Amoxicillin And Clavulanate Potassium
Amoxicillin And Clavulanate Potassium Prescribing Information
Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) (
5.3) 5/2024
Amoxicillin and clavulanate potassium for oral suspension 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 ofHaemophilus influenzaeandMoraxella catarrhalis.
- Acute Bacterial Otitis Media- caused by beta‑lactamase‑producing isolates ofH. influenzaeandM. catarrhalis.
- Sinusitis- caused by beta‑lactamase‑producing isolates ofH. influenzaeandM. catarrhalis.
- Skin and Skin Structure Infections- caused by beta‑lactamase‑producing isolates ofStaphylococcus aureus,Escherichia coli,andKlebsiellaspecies.
- Urinary Tract Infections- caused by beta‑lactamase‑producing isolates ofE. coli,Klebsiellaspecies, andEnterobacterspecies.
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used.
To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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.
• 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. (
See dosing regimens of amoxicillin and clavulanate potassium (based on the amoxicillin component) provided in Table 1 below.
TYPE OF INFECTION | DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM |
| Severe infections and infections of the respiratory tract | one 875 mg tabletaof amoxicillin and clavulanate potassium every 12 hours or one 500 mg tabletb,cof amoxicillin and clavulanate potassium every 8 hours |
| Less severe infections | one 500 mg tabletb,cof amoxicillin and clavulanate potassium every 12 hours or one 250 mg tabletdof amoxicillin and clavulanate potassium every 8 hours |
aAdults 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.
bAdults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL suspension or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet.
cTwo amoxicillin and clavulanate potassium 250 mg/125 mg tablets are
dAmoxicillin and clavulanate potassium 250 mg/125 mg tablet is
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
PATIENT POPULATION | DOSING REGIMEN |
A moxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL for oral suspension a | |
| Neonates and Infants aged less than 12 weeks (less than 3 months) | 30 mg/kg/day every 12 hours |
aExperience with the amoxicillin and clavulanate potassium for oral suspension 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.
- The every 12 hour regimen is recommended as it is associated with significantly less diarrhea[see Clinical Studies ].
- 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 contain aspartame and should not be used by phenylketonurics[see Warnings and Precautions ].
INFECTION | DOSING REGIMEN | |
Every 12 hours | Every 8 hours | |
| Amoxicillin and clavulanate potassium for oral suspension 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspensiona | Amoxicillin and clavulanate potassium for oral suspension 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL for oral suspensiona | |
| Otitis mediab, 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 |
aEach strength of amoxicillin and clavulanate potassium for oral suspension is available as a chewable tablet for use by older children.
bDuration of therapy studied and recommended for acute otitis media is 10 days.
- The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium shouldNOTbe 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.
• 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. (
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
PATIENT POPULATION | DOSING REGIMEN |
A moxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL for oral suspension a | |
| Neonates and Infants aged less than 12 weeks (less than 3 months) | 30 mg/kg/day every 12 hours |
aExperience with the amoxicillin and clavulanate potassium for oral suspension 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.
- The every 12 hour regimen is recommended as it is associated with significantly less diarrhea[see Clinical Studies ].
- 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 contain aspartame and should not be used by phenylketonurics[see Warnings and Precautions ].
INFECTION | DOSING REGIMEN | |
Every 12 hours | Every 8 hours | |
| Amoxicillin and clavulanate potassium for oral suspension 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspensiona | Amoxicillin and clavulanate potassium for oral suspension 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL for oral suspensiona | |
| Otitis mediab, 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 |
aEach strength of amoxicillin and clavulanate potassium for oral suspension is available as a chewable tablet for use by older children.
bDuration of therapy studied and recommended for acute otitis media is 10 days.
- The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium shouldNOTbe 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.
• 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. (
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows:
PATIENT POPULATION | DOSING REGIMEN |
A moxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL for oral suspension a | |
| Neonates and Infants aged less than 12 weeks (less than 3 months) | 30 mg/kg/day every 12 hours |
aExperience with the amoxicillin and clavulanate potassium for oral suspension 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.
- The every 12 hour regimen is recommended as it is associated with significantly less diarrhea[see Clinical Studies ].
- 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 contain aspartame and should not be used by phenylketonurics[see Warnings and Precautions ].
INFECTION | DOSING REGIMEN | |
Every 12 hours | Every 8 hours | |
| Amoxicillin and clavulanate potassium for oral suspension 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspensiona | Amoxicillin and clavulanate potassium for oral suspension 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL for oral suspensiona | |
| Otitis mediab, 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 |
aEach strength of amoxicillin and clavulanate potassium for oral suspension is available as a chewable tablet for use by older children.
bDuration of therapy studied and recommended for acute otitis media is 10 days.
- The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium shouldNOTbe 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.
- 200 mg/28.5 mg per 5 mL:White to off-white powder for oral suspension – Each 5 mL of reconstituted white to off-white, orange-golden caramel-raspberry-flavored suspension contains 200 mg of amoxicillin as the trihydrate and 28.5 mg of clavulanic acid as the potassium salt.
- 400 mg/57 mg per 5 mL:White to off-white powder for oral suspension – Each 5 mL of reconstituted white to off-white, orange-golden caramel-raspberry-flavored suspension contains 400 mg of amoxicillin as the trihydrate and 57 mg of clavulanic acid as the potassium salt.
• Pediatric Use: Modify dose in patients 12 weeks or younger. (
The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established in pediatric patients. Use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months)
• Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30mL/min). (
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
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 |
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment
• History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). (
Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drugs (e.g., penicillins and cephalosporins).
• History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. (
Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.