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.
Each plastic bottle contains 8 fluid ounces of oral mucoadhesive.
MuGard 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.
DOSAGE AND ADMINISTRATION
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 mucositis/stomatitis, it 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.
Store this product at room temperature out of direct sunlight.
Federal law restricts this device to sale by or on the order of a physician or properly licensed medical practitioner.
Distributed by: AMAG Pharmaceuticals, Inc., 1100 Winter Street, Waltham, MA 02451. Revised: December 2014
Included as part of the PRECAUTIONS section.
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.
There have been no adequate and well controlled studies of the use of MuGard in pregnant animals or in pregnant women.
There have been no adequate and wellcontrolled studies of the use of MuGard in pediatrics.
Safety and effectiveness of MuGard in geriatric patients have not been established.
Good oral hygiene, especially as recommended by a physician, should be used in addition to the use of MuGard.
Mode of Operation: MuGard is formulated to adhere to the mucosal surface of the mouth and thereby forms a soothing, protective layer.
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.
No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.
Report Problems to the Food and Drug Administration
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.