Prescription Drug Information: Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM — amoxicillin and clavulanate potassium tablet, film coated
A-S Medication Solutions

1 INDICATIONS AND USAGE

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 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.
  • Skin and Skin Structure Infections — caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
  • Urinary Tract Infections — caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.

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.

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 or prevent 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.

2 DOSAGE AND ADMINISTRATION

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 tablets (based on the amoxicillin component) provided in Table 1 below.

Table 1. Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Adult Patients

TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
Severe infections and infections of the respiratory tract one 875 mg/125 mg tableta of amoxicillin and clavulanate potassium tablets every 12 hours orone 500 mg/125 mg tabletb,c of amoxicillin and clavulanate potassium tablets every 8 hours
Less severe infections one 500 mg/125 mg tabletb,c of amoxicillin and clavulanate potassium tablets every 12 hoursor one 250 mg/125 mg tabletd of amoxicillin and clavulanate potassium tablets every 8 hours

a Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.

b Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet.

c Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration (2.6)].

d Amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration (2.6)].

2.3 Pediatric Patients

Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:

Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of amoxicillin and clavulanate potassium tablets provided in Table 2 below.

Table 2: Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months)

PATIENT POPULATION DOSING REGIMEN
Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspensiona
Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours

a Experience with the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg: See dosing regimens provided in Table 3 below.

  • The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)].

Table 3: Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg

INFECTION DOSING REGIMEN
Every 12 hours Every 8 hours
Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 400 mg/57 mg per 5 mL for oral suspensiona Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 250 mg/62.5 mg per 5 mL for 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

a Each strength of amoxicillin and clavulanate potassium for oral suspension 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.

Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

  • The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should NOT be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium.

2.4 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 (GFR) of less than 30 mL/min should NOT receive the 875 mg dose (based on the amoxicillin component) of amoxicillin and clavulanate potassium tablet. See dosing regimens in patients with severe renal impairment provided in Table 4.

Table 4. Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Patients with Severe Renal Impairment

Patients with Renal Impairment Dosing Regimen
GFR 10 mL/min to 30 mL/min 500 mg or 250 mg every 12 hours, depending on the severity of the infection
GFR less than 10 mL/min 500 mg or 250 mg every 24 hours, depending on severity of the infection
Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infectionAdminister an additional dose both during and at the end of dialysis

2.6 Switching between Dosage Forms and between Strengths

A moxicillin and Clavulanate Potassium 250 mg/125 mg Tablet is NOT Substitutable with Amoxicillin and Clavulanate Potassium 250 mg/62.5 mg Chewable Tablet

The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium should NOT be substituted for each other and the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should NOT be used in pediatric patients weighing less than 40 kg [see Dosage and Administration (2.3)]. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium do not contain the same amount of clavulanic acid. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium contains 62.5 mg of clavulanic acid.

Two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are NOT Substitutable with One 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet

Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.

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, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt.
  • 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, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt.
  • 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, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt.

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