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)
PD-Rx Pharmaceuticals, Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . - Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . - Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . - Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. - Urinary Tract Infections – caused by beta–lactamase–producing isolates of E. coli , Klebsiella species, and En
Amoxicillin and clavulanate potassium tablets, USP are supplied as follows: 500 mg/125 mg: White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of: NDC 55289-845-06 Bottles of 6 NDC 55289-845-20 Bottles of 20 NDC 55289-845-21 Bottles of 21 NDC 55289-845-28 Bottles of 28 NDC 55289-845-30 Bottles of 30 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light–resistant container as defined in the USP, with a child–resistant closure (as required). Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1984 RECENT MAJOR CHANGES Warnings and Precautions ( 5) 8/2022 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are combination of amoxicillin, a penicillin– class antibacterial and clavulanate potassium, a beta–lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta–lactamase production, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used. ( 1) Usage 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 or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1) DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater th पूरा दस्तावेज़ पढ़ें