Benzydamine + Chlorhexidine gluconate

Approved Indications:

• Symptomatic relief of pain, inflammation, and discomfort in the oral cavity and throat, including:
• Sore throat, tonsillitis
• Gingivitis, inflamed gums
• Mouth ulcers, aphthous stomatitis
• Post-dental procedures and oropharyngeal surgery pain and inflammation

Clinically Accepted Off-Label Uses:

• Adjunct treatment in bacterial pharyngitis to reduce symptom severity alongside systemic antibiotics
• Pre-procedural oral antiseptic use
• Temporary oral hygiene substitute when brushing is contraindicated due to pain or injury

Formulation and Route:

• Oral rinse/gargle solution

Adults and Adolescents (≥13 years):

• Use 15 mL undiluted for gargling or rinsing for 30 to 60 seconds, every 1.5 to 3 hours as needed.
• Spit out after use; do not swallow.

Dilution:

• Undiluted preferred; may dilute 1:1 with water if irritation occurs.

Duration:

• Use for up to 7 days. If symptoms persist beyond this, seek medical advice.

Pediatrics (<13 years):

• Not recommended for children under 12-13 years without medical supervision.

Special Populations:

• No dose adjustments required for renal or hepatic impairment due to minimal systemic absorption.
• Use cautiously in patients with liver disease.

Benzydamine is a topical non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and mild local anesthetic properties by inhibiting pro-inflammatory cytokines and stabilizing cell membranes, thereby reducing pain and inflammation in the oral mucosa. Chlorhexidine gluconate is a cationic antiseptic that binds to oral tissues and bacterial membranes, causing disruption of microbial cell walls and reducing bacterial load. The combination relieves oral pain and inflammation while exerting antimicrobial effects to reduce infection risk and plaque formation.

• Absorption: Benzydamine shows minimal systemic absorption when applied topically in the oral cavity; chlorhexidine remains primarily localized due to high substantivity.
• Distribution: Confined to mucosal surfaces.
• Metabolism: Benzydamine is metabolized hepatically; chlorhexidine is not significantly metabolized systemically.
• Elimination: Benzydamine metabolites are excreted renally; chlorhexidine is cleared gradually from the oral cavity.
• Onset of Action: Symptom relief typically occurs within minutes; anti-inflammatory effects develop over hours.
• Half-life: Benzydamine approximately 13 hours; chlorhexidine retention in oral cavity lasts several hours post-rinse.

• Pregnancy: Limited human data. Benzydamine is classified as pregnancy category B2 in some regions. Chlorhexidine exhibits minimal systemic absorption and is considered relatively safe when used intermittently and topically during pregnancy. Use only if clearly needed and under medical supervision.
• Lactation: Minimal systemic absorption suggests low risk; however, use with caution and avoid application near the breast to prevent infant exposure.

• Topical NSAID and antiseptic combination.
• Benzydamine: Locally acting NSAID/analgesic.
• Chlorhexidine gluconate: Cationic antiseptic mouthwash.

• Hypersensitivity to benzydamine, chlorhexidine, or any formulation excipients.
• Children under 12–13 years (depending on local labeling).
• Known allergy to NSAIDs or antiseptic agents.
• Application on severely damaged oral mucosa or open wounds where swallowing risk exists.

• Not intended for use beyond 7 days without medical consultation.
• Avoid swallowing the product; for topical oral use only.
• Monitor for allergic reactions or mucosal irritation.
• Caution in patients with NSAID hypersensitivity or liver disease.
• Discontinue immediately if severe mucosal ulceration, swelling, or difficulty breathing occurs.

Common:

• Oral burning or stinging sensation.
• Altered or bitter taste.
• Mild numbness of the oral mucosa.
• Mild dryness or irritation.
• Possible transient staining of teeth due to chlorhexidine.

Less Common:

• Increased dental plaque formation with prolonged use.
• Numbness in a small percentage of users.

Rare / Serious:

• Allergic reactions such as rash, urticaria, facial swelling.
• Severe oral mucosal irritation or anaphylaxis (extremely rare).

• Use with oral hygiene products containing anionic surfactants (e.g., sodium lauryl sulfate) may reduce chlorhexidine efficacy; spacing brushing and rinsing by 30 minutes is recommended.
• Alcohol-containing mouthwashes may exacerbate mucosal irritation.
• Minimal systemic drug interaction potential due to low systemic absorption.

• Continued endorsement for adjunctive use in symptomatic bacterial pharyngitis alongside antibiotics.
• Emphasis on combined anti-inflammatory and antiseptic therapy for postoperative oral care and painful mucosal lesions.
• Highlighted role in reducing antibiotic resistance by limiting antibiotic use and maintaining oral hygiene.

• Store at 20°C to 25°C in a dry place away from direct sunlight.
• Keep container tightly closed.
• Avoid freezing.
• For external use only; do not ingest.
• Keep out of reach of children.
• Use as directed and discard after the recommended period post-opening.