PHARMACY

Genetically engineered somatotropic hormone, acting on the epiphysis plates of tubular bones, stimulates the growth of skeletal bones. It activates the synthesis of chondroitin sulfate and collagen, increases the excretion of hydroxyproline, and helps to increase body weight. Regulates protein metabolism: stimulates the transport of amino acids into the cell and protein synthesis. Increases the number and size of muscle cells, hepatocytes, cells of the thymus, thyroid, adrenal and gonads. Mobilizes fats: lowers cholesterol concentration and increases TG, reduces adipose tissue. Retains Na +, K +, phosphorus and water in the body (prevents excretion); has anabolic (stimulates the transport of amino acids into the cell and protein synthesis), hyperglycemic action (inhibits the release of insulin). The increased excretion of Ca2 + by the kidneys is compensated by its increased absorption in the gastrointestinal tract. The duration of the therapeutic action is 12-48 hours.

INDICATIONS

Replacement therapy in childhood in patients with endogenous growth hormone deficiency (pituitary dwarfism), incl. against the background of chronic renal failure, Prader-Willi syndrome;

Shereshevsky-Turner syndrome;

replacement therapy of severe STH deficiency in adults.

There are reports in the literature on the use of somatropin in the symptomatic treatment of the following diseases (indications not approved): kwashiorkor, osteoporosis, cachexia, or significant weight loss in AIDS patients.

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CONTRAINDICATIONS

Hypersensitivity, brain tumors, malignant tumors of any localization (acceleration of their growth is possible, treatment is possible after effective anticancer therapy), urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure).

Carefully. Diabetes mellitus (possibly decreased insulin sensitivity), intracranial hypertension, hypothyroidism (unpredictable decrease in the effect of STH administration), pregnancy, lactation.

Dosage

V / m, with low growth due to inadequate endogenous secretion of growth hormone - 12 IU / sq. m / week or 0.6 IU / kg / week; if ineffective, the dose is increased to 20 IU / sq. m / week or up to 0.8 IU / kg / week. The weekly dose should be divided into 3-6 injections (4 IU / m2 or 0.2 IU / kg). Injections should be given in the evenings. With insufficient growth in patients with gonadal dysgenesis (Turner syndrome) - 18 IU / sq. m / week or 0.6-0.7 IU / kg / week. In the second year of treatment, the dose can be increased to 24 IU / sq. m / week or 0.8-1 IU / kg / week. The weekly dose of the drug should be divided into 7 single sc injections of 2.6 IU / sq. m or 0.09-0.1 IU / kg.

SIDE EFFECTS

Headache, excessive fatigue or weakness, epiphyseolysis of the femoral head (limping, pain in the hip and knee), peripheral edema in the first weeks of treatment, arthralgia, myalgia, increased intracranial pressure (severe and frequent headaches, nausea, vomiting, visual impairment, edema of the optic nerve head (usually observed during the first 8 weeks of treatment, most often in patients with Shereshevsky-Turner syndrome), pancreatitis (abdominal pain, nausea, vomiting), otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome ), gynecomastia, tunnel syndrome, fluid retention, peripheral edema, leukemoid reactions, accelerated growth of a preexisting nevus (possible malignancy) Progression of scoliosis (in patients with overgrowth) Allergic reactions: skin rash, itching.

Local reactions in the area of ​​administration: soreness, numbness, hyperemia, swelling, lipoatrophy, itching.

In a small percentage of patients - the formation of antibodies to STH with a decrease in its effectiveness.

Increased blood concentration of inorganic phosphate, parathyroid hormone and alkaline phosphatase activity.

Overdose. Symptoms: single overdose - hypoglycemia followed by hyperglycemia, rarely - glucosuria.

Long-term administration of excessive doses - acromegaly and / or gigantism, hypothyroidism, decreased serum cortisol.

Treatment: drug withdrawal, symptomatic therapy.

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