देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Aidarex Pharmaceuticals LLC
AMOXICILLIN
AMOXICILLIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Amoxicillin and clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis . Caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis . Caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis . Caused by β-lactamase-producing strains of S. aureus , E. coli , and Klebsiella spp. Caused by β-lactamase-producing strains of E. coli , Klebsiella spp., and Enterobacter spp. While amoxicillin and clavulanate potassium tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium tablets due to their amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and clavulanate po
Amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg are available as white, oblong-shaped, biconvex, film-coated tablets, debossed “93” on one side and “2274” on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20. Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are available as white, capsule-shaped, biconvex, film-coated tablets, debossed “93” on one side and “22”, score, “75” on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 and 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 MG/125 MG AND 875 MG/125 MG 2274 2275 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 tablets USP are 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. 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 has the following structural formula: C H N O S•3H O M.W. 419.46 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. Chemically, clavulanate potassium is potassium (_Z_)-(2_R_,5_R_)-3-(2- hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula: 16 19 3 5 2 C H KNO M.W. 237.25 Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet USP contains 0.63 mEq potassium. INACTI पूरा दस्तावेज़ पढ़ें