AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

DIRECT RX

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 875 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, 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 tablets, USP are 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*: 1.1 Lower Respiratory Tract Infections caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media

Product summary:

Amoxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side.      Bottles of 30                                    NDC 65862-501-30      Bottles of 500                                  NDC 65862-501-05      10 x 10 Unit-dose Tablets                NDC 65862-501-10 Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side.      Bottles of 20                                     NDC 65862-502-20      Bottles of 500                                   NDC 65862-502-05      10 x 10 Unit-dose Tablets                 NDC 65862-502-10 Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side.      Bottles of 20                                     NDC 65862-503-20      Bottles of 100                                   NDC 65862-503-01      10 x 10 Unit-dose Tablets                 NDC 65862-503-10 Dispense in a tight container [see USP]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
DIRECT RX
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AMOXICILLIN AND CLAVULANATE POTASSIUM
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
amoxicillin and clavulanate potassium tablets, USP and other
antibacterial drugs,
amoxicillin and clavulanate potassium tablets, 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 tablets, USP are 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*:
1.1 Lower Respiratory Tract Infections
caused by beta-lactamase–producing isolates of Haemophilus
influenzae and Moraxella
catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamase–producing isolates of H. influenzae and M.
catarrhalis.
1.3 Sinusitis
caused by beta-lactamase–producing isolates of H. influenzae and M.
catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamase–producing isolates of Staphylococcus
aureus, Escherichia
coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamase–producing isolates of E. coli, Klebsiella
species, and
Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin,
indicating no beta-
lactamase production, amoxicillin and clavulanate potassium tablets,
USP should not be
used.
DOSAGE & ADMINISTRATION SECTION
Amoxicillin and clavulanate potassium tablets may be taken without
regard to meals;
however, absorption of clavulanate potassium is en