14. CLINICAL STUDIES
15. REFERENCES
16. HOW SUPPLIED/STORAGE AND HANDLING
Storage
17. PATIENT COUNSELING INFORMATION
17.1 Instructions for Administration of MOXATAG
17.2 Hypersensitivity Reactions
17.3 Clostridium difficile Associated Diarrhea
* Sections or subsections omitted from the full prescribing information are not listed.
1. INDICATIONS AND USAGE
Tonsillitis and/or Pharyngitis
MOXATAG 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 yrs 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
2. DOSAGE AND ADMINISTRATION
Tonsillitis and/or Pharyngitis
The recommended dose of MOXATAG is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes.
Do not chew or crush tablet.
3. DOSAGE FORMS AND STRENGTHS
775 mg blue film-coated, oval-shaped tablets printed with ”MB-111” on one side in black edible ink.
4. CONTRAINDICATIONS
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.
5. WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis and Hypersensitivity Reactions
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. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. 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.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
5.2 Clostridium difficile Associated Diarrhea (CDAD)
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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strai |
