Clinical Information
Gen. Code and Des.
25898 amoxicillin/potassium clav ORAL SUSP RECON 400-57MG/5
GCN and Des.
67153 amoxicillin/potassium clav ORAL SUSP RECON 400-57MG/5
Strength
400-57MG
Dose Form
SUSPENSION, RECONSTITUTED, ORAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8121608 AMINOPENICILLIN ANTIBIOTICS
Active Ingredients
2707 amoxicillin trihydrate 61336707
2809 potassium clavulanate 61177455
Inactive Ingredients
2468 propylene glycol 57556
2605 aspartame 22839470
AUGMENTIN- amoxicillin and clavulanate potassium tablet, film coated
AUGMENTIN- amoxicillin and clavulanate potassium powder, for suspension
Dr. Reddy?s Laboratories Inc
DESCRIPTION
AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta?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 C16 H19 N3 O5 S?3H2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta?lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8 H8 KNO5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.
INDICATIONS AND USAGE
To reduce the development of drug?resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility info. 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.
AUGMENTIN? is combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections 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.
1.2 Acute Bacterial Otitis Media
caused by beta?lactamase?producing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta?lactamase?producing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta?lactamase?producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta?lactamase?producing isolates of E. coli, Klebsiella species, and Enterobacter species.
DOSAGE AND ADMINISTRATION
AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of meal. To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of meal.
2.1 Adults
The usual adult dose is one 500-mg tablet of AUGMENTIN every 12 hours or one 250-mg tablet of AUGMENTIN every hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours or one 500-mg tablet of AUGMENTIN every hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet. Dosing in Patients Aged 12 weeks onths) and Older
INFECTION
DOSING REGIMEN
Every 12 hours
Every hours
200 mg/5 mL or 400 mg/5 mL oral suspensiona
125 mg/5 mL or 250 mg/5 mL oral suspensiona
Otitis mediab sinusitis, lower respiratory tract infections, and more severe infections
45 mg/kg/day every 12 hours
40 mg/kg/day every hours
Less severe infections
25 mg/kg/day every 12 hours
20 mg/kg/day every hours
