Amoxicillin and Clavulanate Potassium
Generic: AMOXICILLIN AND CLAVULANATE POTASSIUM
Basic Information
Manufacturer
USAntibiotics, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
45c60b69-1b65-01ed-e063-6294a90a57be
Indications & Usage
1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H.
influenzae , M.
catarrhalis , H.
parainfluenzae , K.
pneumoniae , or methicillin-susceptible S.
aureus ) and S.
pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
Data are limited with regard to infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/ mL [see Clinical Studies (14) ].
Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent 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.
In patients with community-acquired pneumonia in whom penicillin-resistant S.
pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S.
pneumoniae plus a beta-lactamase-producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours).
Acute bacterial sinusitis or community-acquired pneumonia due to S.
pneumoniae alone can be treated with amoxicillin.
Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for treatment of adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H.
influenzae , M.
catarrhalis , H.
parainfluenzae , K.
pneumoniae , or methicillin-susceptible S.
aureus ) and S.
pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
(1) Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
Data are limited with regard to infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
(1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria .
(1)
influenzae , M.
catarrhalis , H.
parainfluenzae , K.
pneumoniae , or methicillin-susceptible S.
aureus ) and S.
pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
Data are limited with regard to infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/ mL [see Clinical Studies (14) ].
Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent 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.
In patients with community-acquired pneumonia in whom penicillin-resistant S.
pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S.
pneumoniae plus a beta-lactamase-producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours).
Acute bacterial sinusitis or community-acquired pneumonia due to S.
pneumoniae alone can be treated with amoxicillin.
Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for treatment of adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H.
influenzae , M.
catarrhalis , H.
parainfluenzae , K.
pneumoniae , or methicillin-susceptible S.
aureus ) and S.
pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
(1) Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
Data are limited with regard to infections due to S.
pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL.
(1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria .
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic Dysfunction [see Warnings and Precautions (5.4) ] Clostridioides difficile -associated diarrhea (CDAD) [see Warnings and Precautions (5.5) ] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions were (incidence >2%) diarrhea, vaginal mycosis, nausea, and loose stools.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 5,643 patients have been treated with Amoxicillin and Clavulanate Potassium Extended Release Tablets.
The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%).
Amoxicillin and Clavulanate Potassium Extended Release Tablets had a higher rate of diarrhea which required corrective therapy (4% versus 3% for Amoxicillin and Clavulanate Potassium Extended Release Tablets and all comparators, respectively).
Two percent of patients discontinued therapy due to adverse reactions.
6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Amoxicillin and Clavulanate products, including Amoxicillin and Clavulanate Potassium Extended Release Tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal : Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.3 , 5.5 )] .
Immune : Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1) ] .
Skin and Appendages : Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis [see Warnings and Precautions ( 5.1 , 5.2 , 5.6 )] .
Liver : A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials, but the significance of these findings is unknown.
Hepatic dysfunction, including hepatitis and cholestatic jaundice, [see Contraindications (4.2) ], increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Amoxicillin and Clavulanate.
It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.
The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.
The hepatic dysfunction, which may be severe, is usually reversible.
Deaths have been reported [see Contraindications (4.2) , Warnings and Precautions (5.4) ] .
Renal : Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10) ] .
Hemic and Lymphatic Systems : Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins.
These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
There have been reports of increased prothrombin time in patients receiving Amoxicillin and Clavulanate and anticoagulant therapy concomitantly [see Drug Interactions (7.2) ] .
Central Nervous System : Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity have been reported.
Miscellaneous : Tooth discoloration (brown, yellow, or gray staining) has been reported.
Most reports occurred in pediatric patients.
Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 5,643 patients have been treated with Amoxicillin and Clavulanate Potassium Extended Release Tablets.
The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%).
Amoxicillin and Clavulanate Potassium Extended Release Tablets had a higher rate of diarrhea which required corrective therapy (4% versus 3% for Amoxicillin and Clavulanate Potassium Extended Release Tablets and all comparators, respectively).
Two percent of patients discontinued therapy due to adverse reactions.
6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Amoxicillin and Clavulanate products, including Amoxicillin and Clavulanate Potassium Extended Release Tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal : Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.3 , 5.5 )] .
Immune : Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1) ] .
Skin and Appendages : Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis [see Warnings and Precautions ( 5.1 , 5.2 , 5.6 )] .
Liver : A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials, but the significance of these findings is unknown.
Hepatic dysfunction, including hepatitis and cholestatic jaundice, [see Contraindications (4.2) ], increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Amoxicillin and Clavulanate.
It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.
The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.
The hepatic dysfunction, which may be severe, is usually reversible.
Deaths have been reported [see Contraindications (4.2) , Warnings and Precautions (5.4) ] .
Renal : Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10) ] .
Hemic and Lymphatic Systems : Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins.
These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
There have been reports of increased prothrombin time in patients receiving Amoxicillin and Clavulanate and anticoagulant therapy concomitantly [see Drug Interactions (7.2) ] .
Central Nervous System : Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity have been reported.
Miscellaneous : Tooth discoloration (brown, yellow, or gray staining) has been reported.
Most reports occurred in pediatric patients.
Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.