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Indications & Uses
Apsol is used to treat mouth ulcers (aphthous ulcers).
Pharmacology
The exact mechanism by which Amlexanox speeds the healing of aphthous ulcers is not known. In laboratory studies, it has proven to be a strong inhibitor of the formation and release of inflammatory substances, such as histamine and leukotrienes, from mast cells, neutrophils and mononuclear cells. When given orally to animals, Amlexanox has shown anti-allergic and anti-inflammatory activity and has been found to suppress both immediate and delayed-type hypersensitivity reactions. How these activities relate to its effect on aphthous ulcers has not been established. Following a single oral application of 100 mg of paste (containing 5 mg of Amlexanox), peak serum levels are reached at around 2.4 hours. Most systemic absorption of Amlexanox occurs through the gastrointestinal tract, with only a small portion of the applied dose absorbed directly through the active ulcer. In healthy individuals, the elimination half-life was 3.5 ± 1.1 hours.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Apply the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Continue to use the paste four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. Dry the ulcer(s) by gently patting it with a soft, clean cloth. Wash hands before applying. Moisten the tip of the index finger. Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a fingertip. Gently dab the paste onto the ulcer. Repeat the process if more than one ulcer are present. Wash hands after application. Wash eyes promptly if they should come in contact with the paste. Use the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consultation with the physician is required.
Side Effects
Reported by 1-2% of patients, side effects included brief pain, stinging, and/or burning where the medicine was applied. Less common, affecting fewer than 1% of patients in clinical studies, were mucositis at the application site, nausea, and diarrhea.
Cautions & Contraindications
Warnings & Precautions
Wash your hands right away after using your fingertip to apply Apsol oral paste directly onto the ulcer. If a rash or mucosal irritation develops at the application site, stop using it.
Contraindications
Amlexanox oral paste should not be used by patients who are known to be hypersensitive to Amlexanox or to any other ingredient in the formulation.
Pregnancy & Breastfeeding
Amlexanox falls under US FDA pregnancy category B. Animal studies tested doses two hundred to six hundred times the projected human daily dose and found no adverse effects on the fetus. However, well-controlled studies in pregnant women are lacking, and since animal data don't always predict how humans will respond, this medicine should only be used during pregnancy if clearly necessary. Amlexanox has also been detected in the breast milk of nursing rats, so caution is advised when giving Amlexanox oral paste to a breastfeeding woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Amlex oral paste has not been shown to be safe or effective in pediatric patients.
Overdose
If a person swallowed a whole 5 gram tube of Amlexanox paste, the amount absorbed into the body would still be well below the maximum nontoxic dose of Amlex found in animals. An overdose could cause stomach and bowel upset, such as diarrhea and vomiting.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Amlexanox in a cool, dry place and protect it from light. Keep it out of the reach of children.
Common questions about Rupsol 5%
What is Rupsol 5% Oral Paste?
Rupsol 5% Oral Paste is a medicine that contains Amlexanox. It is made by Drug International Unani Ltd.
What is Rupsol used for?
Apsol is used to treat mouth ulcers (aphthous ulcers).
What are the side effects of Rupsol?
Reported by 1-2% of patients, side effects included brief pain, stinging, and/or burning where the medicine was applied. Less common, affecting fewer than 1% of patients in clinical studies, were mucositis at the application site, nausea, and diarrhea.
Can I take Rupsol during pregnancy or while breastfeeding?
Amlexanox falls under US FDA pregnancy category B. Animal studies tested doses two hundred to six hundred times the projected human daily dose and found no adverse effects on the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Rupsol?
If a person swallowed a whole 5 gram tube of Amlexanox paste, the amount absorbed into the body would still be well below the maximum nontoxic dose of Amlex found in animals. An overdose could cause stomach and bowel upset, such as diarrhea and vomiting. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Rupsol?
Keep Amlexanox in a cool, dry place and protect it from light. Keep it out of the reach of children.
Do I need a prescription for Rupsol?
Rupsol is a prescription (Rx) medicine. Take it as your doctor advises.