Product Description.:
Suspension , white , caramel-orange-raspberry
(amoxicillin/clavulanate potassium) Tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin/clavulanate potassium is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S?3H2O, and the molecular weight is 419.46.
Inactive Ingredients: Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.
Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium.
INDICATIONS
Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower Respiratory Tract Infections - caused by β-lactamase - producing strains of H. influenzae and M. (Branhamella) catarrhalis.
Otitis Media - caused by β-lactamase - producing strains of H. influenzae and M. catarrhalis.
Sinusitis - caused by β-lactamase - producing strains of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by β-lactamase - producing strains of S. aureus, E. coli and Klebsiella spp.
Urinary Tract Infections - caused by β-lactamase - producing strains of E. coli, Klebsiella spp., and Enterobacter spp.
While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase?producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium 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.
Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.
DOSAGE AND ADMINISTRATION
Since both the 250-mg and 500-mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin/clavulanate potassium 250-mg tablets are not equivalent to one 500-mg amoxicillin/clavulanate potassium tablet. Therefore two 250-mg amoxicillin/clavulanate potassium tablets should not be substituted for one 500-mg amoxicillin/clavulanate potassium tablet.
