Drug ID: 1d00000087
Drug Name: Amlexanox
Generic Names: Aphthasol
Category: Anti-allergic and Anti-inflammatory Agents
Legal Status: Non opioid general use
Indication for Mother: Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Recommended Dose: Adult: Topical- As a 5% oral paste: Apply approx 0.5 cm of oral paste directly on to each ulcer 4 times/day following oral hygiene after meals and at bedtime.
Recommended In: This medication is an anti-allergic and anti-inflammatory agent, prescribed for aphthous ulcers or canker sores in people with normal immune systems. Because amlexanox decreases the healing time, it also decreases the pain you feel.
Directions For Use: It comes as a paste to apply topically, as directed by your physician.
Storage: Store it at controlled room temperature (15°-30°C).
Dosage Forms: Oral Paste
Side Effects: Mucositis (inflammation of mucous membrane), white patches or sores inside the mouth or on the lips, slight pain, stinging, or burning of the skin that appears and disappears, severe dizziness, trouble breathing, nausea, and diarrhea.
In Case of Overdose: There are no reports of human ingestion overdosage.
Avoid If: For topical use on mouth ulcers only, avoid contact with the eyes.
Wash your hands thoroughly after using this medication.
Caution should be exercised in patients with history of weakened immune system, who are taking other medications, during pregnancy and breastfeeding.
Avoid alcohol and nicotine because these products can irritate the sores.
Drug Interaction: No information provided.