Dosing and uses of Gelclair (bioadherent oral)
Adult dosage forms and strengths
concentrated oral geL
- 15mL/packet
Mucositis & Oral Irritation
Indicated for management of pain in the mucosal surface of the mouth
Rinse diluted solution around the mouth for at least 1 minute or as long as possible to coat tongue, palate, throat, inside of cheeks and all oral tissue thoroughly
Gargle and spit out
Use 3 times a day or as needed
Preparation
- Pour the entire contents (15 mL) of the single-use packet into a glass and add 1 tablespoon of water
- If this dilution is too thick, it may be diluted with an additional 1-2 tablespoons of water to achieve the desired thickness
- Stir mixture well and use immediately
- If water is not available, may be used undiluted
Dosing Considerations
Examples of etiologies causing oral mucosal pain
- Oral mucositis/stomatitis (eg, chemotherapy or radiation therapy)
- Irritation due to oral surgery
- Traumatic ulcers caused by braces or ill-fitting dentures, or disease
- Diffuse aphthous ulcers
Administration
Avoid eating or drinking for at least 30-60 minutes after use
Store at room temperature, out of direct sunlight
Gel may become a little darker and thicker over time, but this does not affect its efficacy or safety
Pediatric dosage forms and strengths
concentrated oral geL
- 15mL/packet
Mucositis & Oral Irritation
Indicated for management of pain in the mucosal surface of the mouth
Rinse diluted solution around the mouth for at least 1 minute or as long as possible to coat tongue, palate, throat, inside of cheeks and all oral tissue thoroughly
Gargle and spit out
Use 3 times a day or as needed
Preparation
- Pour the entire contents (15 mL) of the single-use packet into a glass and add 1 tablespoon of water
- If this dilution is too thick, it may be diluted with an additional 1-2 tablespoons of water to achieve the desired thickness
- Stir mixture well and use immediately
- If water is not available, may be used undiluted
Dosing Considerations
Examples of etiologies causing oral mucosal pain
- Oral mucositis/stomatitis (eg, chemotherapy or radiation therapy)
- Irritation due to oral surgery
- Traumatic ulcers caused by braces or ill-fitting dentures, or disease
- Diffuse aphthous ulcers
Administration
Avoid eating or drinking for at least 30-60 minutes after use
Store at room temperature, out of direct sunlight
Gel may become a little darker and thicker over time, but this does not affect its efficacy or safety
Gelclair (bioadherent oral) adverse (side) effects
Postmarketing Reports
Burning sensation in mouth
Warnings
Contraindications
Hypersensitivity
Cautions
Do not use any packet that is not intact (torn, split, or otherwise damaged in any way)
If no improvement is noticed after 7 days, consult a physician
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk
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.
Pharmacology of Gelclair (bioadherent oral)
Mechanism of action
Mucoadherent; elicits mechanical action by adhering to the mucosal surface of the mouth
Contents: water, maltodextrin, propylene glycol, polyvinylpyrrolidone (PVP), sodium hyaluronate, potassium sorbate, sodium benzoate, hydroxy ethylcellulose, PEG-40 hydrogenated castor oil, disodium edetate, benzalkonium chloride, flavoring, saccharin sodium, glycyrrhetinic acid
