Agisept (Tablets) Instructions for Use

ATC Code

R02AA20 (Other antiseptics)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

A combined antiseptic preparation for topical use in the oral cavity and pharynx. It has an antimicrobial effect. It is active against gram-positive and gram-negative microorganisms.

Pharmacokinetics

Due to low systemic absorption, data on the pharmacokinetics of Agisept are not available.

Indications

• Infectious and inflammatory diseases of the oral cavity and pharynx, including acute and chronic pharyngitis, tonsillitis, and laryngitis.
• Inflammatory conditions of the gingiva and periodontal tissues, such as gingivitis and other periodontal diseases.
• Various forms of stomatitis and other related lesions affecting the oral mucosa for antiseptic management and symptomatic relief.

ICD codes

Dosage Regimen

Dissolve one tablet slowly in the mouth. For adult patients, administer one tablet every two hours during waking hours.

Strictly adhere to a maximum daily dose of eight tablets to prevent excessive intake. For children over the age of five years, administer one tablet every four hours.

Ensure the tablet is completely dissolved in the oral cavity; do not chew or swallow it whole to ensure proper local antiseptic action.

Adverse Reactions

When used as directed, the drug is generally well tolerated, and adverse reactions are rare.

In cases of individual hypersensitivity to any component, localized allergic reactions such as skin rash, itching, or redness may occur. Discontinue use immediately if any signs of hypersensitivity appear.

No other significant adverse effects have been reported with recommended topical use in the oral cavity and pharynx.

Contraindications

• Hypersensitivity to amylmetacresol, dichlorobenzyl alcohol, or any of the excipients listed in the formulation, as this may precipitate allergic reactions.
• Administration to children under 5 years of age due to the risk of choking and the lack of established safety and efficacy data in this very young pediatric population.
• Patients with a known hereditary intolerance to fructose, or those with glucose-galactose malabsorption or sucrase-isomaltase deficiency, owing to the sucrose and dextrose content in the tablets.

Drug Interactions

No clinically significant pharmacokinetic or pharmacodynamic interactions with other medicinal products have been observed or reported.

Due to the topical mechanism of action and minimal systemic absorption, the potential for interactions is considered low. No specific precautions regarding concomitant use with other drugs are required.

Overdose

Exceeding the recommended dosage is unlikely to lead to serious systemic effects due to minimal absorption from the gastrointestinal tract.

Symptoms of overdose may include gastrointestinal discomfort. Treatment should be symptomatic and supportive. Immediately discontinue the medication and consult a healthcare professional if a large number of tablets have been ingested.

Tablets

For dissolution in the oral cavity. Adults are prescribed 1 tablet every 2 hours. The maximum daily dose is 8 tablets. Children over 5 years are prescribed 1 tablet every 4 hours. The tablets should be dissolved until completely dissolved.

Pediatric Use

Contraindicated in children under 5 years of age.

Special Precautions

When taking Agisept, patients with diabetes mellitus should take into account the sugar content in each tablet: Agisept lozenges [lemon] – 1010 mg of dextrose and 1.56 g of sucrose, Agisept lozenges [orange] – 1010 mg of dextrose and 1.56 g of sucrose; Agisept lozenges [pineapple] – 1010 mg of dextrose and 1.56 g of sucrose.

If one or several doses are accidentally missed, the dose should not be increased.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

The shelf life is 3 years.

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.