Manufacturer:

MiddleBrook Pharmaceuticals

Pharmacological Class:

Antibiotic (broad-spectrum penicillin)

Active Ingredient(s):

Amoxicillin (as trihydrate) 775mg; ext-rel tabs.

Indication(s):

Treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older.

Pharmacology:

Moxatag is a once-daily formulation of amoxicillin with a unique dosage strength that is indicated for treating pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes. This extended-release tablet consists of three components: one is immediate-release and two are delayed-release. The rate of absorption of amoxicillin from this product is slower than that of immediate-release amoxicillin suspension, but total exposure of the drug from Moxatag is similar to that of a comparable dose of amoxicillin immediate-release oral suspension.

Amoxicillin is a semi-synthetic antimicrobial belonging to the penicillin class with activity against gram (+) bacteria. Like other penicillins, amoxicillin exerts its antibacterial effect by interfering with the production of cell wall mucopeptides in multiplying bacteria.

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

Clinical Trials:

A randomized, parallel-group, double-blind study was conducted in patients 12 years of age and older who had been diagnosed with pharyngitis and/or tonsillitis secondary to S. pyogenes. Moxatag 775mg once daily for 10 days was shown to be as effective as penicillin VK 250mg four times daily for 10 days. In an intent-to-treat analysis, those patients who were found to have had a positive throat culture for S. pyogenes at baseline and were treated with Moxatag had a 79.7% bacteriological eradication rate, compared to 78.0% for those treated with penicillin VK. For those patients who had post-therapy cultures, were compliant with treatment, and who had no major protocol variations, Moxatag therapy was associated with an 85% bacteriological eradication rate, compared to 83.4% for penicillin VK.

Legal Classification:

Rx

Adults:

Take with food. Swallow whole. 775mg once daily for 10 days.

Children:

Not recommended.

Warnings/Precautions:

Have epinephrine available. Cephalosporin, imipenem, other allergy or mononucleosis: not recommended. Severe renal impairment (CrCl <30mL/min); hemodialysis: not recommended. If serious diarrhea occurs, discontinue therapy. Pregnancy (Cat.B). Labor & delivery. Nursing mothers.

Interaction(s):

Potentiated by probenecid. May cause false (+) glucose with Clinitest, Benedict's, or Fehling's soln. May reduce efficacy of oral contraceptives. May be antagonized by bacteriostatic antibiotics (eg, tetracyclines, sulfonamides, macrolides).

Adverse Reaction(s):

GI upset, headache; hypersensitivity reactions (eg, rash, Stevens Johnson syndrome, anaphylaxis, urticaria), superinfection, hyperactivity, blood dyscrasias, pseudomembranous colitis.

Notes:

Report suspected adverse events to MiddleBrook at (877) 363-8080 or FDA at (800) FDA-1088.

How Supplied:

Tabs—30

Last Updated:

6/23/2009