Omnitrope (Omnitrope) 30 IU

Description

Manufacturer : SANDOZ
Release form: cartridge 1.5 ml – 10 mg (30 IU)
Active Ingredient : Human Growth Hormone
Country : Austria

pharmachologic effect

Somatropin has a pronounced effect on the metabolism of fats, proteins and carbohydrates. In children with growth hormone deficiency, somatropin stimulates the growth of skeletal bones in length by acting on the plates of the epiphysis of tubular bones. In both adults and children, somatropin contributes to the normalization of body structure by increasing muscle mass and reducing body fat. Visceral adipose tissue is especially sensitive to the action of somatropin. In addition to enhancing lipolysis, somatropin reduces the flow of triglycerides into body fat. Under the action of somatropin, the concentration of insulin-like growth factor I (IGF-I) and its binding protein (IGF-SB3, insulin-like growth factor binding protein) increases.

Fat metabolism

Somatropin activates low-density lipoprotein (LDL) receptors in the liver and alters the profile of lipids and lipoproteins in the blood. In general, the appointment of somatropin in patients with growth hormone deficiency leads to a decrease in blood LDL and apolipoprotein B. A decrease in cholesterol concentration is also observed.

Carbohydrate metabolism

Somatropin increases the release of insulin, but the concentration of glucose on an empty stomach usually does not change. Children with hypopituitarism may develop fasting hypoglycemia. This condition is reversible with the introduction of somatropin.

Water and mineral exchange

Growth hormone deficiency is associated with decreased plasma and extracellular fluid volume. The appointment of somatropin leads to a rapid increase in both parameters. Somatropin contributes to the retention of sodium, potassium and phosphorus.bone metabolism

Somatropin stimulates bone metabolism. Long-term treatment with somatropin in children with growth hormone deficiency and osteoporosis leads to the normalization of the mineral composition and bone density.

Physical activity

Long-term replacement therapy with somatropin leads to an increase in muscle strength and physical endurance.

Cardiac output also increases, although the mechanism of this action is not completely clear. The decrease in peripheral vascular resistance may partly explain this effect of somatropin.

Side effect

The following is a summary of adverse reactions reported according to the system organ classification (MedDRA) and WHO classification by frequency of occurrence: very often (&ge.1/10), often (&ge.1/100, &lt.1/10), infrequently (&ge.1/1000, &lt.1/100), rarely (&ge.1/10000, &lt.1/1000) and very rarely (&lt.1/10000).

A feature of patients with growth hormone deficiency is the lack of extracellular fluid volume. With the appointment of somatropin, this deficiency is quickly eliminated. In adult patients, adverse reactions associated with fluid retention are often observed, such as peripheral edema, limb stiffness, arthralgia, myalgia, and paresthesia. As a rule, the severity of these reactions varies from moderate to moderate, they develop in the first months of treatment and disappear spontaneously or when the dose is reduced. The likelihood of these reactions depends on the dose of the drug, the age of the patient and is probably irreversibly associated with age when growth hormone deficiency occurs. In children, these side effects are unknown.

Benign, malignant and unspecified neoplasms: very rarely – leukemia.Growth hormone deficient leukemia has been reported in very rare cases in children treated with somatotropin, but the incidence has been found to be similar to that in children with normal growth hormone levels.

On the part of the immune system: often – the formation of antibodies to somatropin. When prescribing somatropin, approximately 1% of patients develop antibodies to it. The binding capacity of these antibodies is small and clinical manifestations of such antibody production were not observed.

From the endocrine system: rarely – type 2 diabetes mellitus.

From the nervous system: often – paresthesia (in adults), infrequently – carpal tunnel syndrome (in adults), paresthesia (in children), rarely – benign intracranial hypertension.

On the part of the musculoskeletal and connective tissue: often – limb stiffness, arthralgia, myalgia (in adults), infrequently – limb rigidity, arthralgia, myalgia (in children).

General disorders and disorders at the injection site: often – peripheral edema (in adults), transient skin reactions at the injection site (in children), infrequently – peripheral edema (in children).

Contraindications

malignant neoplasms,

urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure),

growth stimulation in patients with closed epiphyseal growth zones,

pregnancy,

the period of breastfeeding (for the duration of treatment it is necessary to refuse breastfeeding),

the neonatal period (including premature babies) due to the presence of benzyl alcohol in the composition,

hypersensitivity to any component of the drug.

With caution: diabetes mellitus, craniocerebral hypertension, concomitant therapy with corticosteroids, hypothyroidism (including during thyroid hormone replacement therapy).