Apsol 5% Oral Paste

Description

Indications

Apsol is indicated for the treatment of aphthous ulcers.

Use as directed by a registered physician.

Pharmacology

The exact mechanism by which Amlexanox accelerates the healing of aphthous ulcers remains unclear. In vitro studies have shown that Amlexanox is a potent inhibitor of the formation and release of inflammatory mediators, such as histamine and leukotrienes, from mast cells, neutrophils, and mononuclear cells. In animal studies, Amlexanox has demonstrated anti-allergic and anti-inflammatory activities, suppressing both immediate and delayed-type hypersensitivity reactions. However, the relevance of these activities to its effect on aphthous ulcers is not fully established.

Amlexanox is primarily absorbed through the gastrointestinal tract, with a small amount absorbed through the active ulcer site. Peak serum levels occur approximately 2.4 hours after a single 100 mg oral application of the paste (5 mg Amlexanox). The elimination half-life of Amlexanox is 3.5 ± 1.1 hours in healthy individuals.

Dosage & Administration

• Apply the paste as soon as possible after noticing symptoms of an aphthous ulcer.
• Use the paste four times daily, preferably after meals (breakfast, lunch, dinner) and at bedtime.
• Dry the ulcer(s) gently with a soft, clean cloth before application.
• Wash hands before and after applying the paste.
• Moisten the tip of the index finger and squeeze a small dab of paste (approximately ¼ inch or 0.5 cm).
• Gently dab the paste onto the ulcer. Repeat if there are multiple ulcers.
• Continue using the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consult a physician.

Use as directed by a registered physician.

Contraindications

Apsol is contraindicated in patients with known hypersensitivity to Amlexanox or any other components of the formulation.

Side Effects

Adverse reactions reported in 1-2% of patients include:

• Transient pain
• Stinging or burning at the application site

Infrequent adverse reactions (<1%) include:

• Contact mucositis
• Nausea
• Diarrhea

Pregnancy & Lactation

• Pregnancy: Apsol is classified as US FDA pregnancy category B. Animal studies have shown no adverse fetal effects at doses significantly higher than the human daily dose. However, since animal studies may not predict human response, this drug should only be used during pregnancy if clearly needed.
• Lactation: Amlexanox has been found in the milk of lactating rats. Caution should be exercised when administering Apsol oral paste to nursing women.

Precautions & Warnings

• Wash hands immediately after applying Apsol oral paste to avoid contact with other areas.
• Discontinue use if a rash or contact mucositis occurs.

Use in Special Populations

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

Overdose Effects

Ingestion of an entire 5-gram tube of paste would result in systemic exposure below the maximum nontoxic dose observed in animals. Overdose may cause gastrointestinal upset, such as diarrhea and vomiting.

Storage Conditions

Store in a cool, dry place. Protect from light. Keep out of reach of children.