Amoxicillin (25 brand names, 11 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, TABLET, CHEWABLE, FOR SUSPENSION, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE, TABLET, FOR SUSPENSION, TABLET, EXTENDED RELEASE, CAPSULE, DELAYED RELEASE, CAPSULE, TABLET, CAPSULE, TABLET, TABLET.
Routes of administration: ORAL.
Brand Names
- AMOXICILLIN
- AMOXICILLIN AND CLAVULANATE POTASSIUM
- AMOXICILLIN PEDIATRIC
- AMOXIL
- AUGMENTIN ‘125’
- AUGMENTIN ‘200’
- AUGMENTIN ‘250’
- AUGMENTIN ‘400’
- AUGMENTIN ‘500’
- AUGMENTIN ‘875’
- AUGMENTIN ES-600
- AUGMENTIN XR
- DISPERMOX
- LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- LAROTID
- MOXATAG
- OMECLAMOX-PAK
- POLYMOX
- PREVPAC (COPACKAGED)
- TALICIA …and 5 more
Indications and Usage
Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections – caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. Acute Bacterial Otitis Media – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. Sinusitis – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections – caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. Urinary Tract Infections – caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Adverse Reactions
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic Dysfunction [see Warnings and Precautions (5.4) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5) ]
Mechanism of Action
Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology (12.4)].
Overdosage
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms1. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.4)].