Chlorhexidine hydrochloride + Nystatin

Allopathic
Indications
  • Oral Candidiasis (Thrush): Treatment and prevention of fungal infections caused by Candida species in the oral cavity.
  • Mucosal and Oral Cavity Infections: Management of mixed bacterial and fungal infections in the mouth, gums, and throat.
  • Dentures and Oral Hygiene: Used to reduce microbial load and fungal colonization in denture wearers.
  • Postoperative Oral Care: Prevention of secondary infections after oral surgeries or dental procedures.
  • Off-label Uses: Adjunctive treatment for stomatitis, glossitis, and angular cheilitis with suspected fungal and bacterial involvement.
Dosage & Administration
  • Formulations: Typically available as oral rinses, gels, or lozenges.
  • Oral Rinse: Use 10-15 mL of solution to rinse the mouth for 30 seconds to 1 minute, then expectorate. Frequency is usually 2-4 times daily after meals and at bedtime.
  • Topical Application: Apply gel directly on affected mucosal areas 2-3 times daily.
  • Duration: Generally prescribed for 7 to 14 days, depending on infection severity.
  • Special Populations: Use with caution in children, elderly, and patients with impaired renal or hepatic function; no specific dose adjustments established.
  • Avoid swallowing large quantities.
Mechanism of Action (MOA)

Chlorhexidine hydrochloride is a broad-spectrum cationic antiseptic that binds to bacterial cell membranes, causing disruption of membrane integrity and leakage of intracellular components, leading to rapid bactericidal activity against Gram-positive and Gram-negative bacteria. Nystatin is a polyene antifungal that binds to ergosterol in fungal cell membranes, forming pores that increase membrane permeability, resulting in leakage of cellular contents and fungal cell death. The combination provides effective control of both bacterial and fungal pathogens in the oral cavity.

Pharmacokinetics
  • Absorption: Minimal systemic absorption of both agents when used topically in the oral cavity.
  • Distribution: Limited to the site of application; persists on mucosal surfaces providing prolonged antimicrobial effect.
  • Metabolism: Not systemically metabolized due to negligible absorption.
  • Excretion: Not systemically excreted.
  • Half-life: Not clinically relevant due to topical use and minimal absorption.
Pregnancy Category & Lactation
  • Pregnancy: Category B. Considered safe when used topically in the oral cavity due to minimal systemic absorption; use only if clearly needed.
  • Lactation: Likely safe; negligible systemic absorption reduces risk to breastfed infants. Caution advised.
Therapeutic Class
  • Combined topical antiseptic and antifungal.
Contraindications
  • Known hypersensitivity to chlorhexidine, nystatin, or formulation excipients.
  • Open wounds or mucosal ulcerations that may increase systemic absorption without medical supervision.
  • Not for intravenous or systemic use.
Warnings & Precautions
  • Avoid ingestion or swallowing large amounts.
  • May cause local irritation, staining of oral surfaces, and altered taste sensation.
  • Use with caution in patients with a history of hypersensitivity or allergy to either component.
  • Discontinue use if severe mucosal irritation or allergic reaction occurs.
  • Not a substitute for systemic antifungal therapy in invasive fungal infections.
Side Effects

Common:

  • Oral mucosal irritation, burning sensation, or dryness.
  • Altered or bitter taste.
  • Temporary staining of teeth, tongue, or oral mucosa.

Serious/Rare:

  • Hypersensitivity reactions including rash or angioedema.
  • Allergic contact stomatitis or dermatitis.
Drug Interactions
  • No significant systemic drug interactions expected due to topical administration and minimal absorption.
  • May interact with anionic mouthwashes or dentifrices, which can inactivate chlorhexidine; avoid concurrent use.
  • No known interactions with food or alcohol.
Recent Updates or Guidelines
  • Continued recommendation as an effective combination for oral infections with mixed bacterial and fungal etiology.
  • Emphasis on monitoring for hypersensitivity reactions and minimizing use duration to reduce resistance development.
  • No major changes in dosing or safety warnings in recent authoritative guidelines.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from light, moisture, and freezing.
  • Keep container tightly closed.
  • Use within expiry period; discard if discoloration or contamination occurs.