국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Lake Erie Medical DBA Quality Care Products LLC
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, 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 beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk fa
How Supplied The color of the dry powder for amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is white to off-white powder. Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt. 55700-471-25 Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- 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 POWDER FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1984 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE 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, 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 beta-lactamase–producing strains), or _M. catarrhalis _(including beta-lactamase-producing strains) characterized by the following risk factors (1): DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS 600 mg/42.9 mg per 5 mL. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS The most frequently reported adverse reactions were diaper rash (4%), diarrhea (3%), vomiting (2%), candidiasis (1%), and rash (1%). (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTTEVA USA, PHARMACOVIGILANCE AT 1-866-832-8537 OR DRUG.SAFETY@TEVAPHARM.COM; OR FDA AT 1-800-FDA-1088 ORhttp://www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.or FDA at 1-800-FDA-1088 or htt 전체 문서 읽기