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...Definitive Management of Oral Mucositis
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What is ProThelial™ ?
How ProThelial™ Works
Difference Between ProThelial™
     and Ordinary Sucralfate

How to Use ProThelial™
Who Can Use ProThelial™
Patient Information
 
 

 
About ProThelial™ 

What is ProThelial™? 

ProThelial™ is polymerized sucralfate malate paste that forms a protective layer over 
the oral mucosa by adhering to the mucosal surface, protecting against further irritation 
and relieving pain. The paste is used in the management of mouth lesions of all types, 
including stomatitis and mucositis caused by chemoradiation therapy.

ProThelial™: The First and Only FDA-Cleared Polymerized Sucralfate Paste 
Commercially Available for Oral Mucositis
ProThelial™ is indicated for the 
management (treatment and prevention) 
of oral mucositis of any cause. 
Chemoradiation treatment for cancer is 
the most common cause of oral 
mucositis, affecting approximately 
400,000 individuals. ProThelial™ is 
the first and only FDA-cleared 
polymerized sucralfate paste commercially available for oral mucositis.

ProThelial™: FDA-Cleared Medical Device Not a Drug
Though ProThelial™ contains sucralfate, it is FDA cleared and marketed as a medical
device. Unlike a drug, a medical device has no chemical reaction with body tissues. 
Rather it treats or prevents disease by a mechanical mode of action. ProThelial™ uses a 
mechanical mode of action to treat and prevent oral mucositis. As explained in ProThelial™ MOA, 
the cross-linked polymerization of sucralfate leads to improved adherence to the oral mucosa. 
This improved adherence assists the body’s existing mechanisms for healing. These actions of 
ProThelial™ are entirely mechanical or physical and not chemical as with a drug.

Active Ingredient of ProThelial™
ProThelial's™ active ingredient is polymerized cross-linked sucralfate.

Safety Profile of ProThelial™
The sucralfate component of ProThelial™ has no known serious side effects or adverse reaction. 
Constipation has been traditionally reported to occur with extremely large oral doses of sucralfate,
doses that are 5-10 times the accepted dose of 4 grams daily for 56 consecutive days. Of course,
as with all medications, no one should use ProThelial if they are allergic to sucralfate. Sucralfate 
allergies are extremely rare.
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