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MuGard (Oral Mucoadhesive): Side Effects, Uses, Dosage, Interactions, Warnings

MuGard

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/5/2023

Drug Summary

What Is MuGard?

MuGard Oral Mucoadhesive is 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, such as those caused by oral surgery or ill-fitting dentures or braces.

What Are Side Effects of MuGard?

MuGard may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • rash,
  • itching,
  • red, swollen, blistered, or peeling skin with or without fever,
  • wheezing,
  • tightness in the chest or throat,
  • trouble swallowing or talking, and
  • unusual hoarseness

Get medical help right away, if you have any of the symptoms listed above.

MuGard is unlikely to cause side effects. Tell your doctor if you experience any side effects from use of MuGard. Chemotherapy and radiation therapy can cause uncomfortable side effects, including oral mucositis. When taken during cancer treatment, MuGard can significantly lessen chemotherapy side effects of mouth and throat soreness.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for MuGard

Gently pour a 5 mL dose of MuGard into the mouth and rinse the entire oral cavity for a minute or longer if possible. Avoid eating or drinking for at least one hour after rinsing with MuGard.

What Drugs, Substances, or Supplements Interact with MuGard?

There are no known drug interactions with MuGard. Tell your doctor all medications and supplements you use.

MuGard During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant before using MuGard. Consult your doctor before breastfeeding.

Additional Information

Our MuGard Oral Mucoadhesive Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication

Description for MuGard

MuGard® Oral Mucoadhesive is a mucoadhesive product. When swirled gently around the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa. The device is supplied in plastic bottles and is designed for the management of oral wounds such as mucositis, stomatitis, aphthous ulcers and traumatic ulcers.

Ingredients

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

Contents

Each plastic bottle contains 8 fluid ounces of oral mucoadhesive.

Uses for MuGard

MuGard is indicated for the management of oral mucositis/stomatilis (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, such as those caused by oral surgery or ill-fitting dentures or braces

Dosage for MuGard

Directions for Use

Gently pour 5 ml of MuGard 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, MuGard 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.

For the management of oral mucosilis/stomatitis, ii is recommended that MuGard is used 4-6 times a day. It is recommended that patients purchase MuGard prior to the commencement of cancer therapy.

For other ulcerative conditions of the oral cavity, MuGard should be used 4-6 times a day or as needed.

HOW SUPPLIED

Dosage Forms And Strengths

Each plastic bottle contains 8 fluid ounces of oral mucoadhesive.

Storage And Handling

Store this product at room temperature out of direct sunlight.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: Soleva Pharma LLC Robbinsville NJ 08691. Revised: May 2020.

Side Effects for MuGard

No information provided.

Drug Interactions for MuGard

Interactions with other Medicinal Products

There are no known adverse interactions of this product with other medicinal products.

Warnings for MuGard

Included as part of the "PRECAUTIONS" Section

Precautions for MuGard

Special Precautions for Use

Avoid eating or drinking for at least one hour after rinsing with MuGard. 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.

Oral Care

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

Pregnancy

There have been no adequate and well controlled studies of the use of MuGard in pregnant animals or in pregnant women.

Pediatric Use

There have been no adequate and wellcontrolled studies of the use of MuGard in pediatrics.

Geriatric Use

Safety and effectiveness of MuGard in geriatric patients have not been established.

Caution: Federal law restricts this device to sale by or on the order of a physician or properly licensed medical practitioner.

Overdose Information for MuGard

No cases of overdose have been reported at the time of producing this leaflet.

Contraindications for MuGard

MuGard is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation.

Clinical Pharmacology for MuGard

Mode of Operation

MuGard is formulated to adhere to the mucosal surface of the mouth and thereby forms a soothing, protective layer.

Clinical Studies

A clinical study of MuGard was conducted in patients undergoing radiation therapy for treatment of head and neck cancer. Some patients in the study were also being treated with chemotherapy. The patients in the study used MuGard throughout the course of radiation therapy.

Patient Information for MuGard

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.