Amoxicillin-Clavulanate Potass (amoxicillin/potassium clavulanate)

Dosage of amoxicillin/clavulanate generally is expressed in terms of the amoxicillin content of the fixed combination. Although commercially available amoxicillin/clavulanate contains amoxicillin as the trihydrate and/or the sodium salt and clavulanic acid as the potassium salt, potency of amoxicillin is calculated on the anhydrous basis and potency of clavulanate potassium is expressed in terms of clavulanic acid.

Amoxicillin/clavulanate is commercially available for oral administration as a powder for oral suspension containing a 4:1, 7:1, or 14:1 ratio of amoxicillin to clavulanic acid; as chewable tablets containing a 4:1 or 7:1 ratio of the drugs; as film-coated tablets containing a 2:1 or 4:1 ratio of the drugs; as scored tablets containing a 7:1 ratio of the drugs; and as extended-release tablets containing a 16:1 ratio of the drugs.

Commercially available amoxicillin/clavulanate powders for oral suspension should not be considered interchangeable since they contain different amounts of clavulanic acid. The powder for oral suspension containing 600 mg of amoxicillin and 42.9 mg of clavulanic acid per 5 mL (Augmentin ES-600(R)) is indicated only for the treatment of persistent or recurrent acute otitis media (AOM) in certain pediatric patients 3 months to 12 years of age; safety and efficacy of this preparation in younger children or in adolescents or adults have not been established. Because commercially available amoxicillin/clavulanate film-coated tablets containing 250 mg of amoxicillin contain 125 mg of clavulanic acid and commercially available chewable tablets containing 250 mg of amoxicillin contain 62.5 mg of clavulanic acid, these preparations should not be considered interchangeable. In addition, since the 250- and 500-mg film-coated tablets of the drug both contain the same amount of clavulanic acid, two 250-mg film-coated tablets are not equivalent to one 500-mg film-coated tablet. Because extended-release tablets of amoxicillin/clavulanate contain different ratios of the drugs, the extended-release tablets are not equivalent to conventional or chewable tablets of the drug.

Children weighing less than 40 kg should not receive the 250-mg film-coated tablets since this formulation contains a higher dose of clavulanic acid. (See Dosage: Pediatric Dosage, under Dosage and Administration.) Safety and efficacy of the extended-release tablets have not been established in pediatric patients younger than 16 years of age.

In patients with renal impairment, doses and/or frequency of administration of amoxicillin/clavulanate should be modified in response to the degree of renal impairment. Some clinicians suggest that modification of usual dosage is unnecessary in adults with creatinine clearances greater than 30 mL/minute. These clinicians recommend that adults with creatinine clearances of 15-30 mL/minute receive the usual dose of conventional preparations of the drug every 12-18 hours, adults with creatinine clearances of 5-15 mL/minute receive the usual dose every 20-36 hours, and adults with creatinine clearances less than 5 mL/minute receive the usual dose every 48 hours. However, other clinicians suggest that use of amoxicillin/clavulanate should be avoided in patients with creatinine clearances less than 30 mL/minute until more data are available on use of the drug in these patients.

Some clinicians suggest that adults undergoing hemodialysis receive a 500-mg tablet containing 500 mg of amoxicillin and 125 mg of clavulanic acid halfway through each dialysis period and an additional 500-mg tablet after each dialysis period.

The pharmacokinetics of extended-release tablets of amoxicillin/clavulanate have not been studied in patients with renal impairment, and the manufacturer states that this preparation is contraindicated in patients with severe impairment (creatinine clearance less than 30 mL/minute and those undergoing hemodialysis). The extended-release tablets should be dosed cautiously in patients with hepatic impairment and liver function should be monitored at frequent intervals.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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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.

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