AMLEXANOX

AMLEXANOX
(am-lex'a-nox)
Aphthasol, OraDisc A
Classifications: antiinflammatory agent;
Therapeutic: antiinflammatory
Pregnancy Category: B

Availability

5% paste; 2 mg mucoadhesive disc

Action

Amlexanox is a potent inhibitor of inflammatory mediators (e.g., leukotrienes, IgE, IgG). Its mechanism of healing is unknown.

Therapeutic Effect

Amlexanox reduces healing time and pain related to aphthous ulcers or canker sores.

Uses

Treatment of aphthous ulcers in patients with normal immune systems.

Contraindications

Sensitivity to amlexanox or benzyl alcohol.

Cautious Use

Immunosuppressed patients; pregnancy (category B), lactation. Safety and efficacy in children are not established.

Route & Dosage

Aphthous Ulcers
Adult: Topical Apply 1/4 in. (0.5 cm) to finger and dab onto each mouth ulcer q.i.d. (after oral hygiene p.c. and h.s.) for 10 d cycle; apply disc to each mouth ulcer and allow to dissolve

Administration

Topical

Apply after oral hygiene following each meal and before bedtime.
Avoid prolonged contact with skin and wash off skin if contact occurs.
Store at 15°–30° C (59°–86° F) away from heat and moisture. Do not freeze.

Adverse Effects (≥1%)

Body as a Whole: Transient pain, stinging, or burning at application site.

Pharmacokinetics

Absorption: Minimally absorbed through ulcer. Onset: Approximately 3 d. Elimination: 17% in urine. Half-Life: 3.5 h.

Nursing Implications

Assessment & Drug Effects

Discontinue use if rash or inflamed membranes develop.

Patient & Family Education

Use at first sign of canker sore. Wash hands before and immediately after application.
Flush eyes immediately with large amount of cold water if paste accidentally comes in contact with eyes or eye area.
Contact physician if healing does not result after 10 d of therapy.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

(37)