Orafate™ Prescribing Information
Prescribing Information - Product Package Insert
Orafate™ Polymerized Sucralfate Gel
Rx Only by Dentists, Oral Surgeons or ENT physicians
30mL Product Code: 33801-030-01
Device UPC
Description of Device:
Orafate™ is a 10% sucralfate gel. Sucralfate is an α-D-glucopyranoside,
β-Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular
weight of 2,086.75 having the following structure:
Water containing calcium chelated malic acid added to sucralfate powder converting
sucralfate granules into a polymerized gel.
Ingredients: Polymerized Sucralfate, purified water, methyl parabens, propyl parabens, sodium saccharin.
Contents: White Orafate™ gel in a multi-use 30ml tube.
FDA Indications: Orafate™ Sucralfate Malate Gel forms a protective layer
over the oral mucosa by adhering to the mucosal surface which allows it to protect
against further irritation and relieve pain. The gel may be used in the management
of mouth lesions of all types including those caused by periodontal and gingival
inflammation, tooth extractions, and wounds associated with oral surgery.
Contraindications: The administration of Orafate™ is contraindicated in any
patient with a known or suspected hypersensitivity to any of its ingredients.
Special precautions for use: Do not use any product jar that is not intact or
otherwise damaged in any way. Avoid eating or drinking for at least 1 hour after use.
For Oral Use: Orafate™ is not intended for ingestion but for the management of
oral ulcerations, oral irritations or oral mucosal wounds. However Orafate™ is safe if
swallowed in doses up to 4 grams daily for 56 days.
Physician Swallow Evaluation: Any clinician prescribing Orafate™ should evaluate the
adequacy of patient’s ability to swallow so as to minimize any unintended incidental
ingestion.
Direction of use:
- Following Dental Cleaning (Scaling & Root Planing): Brush ¼ teaspoon of Orafate™
into gingival pocket wounds twice daily x 1 week.
- Following Tooth Extraction: Place ¼ - ½ teaspoon of Orafate™ into wound 3 times
daily, then twice daily or as directed by the dentist.
- Following Tonsillectomy or Uvuloplasty: Squeeze out ½ to 1 tsp (2.5 – 5ml) of gel
from bottle onto tongue, swish, gargle then expectorate as instructed by surgeon.
Orafate™ is safe if swallowed.
Other General Instructions for Dental Use:
Orafate™ should be used 2 times daily for the 1st day or as directed by the dentist or
oral surgeon. Thereafter for 1-4 weeks apply Orafate™ in any of the following ways:
¼ teaspoon of gel may be either:
(a) Brushed alone or with toothpaste over affected tooth-gum line area;
(b) Mix Orafate™ with equal portions of dentifrice (tooth paste, powder, gel) and
layer over areas of teeth cleaned by the dentist;
(c) Dab Orafate™ directly on to affected gum margin;
(d) Layer Orafate™ onto affected gum area; or
(e) Place Orafate™ in mouth, sucked back and forth through spaces between teeth.
Length of Use: Orafate™ is to be used no longer than the time prescribed by the
surgeon or dentist,
ideally no longer than the period of time wherein oral wound, irritation or inflammation
persists.
Maximal Daily Amount: Maximal daily amount of Orafate™ should not exceed 40 ml or
8 teaspoons.
Side effects: At the time of this writing, no adverse side effects have been
reported with the use of Orafate™.
Adverse Reaction: As with all sucralfate products, constipation may be an adverse
reaction if Orafate™ is swallowed.
Warning: Federal law restricts Orafate™ to sale by or on the order of a physician
or properly licensed practitioner.
