Amoxicillindosage

Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component.

Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.

Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended.

2.1 Important

Administration Instructions Amoxicillin and clavulanate potassium tablets, and 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 tablets, and 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 tablets, and amoxicillin and clavulanate potassium for oral suspension 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. § amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet.

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. 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.

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. See dosing regimens in patients with severe renal impairment provided in Table 4. Table 4. Dosing Regimens of amoxicillin and clavulanate potassium 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 infection Administer an additional dose both during and at the end of dialysis

2.5 Directions for

Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Prepare amoxicillin and clavulanate potassium for oral suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure a total (see Table 5 below for total amount of water for reconstitution) OF WATER. Add approximately 2/3 of the water to the powder. Replace cap and shake VIGOROUSLY. Add remaining water. Replace cap and shake VIGOROUSLY.

Table 5: Amount of Water for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Strength of Amoxicillin and Clavulanate potassium for Oral Suspension Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) 200 mg/28.5 mg per 5 mL 50 mL 75 mL 100 mL 47 mL 70 mL 93 mL 200 mg of amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 400 mg/57 mg per 5 mL 50 mL 75 mL 100 mL 45 mL 67 mL 89 mL 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days. Some color change is normal during dosing period.

2.6 Switching between

Dosage Forms and between Strengths Amoxicillin 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. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet of amoxicillin and clavulanate potassium 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 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 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.