Overview
11 DESCRIPTION Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 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,b with Amoxicillin and Clavulanate Potassium Tablets a Mean (± standard deviation) values of 14 normal adults (N equals15 for clavulanate potassium in the low-dose regimens). Peak concentrations occurred approximately 1.
Indications
- 1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium is 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 influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis .
Common Doses
- 875 mg
- 500 mg
- 45 mg
- 40 mg
Dosage
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. ( 2.3 ) 2.
Contraindications
- 4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g.
Side Effects
- 6 ADVERSE REACTIONS 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 )] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). ( 6.
Interactions
- 7 DRUG INTERACTIONS Co‑administration with probenecid is not recommended. ( 7.1 ) Concomitant use of Amoxicillin and Clavulanate Potassium and oral anticoagulants may increase the prolongation of prothrombin time.( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin and Clavulanate Potassium may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid.