Moxatag FAQs | FDA Approval & Clinical Trial Info

Frequently Asked Questions

Q: When was MOXATAG approved?
A: MOXATAG received FDA approval on January 23, 2008.²⁵

Q: What were the results of the MOXATAG pivotal clinical trial?
A: In the largest known multicenter tonsillitis and pharyngitis trial with amoxicillin ever conducted in North America, MOXATAG 775 mg once daily for 10 days was effective demonstrating noninferiority, or comparable efficacy, to penicillin VK 250 mg 4x/day for 10 days. This prospective, double-blind, multicenter, randomized trial enrolled adult and pediatric patients 12 years of age and older.¹

MOXATAG achieved bacterial eradication rates of 85.0% versus 83.4% with penicillin VK at the test-of-cure visit (Day 14 to 18, or 4 to 8 days post-therapy) for the per-protocol bacteriological population (randomized, with a positive culture at baseline compliant with the protocol).¹ These results were consistent in the modified intent-to-treat population (randomized and positive culture for Streptococcus pyogenes [S. pyogenes] at baseline) with bacterial eradication rates of 79.7% with MOXATAG and 78.0% with penicillin VK.¹ MOXATAG achieved a clinical cure rate of 91.8% at a test-of-cure visit "Day 14 through 18, or 4 to 8 days post-therapy). This cure rate was comparable to penicillin VK dosed 4x/day (93.5%).¹⁷
Q: What is the recommended dose for MOXATAG?
A: The recommended dose of MOXATAG is 775 mg once daily taken within one 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 the tablet.¹

Q: How can MOXATAG achieve efficacy with one daily dose of 775 mg for 10 days?
A: Once-daily dosing with MOXATAG refines traditional treatment with amoxicillin, a drug that
has been trusted and relied on for decades.⁷ This once-daily amoxicillin dosing of MOXATAG is made possible by innovative drug delivery achieved through proprietary technology. MOXATAG consists of 3 active amoxicillin components: one immediate-release component and 2 delayed-release components.^1,16

The immediate-release component releases a portion of amoxicillin first in the stomach. Then, the 2 delayed-release components release additional amoxicillin at different time points, triggered by pH levels, at specific regions in the gastrointestinal (GI) tract.¹⁶ These components are combined in a ratio that prolongs the release and absorption of amoxicillin from a single MOXATAG Tablet.^1,16 The extended release of amoxicillin increases the time from a single dose that the drug exceeds the minimum inhibitory concentration (MIC) for S. pyogenes.¹⁶ The prolonged release and absorption of amoxicillin achieved with MOXATAG is important because efficacy is dependent on the amount of time the drug concentration remains above MIC of the target pathogen.^1,16 Extending time above MIC results in effective therapy with 775 mg 1x/day for 10 days.¹ Efficacy of MOXATAG 775 mg 1x/day for 10 days was comparable to penicillin VK 250 mg 4x/day for 10 days in a large clinical trial.¹
Q: What are the benefits of using MOXATAG?
A: Switching to a once-daily amoxicillin dosing schedule with MOXATAG can lead to improved convenience and potentially better patient compliance.^2,3 Antibiotics not taken properly is the #1 reason that patients fail antibiotic therapy, as demonstrated by the 175% greater rate of relapse observed in non-compliant patients.^2,3,19,20 Alternatively, once-daily antibiotic regimens have been shown to provide compliance rates approaching 100%.² Improvement in patient compliance helps to ensure that bacteria are completely eradicated, helping to reduce the risk of treatment failure, worsening health, and additional costs for physician visits and medicines.^2,3,20,21

Q: What is the composition of MOXATAG?
A: MOXATAG consists of 3 active amoxicillin components: one immediate-release component and 2 delayed-release components.^1,16 The immediate-release component releases a portion of the total amoxicillin dose in the stomach to generate Pulse 1.¹⁶ Pulses 2 and 3 are created by 2 delayed-release components that release amoxicillin at different times as the tablet moves through the GI tract, triggered by pH levels at specific regions.¹⁶These 3 components are combined in a specific ratio to prolong the release of amoxicillin from MOXATAG as compared with currently available immediate-release amoxicillin.

Q: Does MOXATAG have any AB-rated alternatives?
A: No, MOXATAG does not have any AB-rated, or therapeutic equivalent, alternatives.²⁵

Q: How can I get clinical information on MOXATAG?
A: Please contact MiddleBrook Customer Service at 1-877-MYMOXATAG.

Q: What adverse events have been associated with MOXATAG?
A: MOXATAG was well tolerated in a large controlled clinical trial, where 302 adult and pediatric patients 12 years and older were treated with MOXATAG 775 mg 1x/day for 10 days. The majority of adverse events were mild and transient in nature. MOXATAG demonstrated a low incidence of drug-related adverse events such as vulvovaginal mycotic infection (2.0%), diarrhea (1.7%), nausea (1.3%), vomiting (0.7%), abdominal pain (0.3%) and headache (1.0%).¹

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.

Q: Are there any drug interactions with MOXATAG?
A: Taking probenecid together with MOXATAG may raise the amount of amoxicillin that is in the blood and the amount of time that the amoxicillin stays in your blood. The medical relevance of this has not been studied.¹
Taking antibiotics like MOXATAG may reduce the effectiveness of oral contraceptives.¹

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of an aminopenicillin-class antibiotic. The clinical significance of this interaction is not well documented.¹
For more information on adverse drug interactions, please see Physician Prescribing Information.

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.