Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Hikma Pharmaceutical
AMOXICILLIN
AMOXICILLIN ANHYDROUS 600 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: - antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 years daycare attendance - age ≤ 2 years - daycare attendance [See CLINICAL PHARMACOLOGY, Microbiology.] NOTE : Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infe
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt. 75 mL bottle 125 mL bottle 200 mL bottle
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION HIKMA PHARMACEUTICAL ---------- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, 600 MG/42.9 MG PER 5 ML RX. ONLY REV. 09/11 PRESCRIBING INFORMATION To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL 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, USP 600 mg/42.9 mg per 5 mL 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 (2_S_,5_R_,6_R_)6-[(_R_)-(-)-2-Amino-2-(_p-_hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4- thia-1azabicyclo[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_)-(2_R_,5_R_)-3-(2- hydroxyethylidene)-7-oxo-4-oxa-1azabicyclo[3.2.0]-heptane-2-carboxylate Baca dokumen lengkapnya