Moxatag References

References:

MOXATAG Prescribing Information. MiddleBrook Pharmaceuticals, Inc. 2008.
Kardas P. Patient compliance with antibiotic treatment for respiratory tract infections. J Antimicrob Chemother. 2002;49(6):897-903.
Sclar DA, Tartaglione TA, Fine MJ. Overview of issues related to medical compliance with implications for the outpatient management of infectious diseases. Infect Agents Dis. 1994;3(5):266-273.
Linder JA, Chan JC, Bates DW. Evaluation and treatment of pharyngitis in primary care practice. Arch Intern Med. 2006;166(13):1374-1379.
Cooper RJ, Hoffman JR, Bartlett JG, et al. Principles of appropriate antibiotic use for acute pharyngitis in adults: background. Ann Intern Med. 2001;134:509-517.
IMS National Prescription Audit, 2008.
IMS Health, National Disease and Therapeutic Index (NDTI), 2008.
Bisno AL, Gerber MA, Gwaltney JM, Kaplan EL, Schwartz RH. Practice guidelines for the diagnosis and management of Group A streptococcal pharyngitis. Clin Infect Dis. 2002;35:113-125.
Acerra JR. Pharyngitis. http://www.emedicine.com/emerg/topic419.htm. Accessed November 18, 2008.
Worrall GJ. Acute sore throat. Can Fam Physician. 2007;53:1961-1962.
Woodbury RL, Klammer KA, Xiong Y, et al. for the Active Bacterial Core Surveillance Team. Plasmid-borne erm(T) from invasive, macrolide-resistant Streptococcus pyogenes strains. Antimicrob Agents Chemother. 2008;52(3):1140-1143.
Farrell DJ, Morrissey I, Bakker S, Felmingham D. Molecular characterization of macrolide resistant mechanisms among Streptococcus pneumoniae and Streptococcus pyogenes isolated from the PROTEKT 1999-2000 study. J Antimicrob Chemother. 2002;50(suppl. 1):39-47.
Zithromax Prescribing Information, Pfizer 2007.
Albrich WC, Monnet DL, Harbarth S. Antibiotic selection pressure and resistance in Streptococcus pneumoniae and Streptococcus pyogenes. Emerg Infect Dis. 2004;10(3):514-517.
Wong DM, Blumberg DA, Lowe LG. Guidelines for the use of antibiotics in acute upper respiratory tract infections. Am Fam Physician. 2006;74(6):956-966.
Rudnic EM, Isbister JD, Treacy Jr DJ, Wassink SE, inventors; MiddleBrook Pharmaceuticals, Inc., assignee. Antibiotic product, use and formulation thereof. U.S. Patents 6,544,555; 6,669,948; 6,723,341.
Data on file, MiddleBrook Pharmaceuticals, Inc.
Greenberg RN. Overview of patient compliance with medication dosing: a literature review. Clin Ther. 1984;6(5):592-599.
NOP World Health Market Research, March 26, 2004.
Green JL, Ray SP, Charney E. Recurrence rate of streptococcal pharyngitis related to oral penicillin. J Pediatr. 1969;75(2):292-294.
Kardas P, Devine S, Golembesky A, Roberts C. A systematic review and meta-analysis of misuse of antibiotic therapies in the community. Int J Antimicrob Agents. 2005;26(2):106-113.
World Health Organization. Antimicrobial resistance. http://www.who.int/mediacentre/factsheets/fs194/en/index.html. Accessed July 14, 2008.
Abdul-Baqi KJ, Shakhatreh FM. Effectiveness of treatment of tonsillopharyngitis: comparative study. J of Laryngol Otol. 2002;116(11):917-919.
Archer GL, Polk RE. Treatment and prophylaxis of bacterial infections. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison’s Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill Medical; 2008:851-864.U.S.
Food and Drug Administration. Electronic Orange Book www.accessdata.fda.gov/scripts/
cder/ob/docs/obdetail.cfm ? Appl_No=050813&TABLE1=OB_Rx Accessed December 12, 2008.

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

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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.