oral mucoadhesive (Rx)

Brand and Other Names:MuGard
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral rinse

  • 8 oz bottle with dose cup

Contents

  • Purified water, glycerin, benzyl alcohol, sodium saccharin, Carbomer Homopolymer A, potassium hydroxide, citric acid, polysorbate 60, and phosphoric acid

Oral Sores or Irritation

Indicated for the management of oral mucositis/stomatitis that may be caused by radiotherapy and/or chemotherapy and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers (eg, caused by oral surgery, ill-fitting dentures, or braces)

5 mL in mouth and rinse entire oral cavity for a minute or longer

If needed, up to 10 mL may be used to fully coat the inside of the mouth

After rinsing, excess rinse may be expelled or swallowed

Oral mucositis/stomatitis: Use 4-6 times/day

Other ulcerative oral cavity conditions: Use 4-6 times/day or prn

Also see Administration

Safety and efficacy not established

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Adverse Effects

None reported

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Warnings

Contraindications

Known hypersensitivity to any of the ingredients (see Dosage Forms and Strengths)

Cautions

Good oral hygiene, especially as recommended by a physician, should be used in addition to the use of oral mucoadhesives

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Not systemically absorbed; not distributed into 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

Formulated to adhere to the mucosal surface of the mouth and thereby forms a soothing, protective layer

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Administration

Directions for Use

Gently pour 5 mL of rinse into the mouth and rinse the entire oral cavity for a minute or longer if possible

If the action of rinsing is inconvenient or too painful, can be spread throughout the mouth by a gentle rotating action of the head

Ensure that all parts of the oral cavity have been coated with the rinse

If necessary, up to 10 mL may be used to fully coat the inside of the mouth

After rinsing, excess rinse may be expelled or swallowed

Oral mucositis/stomatitis: Use 4-6 times/day; purchase rinse prior to the commencement of cancer therapy

Other ulcerative conditions of the oral cavity: Use 4-6 times/day or prn

Use in addition to good oral care

Special precautions

  • Avoid eating or drinking for at least 1 hr after rinsing
  • After use, replace the bottle cap and tightly seal the bottle
  • Do not use this product after the expiration date shown on the product label
  • Do not use this product in patients with a known sensitivity to any of product’s ingredients
  • Dilution of the product prior to use is not recommended

Storage

Store at room temperature out of direct sunlight

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.