Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN - UNII:804826J2HU), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Physicians Total Care, Inc.
AMOXICILLIN
AMOXICILLIN 400 mg
ORAL
PRESCRIPTION DRUG
Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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. 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 and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate
Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable): Amoxicillin and clavulanate potassium tablets (chewable) 400 mg/57 mg contain 400 mg of amoxicillin as the trihydrate and 57 mg of clavulanic acid as clavulanate potassium. Each tablet is a pink colored, circular, biconvex, mottled tablet, debossed with ‘RX754’ on one side and plain on the other side. NDC 54868-0286-0 Bottles of 20 Store dry powder and tablets at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets(chewable) 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 C H N O S•3H 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 and may be represented structurally as: Clavulanic acid is produced by the fermentation of _Streptomyces clavuligerus_. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C H KNO , 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 and may be Läs hela dokumentet