Indications

Apsol is indicated for treating aphthous ulcers. Take this medicine as advised by a registered physician.

Pharmacology

Amlexanox accelerates healing of aphthous ulcers through unknown exact mechanisms. In vitro studies show it inhibits inflammatory mediators like histamine and leukotrienes. Peak serum levels occur 2.4 hours after applying 100 mg paste (5 mg Amlexanox). Most absorption occurs via the gastrointestinal tract. The elimination half-life is 3.5 ± 1.1 hours.

Dosage and Administration

Apply paste as soon as ulcer symptoms appear. Use four times daily after oral hygiene following meals and at bedtime. 
Step 1: Gently dry the ulcer with a soft, clean cloth. 
Step 2: Wash hands and moisten index fingertip. 
Step 3: Apply a ¼ inch (0.5 cm) dab onto the ulcer. Repeat if multiple ulcers are present. 
Step 4: Wash hands after application. Flush eyes immediately if contact occurs. Consult a physician if significant healing does not occur within 10 days.

Contraindications

Contraindicated in patients with known hypersensitivity to Amlexanox or any formulation ingredient.

Side Effects

Common: Transient pain, stinging, or burning at application site. 
Infrequent: Contact mucositis, nausea, and diarrhea.

Pregnancy and Lactation

Pregnancy: Category B. Use during pregnancy only if clearly needed. 
Lactation: Exercise caution as Amlexanox is excreted in milk.

Precautions and Warnings

Discontinue use if rash or contact mucositis develops. Wash hands immediately after application.

Special Populations

Pediatric Use: Safety and effectiveness in children have not been established.

Overdose and Storage

Overdose: Ingestion of a full tube may cause gastrointestinal upset. 
Storage: Store in a cool, dry place away from light and out of reach of children.