Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM — amoxicillin and clavulanate potassium tablet, film coated
NorthStar Rx LLC

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat 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. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

1.1 Lower Respiratory Tract Infections

caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

1.2 Acute Bacterial Otitis Media

caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

1.3 Sinusitis

caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

1.4 Skin and Skin Structure Infections

caused by beta-lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species.

1.5 Urinary Tract Infections

caused by beta-lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species.

1.6 Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.

2 DOSAGE AND ADMINISTRATION

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.

2.1 Adults


The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.
Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.

2.2 Pediatric Patients

Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics.

Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older
a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.b Duration of therapy studied and recommended for acute otitis media is 10 days.
INFECTION DOSING REGIMEN
Every 12 hours Every 8 hours
200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspensiona 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspensiona
Otitis mediab , sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours
Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours


Patients Weighing 40 kg or More:
Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.

2.3 Patients with Renal Impairment


Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

3 DOSAGE FORMS AND STRENGTHS

  • 250 mg/125 mg : White to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side.
  • 500 mg/125 mg: White to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side.
  • 875 mg/125 mg: White to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side.

The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg/125 mg tablet should not be used in children weighing less than 40 kg. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should NOT be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.

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