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Sizen
Medication Saizen (Merck Serono, Switzerland) belongs to the pharmacological group of the hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists.
The active substance of the drug is the synthetic growth hormone somatropin (somatotropic hormone) obtained by modern technology of recombinant DNA of mammalian cells, altered by the addition of the human growth hormone gene.
Indications Sizen
Indications for the use of Sizen are cytogenetic disorders, such as insufficient production or complete absence of growth hormone secretion in childhood, incomplete development of the sex glands. These pathologies are associated with the mutation of certain genes, which lead to underdevelopment of the pituitary gland.
Sisen® is used to treat growth retardation in girls ( gonadal dysgenesis or Turner's syndrome ); insufficient growth in pre-pubertal children caused by chronic renal insufficiency; dysplasia in low-infants over 4 years of age (with SDS of the existing growth <-2.5 and taking into account the growth of parents SDS <-1).
Also, the use of the drug is possible in substitution therapy in adults with a pronounced growth hormone deficiency.
Release form
The preparation Sizen® is available in the form of lyophilizate - a biologically active dry powder for the preparation of a solution for subcutaneous injections. The bottle for the preparation of the injectable solution contains somatropin (8 mg) complete with a solvent (0.3% methacrylate solution) in the cartridges and a device for introducing a "click-out" solution.
Pharmacodynamics
The preparation Sisen® contains recombinant human growth hormone (r-LHR), which stimulates the synthesis of protein and prevents its cleavage (catabolism), thereby affecting the growth and structure of the body. Pharmacodynamics Sayzen® is based on the interaction of the hormone with specific receptors of muscle cell cells (myocytes), liver cells (hepatocytes), fat cells (adipocytes), lymphocytes and hematopoietic bone marrow cells.
The drug helps to increase the level of peptide hormones of the hypothalamus (somatostatin and somatoliberin), which are secreted by the neurosecretory cells of the hypothalamus in the portal veins of the pituitary gland and act on growth hormone release cells (growth hormones). This causes an acceleration of growth (mainly due to the growth of long tubular bones of the limbs), contributes to the normalization of carbohydrate metabolism - the increase in the combustion of subcutaneous fat and the reduction of its deposition.
At the same time, the blood glucose (glycemia) and the level of endogenous secretion of insulin (C-peptide) remain within the physiological norm and can be significantly increased only if high doses of the drug are administered (20 mg).
In addition, somatotropin has an immunostimulatory effect on the growth of most internal organs and has a modulating effect on certain functions of the central nervous system.
Pharmacokinetics
After the administration of the preparation Sizen, the maximum concentration of the active substance in the blood serum is achieved after 4 hours, after which the content of somatotropin in the serum returns to the baseline within 24 hours. This indicates the absence of cumulation, that is, with repeated administration of the hormone does not accumulate.
After intramuscular injection, the maximum content of the hormone in the blood plasma is reached after 3 hours, and when injected under the skin - after 4-6 hours.
Absolute bioavailability of the drug with intramuscular and subcutaneous injection is at least 70-90%.
Contraindications
The use of saisen is contraindicated in the case of the closure of the pineal body (epiphysis) in children, with increased sensitivity to somatropin or another component of the drug, as well as in the presence of active (progression or relapse) neoplasms of the brain. The drug is not used in acute conditions that developed after surgery on the abdominal cavity or heart, as well as with multiple injuries and respiratory failure.
The use of Sizen® can reduce glucose tolerance, because the growth hormone contained in it can cause an excess of sugar in the blood (insulin resistance). Therefore, this drug should be used with caution in patients with diabetes mellitus or the presence of this disease in a family history.
Side effects Sizen
Among the side effects of this drug are: an allergic reaction (with the formation of antibodies to Sisen); pain, loss of sensation, redness and swelling at the injection site.
To prevent fat tissue atrophy of certain areas or areas of the body (local lipoatrophy), the subcutaneous injection sites should be changed daily. In the course of therapy, it is possible to reduce the thyroid function (hypothyroidism), which must be eliminated by the administration of thyroid hormones (triiodothyronine, thyroxine, thyroglobulin).
Dosing and administration
Therapy with hormones is carried out only under conditions of systematic medical control, since non-androgenic steroids can cause an additional increase in the rate of growth.
Dosage and administration of Sizen®: the preparation should be dissolved with the bacteriostatic solvent that is available in the package. The usual weekly dosage of the drug for intramuscular or subcutaneous administration is 0.6-0.8 IU / kg. With intramuscular injection, this dose is divided into three single injections, with subcutaneous injection - for 6-7 single injections. In the second year of Sisen® treatment, the weekly dosage may be increased, but not more than 1 IU / kg.
The treatment of growth hormone deficiency in adult patients or overweight patients may require the determination of the individual dosage in the direction of its reduction. The experience of treating patients older than 60 years and the experience of prolonged use of the drug is limited.
Overdose
The overdose of Sizen® is expressed as a decrease in the normal level of glucose in the blood
(hypoglycemia), which is replaced by high blood sugar (hyperglycemia). When the drug is overdosed for a long time, there may be signs of acromegaly - a violation of the proportions of the skeleton, soft tissues and internal organs (enlargement of facial features, increase in the size of feet and brushes).
Interactions with other drugs
Sensitivity to Sisen® can be suppressed with simultaneous treatment with glucocorticoid drugs (prednisolone, etc.). Simultaneous therapy with concomitant use of corticosteroids (hydrocortisone, etc.) can completely neutralize the therapeutic effect of the drug Sizen. In the course of therapy with Sizen, it is necessary to monitor the level of cortisol in the serum to adjust the dose of corticosteroids.