Overview
Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid.
Mechanism of Action
12.1 Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology ( 12.4)] . 12.3 Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of amoxicillin and clavulanate potassium tablets are shown in Table 6 and following administration of amoxicillin and clavulanate potassium for oral suspension and chewable tablets are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,bwith Amoxicillin and Clavulanate PotassiumTablets Dose and Regimen of Amoxicillin and Clavulanate Potassium C max(mcg/mL) AUC 0 to 24(mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 250...
Indications
- Amoxicillin and clavulanate potassium tablets 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 influenzaeand Moraxella catarrhalis. • Acute Bacterial Otitis Media- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. • Sinusitis- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis.
Common Doses
- 875 mg
- 500 mg
- 250 mg
- 200 mg
Dosage
2.1 Important Administration Instructions Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of amoxicillin and clavulanate potassium (based on the amoxicillin component) provided in Table 1 below. Table 1.
Contraindications
- 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.
Side Effects
- The following are discussed in more detail in other sections of 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 difficileAssociated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5)] 6.
Interactions
- 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium tablets may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants.