Tonzinorm® (Solution, Spray) Instructions for Use
ATC Code
A01AD02 (Benzydamine)
Active Substance
Benzydamine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
NSAIDs for topical use in ENT practice and dentistry
Pharmacotherapeutic Group
Nonsteroidal anti-inflammatory drug
Pharmacological Action
NSAID, an indazole derivative, without a carboxyl group. The absence of a carboxyl group imparts the following features: Benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, penetrates well into the site of inflammation (where pH is lower) along the pH gradient and accumulates in therapeutic concentrations.
It has an anti-inflammatory and local analgesic effect, and possesses antiseptic (against a wide range of microorganisms), as well as antifungal action.
The anti-inflammatory effect is due to a decrease in capillary permeability, stabilization of cell membranes as a result of inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other nonspecific endogenous damaging factors.
Benzydamine suppresses the production of pro-inflammatory cytokines, especially TNFα, and to a lesser extent IL-1β. The main feature of benzydamine is that, being a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of pro-inflammatory cytokines. For this reason, Benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug.
The local anesthetic effect of benzydamine is associated with the structural features of its molecule, similar to local anesthetics. The analgesic effect is due to an indirect decrease in the concentration of biogenic amines with algogenic properties and an increase in the pain sensitivity threshold of the receptor apparatus; Benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity at the site of inflammation.
Benzydamine exerts an antibacterial effect through rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.
It has an antifungal effect against 20 strains of Candida albicans and Candida non-albicans, causing structural modifications of the fungal cell wall and their metabolic chains, thus preventing their reproduction.
Pharmacokinetics
When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissues. It is detected in blood plasma in an amount insufficient to obtain systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.
Indications
Symptomatic therapy of pain syndrome in inflammatory diseases of the oral cavity and ENT organs (of various etiologies): pharyngitis, laryngitis, tonsillitis; gingivitis, glossitis, periodontosis, stomatitis (including after radiation and chemotherapy); calculous inflammation of the salivary glands; after dental treatment or extraction; after surgical interventions and injuries (tonsillectomy, jaw fractures); candidiasis of the oral mucosa (as part of combination therapy).
ICD codes
| ICD-10 code | Indication |
| B37.0 | Candidal stomatitis |
| J02 | Acute pharyngitis |
| J03 | Acute tonsillitis |
| J04.0 | Acute laryngitis |
| J31.2 | Chronic pharyngitis |
| J35.0 | Chronic tonsillitis |
| J37.0 | Chronic laryngitis |
| K05 | Gingivitis and periodontal diseases |
| K08.8 | Other specified disorders of teeth and supporting structures (including toothache) |
| K11.5 | Sialolithiasis |
| K12 | Stomatitis and related lesions |
| K14.0 | Glossitis |
| R07.0 | Pain in throat |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| ICD-11 code | Indication |
| 1F23.0 | Candidiasis of the lips or oral mucosa |
| CA02.Z | Acute pharyngitis, unspecified |
| CA03.Z | Acute tonsillitis, unspecified |
| CA05.0 | Acute laryngitis |
| CA09.2 | Chronic pharyngitis |
| CA0F.Y | Other specified chronic diseases of the palatine tonsils and adenoids |
| CA0G | Chronic laryngitis or laryngotracheitis |
| DA01.Z | Diseases of the oral mucosa, unspecified |
| DA03.0 | Glossitis |
| DA04.4 | Sialolithiasis |
| DA0A.Z | Diseases of teeth and supporting structures, unspecified |
| DA0B.Z | Gingival diseases, unspecified |
| DA0C.Z | Periodontal diseases, unspecified |
| DA0Z | Diseases or disorders of the orofacial complex, unspecified |
| LA30.5Z | Anomalies of tooth resorption or loss, unspecified |
| MD36.0 | Pain in throat |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
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 Tonzinorm® topically for the oral cavity and oropharynx. Determine the dose individually based on the patient’s age and the severity of inflammation.
For the spray, administer the required number of doses directly onto the affected area. For the solution, use the provided measuring cup or undiluted as a gargle.
For adults and adolescents aged 12 years and older, use the spray. Administer 4 to 8 doses (equivalent to 0.6 to 1.2 ml), 2 to 6 times daily. For the solution as a gargle, use 15 ml undiluted every 1.5 to 3 hours as needed.
For children aged 6 to under 12 years, use the spray. Administer 4 doses (0.6 ml), 2 to 6 times daily. For the solution as a gargle, use 10 ml undiluted every 1.5 to 3 hours.
For children aged 3 to under 6 years, use the spray. Administer 1 dose per 4 kg of body weight (maximum of 4 doses or 0.6 ml), 2 to 6 times daily. Do not exceed the maximum single and daily doses.
Gargle with the solution for at least 30 seconds before spitting it out. Do not swallow the medication. Avoid eating or drinking for 15-30 minutes after application to ensure local effect.
The typical treatment course is 7 days. Discontinue use if symptoms persist beyond this period and consult a physician. Do not exceed the recommended duration of use without medical supervision.
Adverse Reactions
Local reactions: rarely – dry mouth, burning sensation in the oral cavity; frequency unknown – numbness sensation in the oral cavity.
Allergic reactions: infrequently – photosensitivity; rarely – sensitivity reactions, skin rash, skin itching; very rarely – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.
Contraindications
Children under 3 years of age; children over 3 years of age (depending on the dosage form used); hypersensitivity to benzydamine.
With caution
Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history).
Use in Pregnancy and Lactation
Should not be used during pregnancy and breastfeeding.
Pediatric Use
Contraindicated in children under 3 years of age; in children over 3 years of age – depending on the dosage form used.
Geriatric Use
There are no special instructions for limiting use in elderly patients.
Special Precautions
If there is an ulcerative lesion of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than 3 days.
Not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
Use with caution in patients with bronchial asthma, as bronchospasm may develop.
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
Metered-dose topical spray 0.255 mg/dose: 30 ml, 50 ml or 100 ml bottle
Marketing Authorization Holder
PharmVILAR NPO, LLC (Russia)
Dosage Form
 |
Tonzinorm® | Metered-dose topical spray 0.255 mg/dose: 30 ml, 50 ml or 100 ml bottle |
Dosage Form, Packaging, and Composition
Metered-dose topical spray in the form of a clear green liquid, with a characteristic eucalyptus odor.
| 1 dose | |
| Benzydamine hydrochloride | 0.255 mg |
Excipients: ethanol 95% – 13.6 mg, glycerol (glycerin) – 8.5 mg, methylparahydroxybenzoate – 0.17 mg, eucalyptus flavor – 0.0255 mg, sodium saccharin – 0.0408 mg, sodium bicarbonate – 0.0187 mg, polysorbate 20 – 0.0085 mg, quinoline yellow dye (E104) – 0.00272 mg, patent blue dye (E131) – 0.000561 mg, purified water – up to 0.17 ml.
30 ml (176 doses) – bottles (1) – cardboard packs.
50 ml (293 doses) – bottles (1) – cardboard packs.
100 ml (586 doses) – bottles (1) – cardboard packs.
Topical solution 0.15% with mint flavor: 100 ml, 150 ml, 200 ml or 250 ml bottle
Topical solution with eucalyptus flavor 0.15%: 100 ml, 150 ml, 200 ml or 250 ml bottle
Marketing Authorization Holder
PharmVILAR NPO, LLC (Russia)
Dosage Forms
|
Tonzinorm® | Topical solution 0.15% with mint flavor: 100 ml, 150 ml, 200 ml or 250 ml bottle |
| Topical solution with eucalyptus flavor 0.15%: 100 ml, 150 ml, 200 ml or 250 ml bottle |
Dosage Form, Packaging, and Composition
Topical solution with mint flavor – a clear green liquid with a characteristic mint odor.
| 100 ml | |
| Benzydamine hydrochloride | 150 mg |
Excipients: ethanol 95% (ethyl alcohol) – 8000 mg, glycerol (glycerin) – 5000 mg, methylparahydroxybenzoate – 100 mg, mint flavor – 15 mg, sodium saccharin – 24 mg, sodium bicarbonate – 11 mg, polysorbate 20 – 5 mg, quinoline yellow dye (E104) – 1.6 mg, patent blue dye (E131) – 0.33 mg, purified water – up to 100 ml.
Note: the amount of sodium bicarbonate may be adjusted depending on the pH of the solution.
100 ml – bottles (1) – cardboard packs (1).
150 ml – bottles (1) – cardboard packs (1).
200 ml – bottles (1) – cardboard packs (1).
250 ml – bottles (1) – cardboard packs (1).
100 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
150 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
200 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
250 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
Topical solution with eucalyptus flavor – a clear green liquid with a characteristic eucalyptus odor.
| 100 ml | |
| Benzydamine hydrochloride | 150 mg |
Excipients: ethanol 95% (ethyl alcohol) – 8000 mg, glycerol (glycerin) – 5000 mg, methylparahydroxybenzoate – 100 mg, eucalyptus flavor – 15 mg, sodium saccharin – 24 mg, sodium bicarbonate – 11 mg, polysorbate 20 – 5 mg, quinoline yellow dye (E 104) – 1.6 mg, patent blue dye (E131) – 0.33 mg, purified water – up to 100 ml.
Note: the amount of sodium bicarbonate may be adjusted depending on the pH of the solution.
100 ml – bottles (1) – cardboard packs (1).
150 ml – bottles (1) – cardboard packs (1).
200 ml – bottles (1) – cardboard packs (1).
250 ml – bottles (1) – cardboard packs (1).
100 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
150 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
200 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
250 ml – bottles (1) – cardboard packs (1) (with a measuring spoon or measuring cup).
![Tonzinorm® [Solution, Spray] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Tonzinorm® [Solution, Spray] 2")