Dinatrop
Dinatrop: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in the elderly
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Dynatrope
ATX code: H01AC01
Active ingredient: Somatotropin (Somatropin)
Producer: Darou Paksh Pharmaceutical Company (Iran)
Description and photo update: 18.10.2018
Dinatrop is a recombinant growth hormone.
Release form and composition
The dosage form of Dinatropa is a lyophilisate for the preparation of a solution for subcutaneous administration: powder / mass of white with a yellowish tinge or white; solvent - transparent, colorless, odorless (in glass bottles, in a cardboard box of 1, 5, 25 or 50 bottles complete with a solvent and a disposable syringe).
Composition of 1 bottle of lyophilisate:
- active substance: somatropin - 1.33; 3.33; 5.33 or 6.67 mg [4, 10, 16 or 20 IU (international units), respectively];
- auxiliary components (1.33 / 3.33 / 5.33 / 6.67 mg): mannitol - 20/40/60/73 mg; glycine - 0.7 / 1.4 / 2.1 / 2.6 mg; sodium dihydrogen phosphate - 1.5 / 1.5 / 1.5 / 1.5 mg; sodium chloride 0.5 / 0.5 / 0.5 / 0.5 mg.
Composition of 1 ampoule of solvent: water for injection - 1 ml.
Pharmacological properties
Pharmacodynamics
Dinatrop is one of the genetically engineered somatotropic hormones that stimulate somatic / skeletal growth, and also have a pronounced effect on metabolic processes. Stimulation of the growth of bones of the skeleton occurs due to the effect on bone metabolism and the lamina of the pineal gland of tubular bones. The normalization of body structure occurs through a decrease in fat and an increase in muscle mass. With a deficiency of growth hormone and osteoporosis, replacement therapy with Dinatrop leads to the normalization of bone density and mineral composition. The therapy allows you to increase the size and number of cells of the adrenal glands, thyroid gland, liver, muscles, sex glands, thymus gland.
Somatropin stimulates the transport of amino acids into the cell and protein synthesis and, by influencing the lipoprotein / lipid profile, reduces cholesterol levels. Promotes the retention of phosphorus, sodium, potassium. Suppresses insulin release. Increases muscle activity, physical endurance and weight.
Pharmacokinetics
Absorption of somatropin after subcutaneous administration is 80%, the maximum plasma concentration in the blood (C max) is reached after 3–6 hours. Penetrates into well-perfused organs. Somatropin is metabolized in the liver and kidneys. It is excreted in the bile and kidneys (including 0.1% unchanged). The half-life (T 1/2) after a single dose is in the range from 3 to 5 hours.
Indications for use
Growth hormone Dinatrop is prescribed to children with growth retardation associated with the following diseases / conditions:
- dysgenesis of the gonads (Shereshevsky-Turner syndrome);
- insufficient secretion of growth hormone;
- chronic renal failure (with a decrease in renal function by more than 50%) in the prepubertal period.
For adults, Dinatrop is prescribed as substitution therapy for confirmed acquired / congenital growth hormone deficiency.
Contraindications
Absolute:
- active brain tumors;
- urgent conditions, including the state of acute respiratory failure and after operations on the abdominal cavity and heart;
- malignant neoplasms;
- pregnancy and the period of breastfeeding;
- established individual intolerance to the components of the drug.
Relative (diseases / conditions in which the use of Dinatrop requires caution and medical supervision):
- diabetes;
- hypothyroidism;
- intracranial hypertension.
Instructions for the use of Dinatrop: method and dosage
The method of administration of Dinatrop is subcutaneously, slowly.
Frequency rate of application - 1 time per day (usually at night). In order to prevent the development of lipoatrophy, it is necessary to change the injection sites.
The dose is determined by the doctor individually, and the severity of growth hormone deficiency, weight / body surface area, and the effectiveness of the therapy should be taken into account.
Recommended daily doses:
- insufficient secretion of growth hormone in children: 0.025–0.035 mg / kg (0.7–1 mg / m 2). Therapy should be started as early as possible. It continues until puberty / until the bone growth zones are closed, and the cancellation of Dinatrop is possible after the desired result is achieved;
- Shereshevsky-Turner syndrome, chronic renal failure in children, accompanied by growth retardation: 0.05 mg / kg (1.4 mg / m 2); in cases of insufficient growth dynamics, the dose is adjusted;
- growth hormone deficiency in adults: 0.15-0.3 mg, depending on the effectiveness of therapy, the dose is increased. When performing dose titration, the serum level of insulin-like growth factor I can be used as a control parameter. The maintenance dose is selected individually; it usually does not exceed 1 mg per day. For elderly patients, Dinatrop is usually prescribed in lower doses.
It is recommended to dissolve the lyophilisate (based on the prescribed dose) in 1 ml of the supplied solvent. After the introduction of the solvent, the vial should be gently shaken until the contents are completely dissolved, avoiding sudden shaking.
Side effects
Possible side reactions: increased intracranial pressure (occurs with headache, nausea, vomiting, visual impairment), tunnel syndrome, decreased thyroid function, myalgia, arthralgia, leukemoid reactions, hyperglycemia, epiphyseolysis of the femoral head, fluid retention with the development of peripheral edema. These disorders are usually transient, dose-dependent, which may lead to the need for dose reduction.
Allergic reactions can manifest as itching and skin rashes.
In rare cases, the formation of antibodies to Dinatrop is noted, which leads to a decrease in the effectiveness of therapy.
The most likely local reactions: swelling, hyperemia, itching, pain, lipoatrophy at the injection site.
There is also information about the development of the following adverse reactions when using the drug Somatropin: weakness, gynecomastia, subluxation of the hip in children (limping, knee / hip pain), fatigue, pancreatitis (nausea, abdominal pain, vomiting), edema of the optic nerve head (usually, observed during the first 2 months of therapy, in most cases with Shereshevsky-Turner syndrome), otitis media and hearing impairment (with Shereshevsky-Turner syndrome), progression of scoliosis (with excessively rapid growth), accelerated growth of a pre-existing nevus, an increase in inorganic phosphate in the blood, the activity of alkaline phosphatase and parathyroid hormone.
Overdose
In acute overdose, hypoglycemia may develop first, then hyperglycemia.
The main symptoms of prolonged overdose: acromegaly / gigantism, hypothyroidism, a decrease in serum cortisol levels in the blood.
Therapy: cancellation of Dinatrop, symptomatic treatment.
special instructions
In patients with diabetes mellitus, during the use of Dinatrop, a dose adjustment of hypoglycemic drugs may be required.
Possible manifestation of latent hypothyroidism. Patients receiving thyroxine may show signs of hyperthyroidism.
During the period of therapy, the state of the fundus should be monitored, especially when symptoms of intracranial hypertension appear. In cases of development of optic nerve edema, Dinatrop is canceled.
If lameness is detected, the condition of the patients should be carefully monitored.
Application during pregnancy and lactation
Growth hormone Dinatrop is contraindicated during pregnancy and breastfeeding.
Use in the elderly
For elderly patients, Dinatrop should be administered in lower doses.
Drug interactions
The stimulating effect of somatropin on growth processes when combined with glucocorticosteroids decreases.
The effectiveness of therapy (in terms of final growth) can also be influenced by combined use with other hormones, including anabolic steroids, gonadotropin, thyroid hormones and estrogens.
Analogs
Dinatrop analogues are: Norditropin NordiLet, Norditropin Simplex, Genotropin, Jintropin, Humatrop, Saizen, Omnitrop, Rastan.
Terms and conditions of storage
Store in a place protected from light at a temperature of 2-8 ° C. Keep out of the reach of children. Do not freeze.
The shelf life is 3 years.
The prepared solution can be used for 14 days if stored at 2–8 ° C.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Dinatrop
According to reviews, Dinatrop is highly effective and generally well tolerated.
Price for Dinatrop in pharmacies
The price of Dinatrop is unknown, since it is currently impossible to buy the drug.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
