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The first and only once-daily amoxicillin1, 2

Moxatag  1 Tablet Once-Daily 10 Days1

INDICATION:

MOXATAG (amoxicillin extended-release) Tablets is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.

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.

IMPORTANT SAFETY INFORMATION:

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. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens, so careful inquiry about a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens should be made. 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) has been reported with nearly all antibacterial agents, including amoxicillin. Evaluate if diarrhea occurs.

  The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

  Mononucleosis rash: Ampicillin-class antibiotics should not be administered to patients with mononucleosis because a high percentage develops a rash.

  Risk of development of drug-resistant bacteria is increased by prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically and is unlikely to provide benefit to the patient.

  False-positive urinary glucose tests may occur with amoxicillin. Glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) are recommended.

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 Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.com 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.

  Reduced efficacy of combined oral estrogen/progesterone contraceptives may result from use of amoxicillin or other antibiotics.

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.

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References: 1. Moxatag [package insert]. 2016. 2. Data on file, Vernalis Therapeutics 3. National Institute of Allergy and Infectious Diseases. Strep throat. http://www.niad.nih.gov/topics/strepthroat/pages/default.aspx. Accessed July 1, 2014.

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