on growth processes.

Overdose

Symptoms of prolonged overdose: gigantism and acromegaly, signs of hypersecretion of growth hormone; One-time - hypo- or hyperglycemia.

Routes of administration

P / to, in / m (intramuscularly).

Precautions

Caution should be exercised in appointing patients with diabetes mellitus or patients with a family predisposition to the disease (possibly an increase in the need for insulin). It is necessary to monitor the level of glucose in the blood and urine.

In patients with growth hormone deficiency due to neoplasm of the brain, more frequent examinations should be conducted to exclude progression and recurrence of tumor growth.

During the period of treatment, it is possible to develop hypothyroidism and decrease the effectiveness of therapy (periodic monitoring of the functional state of the thyroid gland and adequate substitution therapy with thyroid medications is necessary).

Epiphysiolysis of the head of tubular bones is more common in patients with endocrine disorders, including growth hormone deficiency. The detection of lameness on the background of growth hormone therapy in children requires careful observation.

In case of severe or recurring headaches, visual disturbances, nausea, vomiting, examination of the fundus (fundoscopy) is recommended to detect edema of the optic disc, the presence of which suggests the possibility of intracranial hypertension. In this case, if possible, it is necessary to stop treatment with growth hormone. When re-appointment is mandatory careful monitoring of symptoms of intracranial hypertension. It is necessary to change the places of hypodermic injections in connection with the possibility of lipoatrophy development. The best results are observed with the appointment of treatment as early as possible. Treatment continues until puberty and until the bone growth zones are closed. It is possible to stop treatment when the desired growth is achieved.

special instructions

Some drugs contain benzyl alcohol toxic to the newborns as a preservative.

Do not shake when dissolved!