MuGard

What is MuGard and how is it used?

MuGard is a prescription medicine used to treat the symptoms of Oral Sores or Irritation. MuGard may be used alone or with other medications.

MuGard belongs to a class of drugs called Oral Rinses.

It is not known if MuGard is safe and effective in children.

What are the possible 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.

The most common side effects of MuGard include:

• none

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of MuGard. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

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.

INDICATIONS

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.

HOW SUPPLIED

Storage

Store this product at room temperature out of direct sunlight.

Caution

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

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

Interactions With Other Medicinal Products

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

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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.

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.

Oral Care

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

OVERDOSE

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

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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

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