Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Proficient Rx LP
AMOXICILLIN
AMOXICILLIN ANHYDROUS 400 mg in 5 mL
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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 Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (
Amoxicillin and Clavulanate Potassium for Oral Suspension USP Amoxicillin and Clavulanate Potassium for Oral Suspension USP is supplied as follows: 400 mg/57 mg per 5 mL: White to off-white powder – Each 5 mL of reconstituted orange-raspberry-flavored suspension contains 400 mg amoxicillin, USP and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 63187-770-00). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE). AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) FOR ORAL USE INITIAL U.S. APPROVAL: 1984 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS (CHEWABLE) AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS (CHEWABLE) SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated for treatment of the following: DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Formulations and amoxicillin/clavulanate content are: Tablets: 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (3) Powder for Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (3) Chewable Tablets: 200 mg Lees het volledige document