The ugly truth about somatropin. Positive and negative effects when using growth hormone

V / m, with low growth due to inadequate endogenous secretion of growth hormone - 12 IU / sq.m / week or 0.6 IU / kg / week; with inefficiency, 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 made 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, doses may be increased to 24 IU/m2/week or 0.8-1 IU/kg/week. The weekly dose of the drug should be divided into 7 single s / c injections of 2.6 IU / sq.m or 0.09-0.1 IU / kg.

In some cases, when treating patients with Turner's syndrome, it may be necessary to increase the doses already in the first year of treatment. Treatment is stopped when the patient reaches a height sufficient for an adult, or when the epiphyses of the tubular bones are closed.

The supplied NaCl solution is used to prepare the solution; for injection, a strictly required amount of the drug is collected, the remaining solution is discarded. After adding the solvent, it is necessary to carefully, without shaking, rotate the vial until the contents are completely dissolved. The resulting solution should be clear. If the solution is cloudy or contains particles of undissolved drug, it should not be used for injection.

Norditropin penset: with growth hormone deficiency - s / c, 0.07-0.1 IU / kg or 2-3 IU / sq.m 6-7 times a week. With Shereshevsky-Turner syndrome - s / c, 0.14 IU / kg or 4.3 IU / sq.m 6-7 times a week. With chronic renal failure in children, accompanied by growth retardation - s / c, 0.14 IU / kg or 4.3 IU / sq.m 7 times a week. The dry matter is dissolved with the supplied solvent.

Genotropin: the recommended dose is s / c, 0.5-0.7 IU / kg or 12-16 IU / sq.m per week. With Shereshevsky-Turner syndrome - 1 IU / kg or 30 IU / sq.m / week. In chronic renal failure in children, accompanied by growth retardation - 1 IU / kg or 30 IU / sq.m / week. After 6 months of therapy, a dose adjustment is necessary. Adults with severe growth hormone deficiency - 0.125-0.25 IU / kg per week. Dose selection is carried out depending on the effectiveness, adverse reactions, the concentration of insulin-like growth factor in the blood serum. Elderly patients are prescribed lower doses.

Biosome: with growth hormone deficiency in children - 0.6-0.7 IU / kg or 18 IU / sq.m of body surface per week. For patients receiving the drug for a long time, as well as for children during puberty - 1 IU / kg per week. With Shereshevsky-Turner syndrome - up to 1 IU / kg or 30 IU / sq.m per week. The recommended dose is divided into 6-7 injections and administered s / c in the evening. Better results are observed when treatment is given at an earlier age. Treatment is continued until puberty or until the closure of bone growth zones. It is possible to stop treatment when the desired growth is achieved. The drug is dissolved in the supplied solvent containing 0.9% benzyl alcohol: 4 IU - in 1.1 ml, 8 IU - in 2.1 ml. The volume of the solvent drawn into the syringe is injected into the vial, directing the jet of liquid onto the vessel wall and without affecting the drug. Shake the bottle with soft circular motions (do not shake!) until the drug is completely dissolved. Do not use solution that is cloudy or contains undissolved particles.

Humatrope: with growth hormone deficiency - 0.18 mg / kg or 0.54 IU / kg per week. The dose is divided into equal parts and administered for 3 or 6 days a week in / m or s / c. The maximum dose for replacement therapy is 0.1 mg / kg or 0.3 IU / kg 3 times a week. With Shereshevsky-Turner syndrome - s / c, 0.3-0.34 mg / kg or 0.9-1 IU / kg (24-28 IU / sq.m) per week. The weekly dose is divided into 6-7 injections, preferably at night.

Zomacton: the dose is set individually. The recommended dose is 0.5-0.7 IU/kg or 14.8-20.7 IU/sq.m per week. The weekly dose is divided into 6-7 s / c injections. The maximum dose is 0.81 IU/kg or 24 IU/sq.m per week. Treatment continues for several years.

Treatment of cachexia on the background of AIDS: patients weighing more than 55 kg - s / c, 18 IU (6 mg) at bedtime, 45-55 kg - 15 IU (5 mg), 35-44 kg - 12 IU (4 mg) , less than 35 kg - 0.1 mg / kg / day.

Rastan: s / c slowly, 1 time per day (usually at night). With insufficient secretion of growth hormone in children - 25-35 mcg / kg / day (0.07-0.1 IU / kg / day), which corresponds to 0.7-1 mg / sq.m / day (2-3 IU / sq.m / day ). With Shereshevsky-Turner syndrome, with chronic renal failure in children, accompanied by growth retardation - 50 mcg / kg / day (0.14 IU / kg), which corresponds to 1.4 mg / sq.m / day (4.3 IU / sq.m / day). With insufficient growth dynamics, dose adjustment is carried out. With growth hormone deficiency in adults, the initial dose is 0.15-0.3 mg / day (0.45-0.9 IU / day), followed by an increase depending on the effectiveness. When selecting a dose, insulin-like growth factor type 1 (IGF-1) in blood serum can be used as a control indicator. The maintenance dose is selected individually, but should not exceed 1 mg / day (3 IU / day). In the elderly, lower doses are recommended.

Pharmacological group of the substance Somatropin

Nosological classification (ICD-10)

Characteristics of the substance Somatropin

Sterile white or almost white lyophilized powder.

Pharmacology

pharmachologic effect- anabolic, somatotropic, growth stimulant.

Stimulates the growth of bones of the human skeleton, acting on the plates of the epiphysis of tubular bones, causes an increase in the number and size of muscle cells, liver, thymus, gonads, adrenal glands and thyroid gland. Activates the synthesis of chondroitin sulfate and collagen, increases the excretion of hydroxyproline, increases body weight.

Regulates protein metabolism - stimulates the transport of amino acids into the cell and protein synthesis. Reduces cholesterol levels, increases the number of triglycerides, reduces the amount of adipose tissue; inhibits insulin release and causes hyperglycemia. Interferes with removal of liquid, nitrogen, sodium, potassium and phosphorus. The loss of calcium (acceleration of renal excretion) is compensated by its increased absorption in the gastrointestinal tract.

Application of the substance Somatropin

Violation of the growth process in children with endogenous growth hormone deficiency, chronic renal failure in children, accompanied by growth retardation, Shereshevsky-Turner syndrome, osteoporosis, immunodeficiency syndromes, accompanied by weight loss.

Contraindications

Hypersensitivity, malignant neoplasms, epiphyseal closure, pregnancy, breastfeeding.

Use during pregnancy and lactation

Side effects of the substance Somatropin

Headache, increased intracranial pressure, accompanied by severe and frequent headaches, nausea, vomiting, blurred vision, depression of thyroid function with the development of symptoms of hypothyroidism, hyperglycemia, leukemia, epiphysiolysis of the femoral head, edematous syndrome; local reactions - a change in the volume of adipose tissue, pain and itching at the injection site.

Interaction

Glucocorticoids inhibit the stimulating effect of growth hormone on growth processes.

Overdose

Symptoms of prolonged overdose: gigantism and acromegaly, signs of growth hormone hypersecretion; disposable - hypo- or hyperglycemia.

Routes of administration

P / c, in / m.

Somatropin Precautions

Caution should be exercised when prescribing to patients with diabetes mellitus or patients with a family predisposition to this disease (an increase in insulin requirements is possible). It is necessary to control the level of glucose in the blood and urine.

In patients with growth hormone deficiency due to brain tumors, more frequent examinations should be performed to exclude progression and recurrence of tumor growth.

During the treatment period, the development of hypothyroidism and a decrease in the effectiveness of therapy are possible (periodic monitoring of the functional state of the thyroid gland and adequate replacement therapy with thyroid drugs are necessary).

Epiphysiolysis of the heads of tubular bones is more common in patients with endocrine disorders, including growth hormone deficiency. The detection of lameness during growth hormone therapy in children requires careful monitoring.

In case of severe or recurring headaches, visual disturbances, nausea, vomiting, an examination of the fundus (fundoscopy) is recommended to detect swelling of the optic nerve head, the presence of which suggests the possibility of intracranial hypertension. In this case, if possible, it is necessary to stop treatment with growth hormone. With re-appointment, careful monitoring of symptoms of intracranial hypertension is mandatory. It is necessary to change the sites of subcutaneous injections due to the possibility of developing lipoatrophy. The best results are observed when treatment is given as early as possible. Treatment is continued until puberty and until the closure of the bone growth zones. It is possible to stop treatment when the desired growth is achieved.

special instructions

Some preparations contain benzyl alcohol, which is toxic to newborns, as a preservative.

Do not shake when dissolving!

Interactions with other active substances

Trade names

Name	The value of the Wyshkovsky Index ®
	0.0346
	0.0052

Genotropin, Zomacton, Norditropin, Norditropin penset, Rastan, Saizen, Humatrop.

Composition and form of release

Somatropin. Lyophilized dry substance for injection (in 1 vial - 4 IU, 10 IU, 12 IU, 16 IU, 24 IU), cartridges (6 mg, 12 mg).

pharmachologic effect

Somatropin is a recombinant growth hormone that is identical in composition and effects to human pituitary growth hormone. It is a polypeptide of 191 amino acids. The biological activity is approximately 3 IU/mg.

Stimulates skeletal growth and weight gain; stimulates the transport of amino acids into the cell, accelerating intracellular protein synthesis and thus exhibiting an anabolic effect. Causes a delay in the body of nitrogen, mineral salts (calcium, phosphorus, sodium) and fluid. Raises blood sugar levels.

Pharmacokinetics

After s / c introduction, absorption is 80%. Cmax is achieved after 3 hours. It penetrates well into the liver and kidneys. Vd - 0.49-2.11 l / kg. T1 / 2 - 3-5 hours.

Indications

Deficiency of growth hormone in the body (pituitary dwarfism, pituitary dwarfism). Shereshevsky-Turner syndrome.

Application

Usually, s / c is prescribed at 0.07-0.1 IU / kg 1 r / day, and in some cases - at 0.14-0.2 IU / kg every other day. The drug should be administered with caution to patients with diabetes (blood sugar control is necessary). The drug solution should be prepared ex tempore.

Side effect

Increased intracranial pressure (headache, nausea, vomiting, blurred vision). Decreased thyroid function, hyperglycemia. Epiphyseolysis of the femoral head. Fluid retention in the body with the development of peripheral edema. Soreness, redness at the injection site, rash, itching, tissue swelling.

Contraindications

Malignant neoplasms, pregnancy and lactation, hypersensitivity to the drug and solvent preservatives. Do not prescribe the drug to patients with completed bone growth.

Overdose

Symptoms. Hypoglycemia, and subsequently - hyperglycemia; with prolonged overdose - signs of acromegaly.
Treatment. Reducing the dose of the drug.

Name: Human somatotropin for injection

Name: Human somatotropin for injections (Somatotropinum humanum pro injectionibus)

Indications for use:
Disturbances in the development of the body associated with a lack of growth hormone (pituitary dwarfism / dwarfism /). Turner's syndrome (a disease of women characterized by underdevelopment of primary and secondary sexual characteristics).

Pharmachologic effect:
It has an anabolic (enhancing protein synthesis) effect, has a positive effect on mineral metabolism, causes an increase in height and body weight in dwarfism (a proportional decrease in growth due to a decrease in pituitary function, usually combined with a decrease in the function of other endocrine glands) associated with insufficiency growth hormone.

Human somatotropin for injection method of administration and dose:
With a deficiency in the body of growth hormone, 0.07-0.1 IU / kg of body weight is administered subcutaneously every day; intramuscularly -0.14-0.2 IU / kg of body weight 3 times a week. In Turner's syndrome, higher doses are used - in the form of subcutaneous injections, 0.1 IU / kg of body weight is prescribed 1 time every day. Subcutaneous injections are the preferred method of administration. Injection sites should be alternated to prevent lipoatrophy (decrease in the volume of adipose tissue in the subcutaneous tissue).
The solution of the product is prepared immediately before use. The prepared solution should be used within 24 hours. When diluted with a solvent containing preservatives - cresol or benzyl alcohol), the solution is stable for 7-14 days at a temperature of + 2- + S ° C in a place protected from light. Freezing of solution is not allowed. The injected solution must be clear.

Human somatotropin for injection contraindications:
Malignant neoplasms.

Human growth hormone for injection side effects:
Allergic reactions (skin rash, itching, etc.). Nausea, vomiting, breast engorgement, weight gain.

Release form:
Lyophilized (dehydrated by freezing in a vacuum) powder in vials containing 4 IU in a vial complete with a 0.25% solution of novocaine, 2 ml.

Synonyms:
Genotropin, Norditropin.

Storage conditions:
In a dry place at a temperature not exceeding +8 °C.

Human growth hormone for injection composition:
Sterile lyophilized powder, which is dissolved ex tempore in sterile water for injection or in 0.25% novocaine solution.
The activity of the product is determined biologically by its ability to cause an increase in the width of the epiphyseal cartilage of the tibia in rats and is expressed in units of action (U). The drug is released with an activity of 2 or 4 IU in a vial.

Recombinant human growth hormone. It is a 191 amino acid peptide identical to human pituitary growth hormone in amino acid sequence and composition, as well as in peptide map, isoelectric point, molecular weight, isomeric structure and biological activity.
It has an anabolic and anti-catabolic effect, affects the metabolism, growth and development of the body. Interacts with specific receptors on various cell types, including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some of its effects are mediated by another class of hormones, the somatomedins (IGF1 and IGF2).
Depending on the dose, somatropin causes an increase in the level of IGF1, IGFBP3, non-esterified fatty acids and glycerol, a decrease in the level of urea in the blood and nitrogen in the urine, a decrease in the excretion of sodium and potassium. When used in high doses, relative saturation of the effects of somatropin is possible. This does not apply to glycemia and urinary excretion of C-peptide, which increase significantly only after high doses (20 mg).
Pharmacokinetics is linear when used in doses up to 8 IU (2.67 mg). At higher doses (60 IU, or 20 mg), some degree of non-linearity cannot be ruled out, which, however, is of no clinical significance. After intravenous administration to healthy volunteers, the volume of distribution at steady state is almost 7 liters, the total clearance is 15 l / h, while the renal clearance is negligible. The half-life is 20-35 minutes.
After a single s / c and / m administration, the terminal half-life is slightly longer - 2-4 hours. The concentration of growth hormone in the blood reaches a maximum after about 4 hours and returns to its original level within 24 hours, which indicates the absence of cumulation of growth hormone when repeated injections. Bioavailability for both routes of administration is 70-90%.

Indications for the use of the drug Somatropin

Growth retardation in children due to a decrease or lack of secretion of endogenous growth hormone; growth retardation in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis data.

The use of the drug Somatropin

The dose should be set individually depending on the surface area or body weight of the patient.
It is recommended to enter at bedtime, according to the following recommendations:
Growth retardation due to inadequate secretion of endogenous growth hormone:
0.7-1.0 mg / m2 or 0.026-0.035 mg / kg per day s / c.
Growth retardation in girls due to gonadal dysgenesis (Turner syndrome):
1.4 mg / m2 per day or 0.045-0.050 mg / kg s.c.
Concomitant therapy with non-androgenic anabolic steroids in patients with Turner syndrome may increase the growth rate.
Treatment is stopped with an increase in growth sufficient for an adult or in case of closure of the epiphyses.

Contraindications to the use of the drug Somatropin

Do not prescribe to children when closing the epiphyses (cessation of bone growth), as well as to patients with hypersensitivity to somatropin, in the presence of neoplasms.

Side effects of Somatropin

In about 10% of cases, hyperemia and itching of the skin at the injection site are noted.
Some patients may develop antibodies to somatropin; the clinical significance of this fact has not been established. In isolated cases, if short stature is due to a deletion in the growth hormone gene complex, treatment with growth hormone can cause the production of antibodies that inhibit the growth process.
There may be epiphysiolysis with damage to the femoral joint. A child with lameness of unknown origin should be examined.

Special instructions for the use of the drug Somatropin

Clinical experience with the use of growth hormone during pregnancy is limited. In the course of experimental studies, a direct or indirect negative effect on the course of pregnancy, fetal development, childbirth and postnatal development has not been established, however, caution should be exercised when administered during pregnancy.
Endogenous protein hormones can be excreted in breast milk, but the likelihood of absorption of unchanged protein from the digestive tract of an infant is low.
Treatment should be carried out under the systematic supervision of a specialist who has experience in diagnosing and treating patients with growth hormone deficiency.
During therapy with somatropin, hypothyroidism may develop, so it is necessary to periodically conduct a study of thyroid function. To obtain a sufficient therapeutic effect during treatment with growth hormone, possible hypothyroidism should be corrected by the appointment of thyroid hormones.
Patients with intracranial or extracranial neoplasms in remission who receive therapy with growth hormone should undergo a medical examination at regular intervals. Patients with dysplasia due to an intracranial tumor should be periodically examined for progression or recurrence of the underlying disease.
More frequent cases of leukemia have been reported in children with growth hormone deficiency who were not treated or were treated with growth hormone, compared with children who did not have growth hormone deficiency. A causal relationship with growth hormone therapy has not been established.
In case of development of intense headache, visual disturbances, nausea and vomiting, an examination of the fundus is recommended to detect edema of the optic nerve head. If the diagnosis is confirmed, the possibility of developing benign intracranial hypertension should be taken into account, and therefore treatment with somatropin must be discontinued. If growth hormone treatment is subsequently restarted, careful monitoring of symptoms of intracranial hypertension is required, and treatment should be discontinued if it recurs.
The introduction of growth hormone is accompanied by a short-term phase of hypoglycemia for 2 hours, and then over the next 2-4 hours - an increase in blood glucose levels, despite the high concentration of insulin. Patients should be tested for glucose tolerance to detect insulin resistance.
In patients with diabetes mellitus or in the case of a family history of diabetes, somatropin is used with caution. Patients with diabetes may require adjustment of antidiabetic therapy.
In all patients with acute severe illness, it is necessary to evaluate the ratio between the possible therapeutic effect of the use of growth hormone and the potential risk.
To prevent the development of lipoatrophy, it is necessary to change the injection sites. In the case of prolonged edema or severe paresthesia, it is necessary to reduce the dose of somatropin to prevent the development of carpal tunnel syndrome.

Somatropin drug interactions

Simultaneous therapy with corticosteroids can slow down the therapeutic effect of somatropin. May increase the clearance of compounds metabolized by cytochrome P450 3A4 (sex hormones, corticosteroids, anticonvulsants and cyclosporine).

Somatropin overdose, symptoms and treatment

Probably the development of hypoglycemia followed by hyperglycemia. Chronic overdose can cause gigantism and/or acromegaly, which are associated with other known manifestations of excess growth hormone in humans.

List of pharmacies where you can buy Somatropin:

• Saint Petersburg