Version May 2024
Mucosal protection: Oral:
Episil: Apply 1 to 3 pumps to the oral cavity 2 to 3 times daily, or as needed; maximum duration for continuous use: 30 days.
Gelclair: Rinse, gargle, and spit 15 mL (1 single-use packet) mixed in water 3 times daily, or as needed.
Mucotrol: Slowly dissolve 1 wafer by swishing around in the mouth, 3 times daily, or as needed.
MuGard: Rinse with 5 mL 4 to 6 times daily (for oral mucositis/stomatitis) or 4 to 6 times daily or as needed (for other ulcerative conditions); may use up to 10 mL if needed to fully coat inside of mouth.
Orafate:
Aphthous ulcers (canker sores), recurrent:
Single/solitary group of ulcers: Apply with cotton-tipped swab twice daily and at bedtime.
Ulcers throughout mouth: Swish 5 mL in mouth once daily or every 4 to 6 hours (severe cases).
Following dental cleaning, scaling, root planing: Brush 1.25 to 2.5 mL across the affected area of the gums daily for >4 weeks.
Following tooth extraction or gingival (gum) surgery: Place 1.25 to 2.5 mL into wound 3 times daily the first day, then twice daily until healed.
Following tonsillectomy or other oral soft tissue surgery: Place 2.5 to 5 mL into wound 3 times daily on the first day then twice daily.
Oral inflammation around gums: Brush 1.25 to 2.5 mL across the front and back of gingiva 2 times daily for the first day then once daily at bedtime until healed.
Pharyngitis, sore throat: Swish 5 mL in mouth twice daily (in the morning after brushing teeth and at bedtime) or every 4 to 6 hours (severe cases).
ProThelial: Usual dosage: 2.5 to 5 mL every 8 hours on the first day; 2.5 to 5 mL every 12 hours thereafter (maximum: 40 mL daily).
Prevention of chemo-radiation mucositis (beginning the first day of cancer treatment):
Grade 1 or 2: 2.5 to 5 mL 3 times a day for 1 day, followed by 2.5 to 5 mL twice daily until 1 week after completion of chemo-radiation therapy.
Grade 3 or 4: 10 mL 3 times a day, continue until 1 week after completion of chemo-radiation therapy.
Treatment of chemo-radiation mucositis:
Grade 1 or 2: 2.5 to 5 mL 3 times a day for 1 day, followed by 2.5 to 5 mL twice daily until 1 week after completion of chemo-radiation therapy.
Grade 3 or 4: 10 mL 3 times a day for 2 days, followed by 5 to 10 mL twice daily until 1 week after completion of chemo-radiation therapy.
Silatrix: Apply to mucosal wounds 2 to 3 times daily.
Refer to adult dosing.
Mucosal protection: Children ≥12 years and Adolescents: Oral: Orafate: Refer to adult Orafate dosing.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing: Gastrointestinal: Burning sensation of mouth
Hypersensitivity to any ingredient or component of the formulation
Additional product-specific contraindications: Episil: Hypersensitivity to peanuts, soya, or peppermint oil
Concurrent drug therapy related issues:
• Sublingual medications: May decrease absorption of sublingually administered medications.
Dosage form specific issues:
• Episil: Contains alcohol (may cause irritation when applied), propylene glycol (may cause skin irritation), soy, and peppermint oil (may cause allergic reaction).
• Gelclair: Avoid eating or drinking for at least 30 to 60 minutes following use.
• Mucotrol, MuGard, Orafate, ProThelial: Avoid eating or drinking for at least 1 hour following use.
• Orafate, ProThelial: Safe if swallowed; however, evaluate swallowing capability prior to use to minimize incidental ingestion. May cause constipation if swallowed.
• Silatrix: Contains propylene glycol; discontinue use if irritation occurs.
Other warnings/precautions:
• Appropriate use: Consult a health care provider if no improvement is seen after 7 days of use.
Orafate and ProThelial each contain sucralfate (as a 10% paste).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gel, Mouth/Throat:
Gelclair: 15 mL/packet (15 mL [DSC])
Silatrix: (10 g)
Liquid, Mouth/Throat:
Episil: (10 mL)
MuGard: (5 mL, 240 mL) [contains benzyl alcohol]
Paste, Mouth/Throat:
Orafate: 10% (30 mL) [contains methylparaben, propylparaben, saccharin sodium; strawberry flavor]
ProThelial: 10% (125 mL, 250 mL, 500 mL) [contains methylparaben, propylparaben, saccharin sodium]
Wafer, Mouth/Throat:
Mucotrol: (21 ea, 45 ea) [sugar free; mild licorice flavor]
No
Paste (Orafate Mouth/Throat)
10% (30 mL): $453.93
Paste (ProThelial Mouth/Throat)
10% (250 mL): $2383.67
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.
Oral:
Episil: Remove protective cap from pump and prime pump by pumping into a paper cloth until an even liquid stream develops; firmly press pump (1 to 3 times) to apply liquid stream to oral cavity, distribute to affected areas of mouth and wait for gel and protective film to form. Do not swallow. Wait 5 minutes after use before eating and drinking.
Gelclair: Use before meals or as directed. Add 15 mL (1 single use packet) to 15 mL of water and stir (may add additional 15 to 30 mL to achieve desired thickness); rinse around the mouth for a minimum of 1 minute (as long as possible) to coat the tongue, palate, throat, inside of cheeks, and all oral tissue thoroughly. Mixture should be gargled and spit out. Avoid eating or drinking for at least 30 to 60 minutes following treatment. If water is not available, may use undiluted. If unable to rinse and gargle, apply directly to mouth using a sponge or swab. No adverse effects are anticipated is accidently swallowed.
Mucotrol: Wafer should be swished around the mouth and allowed to slowly dissolve. Avoid eating or drinking for at least 1 hour following treatment.
MuGard: Gently pour 5 mL into mouth and rinse entire oral cavity for at least 1 minute (if rinsing is painful, spread throughout mouth by gently rotating head). Ensure all parts of the oral cavity are coated; may use up to 10 mL to coat entire oral cavity if needed. May spit or swallow excess rinse. Avoid eating or drinking for at least 1 hour following treatment.
Orafate: When used for gum inflammation or following oral-related procedures, apply in any of the following ways: Either brushed alone or with toothpaste using a soft bristled brush, tongue depressor, or finger; mix with equal portions of dentifrice (tooth paste, powder, gel) and layer over areas of soft tissue adjacent to teeth cleaned by the dental clinician; dab directly on to affected gum margin (allow to sit 2 minutes, then gargle and spit); layer onto affected oral area (allow to sit 2 minutes, then remove manually or spit); or place in mouth and suck back and forth through spaces between teeth. When used for canker sores (multiple lesions) or sore throat/pharyngitis swish in mouth for 10 seconds, gargle, swish again, then expectorate. Safe if swallowed. Avoid eating or drinking for at least 1 hour following use.
ProThelial: Scoop paste from jar and place in mouth for 30 seconds. Use tongue or cotton-tipped swab to apply paste throughout oral mucosa. Can be swished and then expectorated or swallowed. May be mixed (1:1) with yogurt, pudding, apple sauce, tapioca, or ice cream to improve taste. Avoid eating or drinking for at least 1 hour following use.
Silatrix: May apply directly to mucosal wound; avoid contact with eyes.
Oral:
Orafate: Apply directly to area of inflammation, soreness, wound, or ulceration; may apply using a soft bristled brush, tongue depressor, or finger. After application, swish any residual paste in mouth for 15 seconds, gargle, and then expectorate. Safe if swallowed. Do not rinse, eat, or drink for at least 1 hour following use.
Brushing onto oral surface: Use back and forth movement.
Brushing onto gums: Brush both outer and inner surfaces using side to side movements alternating with up and down movements.
See product labeling for additional details.
Mucosal protection: Management of oral mucosal pain and protection from further irritation caused by oral mucositis/stomatitis (resulting from chemotherapy or radiation therapy); irritation; lesions, periodontal and gingival inflammation, tooth extractions, and wounds/lesions due to oral surgery; chafing; minor lesions; traumatic ulcers, and abrasions caused by braces/ill-fitting dentures or disease; diffuse aphthous ulcers (canker sores); sore throat/pharyngitis (Orafate only)
None known.
There are no known significant interactions.
Monitor mucositis/stomatitis symptoms/severity
Adheres to the mucosal surface of mouth forming a protective film or coating over the irritated areas and lesions, protecting the lesion from further irritation and pain.
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