Amoxicillindosage

Recommended dosage and administration for the amoxicillin and clavulanate potassium depends on the indication, patient age, weight, and ability to swallow tablets. Therefore, carefully follow the recommended dosage and administration instructions specified below. Pediatric Patients less than 3 Months of Age: 30 mg/kg/day divided into 2 doses every 12 hours using amoxicillin and clavulanate potassium for oral suspension 125 mg/31.25 mg per 5 mL Pediatric Patients 3 Months and Older and Weighing Less Than 40 kg Infection Type Frequency Dose Formulation Strength Amoxicillin and Clavulanate Potassium for Oral Suspension Mild to Moderate Infections Every 12 hours 25 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 20 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg Severe Infections Every 12 hours 45 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 40 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg Adjust dose for severe renal impairment (GFR less than 30 mL/min) and in patients on hemodialysis. See full Prescribing Information for preparation of oral suspension.

2.1 Important

Administration Instructions The recommended dosage and administration for the amoxicillin and clavulanate potassium, depends on the indication, patient age, weight, and ability to swallow tablets. Therefore, carefully follow the recommended dosage and administration instructions specified below. Substitution among amoxicillin and clavulanate potassium formulations should only occur when the amoxicillin-to-clavulanic acid ratio is matched; AUGMENTIN Chewable Tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension are substitutable on a mg-per-mg basis, and certain AUGMENTIN Tablet strengths are substitutable with specific Amoxicillin and Clavulanate Potassium for Oral Suspension or AUGMENTIN Chewable Tablet strengths..

2.3 Recommended

Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Less Than 3 Months of Age Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is the recommended formulation for use in this pediatric age group. The recommended dosage for pediatric patients less than 3 months of age, based on the amoxicillin component, is 30 mg/kg/day orally divided into two doses every 12 hours. Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.

2.4 Recommended

Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Aged 3 Months and Older and Weighing Less Than 40 kg The recommended dosage of amoxicillin and clavulanate potassium for oral suspension for pediatric patients aged 3 months and older and weighing less than 40 kg are provided in Table 2. Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.

Table 2: Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Aged 3 Months and Older and Weighing Less Than 40 kg a The every 12 hours regimen is recommended as it is associated with less diarrhea. b Strength of amoxicillin/clavulanate potassium per 5 mL oral suspension c The recommended duration of therapy for acute bacterial otitis media is 10 days Infection Type Frequency a Dose (Amoxicillin component) Formulation Strength Amoxicillin and Clavulanate Potassium for Oral Suspension b Less Severe Infections Every 12 hours 25 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 20 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg Otitis media c, sinusitis, lower respiratory tract infections, and more severe infections Every 12 hours 45 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 40 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg

2.6 Recommended

Dosage in Patients with Renal Impairment Amoxicillin and Clavulanate Potassium for Oral Suspension A reduced dosage is recommended in patients with severe renal impairment (see Table 4). No dosage adjustment is recommended in patients with mild to moderate renal impairment.

Table 4: Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Patients with Severe Renal Impairment Patients with Severe Renal Impairment Dosage GFR 10 mL/min to less than 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 infection Administer an additional dose both during and at the end of dialysis Patients with a GFR of less than 30 mL/min should not receive the 875 mg/125 mg dose of amoxicillin and clavulanate potassium.

2.7 Preparation and

Storage (after reconstitution) of Amoxicillin and Clavulanate Potassium for Oral Suspension Prepare the oral suspension at time of dispensing as follows: Shake the bottle to loosen powder. Measure the total amount of water (see Table 5) to be added in two parts. Add 2/3 of the total required water, close the bottle, and shake vigorously. Add the remaining water, close, and shake again. Shake well before each use. Administer the reconstituted amoxicillin and clavulanate potassium for oral suspension, use a dosing spoon or medicine dropper to a pediatric patient. Rinse the dosing spoon or dropper after each use. Storage Store reconstituted amoxicillin and clavulanate potassium for oral suspension under refrigeration; discard after 10 days. A slight color change during storage is normal.

Table 5: Amount of Water for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Strength of Oral Suspension (amoxicillin/clavulanic acid) Bottle Size Amount of Water for Reconstitution 125 mg/31.25 mg per 5 mL 75 mL 100 mL 150 mL 74 mL 98 mL 146 mL 250 mg/62.5 mg per 5 mL 75 mL 100 mL 150 mL 70 mL 93 mL 137 mL

2.8 Switching

Between Dosage Forms and Strengths Amoxicillin and Clavulanate Potassium for Oral Suspension Substitution among amoxicillin and clavulanate potassium formulations should only occur when the amoxicillin-to-clavulanic acid ratio is matched; AUGMENTIN Chewable Tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension are substitutable on a mg-per-mg basis, and certain AUGMENTIN Tablet strengths are substitutable with specific Amoxicillin and Clavulanate Potassium for Oral Suspension or AUGMENTIN Chewable Tablet strengths. AUGMENTIN Chewable Tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension formulations are for pediatric patients weighing less than 40 kg and in pediatric patients who cannot swallow tablets and may be substituted for each other where appropriate. Table 6 provides guidance on selecting the appropriate strength when switching between AUGMENTIN Tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension or AUGMENTIN Chewable Tablets to ensure the appropriate amoxicillin-to-clavulanic acid ratio.

Table 6: Selecting Appropriate Strengths of Amoxicillin and Clavulanate Potassium When Switching Between Tablets, Oral Suspension, or Chewable Tablets AUGMENTIN Tablet Strength Substitutable Strength of Amoxicillin and Clavulanate Potassium for Oral Suspension or AUGMENTIN Chewable Tablets a 250 mg/125 mg b No equivalent available 500 mg/125 mg c 125 mg/31.25 mg or 250 mg/62.5 mg 875 mg/125 mg 200 mg/28.5 mg or 400 mg/57 mg 1,000 mg/62.5 mg Not substitutable with immediate-release formulations a One Chewable Tablet has the same amount of amoxicillin and clavulanic acid as 5 mL of the corresponding strength of Oral Suspension. Chewable tablets may only be used as a substitute in pediatric patients weighing less than 40 kg. b AUGMENTIN 250 mg/125 mg tablet is NOT substitutable with AUGMENTIN 250 mg/62.5 mg chewable tablet. c Two AUGMENTIN 250 mg/125 mg Tablets are not substitutable with one AUGMENTIN 500 mg/125 mg Tablet.