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bioadherent oral (Rx)Brand and Other Names:Gelclair

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

concentrated oral gel

  • 15mL/packet
more...

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

Dosage Forms & Strengths

concentrated oral gel

  • 15mL/packet
more...

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

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Adverse Effects

Postmarketing Reports

Burning sensation in mouth

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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

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Pregnancy & 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.

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Pharmacology

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

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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