Nosological classification (ICD-10)
- B37.9 Candidiasis, unspecified
- J02.9 Acute pharyngitis, unspecified
- J03.9 Acute tonsillitis, unspecified (angina agranulocytic)
- J04.0 Acute laryngitis
- J37.0 Chronic laryngitis
- K05 Gingivitis and periodontal diseases
- K05.4 Periodontal disease
- K11.8 Other diseases of the salivary glands
- K12 Stomatitis and related lesions
- K14.0 Glossitis
- Z01.2 Dental examination
- Z100* CLASS XXII Surgical practice
Composition and release form
| Lozenges | 1 table |
| benzydamine hydrochloride | 3 mg |
| excipients: isomaltose; racementol; aspartame; citric acid monohydrate; mint flavor; lemon flavoring; quinoline yellow dye (E104); indigo carmine dye (E132) |
in a package there are 10 tablets, each of which is wrapped in waxed paper, placed in a wrapper made of two-layer aluminum foil; in a cardboard pack 2 packages (wrappers).
| Solution for topical use 0.15% | 100 ml |
| benzydamine hydrochloride | 0.15 g |
| excipients: ethanol 96%; glycerin (glycerol); methyl parahydroxybenzoate; menthol flavoring; saccharin; sodium bicarbonate; polysorbate 20; quinoline yellow dye 70% (E104); patented blue dye 85% (E131); purified water |
in bottles of 120 ml; complete with measuring cup; 1 set in a cardboard pack.
| Topical spray dosed 0.255 mg/dose | 100 ml |
| benzydamine hydrochloride | 0.15 g |
| excipients: ethanol 96%; glycerol; methyl parahydroxybenzoate; menthol flavoring (flavoring additive); saccharin; sodium bicarbonate; polysorbate 20; purified water |
in bottles equipped with a pump and a pressure device with a folding cannula of 30 ml; 1 bottle in a cardboard pack.
Tantum Verde rinse solution 0.15% 120ml No. 1
Name
Tantum Verde solution for strips 0.15% in 120 ml bottle with dosage station. in unitary enterprise No. 1
Description
Rinse solution 0.15%: transparent green liquid with a characteristic mint odor.
Main active ingredient
Benzydamine
Release form
Rinse solution
pharmachologic effect
Pharmacodynamics
Benzydamine is a non-steroidal anti-inflammatory drug. Has anti-inflammatory and local analgesic effect. The mechanism of action of the drug is associated with its suppressive activity of pro-inflammatory cytokines, since it inhibits the synthesis of TNF? and, to a lesser extent, IL-l? and MCP-1, and inhibition of prostaglandin synthesis. Clinical studies have shown that benzydamine is effective in the treatment of localized inflammatory processes in the mouth and throat.
Pharmacokinetics
When applied topically, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues, reaching effective concentrations due to its ability to penetrate the superficial epithelial layer. Excretion of the drug occurs mainly by the kidneys and through the intestines in the form of metabolites or conjugation products. Dosage forms for topical use do not have a systemic effect.
Indications for use
Symptomatic treatment of irritations and inflammatory conditions, including those associated with pain in the mouth and throat (eg, pharyngitis, gingivitis, stomatitis), as well as after conservative treatment or tooth extraction.
Precautionary measures
The use of this drug, especially with long-term therapy, may cause a sensitivity reaction. In this case, treatment should be interrupted and a doctor should be consulted to determine acceptable therapy. In a limited number of patients, the oropharyngeal form of an ulcer may be a sign of more serious pathologies. If symptoms persist beyond 3 days, the patient should consult their doctor or dentist, as appropriate. The use of benzydamine is not recommended in case of hypersensitivity to salicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs). The drug should be prescribed with caution to patients with a history of bronchial asthma, since bronchospasms may occur in patients in this group. Tantum® Verde contains methyl parahydroxybenzoate, which can cause allergic reactions (including delayed ones). For patients involved in sports: the use of drugs containing ethyl alcohol may test positive for doping according to the blood alcohol limits set by some sports federations.
Interaction with other drugs
No clinically significant interaction of Tantum® Verde with other drugs has been established.
Contraindications
Hypersensitivity to any of the components of the drug;
Compound
Composition per 100 ml of rinse solution Active component: benzydamine hydrochloride - 0.15 g (which corresponds to 0.18 g in one 120 ml bottle); auxiliary components: ethanol 96%, glycerin (glycerol), methyl parahydroxybenzoate, menthol flavor, saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow dye 70% (E l04), patent blue dye 85% (E 131), purified water.
Directions for use and doses
For adults, elderly patients and children over 12 years of age, use a solution for gargling or mouthwash, 15 ml (measured using a measuring cup) 2-3 times a day. Do not use the drug in children under 12 years of age due to the possibility of swallowing the solution while rinsing the mouth. It is recommended to use the drug in the form of an undiluted solution or a diluted solution (mix 15 ml of the drug and 15 ml of water in a measuring cup). Duration of treatment: - for inflammatory diseases of the mouth and throat (of various etiologies): 3-5 days; — for dental pathology: 3-5 days; When using the drug for a long time, consult a doctor.
Overdose
Very rarely, overdose symptoms such as excitability, convulsions, sweating, ataxia, tremor and vomiting have been reported in children after oral administration of benzydamine in doses that are approximately 300 times higher than recommended. In case of acute overdose, only symptomatic treatment is possible; The stomach should be cleared by inducing vomiting or gastric lavage, and the patient should be under medical supervision with supportive care and adequate hydration.
Side effect
The table below shows side effects classified by organ or organ system according to MedDRA. The frequency categories of side effects are defined as follows: very common (? 1/10); frequent (from ? 1/100 to
Storage conditions
Store at a temperature not exceeding 25°C in a place protected from light. Keep out of the reach of children.
Pharmacodynamics
Benzidamine is a non-steroidal anti-inflammatory drug that belongs to the indazoles group. It has an anti-inflammatory and local analgesic effect, and has an antiseptic effect against a wide range of microorganisms.
The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of PG synthesis.
Benzidamine has an antibacterial and specific antimicrobial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and cell lysis.
Has antifungal effect against Candida albicans. Causes structural modifications of the cell wall of fungi and the metabolic chains of mycetes, thus preventing their reproduction, which is the basis for the use of benzydamine for inflammatory processes in the oral cavity, including infectious etiology.
Tantum verde 3 mg 40 pcs. lozenges multi-flavor
pharmachologic effect
Non-steroidal anti-inflammatory drug.
Composition and release form Tantum verde 3 mg 40 pcs. lozenges multi-flavor
Lozenges - 1 tablet. benzydamine hydrochloride - 3 mg excipients: isomaltose; racementol; aspartame; citric acid monohydrate; mint flavor; lemon flavoring; quinoline yellow dye (E104); indigo carmine dye (E132) in a package of 10 tablets, each of which is wrapped in wax paper, placed in a double-layer aluminum foil wrapper; in a cardboard pack 2 packages (wrappers). Solution for topical use 0.15% - 100 ml benzydamine hydrochloride - 0.15 g excipients: ethanol 96%; glycerin (glycerol); methyl parahydroxybenzoate; menthol flavoring; saccharin; sodium bicarbonate; polysorbate 20; quinoline yellow dye 70% (E104); patented blue dye 85% (E131); purified water in 120 ml bottles; complete with measuring cup; 1 set in a cardboard pack. Spray for topical use dosed 0.255 mg/dose - 100 ml benzydamine hydrochloride - 0.15 g excipients: ethanol 96%; glycerol; methyl parahydroxybenzoate; menthol flavoring (flavoring additive); saccharin; sodium bicarbonate; polysorbate 20; purified water in 30 ml bottles with a dispenser; 1 bottle in a cardboard pack. Spray for topical use dosed 0.51 mg/dose (forte) - 100 ml benzydamine hydrochloride - 0.3 g excipients: glycerol; ethanol 96%; macrogol glyceryl hydroxystearate; menthol flavoring (flavoring additive); methyl parahydroxybenzoate; sodium saccharinate; purified water in bottles with a 15 ml dispenser; 1 bottle in a cardboard pack.
Description of the dosage form
Eucalyptus flavored lozenges: dark green translucent square tablets with a depression in the center with a characteristic eucalyptus odor.
Characteristic
NSAIDs belong to the indazole group.
Directions for use and doses
Inside, after eating. Adults (including elderly patients) and children over 6 years of age: 1 lozenge 3 times a day. Keep the tablets in your mouth until completely dissolved. Do not swallow. Do not chew. Do not exceed the recommended dose. For children from 6 to 12 years old, the drug is used under the supervision of an adult.
The duration of treatment should not exceed 7 days. If after treatment there is no improvement within 7 days or new symptoms appear, you should consult your doctor.
Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
Pharmacodynamics
Benzidamine is a non-steroidal anti-inflammatory drug that belongs to the indazoles group. It has an anti-inflammatory and local analgesic effect, and has an antiseptic effect against a wide range of microorganisms. The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.
Benzidamine has an antibacterial and specific antimicrobial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and cell lysosomes.
Has antifungal effect against Candida albicans. Causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzydamine for inflammatory processes in the oral cavity, including infectious etiology.
Pharmacokinetics
When applied topically, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues; it is found in the blood plasma in quantities insufficient to obtain systemic effects.
Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.
Indications for use Tantum verde 3 mg 40 pcs. lozenges multi-flavor
Symptomatic treatment of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies):
- gingivitis, glossitis, stomatitis (including after radiation and chemotherapy);
- pharyngitis, laryngitis, tonsillitis;
- candidiasis of the oral mucosa (as part of combination therapy);
- calculous inflammation of the salivary glands;
- after surgical interventions and injuries (tonsillectomy, jaw fractures);
- after treatment and tooth extraction;
- periodontal disease.
For infectious and inflammatory diseases requiring systemic treatment, it is necessary to use Tantum® Verde as part of combination therapy.
Contraindications
- hypersensitivity to benzydamine or other components of the drug;
- fructose intolerance;
- children under 6 years of age;
- phenylketonuria, because contains aspartame (for mint or lemon flavored lozenges).
Carefully.
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including a history).
Use during pregnancy and breastfeeding Tantum® Verde should not be used during pregnancy or breastfeeding.
Application of Tantum verde 3 mg 40 pcs. multi-flavor lozenges during pregnancy and breastfeeding
Tantum® Verde should not be used during pregnancy and breastfeeding.
special instructions
When using the drug Tantum® Verde, hypersensitivity reactions may develop. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.
In a limited number of patients, the presence of sores in the throat and mouth may indicate a more serious condition. If symptoms persist for more than 3 days, you should consult your doctor.
The use of Tantum® Verde is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
The drug Tantum® Verde should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm while taking the drug.
The drug contains isomaltose and, therefore, is not recommended for patients with hereditary fructose intolerance.
The use of the drug in children is possible only under adult supervision to avoid swallowing the tablet.
Impact on the ability to drive vehicles and machinery
Does not affect the ability to drive vehicles and operate machinery.
Overdose
Currently, no cases of overdose of Tantum® Verde have been reported.
Symptoms: when using the drug in accordance with the instructions for use, an overdose is unlikely. If the drug is accidentally ingested, the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.
Treatment: symptomatic; empty the stomach by inducing vomiting or flush the stomach using a gastric tube (under medical supervision); provide medical supervision, supportive care and necessary hydration. No antidote is known.
Side effects Tantum verde 3 mg 40 pcs. lozenges multi-flavor
Classification of the frequency of side effects of the World Health Organization (WHO): very often - ≥1/10; often - from ≥ 1/100 to
Within each group, adverse effects are presented in order of decreasing severity.
Local reactions: rarely - dry mouth, burning sensation in the oral cavity; frequency unknown - feeling of numbness in the mouth.
Allergic reactions: uncommon – photosensitivity; rarely – hypersensitivity reactions, skin rash, itching; very rarely - angioedema, laryngospasm; frequency unknown - anaphylactic reactions.
If any of the side effects indicated in the instructions worsen, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor.
Drug interactions
No interaction studies have been conducted with other drugs.
Indications for Tantum® Verde
Inflammatory diseases of the oral cavity and ENT organs (of various etiologies):
gingivitis, glossitis, stomatitis (including after radiation and chemotherapy);
sore throat, pharyngitis, laryngitis, tonsillitis;
candidiasis (as part of combination therapy);
calculous inflammation of the salivary glands;
after surgical interventions and injuries (tonsillectomy, jaw fractures, etc.);
after treatment or tooth extraction;
periodontal disease.
For infectious and inflammatory diseases requiring systemic treatment, it is necessary to use Tantum® Verde as part of combination therapy.
Directions for use and doses
Locally. Lozenges: 1 tablet. 3–4 times a day. The tablet must be kept in the mouth until completely dissolved (for greater effect, preferably for as long as possible).
Solution for topical use: for gargling or mouthwash, use 15 ml of the drug (measuring cup included) 2-3 times a day.
An undiluted solution is used for rinsing during inflammatory processes; a diluted solution (15 ml of the drug and 15 ml of water mixed in a measuring cup) should be used daily for hygienic rinsing of the mouth and throat.
Topical spray dosed at 0.255 mg/dose: adults and elderly patients are prescribed 4-8 doses every 1.5-3 hours.
Children aged 6–12 years - 4 doses; 3-6 years - 1 dose for every 4 kg of body weight (maximum - 4 doses) every 1.5-3 hours.
Side effects of the drug Tantum Verde
The most common side effects when using Tantum Verde include: nausea, vomiting, diarrhea, palpitations, headache, dizziness, drowsiness, tinnitus, increased sweating, confusion. With prolonged use of the drug Tantum Verde, the patient may experience gastrointestinal bleeding, bleeding from the gums, anemia, and a decrease in the number of platelets. Rarely: skin rash, itching, Quincke's edema, urticaria. When using the drug Tantum Verde topically, the patient may experience a feeling of numbness, burning, dry mouth. If the above-mentioned undesirable effects are present, you should consult a doctor.
