ns of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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, 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 eva luation should be instituted as clinically indicated.
5.3 Superinfections
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.
5.4 Mononucleosis Rash
A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
5.5 Development of Drug-Resistant Bacteria
Prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
5.6 False-Positive Urinary Glucose Tests
High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest®, Benedict's Solution or Fehling's Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.
6. ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
6.1 Clinical Study Experience
Tonsillitis and/or Pharyngitis
In a controlled Phase 3 trial, 302 adult and pediatric patients (≥ 12 years) were treated with MOXATAG 775 mg once-daily for 10 days and 306 adult and pediatric patients (≥ 12 years) were treated with penicillin VK 250 mg QID for 10 days.
In this clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature with similar frequency reported in both treatment groups. Discontinuation due to drug-related treatment-emergent adverse reactions occurred in 1.3 % of the MOXATAG-treated patients and 3.3 % of the penicillin VK-treated patients.
The most frequently reported adverse reactions (≥ 1%) which were suspected or probably drug-related are shown in TABLE 1.
Table 1. Drug-Related Treatment-Emergent Adverse Reactions by System Organ Class Experienced by ≥1% of Patients in Either Treatment Group – ITT/Safety Population
*Presented in decreasing order of frequency in the MOXATAG column within each system organ class.
Number (%) of patients
System Organ Class/Preferred Term* MOXATAG
(N =302) Pen VK
(N = 306 )
Patients with at least one drug-related treatment-emergent adverse event 32 (10.6) 45 (14.7)
Infections and infestations
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