Omnitrop

Omnitrop is a growth hormone.

[1]

Indications Omnitrop

Applicable for children - in case of growth retardation due to the following conditions and pathologies:

• weak secretion of somatotropin;
• Ulrich syndrome;
• SPV;
• CRF with decreased renal function (more than 50% decrease);
• children who were born with too low growth rates for this gestation period.

Adults are prescribed for substitution treatment for diagnosed congenital (severe) or acquired deficiency of STH.

[2]

Release form

The substance is released in the form of a liquid for injections (3.3 or 6.7 mg / ml). The volume of glass cartridges of the 1st type is 1.5 ml. Inside the correction there are 1, 5 or 10 such cartridges. In the box - 1 Correct.

Pharmacodynamics

Somatropin has a pronounced effect on protein, fat and carbohydrate metabolism. In children who are deficient in STH, the substance promotes stimulation of bone growth of the skeleton, extending it by affecting the epiphyseal plates inside the tubular bones. This component helps to normalize the body structure, both in children and adults - by increasing muscle mass and simultaneously reducing fat mass. The greatest sensitivity to the effect of GH has visceral fatty tissue. Together with the potentiation of lipolysis, the drug lowers the amount of triglycerides entering the fat stores of the body. The effect of STH leads to an increase in the values of the element of IGF-I, as well as the protein synthesizing it (IRF-SB3).

Additionally, other effects develop:

• fat metabolism. STH stimulates the activity of the liver end of LDL and changes the lipoprotein and lipid profile of the blood. When using the substance in people with a lack of GH, there is a decrease in the blood values of LDL, as well as apolipoprotein B. Along with this, a decrease in the cholesterol indicators is observed;
• carbohydrate metabolism. The drug increases the volume of released insulin, although the sugar values of sugar usually remain unchanged. In children with Shien syndrome, an empty stomach can develop hypoglycemia. Removing this violation can be done with the help of STG;
• processes of water-mineral metabolism. The lack of GH leads to a decrease in plasma volume and the amount of extracellular fluid. Through the use of Omnitrop, both of these parameters are rapidly increasing. Also, the substance helps to retain potassium with sodium and phosphorus;
• metabolic processes inside bone tissue. The drug activates the processes of bone metabolism. With prolonged use of STH in children with osteoporosis, as well as a lack of GH, bone density and mineral composition are stabilized;
• improvement of physical condition. Prolonged substitution treatment with STH causes an increase in physical endurance and muscle strength. The cardiac output also increases, but in this case the mechanism of therapeutic effect remains unclear. The weakening of peripheral vascular resistance may, to some extent, explain this effect of STH.

[3], [4], [5]

Pharmacokinetics

Suction.

With subcutaneous injection, the bioavailability level of the STG is approximately 80%. After subcutaneous administration of 5 mg of the substance to the volunteers, the plasma Cmax and Tmax values were 72 ± 28 μg / l and 4 ± 2 hours, respectively.

Excretion.

Mean values of the half-life of STH for intravenous use in adults with a GH deficiency are approximately 0.4 hours. In this case, after subcutaneous injection, the Omnitropa half-life is 3 hours.

[6]

Dosing and administration

The drug is administered at a low rate, subcutaneously, 1-fold per day (mostly before bedtime). To avoid the appearance of lipoatrophy, it is necessary to regularly change the sites for the introduction of drugs.

Dosages are selected for each patient separately; this takes into account the severity of GH deficiency, weight or body surface area, as well as the therapeutic efficacy of the drug.

Use in children.

If there is an insufficient allocation of GH, you should inject 0,025-0,035 mg / kg or 0,7-1 mg / m ² per day.

Therapy is required to begin as early as possible and continue it until the child's sexual maturation begins (or the bone growth zones start closing). Also, therapy can be stopped when the desired effect is achieved.

When treating Ulrich's syndrome, it is required to use a medicine in a dose of 0.045-0.05 mg / kg or 1.4 mg / m ² per day.

Patients with SLE to increase growth, as well as improve the body composition, should be administered at 0.035 mg / kg or 1 mg / m ² per day. The daily portion of the drug should not be more than 2.7 mg. Therapy is forbidden to prescribe to those children, who have an increase in growth less than 1 cm per year, and also almost closed epiphyseal areas of bone growth.

In the case of CRF, against which growth retardation is noted, it is necessary to administer 0.045-0.05 mg / kg per day. If the growth dynamics is insufficient, it is possible that there is a need for a higher portion of drugs. To revise the optimal dosage is allowed after half a year of therapy.

When there are growth disorders in those children who were born with growth rates too low for their gestational age, 0.035 mg / kg or 1 mg / m ² per day should be used until the required growth is achieved. Stop therapy should be, if after the first year of her growth increased by less than 1 cm.

To cancel treatment also it is necessary, if the growth increase for a year makes less than 2 sm, and besides taking into account a condition of epiphysial growth areas (if it is required). It is established that in girls the bone age is> 14 years, and in boys -> 16 years.

Application in adults.

Adults with a severe degree of GH deficiency are required to begin substitution treatment with low portions (0.15-0.3 mg per day). Further, they are gradually increased, taking into account the serum IGF-I values. This value should stay within 2 deviations from the average for this age group. In individuals with normal initial indices of IGF-I, the portion of the medication should be selected so that the level of IGF-I resides on the VGN, within the limits of 2 permissible deviations.

The size of the maintenance dose is determined individually, but it usually should not be more than 1 mg per day (similar to the 3-day dose per day). For older people, lower dosages are used.

[12], [13]

Use Omnitrop during pregnancy

It is forbidden to prescribe medication for pregnant women. Also for the period of therapy, nursing mothers are required to refuse breastfeeding.

Contraindications

The main contraindications:

• presence of severe sensitivity relative to the elements of the drug;
• malignant neoplasms;
• states of urgent type (among such conditions, marked after surgical procedures on the heart or peritoneum, as well as acute respiratory insufficiency);
• to stimulate growth in people whose epiphyseal growth zones are closed.

[7], [8], [9]

Side effects Omnitrop

People who use medication of adults often have side effects associated with fluid retention. Among them, stiffness in the limbs, peripheral edema, myalgia with arthralgia and paresthesia. Usually the degree of manifestation of such manifestations is moderate, they appear in the first months of therapy and disappear on their own or after a reduction in the portion of the drug. The likelihood of these symptoms depends on the age of the patient and the size of the dosage of the medication (it is very likely that they have an irreversible relationship with the age of development of a lack of GR). In children, such violations are not recorded.

Among other negative features:

• tumors having an evil or benign, and also unspecified nature: leukemia develops single-handedly. Also, in children, there were situations with the appearance of leukemia with a lack of GH during therapy with STH, but it was found that this frequency is similar to cases with children having a normal GH level;
• Immune lesions: antibodies against STG are often formed. Approximately 1% of patients start to develop antibodies to somatotropin after its administration. The synthesizing power of such antibodies is low enough, so there are no clinical symptoms of such antibody production;
• disorders affecting the endocrine function: occasionally develops type 2 diabetes;
• Violations in the work of the National Assembly: Paresthesia (adults) is often noted. More rarely, paresthesias are observed in children. Sometimes adults develop carpal tunnel syndrome. Occasionally, the level of ICP (benign form of the disorder) rises;
• problems arising in the field of connective and musculoskeletal tissues: often in adults there is rigidity in the limbs and myalgia with arthralgia. Sometimes the same symptoms occur in children;
• systemic lesions and disorders at the site of injection: peripheral puffiness (often in adults, more rarely in children). Also, often, children develop transient skin manifestations in the zone of drug administration.

[10], [11]

Overdose

Signs of intoxication: in acute poisoning hypo- and, later, hyperglycemia may develop. Because of a prolonged overdose, manifestations develop that often occur with an excessive amount of human GH (eg, gigantism or acromegaly, and in addition hypothyroidism and a decrease in serum cortisol).

To eliminate the disorders, it is necessary to cancel the use of drugs and carry out symptomatic procedures.

Interactions with other drugs

Data from the tests of drug interaction in adults with a lack of GH suggest that the use of GHG increases the clearance level of drugs that metabolize with hepatic microsomal isoenzymes of cytochrome P450 (especially those that undergo isoenzyme 3A4 metabolism). Among these are GCS, sex hormones, cyclosporine and anticonvulsants. As a result of this combination, a decrease in their level inside the plasma is possible. The clinical significance of this effect has not yet been revealed.

The GCS compounds retard the stimulating effect of STH on growth processes. To influence the drug efficacy (relative to the final growth) can also be combined treatment with the use of other hormones (for example, gonadotropin, estrogens, anabolic steroids, and thyroid hormones).

[14], [15]

Storage conditions

Omnitrop is required to be kept in a place that is closed from access by young children. Do not freeze the medicine. Temperature values are in the range of 2-8 ° C.

[16]

Shelf life

Omnitrop can be used within 24 months (form 3.3 mg / ml) or 18 months (form 6.7 mg / ml) since the release of the drug.

[17],

Application for children

Use Omnitrop in newborns (this includes premature infants) is prohibited - because it contains benzyl alcohol.

[18], [19], [20]

Analogues

Analogues of the drug are such drugs as Norditropin Nordilet, Genotropin, and Rastan with Jintropin.

[21], [22]