Sore Throat Treatment, Pharyngitis Treatment, Strep Throat Treatment, Tonsillitis Treatment

What causes pharyngitis?

Pharyngitis is one of the most common respiratory tract infections and results in approximately 11 million visits to ambulatory practices and emergency departments each year.^4,5 Pharyngitis usually involves inflammation of the central region of the throat.⁸ Because the tonsils are attached to this region, pharyngitis commonly involves tonsillitis.⁹
While most cases of pharyngitis are caused by viruses, up to 40% of cases are caused by bacteria called Group A Streptococcus pyogenes (S. pyogenes).^8,9 It is important for your doctor to make sure that your pharyngitis is actually caused by bacteria before he or she prescribes MOXATAG™. If your infection is caused by a virus, antibiotics are not the right treatment for you.

There are many tests your doctor can perform to determine whether or not your pharyngitis is caused by a bacterial infection. Some tests involve blood work, but many are fast and can be done right in your primary doctor’s office.⁸ Ask your doctor for more information.

What is strep throat?

Pharyngitis that is caused by the bacteria S. pyogenes is also known as “strep throat.”^8,9 Strep throat is more common in children than in adults, especially in school-aged children.⁹ Some symptoms of strep throat include¹⁵:
• Severe throat pain
• Throat redness
• Headache
• Fever
• Nausea and vomiting
• Abdominal pain

Why was I given MOXATAG?

MOXATAG works to eradicate S. pyogenes, the bacteria that causes strep throat.¹MOXATAG contains an antibiotic called amoxicillin, a penicillin-class antibacterial.¹ Amoxicillin is the most commonly prescribed antibiotic for the treatment of strep throat.⁶ Penicillin-class compounds, such as amoxicillin, have become the drugs of choice for fighting against infections caused by this bacteria because they work well and cause few negative side effects.¹⁵MOXATAG 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.¹

Unlike other approved immediate-release amoxicillin regimens that have to be taken multiple times a day, you only need to take MOXATAG once a day.¹ In fact, it has been shown that it takes just one daily dose of MOXATAG 775 mg for 10 days to fight strep throat.¹

How should I take MOXATAG?

• Take MOXATAG exactly as prescribed by your healthcare provider¹
• MOXATAG should be taken by mouth within one hour after eating a meal¹
• Take MOXATAG around the same time every day for 10 days¹
• MOXATAG should not be chewed or crushed¹
• Complete the full 10-day course of therapy for effective treatment with MOXATAG¹
• Do not skip any doses or stop taking MOXATAG until you finish your prescribed treatment, unless¹:
o You have a serious allergic reaction
o Your doctor tells you to stop
• If you miss a dose of MOXATAG, take it as soon as you remember. Do not take more than one
MOXATAG Tablet a day, even if you miss a dose
• If you take too much, call your doctor or get medical help immediately

What are the possible side effects of MOXATAG?

Rare but severe and occasionally fatal allergic reactions have been reported in patients on penicillin.
If an allergic reaction occurs, stop taking MOXATAG immediately and get medical help right away.¹

Diarrhea, or Clostridium difficile Associated Diarrhea (CDAD), is a common problem caused by antibiotics that usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. The diarrhea you experience may range in severity from mild diarrhea to fatal colitis. If this occurs, stop antibiotic treatment and contact your doctor as soon as possible.¹

Skin rash may occur in people taking MOXATAG, even after only one dose. Stop taking MOXATAG at the first sign of a skin rash and call your doctor. Skin rash may be a sign of a more serious reaction to MOXATAG.¹

The possibility of superinfections should be kept in mind during therapy. Call your doctor if you think your condition is not getting better while you are taking MOXATAG.¹

What are the most common side effects of MOXATAG?

Examples of some side effects that you may experience while taking MOXATAG are¹:
• Yeast infection (if you are female)
• Diarrhea
• Nausea
• Vomiting
• Headache
These are not all the possible side effects of MOXATAG. Tell your doctor about any side effect that you experience.

Can I take MOXATAG with other medications?

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.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 penicillin. The clinical significance of this interaction is not well documented.¹

For more information about MOXATAG, talk to your doctor or pharmacist.

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 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

This site is published by MiddleBrook Pharmaceuticals, Inc., which is solely responsible for its contents. It is intended soley for residents of the United States.

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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.

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