AUGMENTIN (amoxicillin/potassium clavulanate)

There are 0 contraindications.

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection
Infectious mononucleosis

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Kidney disease with likely reduction in glomerular filtration rate (GFr)

There are 50 severe adverse reactions.

More Frequent	Less Frequent
None.	Anaphylaxis Dyspnea Serum sickness

Rare/Very Rare

Acute coronary syndrome Acute generalized exanthematous pustulosis Acute pancreatitis Agranulocytosis Allergic dermatitis Anemia Angioedema Cholestasis Cholestatic hepatitis Clostridioides difficile infection DRESS syndrome Edema Enterocolitis Eosinophilia Eosinophilic pneumonia Erythema multiforme Exfoliative dermatitis Hemolytic anemia Hepatitis Hepatocellular damage Hyperbilirubinemia Hypersensitivity angiitis Hypersensitivity drug reaction Hypotension Increased alanine transaminase Increased alkaline phosphatase Increased aspartate transaminase Increased risk of bleeding due to coagulation disorder Interstitial nephritis Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Kounis syndrome Leukopenia Linear immunoglobulin A bullous dermatosis Multiple organ failure Non-infective meningitis Obstructive hyperbilirubinemia Pancytopenia Qualitative platelet disorder Seizure disorder Stevens-johnson syndrome Symmetrical drug-related intertriginous and flexural exanthema Thrombocytopenic disorder Thrombocytosis Thrombophlebitis Thrombotic thrombocytopenic purpura Toxic epidermal necrolysis

There are 39 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Gastrointestinal irritation Headache disorder Loose stools Oral candidiasis Vulvovaginal candidiasis	Constipation Insomnia Nausea Phlebitis after infusion Pruritus of skin Skin rash Urticaria Vomiting

Rare/Very Rare
Acute abdominal pain Acute cognitive impairment Agitation Back pain Black tarry stools Chills Crystalluria Dental discoloration Dizziness Dysgeusia Dyspepsia Fever Flatulence Furred tongue Gastritis Glossitis Hematuria Injection site sequelae Malaise Mucocutaneous candidiasis Myalgia Stomatitis Symptoms of anxiety Tremor Vaginitis

Safe use of amoxicillin/clavulanate during pregnancy has not been definitely established. There are no adequate or controlled studies using amoxicillin/clavulanate in pregnant women, and the drug should be used during pregnancy only when clearly needed. Aminopenicillins are generally poorly absorbed when given orally during labor.

Although the mechanism is unclear and the clinical importance has not been determined to date, studies using oral ampicillin indicate that, when administered during pregnancy, the drug interferes with metabolism and enterohepatic circulation of steroids resulting in decreased urinary concentrations of estrogen metabolites. The manufacturers state that this effect could also occur with amoxicillin/clavulanate. IV administration of ampicillin to guinea pigs has decreased uterine tone and decreased the frequency, height, and duration of uterine contractions; however, it is not known whether use of amoxicillin/clavulanate in humans during labor or delivery could have any immediate or delayed adverse effects on the fetus, prolong the duration of labor, or increase the likelihood of forceps delivery, other obstetrical intervention, or resuscitation of the neonate.

Because amoxicillin and clavulanic acid are distributed into milk, amoxicillin/clavulanate should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.