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Moxatag 775 mg Tablets 1X30 Mfg. By Shionogi Pharma Inc

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Moxatag 775 mg Tablets 1X30 Mfg. By Shionogi Pharma Inc

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Moxatag 775 mg Tablets 1X30 Mfg. By Shionogi Pharma Inc This Item Requires A Valid Order From A Physician Licensed in The USA. Item No.: Item No.:RXD4143467/RXB10118982. NDC: 59630-0142-03
UPC Barcode :
Supplier: 0050001719 SHIONOGI PHARMA, INC.
Supplier Material : 014203
Generic Code : 063606 AMOXICILLIN ORAL TBMP 24HR 775 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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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.

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