Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tabletsshould 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 is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: - caused by beta-lactamase-producing isolates of Haemophilus influenzae and Moraxella catarrhalis . - caused by beta-lactamase-producing isolates of
Amoxicillin and Clavulanate Potassium Tablets, USP 875mg/125mg : Each scored white capsule-shaped tablet, debossed with WW949 on the upper side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 68071-5026-4 BOTTLES OF 14 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET NUCARE 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 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS 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 are a combination penicillin-class antibacterial and beta- lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections ( 1.1) Acute bacterial otitis media ( 1.2) Sinusitis ( 1.3) Skin and skin structure infections ( 1.4) Urinary tract infections ( 1.5) DOSAGE AND ADMINISTRATION Adults and Pediatric Patients > 40 kg: 875 mg every 12 hours ( 2.1) DOSAGE FORMS AND STRENGTHS Formulations and amoxicillin/clavulanate content are: Tablets: 875 mg/125 mg. Tablets are scored. ( 3) CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium Tablets or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium Tablets ( 4) WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium Tablets if a reaction occurs. ( 5.1) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ( 5.2) read_full_document