Zamakton

Zomakton is a hormone of the hypothalamic-pituitary system.

Indications Zomactone

It is used in such conditions:

• children who are stunted due to lack of GH release;
• children with growth retardation caused by Turner syndrome, which was confirmed during the chromosomal examination procedure.

Release form

The release of the medicament is in the form of a lyophilisate for the injection liquid, together with the solvent substance, inside the vials with a capacity of 4 and 10 mg.

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Pharmacodynamics

Somatotropin is an active component of the drug, which is a polypeptide similar to the pituitary human STH in its structure, amino acid sequence, and pharmacokinetics.

Zomakton leads to systemic proportional growth of the bones of the skeleton in a child with a lack of pituitary GH, affecting the plates of the growth of the epiphysis of the long bones, as well as bone metabolism. In persons with a lack of growth hormone and osteoporosis, HRT helps stabilize bone density and mineral structure. The drug substance activates the processes of binding collagen with chondroitin sulfate and enhances the elimination of hydroxyproline. Along with this, an increase in the average serum indicators of alkaline phosphatase is also noted.

As a reaction to the use of GH, along with systemic growth, there is a proportional increase in the size of the musculature of the skeleton, as well as an increase in the size and number of muscle cells. In addition, the drug leads to an increase in the size of other tissues (epidermis with connective tissues, thymus, liver with enhanced cell proliferation, and also an insignificant increase in the size of the adrenal glands, sex glands and thyroid gland). HRT with STH did not lead to accelerated puberty and a disproportionate growth process.

The drug helps to stimulate the movement of amino acids into cells, and in addition to protein binding. It also reduces cholesterol, affecting the lipid and lipoprotein profile. Helps to delay potassium with sodium and phosphorus. Enhanced renal excretion of calcium is compensated by increased intestinal absorption of this element. The cumulation of these salts indicates that there is an increased need for them during tissue growth.

[2], [3], [4]

Pharmacokinetics

The degree of absorption of the component STH in s / c injection is 80%. Plasma indicators Cmax are recorded after 3-6 hours and equal to 13-35 ng / ml. Metabolic processes develop inside the liver.

Half-life is 3-4 hours. The excretion of the drug is made by the intestines.

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Dosing and administration

Therapy with the use of Zomakton should be performed under the supervision of a qualified physician who has experience in managing people with a deficiency in the GH element.

The scheme of administration and the size of the dosage of the drug are selected individually for each patient.

Often, this therapy lasts for several years and is determined by the maximum possible medical result.

In order to prevent the appearance of lipoatrophy in the injection area, the injection sites must be regularly changed.

It is necessary to begin therapy, taking into account the standard recommended dosages.

The lack of allocated element STG.

For a week, a dosage of 0.17–0.23 mg / kg (corresponding to 4.9–6.9 mg / m ^{2 of} the body surface area) is used, which is divided into 6–7 infusions of the s / c method (the size of the daily ration is thus equal to 0.02-0.03 mg / kg (0.7-1 mg / m ² body area)). It is forbidden to use a total portion exceeding 0.27 mg / kg (8 mg / m ² ) for a weekly period, which corresponds to a daily dosage of 0.04 mg / kg.

Terner Syndrome.

For a week, it is required to inject 0.33 mg / kg of the substance (about 9.86 mg / m ^{2 of the} body surface), which is divided into 6-7 injections of the sc / c method (the daily dosage is 0.05 mg / kg (approximately 1 , 40-1.63 mg / m ² )).

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Use Zomactone during pregnancy

Zomaticone should not be given to pregnant women or women in child-bearing age who do not use contraceptive agents.

Clinical tests with the use of medicines that contain GH, with the participation of nursing mothers, have not been performed, so there is no information as to whether GH is excreted in human milk.

Contraindications

It is contraindicated to use the drug with a strong intolerance against GH or its other components. Also not assigned to children who have already had the closure of the bone epiphyses.

You can not use the medicine if the patient has symptoms of active tumor development. It is required to finish the antitumor treatment before starting therapy with the introduction of growth hormone; in addition, there should be no manifestations of tumor growth inside the skull. If symptoms of tumor growth are observed, therapy should be stopped.

It is forbidden to use the drug in people who are in a critical condition, and in addition to those who have complications associated with open cardiac surgery, abdominal operations and polytrauma, as well as acute respiratory failure and other similar conditions.

It is necessary to cancel therapy with the use of GH in children with chronic kidney disease in the event of a kidney transplant.

Side effects Zomactone

When s / he injects a substance STH, atrophy or growth of the subcutaneous fat layer may develop, and bruising and punctate hemorrhages in the injection area may also occur. Sometimes people develop an erythema of an itchy nature or pain at the site of administration.

Among other adverse symptoms:

• dysfunction of the lymph and blood system: sometimes anemia appears;
• disorders of the cardiovascular system: sometimes the level of blood pressure (adults) increases or tachycardia develops. A single increase in blood pressure values is observed in children;
• lesions of the vestibular apparatus with the organs of hearing: sometimes dizziness occurs;
• problems with the work of the endocrine system: hypothyroidism is often observed;
• manifestations associated with the visual organs: sometimes there is diplopia or edema of the disc in the region of the optic nerve;
• disorders of the gastrointestinal tract: sometimes nausea, pain in the abdominal area, vomiting or bloating. Single diarrhea develops;
• systemic disorders and signs in the injection area: most often, adults develop peripheral edema or just edema (they occur less frequently in children) at the injection site, and also asthenia. Sometimes there is atrophy in the area of the injection, a feeling of weakness, hemorrhage in the area of drug administration, as well as hypertrophy;
• immune lesions: antibody production often occurs;
• changes in test results: single cases of kidney related diseases are observed;
• eating disorders and metabolic processes: most often, adults develop mild hyperglycemia. Less common is glucose tolerance disorder (children). Sometimes hyperphosphatemia or hypoglycemia is recorded. Diabetes mellitus of the 2nd subtype is rare;
• lesions of the connective, and at the same time musculoskeletal tissues: often in adults, myalgia or arthralgia is noted. Less often, these disorders occur in children. Often, adults may experience stiff limb movement (sometimes in children). Sometimes there are bone pains, muscular atrophy, carpal tunnel syndrome;
• tumors that have a diverse nature: sometimes there are tumors that have a malignant or rare nature. Children rarely develop leukemia;
• problems with NA function: often an adult has paresthesias or headaches. Insomnia or hypertension is also common. Sometimes there is a nystagmus or a feeling of sleepiness. The values of ICP increase individually, neuropathy occurs, and also (in children) paresthesia or insomnia;
• mental disorders: sometimes personality disorders are noted;
• lesions of the urinary system and kidney: sometimes hematuria, urinary incontinence, abnormal urine, polyuria, and disorder of the frequency of urinary processes appear;
• signs of breast and genital organs: adults sometimes have gynecomastia or discharge from the genitals. Occasionally, gynecomastia has been reported in children;
• disturbances in the subcutaneous layer and epidermis: sometimes skin hypertrophy or atrophy, lipodystrophy, urticaria, and in addition hirsutism or exfoliative form of dermatitis occur.

There is data on the development of pancreatitis during post-registration use of GH (there is no data on the frequency of such cases).

Children who took STH sometimes developed femoral head epiphyseolysis, as well as Perthes disease. The first disorder mainly develops with disorders associated with the endocrine system, and the second - in the case of short stature. But there is no information as to whether these diseases develop more frequently with the use of GH. With such diagnoses appear pain and discomfort in the thigh or knee.

Other negative signs are considered to be characteristic of growth hormone - among them hyperglycemia, caused by a decrease in sensitivity to insulin, a decrease in free thyroxin, and in addition an increase in ICP values, which is benign.

There is also a risk of developing intolerance symptoms.

Overdose

Although there is no information regarding intoxication with Zomakton, in acute poisoning, an initial form of hypoglycemia may develop, after which hyperglycemia occurs.

There are no data on the effects of prolonged intoxication. But there is an assumption that at the same time there are signs that are noted in the case of excessive production of human GH (for example, the development of acromegaly).

Interactions with other drugs

Treatment using GCS is able to slow down the growth stimulation provided by the drug. People with existing ACTH deficiency need to carefully select the replacement portion of the GCS to prevent the overwhelming effect on the GH activity.

Large portions of estrogen with androgens or anabolic steroids can lead to an acceleration of bone maturation, which reduces the increase in body length.

Because growth hormone can cause insulin resistance in a patient, it is likely that correction of therapy will be needed in diabetics.

Information that was found out after studying drug interactions in adults with GH deficiency shows that the use of somatotropin can significantly increase the clearance of components undergoing metabolic processes within the P450 3A4 hemoprotein system (among those corticosteroids, cyclosporine with sex hormones, and also anticonvulsants) - due to which their plasma values are reduced. There are no data on the effect of this fact on the clinical picture.

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Storage conditions

Zomakton is required to be kept in a place closed from the infiltration of children. Temperature values - in the range of marks 2-8 ° C.

[8], [9]

Shelf life

Zomakton can be used for a 3-year period from the date of manufacture of a therapeutic drug. The diluted liquid must be stored in the refrigerator (temperature is 2-8 ° C), placing the bottle vertically, within 28 days.

Analogs

Analogues of the drug are the substances Biorostan, Somatin, Dzhintropin and Groutropin with Biosome and Rastan, and in addition, Genotropin, Humatrop and Nutropin with Norditropin.

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