Apsol 5%

Description

Indications
Apsol is used for the treatment of aphthous ulcers.
Use this medication as directed by a registered physician.

Pharmacology
The exact mechanism by which Amlexanox promotes the healing of aphthous ulcers is not fully understood. However, in vitro studies indicate that Amlexanox acts as a potent inhibitor of inflammatory mediators such as histamine and leukotrienes, which are released by mast cells, neutrophils, and mononuclear cells. When administered orally in animal studies, Amlexanox has shown anti-allergic and anti-inflammatory properties, effectively suppressing both immediate and delayed hypersensitivity reactions. However, the direct relevance of these effects to its action on aphthous ulcers remains uncertain.

Following a single oral application of 100 mg of paste (containing 5 mg of Amlexanox), peak serum levels are reached within 2.4 hours. Most of the drug is absorbed through the gastrointestinal tract, with minimal absorption occurring directly through the ulcer site. The elimination half-life in healthy individuals is approximately 3.5 ± 1.1 hours.

Dosage & Administration

• Begin application as soon as aphthous ulcer symptoms appear.
• Apply the paste four times daily, preferably after oral hygiene following breakfast, lunch, dinner, and before bedtime.
• Dry the ulcer gently with a soft, clean cloth.
• Wash hands before application.
• Moisten the tip of the index finger.
• Squeeze out approximately ¼ inch (0.5 cm) of the paste onto the fingertip.
• Gently dab the paste onto the ulcer. If multiple ulcers are present, repeat the process for each ulcer.
• Wash hands thoroughly after application.
• If the paste comes into contact with the eyes, rinse them immediately with water.
• Continue using the paste until the ulcer heals. If there is no significant improvement or pain relief within 10 days, consult a physician.
  Use this medication as directed by a registered physician.

Contraindications
Amlexanox oral paste should not be used by individuals with a known allergy to Amlexanox or any other component of the formulation.

Side Effects
Reported side effects in 1-2% of patients include temporary pain, stinging, or burning at the application site. Less common (<1%) adverse effects observed in clinical studies include contact mucositis, nausea, and diarrhea.

Pregnancy & Lactation

• The US FDA classifies Amlexanox as a pregnancy category B drug. Animal studies conducted at doses significantly higher than human exposure levels did not show harmful effects on fetal development. However, there are no adequate and well-controlled studies in pregnant women. Therefore, Amlexanox should only be used during pregnancy if clearly necessary.
• Amlexanox has been detected in the milk of lactating rats. Due to potential risks, caution should be exercised when administering this medication to nursing mothers.

Precautions & Warnings

• Wash hands immediately after applying Apsol oral paste to prevent unintentional contact with sensitive areas.
• If a rash or contact mucositis develops, discontinue use and consult a healthcare provider.

Use in Special Populations

• Pediatric Use: The safety and effectiveness of Apsol oral paste in children have not been established.

Overdose Effects
Ingesting an entire 5-gram tube of the paste is unlikely to cause severe toxicity, as the systemic exposure remains well below toxic levels observed in animal studies. However, overdose may cause gastrointestinal discomfort, including diarrhea and vomiting.

Storage Conditions

• Store in a cool, dry place, away from direct light.
• Keep out of reach of children.