Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated
Northstar RxLLC

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 should not be used.

2 DOSAGE AND ADMINISTRATION

Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.

2.1 Adults

The usual adult dose is one 500 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet.

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

The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.

2.2 Pediatric Patients

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

Neonates and Infants Aged <12 weeks (<3 months)

The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/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/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.

Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older

DOSING REGIMEN

Every 12 hours

Every 8 hours

INFECTION

200 mg/5 mL or400 mg/5 mLoral suspension

125 mg/5 mL or250 mg/5 mLoral suspension

Otitis media , sinusitis, lower respiratory tract infections, and more severe infections

45 mg/kg/dayevery 12 hours

40 mg/kg/dayevery 8 hours

Less severe infections

25 mg/kg/dayevery 12 hours

20 mg/kg/dayevery 8 hours

* Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.

† 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 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 tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250 mg chewable tablet of amoxicillin and clavulanate potassium (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 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 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

Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg tablet should not be used in children weighing less than 40 kg. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.

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

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