Amoxicillin and Clavulanate Potassium

AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated
Bryant Ranch Prepack

amoxicillin-chemical-structureclavulanate-chemical-structure

1 INDICATIONS AND USAGE

Amoxicillin and clavulanate potassium is 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 should not be used.

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 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 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.

2.2 Adult Patients

See dosing regimens of amoxicillin and clavulanate potassium (based on the amoxicillin component) provided in Table 1 below.

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

TYPE OF INFECTION

DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM

Severe infections and infections of the respiratory tract

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

Less severe infections

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

* 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.

† 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.

‡ 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)].

§ 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 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 provided in Table 2 below.

Table 2: Dosing Regimens of Amoxicillin and Clavulanate Potassium 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 suspension*

Neonates and Infants aged less than 12 weeks (less than 3 months)

30 mg/kg/day every 12 hours

* 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)].
The amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspension and amoxicillin and clavulanate potassium 200 mg/28.5 mg and amoxicillin and clavulanate potassium 400 mg/57 mg chewable tablets contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.7)].

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 400 mg/57 mg per 5 mL for oral suspension*

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 for 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

* 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.

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.

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