Amlex 5% (Oral Paste)

5 gm tube: ৳ 75.23

Medicine Details

Category Details
Generic Amlexanox
Company Aci limited

Indications

  • Treatment of aphthous ulcers

Pharmacology

  • Mechanism of action is unknown
  • Inhibits formation and release of inflammatory mediators
  • Demonstrated anti-allergic and anti-inflammatory activities
  • Suppresses hypersensitivity reactions
  • Maximal serum levels observed at 2.4 hours
  • Half-life for elimination is 3.5 +/- 1.1 hours

Dosage & Administration

  • Apply paste four times daily
  • Dry the ulcer(s) before applying
  • Wash hands before and after application
  • Moisten the tip of the index finger
  • Use until the ulcer heals
  • Consult physician if no significant healing in 10 days

Contraindications

  • Contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients

Side Effects

  • Transient pain, stinging, or burning at the site of application
  • Infrequent adverse reactions include contact mucositis, nausea, and diarrhea

Pregnancy & Lactation

  • US FDA pregnancy category B
  • No well-controlled studies in pregnant women
  • Caution in nursing women
  • No adverse fetal effects observed in teratology studies with animals

Precautions & Warnings

  • Wash hands immediately after application
  • Discontinue use if rash or contact mucositis occurs

Use in Special Populations

  • Safety and effectiveness not established in pediatric patients

Overdose Effects

  • Ingestion of a full tube would result in systemic exposure below maximum nontoxic dose in animals
  • Overdose may result in gastrointestinal upset

Storage Conditions

  • Store in a cool & dry place
  • Protect from light
  • Keep out of reach of children

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