Prescription Drug Information: Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated
NuCare Pharmaceuticals,Inc.

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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 USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors 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, USP, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should not be used.

2 DOSAGE AND ADMINISTRATION

Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.

2.1 Adults

The usual adult dose is one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet every 12 hours or one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet 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 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets should not be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.

The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet 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 for Oral Suspension should be dosed as follows:

Neonates and Infants Aged < 12 Weeks (< 3 Months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 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. [see Warnings and Precautions ( 5.6)]

*
Each strength of Amoxicillin and Clavulanate Potassium for Oral Suspension is available as a chewable tablet for use by older children.
Duration of therapy studied and recommended for acute otitis media is 10 days.

Table 1: Dosing in Patients Aged 12 Weeks (3 Months) and Older

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 suspension *

125 mg/31.25 mg per 5 mL or
250 mg/62.5 mg per 5 mL
oral suspension *

Otitis media , 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 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets 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 Amoxicillin and Clavulanate Potassium Tablets (250/125) versus the 250 mg/62.5 mg Amoxicillin and Clavulanate Potassium Tablets (Chewable) (250/62.5).

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/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 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 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 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.

2.4 Directions for Mixing Oral Suspension

Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension

Strength

Bottle Size

Amount of Water for Reconstitution

Contents of Each Teaspoonful (5 mL)

200 mg/28.5 mg per 5 mL

100 mL

92 mL

200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt

400 mg/57 mg per 5 mL

100 mL

87 mL

400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt

Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

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