Properties
What is it?
Composition and Dosage Form Gargle - Oral Solution: 200 ml bottle. Benzydamine hydrochloride . . . . 300 mg Chlorhexidine gluconate . . . . 240 mg Excipients: Saccharin, ethanol, and mint essence. Oral Spray: 30 ml bottle Benzydamine hydrochloride . . . . 0.15% Chlorhexidine gluconate . . . . 0.12% Excipients: Saccharin, ethanol, and mint essence. Each spray volume is 0.13 ml, containing 0.156 mg of chlorhexidine gluconate and 0.195 mg of benzydamine hydrochloride. Clinical-Pharmacological Group Non-steroidal anti-inflammatory drug for topical use in oral diseases. Pharmacological Properties Benzydamine is an anti-inflammatory and analgesic agent structurally different from steroids. Benzydamine has a different pharmacological profile and pharmacokinetic characteristics from other non-steroidal anti-inflammatory drugs. Following topical application, benzydamine exhibits a local anesthetic effect. In experiments, benzydamine's analgesic activity was more frequently observed in inflammatory conditions than in non-inflammatory pain. Like other non-steroidal anti-inflammatory drugs, benzydamine inhibits the biosynthesis of certain prostaglandins. However, its anti-inflammatory action is not fully understood to date. Its effects may be due to its cell membrane-stabilizing properties. Chlorhexidine, after topical application, exhibits prolonged bacteriostatic and bactericidal effects. Chlorhexidine is effective against many gram-positive and gram-negative bacteria, as well as some types of yeasts and fungi, and enveloped viruses. Through prolonged surface action, chlorhexidine inhibits bacterial growth; by being absorbed from the microbial cell wall, chlorhexidine causes membrane rupture. Chlorhexidine is a biguanide antiseptic agent and, when used topically in the oral cavity, prevents the development of dental calculus and gingivitis. Chlorhexidine has a high affinity for tooth enamel structures; chlorhexidine is absorbed by enamel and has rapid bactericidal and prolonged bacteriostatic effects. Chlorhexidine reduces the development of plaque and associated gingivitis, characterized by gum hyperemia, swelling, and bleeding. It reduces the incidence of aphthous ulcers and increases the healing coefficient after periodontal surgery. Pharmacokinetics With topical use of Beneti Plus, benzydamine is rapidly absorbed from the inflamed mucous membrane, where its local anesthetic and anti-inflammatory effects are manifested. Approximately 30% of chlorhexidine gluconate remains in the oral cavity and is slowly released into saliva over 24 hours. Indications - Adjunctive therapy for antibacterial treatment of sore throat, pharyngitis, laryngitis, and tonsillitis; - In mucositis, inflammation of the oral mucosa caused by chemotherapy, radiotherapy, and other physical causes (e.g., tracheal intubation); - Aphthous ulcers, glossitis; - For relief of oropharyngeal and throat pain after periodontal procedures, as well as surgical operations in the oral cavity, on teeth, and jaws; - Treatment and prevention of gingivitis; - Treatment of oral infections and their complications; - Treatment of inflammation of the oral mucosa (stomatitis); - Prevention of dental plaque and calculus; - Periodontal diseases, periodontosis caused by physical exertion; - As adjunctive treatment after conservative dental therapy and tooth extraction; - For oral hygiene. Dosage Regimen Gargle Usually, Beneti Plus gargle is used undiluted. After rinsing, the solution should be expectorated from the oral cavity. Adults: The single dose of Beneti Plus gargle is 15 ml (measuring cap filled to the last mark). It is used for rinsing for 30 seconds at intervals of 1.5-3 hours throughout the day. Chlorhexidine in Beneti Plus gargle reduces the formation of dental calculus and gingivitis during the treatment period. Therefore, if Beneti Plus gargle is used as an oral hygiene procedure, the preparation should be held in the oral cavity for at least 1 minute, and after use, the solution should be expectorated. To minimize staining caused by chlorhexidine, it is advisable to brush teeth before using Beneti Plus. Children (6-12 years): Rinsing the oral cavity with 5-15 ml of Beneti Plus solution for 30 seconds at intervals of 1.5-3 hours. The duration of treatment should not exceed 7 days. The preparation can be diluted with water if burning or numbness is felt. Spray Adults: The spray should be applied directly to the inflamed area of the throat/oropharynx or ulcer. The usual dose is 4-8 sprays at a time. If necessary, the preparation is used every 1.5-3 hours, with a maximum of 32 sprays per day. Chlorhexidine in Beneti Plus spray reduces the formation of dental calculus and gingivitis during the treatment period. Therefore, if Beneti Plus spray is used as an oral hygiene procedure, the preparation should be held in the oral cavity for at least 1 minute, and after use, the solution should be expectorated. To minimize staining caused by chlorhexidine, it is advisable to brush teeth before using Beneti Plus. Children (6-12 years): The spray should be applied directly to the inflamed area of the throat/oropharynx or ulcer. The usual dose is 2-4 sprays. If necessary, the preparation is used every 1.5-3 hours, with a maximum of 16 sprays per day. Side Effects Beneti Plus is generally well-tolerated and has very few side effects. Serious side effects are not expected with its use. Local side effects: Generally, the most common side effect is temporary loss of sensation in the oral cavity. Burning has occasionally been reported. Other side effects, such as local dryness, tingling, sensation of cold in the mouth, altered taste perception, staining of teeth or other oral surfaces, and increased calculus formation, are less frequent. Tooth staining is not dangerous and can be reduced by brushing teeth before using the preparation. Systemic side effects: Generally rare and not serious. They include nausea, vomiting, other gastrointestinal symptoms, dizziness, headache, and drowsiness. Hypersensitivity reactions are very rare but can manifest as itchy rash, urticaria, photodermatitis, and rarely laryngospasm and/or bronchospasm. Contraindications Hypersensitivity to benzydamine or chlorhexidine or any other ingredient of the preparation. Pregnancy and Lactation Pregnancy (Category B): There are no controlled study data on the use of chlorhexidine and benzydamine during pregnancy and lactation. This preparation should be used during pregnancy only if necessary. Lactation: It is not known whether chlorhexidine and benzydamine are excreted in breast milk, so the use of the preparation during lactation should be done with caution. Special Instructions - For topical use only; - Due to insufficient clinical data, Beneti Plus is not recommended for children under 6 years of age; - The preparation is used only for rinsing or spraying in the oral cavity. The patient should keep the preparation away from eyes and ears; - May cause temporary discoloration of the tongue or teeth; - Beneti Plus must not be swallowed; - If sore throat is caused by a bacterial infection, antibacterial treatment may also be necessary along with Beneti Plus treatment; - Renal insufficiency: Benzydamine and its metabolites are excreted in urine, so the possibility of systemic effects should be considered in patients with acute renal insufficiency; - Hepatic insufficiency: Benzydamine is metabolized in the liver, so the possibility of systemic effects should be considered in patients with acute hepatic insufficiency. Effect of the preparation on driving and operating other machinery: Not described. Overdose If Beneti Plus gargle is accidentally swallowed, symptomatic treatment may be necessary. There is no specific antidote. If Beneti Plus oral spray is accidentally swallowed, symptomatic treatment is not necessary. Interactions with Other Drugs Chlorhexidine: - Chlorhexidine salts are incompatible with soaps and other anionic compounds; - Chlorhexidine salts are compatible with cationic and non-ionic surfactants, but when used simultaneously at high concentrations, the activity of chlorhexidine may be reduced due to cellular linkages; - Incompatible with anionic polyelectrolytes such as sodium carboxymethylcellulose, gum arabic, sodium alginate, and starch. In addition, its effect is also reduced with these compounds; - Incompatible with compounds such as brilliant green, chloramphenicol, copper sulfate, sodium fluorescein, formaldehyde, silver nitrate, zinc sulfate; - When diluted in hard water, due to the interaction of calcium and magnesium cations, chlorhexidine may precipitate as insoluble salts; - Chlorhexidine is compatible with gluconate, cetrimide, and benzalkonium chloride. They jointly increase the bactericidal effect of chlorhexidine. Cetrimide prevents the precipitation of chlorhexidine in hard water; - Besides chlorhexidine gluconate, chlorhexidine and its salts are better soluble in alcohol than in water. The presence of 7% alcohol in the composition makes the solution more effective against gram-negative microorganisms. Interactions of benzydamine with other preparations have not been described. Storage Conditions and Expiry Date The preparation should be stored at a temperature not exceeding 25°C, in a dry place inaccessible to children. Shelf life - 2 years.