Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
NuCare Pharamaceuticals,Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 600 mg in 5 mL
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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. Amoxicillin and clavulanate potassium for oral suspension, USP 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 beta-lactamase – producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: - antiba
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, strawberry flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt. NDC 68071-1661-5 Bottles of 125 mL Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in original container.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION NUCARE PHARAMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP. AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1984 To reduce the development of drug-resistant bacteria and maintain th e effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1) INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension, USP 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 beta- lactamase–producing strains), or _M. catarrhalis _(including beta-lactamase-producing strains) characterized by the following risk factors (1): antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years or younger 2) daycare attendance DOSAGE AND ADMINISTRATION Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2) DOSAGE FORMS AND STRENGTHS 600 mg/42.9 mg per 5 mL. ( 3) CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium for oral suspension or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension. ( 4.2) WARNINGS AND PRE Belgenin tamamını okuyun