Hepon (Solution, Lyophilisate) Instructions for Use
ATC Code
L03AX (Other immunostimulants)
Clinical-Pharmacological Group
Immunostimulating drug
Pharmacotherapeutic Group
Immunomodulatory agent
Pharmacological Action
An immunomodulatory agent. It has an antiviral effect. It induces alpha and beta interferons, mobilizes and activates macrophages, limits the production of inflammatory cytokines (interleukins 1, 6, 8 and tumor necrosis factor), stimulates the production of antibodies to various infectious antigens, suppresses virus replication, and increases the body’s resistance to infections caused by viruses, bacteria, or fungi.
In HIV-infected patients, it reduces the concentration of HIV in blood cells and plasma, while simultaneously activating immune responses specific to HIV. In most HIV-infected patients, an increase in the content of CD4+ T- and NK-cells is noted, the functional activity of neutrophils and CD8+ T-cells, which are key components of the body’s defense against bacteria, viruses, and fungi, is increased, and the production of antibodies specific to HIV antigens, as well as to antigens of opportunistic infection pathogens, is enhanced.
With course use, it prevents recurrences of opportunistic infections for 3-6 months.
When applied topically in short courses, it is effective in the treatment of recurrent infections of the mucous membranes and skin caused by fungi of the genus Candida.
It has an anti-inflammatory effect. It eliminates dryness of the mucous membranes.
Pharmacokinetics
Pharmacokinetics has not been studied due to its peptide nature.
Indications
Correction of weakened immunity in immunodeficiency states; treatment of HIV infection; increasing immune defense against infections; treatment and prevention of opportunistic infections caused by bacteria, viruses, or fungi; treatment and prevention of candidiasis of the skin and mucous membranes (including that resulting from antibiotic therapy); reduction of inflammation (redness, swelling, itching, burning, pain) of the mucous membranes and skin, as well as dryness of the mucous membranes.
ICD codes
| ICD-10 code | Indication |
| A49.9 | Unspecified bacterial infection |
| B24 | Human immunodeficiency virus [HIV] disease, unspecified |
| B34.9 | Viral infection, unspecified |
| B37.0 | Candidal stomatitis |
| B37.2 | Candidiasis of skin and nails |
| B37.3 | Candidiasis of vulva and vagina |
| B37.4 | Candidiasis of other urogenital sites |
| B49 | Mycosis, unspecified |
| D84.9 | Immunodeficiency, unspecified |
| ICD-11 code | Indication |
| 1C41 | Bacterial infection of unspecified site |
| 1C62.1 | HIV disease, clinical stage 2, without mention of tuberculosis or malaria |
| 1D9Z | Unspecified viral infections of unspecified site |
| 1F23.0 | Candidiasis of the lips or oral mucosa |
| 1F23.10 | Candidiasis of vulva and vagina |
| 1F23.11 | Candidal balanoposthitis |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| 1F2Z | Mycoses, unspecified |
| 4A0Z | Unspecified primary immunodeficiencies |
| MA15.0 | Bacteremia |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| XA5FG3 | Genital region |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Use Hepon externally and topically only.
For treatment of candidiasis of the oral mucosa, prepare a solution from lyophilisate. Apply the prepared solution to the affected areas twice daily for 5-7 days.
For treatment of urogenital candidiasis, use a solution for irrigation or tampons. Apply once daily for 7-10 days.
For treatment of skin candidiasis, apply the solution to cleansed affected areas twice daily. Continue treatment for 10-14 days.
For immunodeficiency states and HIV infection, follow the specific regimen prescribed by a physician. The typical course involves administration for several weeks.
For prevention of opportunistic infections, use in courses as directed. A single course can provide protection for 3 to 6 months.
For intestinal dysbiosis, administer as microenemas once daily. The treatment duration is determined by the physician.
Do not use in children under 12 years of age.
Discontinue use immediately and consult a physician if allergic reactions occur.
Adverse Reactions
Possible allergic reactions.
Contraindications
Hypersensitivity; children under 12 years of age.
Use in Pregnancy and Lactation
Use during pregnancy is not recommended except in cases where the intended benefit to the mother outweighs the potential risk to the fetus.
It is not recommended for use during lactation.
Pediatric Use
The drug is contraindicated in children under 12 years of age.
Geriatric Use
The drug is approved for use in elderly patients.
Special Precautions
Results of clinical studies show that activation of local immunity has a positive effect on the course of erosive-ulcerative lesions of the gastroduodenal zone in elderly patients.
Activation of local immunity of the intestinal mucosa is effective for the treatment of intestinal dysbiosis and irritable bowel syndrome, and it can be prescribed as monotherapy (microenemas).
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lyophilizate for preparation of oral solution 10 mg: amp. or fl. 1, 2 or 3 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
ImmaPharma LLC (Russia)
Dosage Form
 |
Hepon | Lyophilizate for preparation of oral solution 10 mg: amp. or fl. 1, 2 or 3 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for preparation of oral solution as a white powder, odorless.
| 1 amp./1 fl. | |
| Threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate | 10 mg |
10 mg – ampoules (1) – cardboard packs.
10 mg – ampoules (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs.
10 mg – ampoules (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs.
10 mg – ampoules (2) – cardboard packs.
10 mg – ampoules (3) – cardboard packs.
10 mg – vials (1) – cardboard packs.
10 mg – vials (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs.
10 mg – vials (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs.
10 mg – vials (2) – cardboard packs.
10 mg – vials (3) – cardboard packs.
Oral solution 0.1%: fl. 1 ml or 2 ml
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
ImmaPharma LLC (Russia)
Dosage Form
|
Hepon | Oral solution 0.1%: fl. 1 ml or 2 ml |
Dosage Form, Packaging, and Composition
Oral solution as a clear, colorless liquid.
| 1 ml | |
| Threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate | 1 mg |
Excipients : water for injections – up to 1 ml.
1 ml – glass vials (1) – cardboard packs×.
1 ml – glass vials (1) in a set with a syringe – cardboard packs×.
1 ml – glass vials (1) in a set with a pipette – cardboard packs×.
2 ml – glass vials (1) – cardboard packs×.
2 ml – glass vials (1) in a set with a syringe – cardboard packs×.
2 ml – glass vials (1) in a set with a pipette – cardboard packs×.
× with first opening control.
Topical and external solution 0.02%: fl. 5 ml or 10 ml
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
ImmaPharma LLC (Russia)
Dosage Form
 |
Hepon | Topical and external solution 0.02%: fl. 5 ml or 10 ml |
Dosage Form, Packaging, and Composition
Solution for topical and external use as a clear, colorless liquid.
| 1 ml | |
| Threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate | 200 mcg |
Excipients : water for injections – up to 1 ml.
5 ml – glass vials (1) – cardboard packs×.
5 ml – glass vials (1) in a set with a dropper cap – cardboard packs×.
5 ml – glass vials (1) in a set with a spray nozzle – cardboard packs×.
5 ml – glass vials (1) in a set with a pipette – cardboard packs×.
5 ml – glass vials (1) in a set with a syringe – cardboard packs×.
10 ml – glass vials (1) – cardboard packs×.
10 ml – glass vials (1) in a set with a dropper cap – cardboard packs×.
10 ml – glass vials (1) in a set with a spray nozzle – cardboard packs×.
10 ml – glass vials (1) in a set with a pipette – cardboard packs×.
10 ml – glass vials (1) in a set with a syringe – cardboard packs×.
× with first opening control.
Lyophilizate for preparation of solution for topical and external use 1 mg: amp. or fl. 1, 2 or 3 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
ImmaPharma LLC (Russia)
Dosage Form
|
Hepon | Lyophilizate for preparation of solution for topical and external use 1 mg: amp. or fl. 1, 2 or 3 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for preparation of solution for topical and external use as a white powder, odorless.
| 1 amp./1 fl. | |
| Threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate | 1 mg |
1 mg – glass ampoules (1) – cardboard packs×.
1 mg – glass ampoules (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs×.
1 mg – glass ampoules (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs×.
1 mg – glass ampoules (2) – cardboard packs×.
1 mg – glass ampoules (3) – cardboard packs×.
1 mg – glass vials (1) – cardboard packs×.
1 mg – glass vials (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs×.
1 mg – glass vials (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs×.
1 mg – glass vials (2) – cardboard packs×.
1 mg – glass vials (3) – cardboard packs×.
× first opening control labels may be applied to the pack.
Lyophilizate for preparation of solution for topical and external use 2 mg: amp. or fl. 1, 2 or 3 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
ImmaPharma LLC (Russia)
Dosage Form
|
Hepon | Lyophilizate for preparation of solution for topical and external use 2 mg: amp. or fl. 1, 2 or 3 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for preparation of solution for topical and external use as a white powder, odorless.
| 1 amp./1 fl. | |
| Threonyl-glutamyl-lysyl-lysyl-arginyl-arginyl-glutamyl-threonyl-valyl-glutamyl-arginyl-glutamyl-lysyl-glutamate | 2 mg |
2 mg – glass ampoules (1) – cardboard packs×.
2 mg – glass ampoules (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs×.
2 mg – glass ampoules (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs×.
2 mg – glass ampoules (2) – cardboard packs×.
2 mg – glass ampoules (3) – cardboard packs×.
2 mg – glass vials (1) – cardboard packs×.
2 mg – glass vials (1) in a set with solvent (water for injections 5 ml – amp.) – cardboard packs×.
2 mg – glass vials (1) in a set with solvent (water for injections 5 ml – amp.) and a disposable syringe – cardboard packs×.
2 mg – glass vials (2) – cardboard packs×.
2 mg – glass vials (3) – cardboard packs×.
× first opening control labels may be applied to the pack.
![Hepon [Solution, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Hepon [Solution, Lyophilisate] 2")