Thymogen® (Solution, Cream, Spray, Powder) Instructions for Use
ATC Code
A16AX (Other drugs for the treatment of gastrointestinal diseases and metabolic disorders)
Active Substance
Alpha-glutamyl-tryptophan (Grouping name)
Clinical-Pharmacological Group
Tissue repair stimulant with anti-inflammatory action
Pharmacotherapeutic Group
Tissue repair stimulant
Pharmacological Action
Immunomodulatory agent. It has a regulatory effect on the reactions of cellular and humoral immunity and the body’s non-specific resistance.
It stimulates regeneration processes when they are suppressed. It improves the course of cellular metabolism processes.
It enhances the expression of differentiation receptors on lymphocytes, normalizes the number of T-helpers, cytotoxic T-lymphocytes and their ratio in patients with various immunodeficiency states.
When taken orally, it has a reparative, anti-inflammatory and enveloping effect in inflammatory-dystrophic diseases of the gastric mucosa.
It stimulates regeneration processes in the presence of foci of gastric mucosal atrophy, preventing a reduction in the number of gastric glands.
It contributes to the normalization of gastric pH (due to an increase in the number of gastric secretion glands in the preserved areas of the gastric mucosa), a decrease in the level of gastrin-17 in the blood, an increase in the pepsinogen I/pepsinogen II ratio, which is an indicator of the restoration of acid-forming and pepsin-forming functions and the weakening of pro-oncogenic processes associated with these disorders.
It has an anti-inflammatory effect, reducing the level of leukocyte infiltration of the gastric mucosa mainly due to eosinophilic granulocytes and macrophages.
After eradication therapy (in individuals with Helicobacter pylori infection), treatment with alpha-glutamyl-tryptophan promotes a more pronounced decrease in the titer of anti-Helicobacter antibodies, reducing the activity of the autoimmune component of gastric mucosal inflammation.
Pharmacokinetics
After parenteral administration, it quickly enters the systemic bloodstream.
Alpha-glutamyl-tryptophan sodium is cleaved by peptidases into L-glutamic acid and L-tryptophan, which are used by the body in peptide synthesis.
When taken orally, it has a local effect on the gastric mucosa; only a small part of the administered dose reaches the systemic bloodstream.
Indications
As part of complex therapy for acute and chronic viral and bacterial diseases accompanied by reduced immunity: viral hepatitis, acute and chronic non-specific lung diseases (chronic bronchitis, acute and chronic pneumonia), diseases of the skin and subcutaneous tissue (pyoderma, furunculosis, erysipelas); severe diffuse forms of atopic dermatitis, severe mechanical, chemical, radiation and thermal injuries (burn disease), wound and surgical infections, including purulent-septic complications in the postoperative period; during preoperative preparation for planned surgical operations to prevent infectious complications and stimulate regeneration processes; after radiation therapy, chemotherapy, as well as long-term antibiotic therapy in high doses; in the complex therapy of chronic atrophic gastritis.
ICD codes
| ICD-10 code | Indication |
| A46 | Erysipelas |
| B15 | Acute hepatitis A |
| B16 | Acute hepatitis B |
| B17 | Other acute viral hepatitis |
| B18 | Chronic viral hepatitis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J20 | Acute bronchitis |
| J42 | Unspecified chronic bronchitis |
| K29.4 | Chronic atrophic gastritis |
| L02 | Cutaneous abscess, furuncle and carbuncle |
| L08.0 | Pyoderma |
| L20.8 | Other atopic dermatitis (neurodermatitis, eczema) |
| T14.9 | Injury, unspecified |
| T30 | Burns and corrosions of unspecified body region |
| T66 | Unspecified effects of radiation (radiation sickness) |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| Y40 | Systemically acting antibiotics |
| Y43.1 | Antineoplastic antimetabolites |
| Y43.3 | Other antineoplastic drugs |
| Y84.2 | Radiological procedure and radiotherapy |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 1B70.0Z | Erysipelas, unspecified |
| 1B70.Z | Bacterial cellulitis or lymphangitis caused by unspecified bacterium |
| 1B75.0 | Furuncle |
| 1B75.1 | Carbuncle |
| 1B75.2 | Furunculosis |
| 1B75.3 | Pyogenic skin abscess |
| 1E50.0 | Acute hepatitis A |
| 1E50.1 | Acute hepatitis B |
| 1E50.Z | Acute viral hepatitis, unspecified |
| 1E51.Z | Chronic viral hepatitis, unspecified |
| 8E61.0 | Radiation-induced brain injury |
| 8E61.1 | Radiation-induced spinal cord injury |
| 9A06.70 | Atopic eczema of the eyelids |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| DA42.73 | Chronic atrophic gastritis of unknown etiology |
| EA80.0 | Infantile atopic eczema |
| EA80.1 | Childhood atopic eczema |
| EA80.2 | Adult atopic eczema |
| EA80.Z | Atopic eczema, unspecified |
| EA85.20 | Atopic hand eczema |
| EB21 | Pyoderma gangrenosum |
| ND56.Z | Unspecified injury of unspecified part of trunk, limb or body region |
| NE11 | Burn of unspecified body region |
| NF00 | Exposure to radiation, not elsewhere classified |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
| PK81.C | Radiotherapy causing injury or harm in the course of therapeutic use |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
| QB9A | Preparatory procedures for subsequent treatment |
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. |
Administer intramuscularly or orally as directed by a physician.
For intramuscular injection, dissolve the powder in 1 ml of water for injection or 0.9% sodium chloride solution immediately before administration.
For adults, the typical intramuscular dose is 100 mcg once daily or 300 mcg every other day.
For children aged 6 months to 1 year, administer 25 mcg once daily.
For children aged 1 to 3 years, administer 50 mcg once daily.
For children aged 4 to 6 years, administer 75 mcg once daily.
For children aged 7 to 14 years, administer 100 mcg once daily.
For children aged 15 to 18 years, administer the adult dose.
The standard course of parenteral therapy is 5 to 10 injections.
Repeat courses may be administered as clinically indicated, typically after a 1-4 week interval or as directed by a physician.
For oral administration in chronic atrophic gastritis, use only in adults.
Take the solution orally 20-30 minutes before a meal.
The typical oral dose is 200 mcg (20 ml of a 0.01 mg/ml solution) twice daily.
The standard course of oral therapy is 90 days.
For preoperative preparation, administer intramuscularly for 3 days prior to surgery.
For postoperative management of infectious complications, continue the course for 5-7 days after surgery.
Adjust the duration of therapy based on the clinical response and specific indication.
For topical application of cream or spray, apply a thin layer to the affected area 1-2 times daily.
The duration of topical use is determined by the rate of wound healing and epithelialization.
Adverse Reactions
From the immune system frequency unknown – allergic reactions, hypersensitivity reactions to the active substance.
From the digestive system (when taken orally): frequency unknown – loose stools.
Contraindications
For parenteral use: hypersensitivity to alpha-glutamyl-tryptophan; children under 6 months of age.
For oral administration: hypersensitivity to alpha-glutamyl-tryptophan; acute inflammatory diseases of the stomach and duodenum, oncological diseases, pregnancy, breastfeeding period; age under 18 years.
Use in Pregnancy and Lactation
The use of oral dosage forms is contraindicated during pregnancy and breastfeeding.
Parenteral use during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.
Pediatric Use
Parenteral administration is contraindicated in children under 6 months of age.
Oral dosage forms are contraindicated under 18 years of age.
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
Rx Only
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
Powder for the preparation of oral gel: jar 90 g
Marketing Authorization Holder
MBNPK Cytomed, JSC (Russia)
Dosage Form
 |
Thymogen® | Powder for the preparation of oral gel: jar 90 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral gel from white to yellowish-brown color.
| 1 g | |
| Alpha-glutamyl-tryptophan sodium (thymogen sodium) | 0.352 mg, |
| Calculated as Alpha-glutamyl-tryptophan | 0.33 mg |
Excipients : sodium alginate, sodium carboxymethylcellulose, fructose, colloidal silicon dioxide.
90 g – polyethylene jars (1) – cardboard packs.
Cream for external use 0.05%: tubes 20 g or 30 g
Marketing Authorization Holder
MBNPK Cytomed, JSC (Russia)
Dosage Form
 |
Thymogen® | Cream for external use 0.05%: tubes 20 g or 30 g |
Dosage Form, Packaging, and Composition
Cream for external use white or white with a yellowish tint.
| 100 g | |
| Alpha-glutamyl-tryptophan (in the form of alpha-glutamyl-tryptophan sodium) | 0.05 g |
Excipients : liquid paraffin – 13 g, petrolatum – 4 g, polysorbate 60 (polyoxyethylene sorbitan monostearate-60) – 4 g, glycerol – 3 g, sorbitan stearate – 3 g, stearyl alcohol – 3 g, cetyl alcohol – 2 g, diethylene glycol monoethyl ether – 2 g, methylparahydroxybenzoate (nipagin E218) – 0.3 g, xanthan gum – 0.2 g, propylparahydroxybenzoate (nipasol E216) – 0.1 g, purified water – up to 100 g.
20 g – aluminum tubes with first opening control (membrane) and cap (1) – cardboard packs.
30 g – aluminum tubes with first opening control (membrane) and cap (1) – cardboard packs.
Solution for intramuscular injection 100 mcg/1 ml: amp. 5 or 10 pcs.
Marketing Authorization Holder
MBNPK Cytomed, JSC (Russia)
Manufactured By
Deko Company, LLC (Russia)
Dosage Form
|
Thymogen® | Solution for intramuscular injection 100 mcg/1 ml: amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intramuscular injection colorless, transparent, odorless.
| 1 ml | |
| Alpha-glutamyl-tryptophan sodium (calculated as Alpha-glutamyl-tryptophan) | 100 mcg |
Excipients : sodium chloride – 9000 mcg, water for injection – up to 1 ml.
1 ml – ampoules of colorless glass (5) – blister packs (1) – cardboard packs.
1 ml – ampoules of colorless glass (5) – blister packs (2) – cardboard packs.
1 ml – ampoules of colorless glass (5) – cardboard packs.
Dosage nasal spray 25 mcg/1 dose: 10 ml bottle (no less than 80 doses) with pump dispenser
Marketing Authorization Holder
MBNPK Cytomed, JSC (Russia)
Dosage Form
|
Thymogen® | Dosage nasal spray 25 mcg/1 dose: 10 ml bottle (no less than 80 doses) with pump dispenser |
Dosage Form, Packaging, and Composition
Dosage nasal spray in the form of a colorless, transparent liquid; the presence of a characteristic odor of benzalkonium chloride is allowed.
| 1 dose (0.1 ml) | |
| Alpha-glutamyl-tryptophan | 25 mcg |
Excipients : sodium chloride, benzalkonium chloride, purified water.
10 ml (no less than 80 doses) – dark glass bottles× (1) with a pump dispenser (100 µl) with a plastic body, nozzle and with a protective cap – cardboard packs.
× self-adhesive labels are affixed to the bottles.
![Thymogen® [Solution, Cream, Spray, Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Thymogen® [Solution, Cream, Spray, Powder] 2")