Pharmacotherapeutic group: immunostimulant
ATX code: L03AH
Pharmacological properties:
Pharmacodynamics:The drug is a means of etiotropic and immunostimulant therapy, has mediated antiviral action against the causative agents of influenza A and B, as well as other viruses causing acute respiratory diseases.
In in vitro studies the drug specifically suppresses (inhibits) multiplication (replication) of SARS-CoV-2 virus which is the causative agent of a new coronavirus infection (COVID-19).
The degree of inhibition of the pathogen increases with increasing drug concentration (dose-effect linearity is shown).
Limits the severity of the main clinical symptoms of influenza and acute respiratory infections, as well as reduces the duration of the disease and contributes to its uncomplicated course.
It increases the content of secretory immunoglobulin A (sIgA) in the nasopharynx mucosa, the entry gate of infection, increasing the local immunoresistance of the body to respiratory infections of viral and bacterial nature.
In case of preventive action the preparation increases potential metabolic activity of cells of innate immunity (neutrophil granulocytes and monocytes) which in case of development of infection increases their ability to absorb and destroy bacterial and viral agents due to increase of enzymatic (oxidative) activity, synthesis of cationic proteins and increase of the number of phagocytes. At the same time the initial state of the metabolic activity of cells of innate immunity, in the absence of infectious agents, does not change, being within normal values.
Bendazole induces in the body the production of endogenous interferon and has immunomodulatory effects (normalizes the immune response of the body). Enzymes produced by interferon in cells of various organs inhibit the replication of viruses.
Alpha-glutamyl-tryptophan (thymogen) is a synergist of immunomodulatory action of bendazole, normalizing the T-cell link of immunity.
Ascorbic acid activates the humoral part of the immune system, normalizes capillary permeability, thus reducing inflammation, and shows antioxidant properties, neutralizing the oxygen radicals that accompany the inflammatory process, increases the body’s resistance to infection.
Pharmacokinetics:when taken orally, the drug is completely absorbed from the gastrointestinal tract. Bioavailability of bendazole is about 80%, alpha-glutamyl-tryptophan – no more than 15%, ascorbic acid – up to 70%. Ascorbic acid is absorbed in the gastrointestinal tract (mainly in the jejunum). Binding with plasma proteins –
25%. TCmax after oral administration – 4 hours. It easily penetrates into leukocytes, platelets and then into all tissues, penetrates through the placenta.
Gastrointestinal diseases (gastric and 12 duodenal ulcer, bowel motility disorders, helminth infestation, giardiasis), consumption of vegetable and fruit juices, alkaline drinking reduce the binding of ascorbic acid in the intestine. Ascorbic acid is metabolized mainly in the liver to deoxyascorbic acid, then to oxalic acetic acid and diketogulonic acid. It is excreted by the kidneys, through the intestines, with sweat, breast milk unchanged and as metabolites. The products of bendazole biotransformation in blood are two conjugates formed due to methylation and carboethoxylation of imino group of imidazole ring of bendazole: 1-methyl-2-benzylbenzimidazole and 1-carboethoxy-2-benzylbenzimidazole. Bendazole metabolites are excreted in the urine. Alpha-glutamyl-tryptophan is cleaved by peptidases into L-glutamic acid and L-tryptophan, which are used by the body in protein synthesis.
Indications
Prevention and comprehensive treatment of influenza and acute respiratory viral infections in children from one year of age.
Composition
1 ml of the prepared solution contains:
Active ingredients:
Alpha-glutamyl-tryptophan
(Timogen sodium in terms of thymogen) 0.15 mg
Ascorbic acid 12 mg
Bendazol hydrochloride [Dibazole] 1.25 mg
Excipients:
Lactose monohydrate 20 mg
In the preparation without flavoring:
Fructose 366.6 mg
In the preparation with flavoring:
Fructose 366.2 mg
Food flavoring
“Orange” or “Strawberry” or “Cranberry” 0.4 mg
How to take, the dosage
Ingestion 30 minutes before a meal.
For treatment:
For children aged 1 to 3 years, 2 ml 3 times a day; for children aged 3 to 6 years, 4 ml 3 times a day; for children aged 6 to 10 years, 8 ml 3 times a day; for children over 10 years, 12 ml 3 times a day.
The course of application is 4 days. If after 3 days of treatment there is no improvement, or the symptoms worsen, or new symptoms appear, it is necessary to consult a physician.
To prevent:
In direct contact with patients with influenza and other acute respiratory infections:
For children aged 1 to 3 years, 2 ml 3 times a day; for children aged 3 to 6 years, 4 ml 3 times a day; for children aged 6 to 10 years, 8 ml 3 times a day; for children over 10 years, 12 ml 3 times a day.
The course of application is 4 days.
Preventive courses, if necessary, should be repeated in 3 weeks (until normalization of the epidemic situation).
Rules for preparing the solution: In a bottle with powder add 40 ml of water (boiled, cooled to room temperature), shake well. The contents should dissolve completely. The volume of the solution after adding water is 50 ml.
Take the product only according to the route of administration and in the doses described in the instructions. If necessary, please talk to your doctor before taking this medicine.
Take only according to the directions given.
Interaction
No interaction of alpha-glutamyl-tryptophan with drugs was detected. Bendazole prevents an increase in total peripheral vascular resistance due to the use of non-selective beta-adrenoblockers. It enhances the hypotensive (blood pressure reduction) effect of hypotensive and diuretic drugs. Phentolamine enhances the hypotensive effect of bendazole. Ascorbic acid increases the blood concentration of tetracycline-type antibacterial drugs and benzylpenicillin. Improves intestinal absorption of iron preparations (Fe). Reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drinking reduce its absorption and assimilation. When concomitant use with ASA, urinary excretion of ascorbic acid is increased and excretion of ASA is reduced. ASA reduces absorption of ascorbic acid by about 30%. Ascorbic acid increases the risk of crystalluria when using drugs containing acetylsalicylic acid (ASA) and short-acting sulfonamides, delays renal excretion of acids, increases excretion of drugs with an alkaline reaction (including alkaloids), reduces the blood concentration of oral contraceptives. Simultaneous use reduces the chronotropic effect of isoprenaline. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubal reabsorption of amphetamine and tricyclic antidepressants. Barbiturates and primidone increase excretion of ascorbic acid with urine. Concomitant use with antiviral drugs and agents of symptomatic therapy of influenza and acute respiratory viral infections is possible. Consult your doctor if you are taking the drugs mentioned in the section or other drugs.
Special Instructions
The drug contains fructose, use for more than 2 weeks may cause dental damage.
After repeated course it is recommended to control blood glucose concentration.
Information for diabetics: 1 ml of the solution of the drug contains 20 mg of lactose and 366.6 mg of fructose (in the unscented product or 366.2 mg of fructose in the flavored product), which corresponds to 0.032 bread units (BE).
The content of sugars in single and daily doses of the product, in units of units:
Ready solution, ml | Disposable dose, units | Daily dose, units | |
2 | 0.06 | 0.19 | |
4 | 0.13 | | |
8 | 0.26 | 0.7 | |
12 | | 1.15 |
.
Impact on the ability to operate vehicles, machinery:
The drug does not affect the ability to drive vehicles, operate moving machinery and engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.
Synopsis
powder of white or white with a yellowish tint. The aqueous solution is odorless or with a characteristic odor of orange or cranberry or strawberry.
Contraindications
Hypersensitivity to the drug components, lactase deficiency, lactose intolerance, sugar/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, children under 1 year of age. If necessary, please consult a physician before taking the drug.
With caution:
Please consult your doctor before taking the drug if you have diabetes, intolerance to certain sugars, or arterial hypotension.
Side effects
There may be a short-term decrease in blood pressure. Allergic reactions: urticaria. In these cases, the drug is discontinued and symptomatic treatment, antihistamines are prescribed. Consult your doctor if you experienced the mentioned side effects or other side effects not specified in the instructions. If the side effects mentioned in the instructions worsen, tell your doctor.
Overdose
No cases of overdose have been described.
Pregnancy use
administration of the drug during pregnancy is not recommended due to insufficient clinical data. During breastfeeding the drug may be used if the estimated benefit to the mother exceeds the potential risk to the baby. If it is necessary to take the drug during breastfeeding, please consult your doctor.
Weight | 0.100 kg |
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Shelf life | 3 years. Shelf life of the prepared solution is 10 days. Do not use after the expiration date stated on the package. |
Conditions of storage | Store at a temperature not exceeding 25 oC. Keep out of reach of children. Store the prepared solution in the light-protected place at the temperature from 2 oC to 8 oC. |
Manufacturer | Cytomed MBNPK, Russia |
Medication form | Powder for preparation of solution for oral administration |
Brand | Cytomed MBNPK |
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