Dosing and uses of Aphthasol (amlexanox)
Adult dosage forms and strengths
oral paste
- 5%
Aphthous Ulcers
Discontinued in the U.S. January 2014
Indicated for recurrent aphthous ulcers in people with normal immune systems
Aphthasol: Apply ~0.5 cm to affected area in mouth q6hr qHS after brushing teeth
Pediatric dosage forms and strengths
Not recommended
Aphthasol (amlexanox) adverse (side) effects
1-10%
Contact mucositis (1-2%)
Local stinging (1-2%)
Warnings
Contraindications
Hypersensitivity
Cautions
Re-evaluate if not healed in 10 days
Discontinue if rash or contact mucositis develops
Pregnancy and lactation
Pregnancy category: B
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Aphthasol (amlexanox)
Mechanism of action
Studies have suggested that it inhibits formation & release of proinflammatory substances; may have antigonistic effects on interleukin
Pharmacokinetics
Half-Life: 3.5 hr
Metabolism: Conjugated and hydroxylated metabolites
Excretion: Urine (17%)
Peak plasma time: 2 hr
Absorption: Minimal from swallowed paste
