What is Tonsillitis and Pharyngitis?

Pharyngitis is one of the most common respiratory tract infections and accounts for approximately
11 million visits to ambulatory practices and emergency departments annually.^4,5 Overall, approximately 21 million adult and pediatric prescriptions were written for pharyngitis and tonsillitis in the United States in 2008.^6,7 Pharyngitis usually involves inflammation of the central region of the pharynx, known as the oropharynx.⁸ Because the tonsils are attached to the oropharynx, pharyngitis commonly involves tonsillitis.⁹

Causative pathogen

The most common bacterial cause of pharyngitis is Group A Streptococcus pyogenes (S. pyogenes), also called Group A beta-hemolytic strep (GABHS).¹⁰These bacteria are responsible for approximately 33% of pharyngitis cases in children (ages 5 to 15) and 5% to 15% of those in adults.^5,10 This form of pharyngitis is also known as streptococcal pharyngitis, GABHS pharyngitis, or “strep throat.”^8,9
S. pyogenes remains uniformly sensitive to penicillin and amoxicillin, with no resistant strains reported.⁸However, mechanisms of macrolide resistance for S. pyogenes are well documented as resistant strains have been reported.^11-14 Amoxicillin remains appropriate treatment for streptococcal pharyngitis and MOXATAG is approved as first-line therapy for this indication.¹

Clinical presentation and symptoms

Symptoms of tonsillitis and/or pharyngitis include¹⁵:

Severe throat pain
Throat redness and exudates
Headache
Fever
Nausea and vomiting
Abdominal pain
Swelling of lymph nodes in the neck
Thick white exudates

Diagnosis

Because pharyngitis is contagious and can have serious complications, proper diagnosis and treatment of this infection is important.⁸Precise diagnosis regarding the type of infection and the likely causative pathogen is essential to identifying the best treatment.⁹ Many tests are available to identify bacterial pathogens and their characteristics, such as a complete blood count, laboratory culture, biochemical identification, and serologic tests, as well as medical imaging.⁹ However, there can be a delay in obtaining the results of these tests, and other rapid diagnostic tests can be performed in the physician’s office at the patient’s primary visit.⁸

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

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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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.