The drug Groutropin contains recombinant human growth hormone (somatropin), produced using genetically engineered methods from mammalian cells. Somatropin is a peptide consisting of 191 amino acids and is identical to human pituitary growth hormone in amino acid sequence and composition, as well as in the peptide map, isoelectric point, molecular weight, isomeric structure, and biological activity. Somatropin has anabolic and anti-catabolic properties, that is, it affects not only growth, but also the structure of the body and metabolism. Somatropin interacts with specific receptors on various types of cells, including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some of these effects are mediated by another class of hormones known as Somatomedin (IGF-1 and IGF-2). Depending on the dose, administration of the drug leads to an increase in the levels of IGF-1, IGFBP-3, non-esterified fatty acids and glycerol and a decrease in the level of urea in the blood, as well as to a decrease in the urinary output of nitrogen, sodium and potassium. Duration an increase in the level of growth hormone can play an important role in determining the degree of its effectiveness. For high doses of somatropin, the phenomenon of relative saturation of the effect is likely to exist, but this does not apply to glycemia and urinary excretion of C-peptide, which significantly increase only after administration of high doses of the drug (20 mg). Pharmacokinetics. The pharmacokinetics of the drug is linear at least when using doses up to 8 IU (2.67 mg). When using high doses (60 IU / 20 mg), some non-linearity of the response can not be excluded, which, however, does not have clinical significance. After administration of the drug to healthy volunteers, the volume of distribution in the equilibrium state is about 7 liters, the total metabolic clearance is ~ about 15 liters / hour, while the renal clearance is insignificant. The half-life is 20-35 minutes. After a single subcutaneous or intramuscular injection of the drug, the imaginary final half-life is long and is approximately 2 to 4: 00, due to the absorption process that limits the rate of withdrawal. Maximum serum concentrations of somatropin are reached at 4: 00 after administration, after which the serum level of growth hormone returns to the baseline within 24 hours, indicating that there is no accumulation of somatropin during repeated administration. The bioavailability of somatropin with intravenous and subcutaneous administration is 70-90%.
Hypersensitivity to the active substance or to any excipients of powder or solvent, closure of the epiphyseal growth zones in children, the presence of active neoplasms; before starting treatment, make sure that any existing neoplasms are in an inactive form and any antitumor therapy is completed, the progression or relapse of the main intracranial volumetric process is confirmed;
acute critical conditions that have developed as a result of complications after open heart surgery, abdominal cavity, as a result of multiple injuries, acute respiratory failure or similar pathologies, kidney transplantation in children with chronic renal failure, the use of somatropin should be discontinued for the duration of kidney transplantation, proliferative or preproliferative diabetic retinopathy.
Interactions with other drugs and other types of interactions
Concomitant use of corticosteroids inhibits the growth acceleration caused by drugs containing somatropin. To prevent any inhibitory effect of corticosteroids on the effect of growth hormone, careful adjustment of replacement therapy in patients with ACTH deficiency should be carried out. The data obtained in the study of drug interactions in the treatment of adult patients with growth hormone deficiency suggest that the administration of somatropin may increase the clearance of compounds metabolized by cytochrome P450 isoenzymes. The clearance of compounds that are metabolized with the participation of the cytochrome P450 ZA4 system (for example, sex hormones, corticosteroids, anticonvulsants and cyclosporine) can significantly increase, which will lead to a decrease in the level of these compounds in the blood plasma. The clinical significance of this phenomenon is unknown.
Use during pregnancy or lactation
There are no clinical data on the use of the drug during pregnancy. Therefore, somatropin preparations are not recommended for use during pregnancy, as well as in women of childbearing age who do not take appropriate measures for contraception. Lactation. Clinical studies of the use of somatropin in breast-feeding women have not been conducted. It is not known whether somatropin penetrates into breast milk. Therefore, breast-feeding, somatropin preparations should be prescribed with caution.
Ability to influence the reaction speed when driving vehicles or other mechanisms
Somatropin preparations do not affect the patient's ability to drive a car or work with mechanisms.
Method of administration and dosage
The drug Groutropin is intended for reusable use. The dosage of Groutropin should be selected individually for each patient, depending on the body surface area or body weight. Treatment of children. The drug Groutropin is recommended to be administered before bedtime in the following doses: growth retardation caused by insufficient secretion of endogenous growth hormone. Subcutaneously, 0.7-1.0 mg / m2 of body surface area per day or 0.025 - 0.035 mg / kg of body weight per day is administered. Growth retardation in girls caused by gonadal dysgenesis (Turner syndrome). Subcutaneously, 1.4 mg / m2 of body surface area per day or 0.045-0.050 mg / kg of body weight per day is administered. Simultaneous therapy with the use of non-androgen anabolic steroids in patients with Turner syndrome may lead to an increased response to the administration of growth hormone. Growth retardation in adolescent children caused by chronic kidney failure. Subcutaneously, 1.4 mg / m2 of body surface area per day is administered, which is approximately 0.045-0.050 mg / kg of body weight per day. Growth disorders in short children born with growth do not correspond to gestational age (NGV). It is recommended to administer 0.035 mg / kg of body weight daily (or 1 mg / m2 of body surface area per day, which is 0.1 IU / kg / day or 3 IU / m2 / day) subcutaneously. Duration of treatment. Treatment should be discontinued when the patient reaches a height sufficient for adults, or when the epiphyseal growth zones are closed. Treatment of growth disorders in short children born with NGV is usually recommended to continue until they reach their final growth. Treatment should be discontinued after the first year of treatment if the SDS growth rate is less than 1. Treatment should be discontinued when the patient reaches the final growth (determined by the growth rate <2 cm / year). Confirmation of the need for treatment is required if the age of the bones corresponds to the age of> 14 years (girls) or> 16 years (boys), which corresponds to the closure of the epiphyseal growth zones. Growth hormone deficiency in adults. At the beginning of therapy, it is recommended to subcutaneously administer low doses of the drug, which are 0.15-0.3 mg of somatropin per day. The dose should be gradually adjusted and monitored for levels of insulin-like growth factor 1 (IGF-1). The recommended final dose of growth hormone rarely exceeds 1.0 mg / day. In general, the lowest effective doses of the drug should be administered. For elderly patients or overweight patients, it may be necessary to reduce the dose of the drug. Growth hormone deficiency in adults is a lifelong pathology that requires appropriate treatment. However, the experience of treating patients over the age of 60 years and the experience of long-term use of the drug is limited. Method of preparation of the solution and injection. It is recommended to administer the drug subcutaneously, since compared to intramuscular administration, this method provides stable serum concentrations of growth hormone, close to physiological ones. In addition, the subcutaneous method of administration allows the close environment of a child or an adult patient to independently inject a solution of the drug after passing the appropriate training. It should be borne in mind that prolonged subcutaneous administration of the drug Groutropin in the same place can cause the development of lipoatrophy; therefore, it is recommended to change the place of administration of the drug every time.
No cases of acute drug overdose have been reported. However, exceeding the recommended doses can cause the development of side effects. Overdose can lead to the development of hypoglycemia, followed by hyperglycemia. In addition, it is likely that an overdose of somatropin can lead to the development of fluid retention phenomena.
|Active ingredient, IU||16|
|1 bottle, IU||16|
|Bottles in the package, pcs||10|
|Manufacturer||Dong-A ST Ko|
|Packing||Packing (10 ampoules), Bottle|