Moxatag

Generic Name: amoxicillin
Date of Approval: January 23, 2008
Company: MiddleBrook Pharmaceuticals, Inc.

Treatment for: Pharyngitis/Tonsillitis

FDA Approves Moxatag

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The U.S. Food and Drug Administration has approved once-daily Moxatag Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily Moxatag for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. Moxatag was very well tolerated in the clinical trial.

Moxatag is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older.

Moxatag is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

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 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. 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, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

In a controlled U.S. clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature. The most frequently reported adverse reactions (> 1%) which were suspected or probably drug- related were vaginal yeast infection (2.0%), diarrhea (1.7%), nausea (1.3%), and headache (1.0%).

Safety and effectiveness of Moxatag in pediatric patients less than 12 years of age has not been established.

About Moxatag

Moxatag (amoxicillin extended-release tablets) is a once-a-day extended- release formulation of amoxicillin for oral administration consisting of three components: one immediate-release and two delayed-release. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin.

Moxatag is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. MiddleBrook utilized its proprietary PULSYS once-daily pulsatile delivery technology to develop Moxatag.

Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). Group A streptococcus, the primary bacteria causing pharyngitis, have been uniformly susceptible to amoxicillin and have not developed resistance to the penicillins, despite the long-term use of amoxicillin for pharyngitis.

About Pharyngitis/Tonsillitis

Pharyngitis is a painful inflammation of the throat caused by a variety of microorganisms, both viral and bacterial. About 15 million patients annually seek relief of sore throat symptoms in the United States. The most common bacterial cause of acute pharyngitis is Streptococcus pyogenes, or Group A streptococcus, which is referred to as "strep throat." Symptoms of strep throat include fever, painful swallowing, swelling of the throat, and headache. Symptomatic strep throat can lead to complications, such as rheumatic fever, and should be treated with antibiotic therapy. Pharyngitis ranks in the top ten diagnoses made by pediatricians, family physicians, and emergency medicine specialists.

Source: MiddleBrook Pharmaceuticals, Inc.

Highlights of Moxatag Prescribing Information

These highlights do not include all the information needed to use Moxatag safely and effectively. See full prescribing information for Moxatag.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxatag and other antibacterial drugs, Moxatag should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Moxatag Indications and Usage
Moxatag is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older.

Moxatag Dosage and Administration
Moxatag is indicated for tonsillitis and/or pharyngitis: 775 mg once daily for 10 days with a meal. Do not chew or crush Moxatag tablet.

Dosage Forms and Strengths
Tablets: 775 mg

Moxatag Contraindications
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

Warnings and Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate Moxatag treatment if diarrhea occurs.

Adverse Reactions
The most common drug-related adverse reactions (incidence >1.0 %) are vulvovaginal mycotic infection, diarrhea, nausea, vomiting and headache.

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.

Drug Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Use in Specific Populations

Pediatrics: The safety and effectiveness of Moxatag in pediatric patients younger than 12 years has not been established.
Renal Impairment: Moxatag has not been studied in patients with renal impairment; however, a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, Moxatag is not recommended for use in patients with severe renal impairment (CrCl < 30 mL/min) or patients on hemodialysis.

Patient Counseling Information

Patients should be informed that the recommended dose of Moxatag is 775 mg once daily taken with food for 10 days.
Moxatag should be taken within 1 hour of finishing a meal and at approximately the same time every day.
The full 10 day course of Moxatag therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes.
Patients should be instructed not to chew or crush the tablet.
No other forms of immediate-release amoxicillin can be substituted for Moxatag.

Hypersensitivity Reactions

Patients should be informed that serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported while on penicillin therapy. Patients should be questioned regarding any hypersensitivity reactions to penicillins, cephalosporins or other allergens. Whenever such reactions occur, the patient should be instructed to contact their physician immediately. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Clostridium difficile Associated Diarrhea

Patients should be informed that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

For more information, please see Moxatag Product Label (PDF).