Moxatag Information For Healthcare Professionals

Amoxicillin Therapy Refined

MOXATAG™ delivers efficacy with the convenience of once-daily dosing¹

MOXATAG is the first and only once-daily penicillin-class antibiotic approved by the Food and Drug Administration (FDA) for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.¹ Its patented, extended-release tablets efficiently deliver amoxicillin using a once-daily dose of 775 mg for 10 days.¹ MOXATAG also has a well-tolerated safety profile with observed minimal gastrointestinal (GI) upset.¹ By offering patients convenient, once-daily dosing, MOXATAG can potentially lead to improved patient compliance.^2,3.

Brought to you by MiddleBrook Pharmaceuticals, a specialty pharmaceutical company using proprietary technology to bring novel anti-infective products to market.

Learn more about MOXATAG.
About Moxatag
What Is Tonsillitis and Pharyngitis?
How MOXATAG Works
775 Total Daily Dose
Proven Efficacy
Safety Profile
Antibiotic Compliance

How MOXATAG Works

MOXATAG ™ (amoxicillin extended-release) Tablets is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.
MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacterial.
The full 10-day course of therapy should be completed for effective treatment.
Patients taking MOXATAG should not chew or crush tablet.

IMPORTANT SAFETY INFORMATION

MOXATAG is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta lactams. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. If an allergic reaction occurs, MOXATAG should be discontinued and appropriate therapy instituted.
Clostridium Difficile Associated Diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, MOXATAG should be discontinued and appropriate therapy instituted.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, MOXATAG should be discontinued and appropriate therapy instituted.
The most common drug-related adverse reactions associated with MOXATAG observed in clinical studies are vulvovaginal mycotic infection (2.0%), diarrhea (1.7%), nausea (1.3%), vomiting (0.7%), abdominal pain (0.3%) and headache (1.0%). Please see the accompanying full Prescribing Information for additional adverse reactions for other amoxicillin products.

Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with MOXATAG, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, MOXATAG should be discontinued and the patient should contact his or her physician immediately.

Clostridium difficile Associated Diarrhea (CDAD): CDAD has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed the patient should contact his or her physician immediately and ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Taking probenecid together with MOXATAG may raise the amount of amoxicillin that is in your blood and the amount of time that the amoxicillin stays in your blood. The medical relevance of this has not been studied.

Taking antibiotics like MOXATAG may reduce the effectiveness of oral contraceptives.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of a penicillin-class antibiotic. The clinical significance of this interaction is not well documented.

Use in Specific Populations

MOXATAG has not been studied in patients with renal impairment; however, MOXATAG is not recommended for use in patients with severe renal impairment or patients on hemodialysis.

The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established.

To report suspected adverse reactions, contact MiddleBrook Pharmaceuticals, Inc. at 1-877-363-8080 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

MiddleBrook, MiddleBrook (stylized), MOXATAG, MOXATAG1 (stylized), M1 (stylized), MOX-10, MOXATEN, MOX-PAK, MOXPAK, and MOXAKIT are trademarks of MiddleBrook Pharmaceuticals, Inc.

U.S. Patents 6,544,555; 6,669,948; 6,723,341

This site is published by MiddleBrook Pharmaceuticals, Inc., which is solely responsible for its contents. It is intended soley for residents of the United States.

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Please read the Physician Prescribing Information before using MOXATAG.
MOXATAG is manufactured in Clonmel, Ireland.
Manufactured for MiddleBrook Pharmaceuticals, Inc.
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NOTICE

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The following information is intended for use only by residents of the United States. Countries outside of the United States may have regulatory requirements or medical practices that are different than those in the United States and may require reference to different or additional information. Therefore, this information may not be appropriate outside of the United States.

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