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amlexanox (Discontinued)Brand and Other Names:Aphthasol

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral paste

  • 5%
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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

Not recommended

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Adverse Effects

1-10%

Contact mucositis (1-2%)

Local stinging (1-2%)

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Warnings

Contraindications

Hypersensitivity

Cautions

Re-evaluate if not healed in 10 days

Discontinue if rash or contact mucositis develops

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Pregnancy & 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.

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Pharmacology

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

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