Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, topical [for oral mucosa]:
Debacterol®: Sulfonated phenolics 50% and sulfuric acid 30% (1.5 mL) [for professional use only]
Swab, topical [for oral mucosa]:
Debacterol®: Sulfonated phenolics 50% and sulfuric acid 30% (12s) (0.2 mL) [for professional use only]
Pharmacology
Mechanism of Action
Semiviscous, chemical cautery agent which provides controlled, focal debridement and sterilization of necrotic tissues; relieving pain, sealing damaged tissue, and providing local antiseptic action
Use: Labeled Indications
Oral ulcers: Treatment of ulcerating oral lesions such as recurrent aphthous stomatitis (canker sores)
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Oral ulcers: Topical: Apply 1 coated applicator swab to ulcer for 5 to 10 seconds. Note: Not recommended to apply more than 1 treatment to each ulcer; however, if ulcer pain returns shortly after rinsing with water, 1 repeat application may be used.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Oral ulcers: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.
Administration
For external use only; avoid contact with eyes. Prior to application/treatment, the ulcerated mucosal area should be thoroughly dried with a cotton-tipped applicator or similar method. After drying, apply solution coated applicator swab directly to the ulcerated area (most patients experience a brief stinging sensation immediately) and hold the applicator in contact with the ulcer for at least 5 to 10 seconds. Thoroughly rinse out the mouth with water and spit out the rinse water. The stinging sensation and ulcer pain will subside almost immediately after the rinse.
Storage
Store at room temperature of 15°C to 30°C (59°F to 86°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined.
Local: Local irritation (upon administration)
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: If excess irritation occurs, rinse with a sodium bicarbonate (baking soda) solution (1/2 teaspoonful mixed in 120 mL [4 oz] water); if irritation persists, contact health care provider.
Dosage form specific issues:
- Sulfur: Do not use if allergic to sulfur in any form.
Other warnings/precautions:
- Accidental ingestion: If ingested, do not induce vomiting; rinse out mouth and immediately dilute liquids (no more than 8 ounces in adults and 4 ounces in children) and get medical help or contact a Poison Control Center.
- Appropriate use: For topical use only. Debacterol® is not intended for the treatment of cold sores and fever blisters. Prolonged use of Debacterol on normal tissue should be avoided.
- Eye exposure: Avoid contact with eyes. If eye exposure occurs, immediately remove contact lenses, irrigate eyes for at least 15 minutes with lukewarm water, and contact a physician.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
