MOXATAG(amoxicillin extended-release) Tablets
SPL UNCLASSIFIED SECTION
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 bacteria. (2)
INDICATIONS AND USAGE
MOXATAG is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older. (1)
DOSAGE AND ADMINISTRATION
Tonsillitis and/or Pharyngitis: 775 mg once daily for 10 days with a meal.
Do not chew or crush tablet. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 775 mg (3)
CONTRAINDICATIONS
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 (4)
WARNINGS AND PRECAUTIONS
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. (5.1)
Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis): eva luate if diarrhea occurs. (5.2)
ADVERSE REACTIONS
The most common drug-related adverse reactions (incidence≥1.0 %) are vulvovaginal mycotic infection, diarrhea, nausea, vomiting and headache. (6.1)
DRUG INTERACTIONS
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. (7.1)
USE IN SPECIFIC POPULATIONS
Pediatrics: The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established. (8.4)
Renal Impairment: MOXATAG has not been studied in patients with renal impairment; however, a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, MOXATAG is not recommended for use in patients with severe renal impairment (CrCl < 30 mL/min) or patients on hemodialysis. (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis and Hypersensitivity Reactions
5.2 Clostridium difficile Associated Diarrhea (CDAD)
5.3 Superinfections
5.4 Mononucleosis Rash
5.5 Development of Drug-Resistant Bacteria
5.6 False-Positive Urinary Glucose Tests
6. ADVERSE REACTIONS
6.1 Clinical Study Experience
6.2 Adverse Reactions for Other Amoxicillin Products
7. DRUG INTERACTIONS
7.1 Probenecid
7.2 Other Antibiotics
7.3 Oral Contraceptives
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility