Ambazon (Tablets) Instructions for Use

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Vifitech, CJSC (Russia)

ATC Code

R02AA01 (Ambazone)

Active Substance

Ambazone (Rec.INN registered by WHO)

Dosage Form

Ambazone

Lozenges 10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges brown in color with intact edges, round, flat-cylindrical, beveled to the edge; the presence of light and dark inclusions is allowed.

Excipients: sucrose – 729 mg, lactose monohydrate – 150 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, vanillin – 1 mg, stearic acid – 10 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic agent for topical use in ENT practice and dentistry.

It has a bacteriostatic effect.

It is active against Streptococcus haemoliticus, Streptococcus viridans, and Pneumococcus.

Indications

• Prevention and treatment of acute infectious and inflammatory diseases of the oral cavity and larynx, including tonsillitis, stomatitis, and gingivitis.
• Prevention of infectious and inflammatory diseases following tooth extraction procedures.

Use only for the conditions specified in the official labeling.

ICD codes

Dosage Regimen

Administer the lozenges by allowing them to dissolve slowly in the mouth.

For adults, the typical dosage is 30-50 mg per day, which corresponds to 3 to 5 lozenges, divided over the day for a duration of 3-4 days.

For children from 3 to 7 years of age, the dosage is 30 mg per day, equivalent to 3 lozenges, also for a period of 3-4 days.

Do not exceed the recommended daily dose or treatment duration.

Adverse Reactions

Adverse reactions are generally infrequent and mild due to local application.

The most commonly reported adverse reaction is the development of allergic reactions, which may include skin rash, itching, or urticaria.

Discontinue use immediately and consult a physician if any signs of hypersensitivity or other undesirable effects appear.

Drug Interactions

Formal studies of drug interactions have not been conducted.

Due to the topical mechanism of action, systemic interactions are considered unlikely.

Concomitant use with other locally applied antiseptic or antimicrobial agents is not recommended without medical advice.

Inform your physician about all other medications you are taking.

Contraindications

• Known hypersensitivity to ambazone or to any of the excipients listed in the composition.
• Contraindicated in children under 3 years of age due to the risk of choking and the inability to use lozenges properly.

Do not use in patients with a history of allergic reactions to the product.

Overdose

Overdose is unlikely due to the topical application and low systemic absorption.

Symptoms of acute overdose with a significant number of lozenges may include gastrointestinal discomfort such as nausea or abdominal pain due to excipient load.

Treatment should be symptomatic and supportive. In case of suspected overdose, seek medical attention or contact a poison control center.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is used in cases where the expected benefit of therapy for the mother outweighs the possible risk to the fetus or infant.

Use in Hepatic Impairment

No special precautions.

Use in Renal Impairment

No special precautions.

Pediatric Use

Used in children over 3 years of age.

Geriatric Use

No special precautions.

Special Precautions

After taking ambazone, it is recommended to refrain from eating and drinking for 3 hours.

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.