Vulvovaginal mycotic infection 6 (2.0) 8 (2.6)
Gastrointestinal disorders
Diarrhea 5 (1.7) 6 (2.0)
Nausea 4 (1.3) 2 (0.7)
Vomiting 2 (0.7) 5 (1.6)
Abdominal pain 1 (0.3) 3 (1.0)
Nervous system disorders
Headache 3 (1.0) 3 (1.0)
6.2 Adverse Reactions for Other Amoxicillin Products
The following adverse reactions have been reported for other products containing amoxicillin:
Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Nausea, vomiting, diarrhea, and hemorrhagic/ pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions: Anaphylaxis (See WARNINGS AND PRECAUTIONS)
Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported. (NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.)
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.
Renal: Crystalluria has also been reported
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
7. DRUG INTERACTIONS
7.1 Probenecid
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of MOXATAG and probenecid may result in increased and prolonged blood levels of amoxicillin. The clinical relevance of this finding has not been eva luated.
7.2 Other Antibiotics
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
7.3 Oral Contraceptives
As with other antibiotics, amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and potentially resulting in reduced efficacy of combined oral estrogen/progesterone contraceptives.
8. USE IN SPECIFIC POPULATIO |
