AUGMENTIN '200'

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AUGMENTIN '200' (AUGMENTIN '200').

How it works

Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), while clavulanate irreversibly inhibits beta-lactamases, preventing degradation of amoxicillin.

What the body does with it

Metabolism	Amoxicillin is partially metabolized by hydrolysis and excreted renally unchanged; clavulanate is extensively metabolized and excreted renally and fecally.
Excretion	Amoxicillin: ~50-70% excreted unchanged in urine via glomerular filtration and tubular secretion, with the remainder hepatically metabolized and excreted in bile and feces. Clavulanate: ~30-50% excreted unchanged in urine, the rest metabolized and eliminated in bile and feces.
Half-life	Amoxicillin: ~1 hour in healthy adults, prolonged to 7-20 hours in renal impairment (CrCl <10 mL/min). Clavulanate: ~1 hour, similarly prolonged in renal impairment. The combination's half-life supports twice-daily dosing for most infections.
Protein binding	Amoxicillin: ~17-20% bound to serum proteins, primarily albumin. Clavulanate: ~25% bound to albumin.
Volume of Distribution	Amoxicillin: ~0.3-0.4 L/kg, indicating distribution into extracellular fluid and tissues. Clavulanate: ~0.3 L/kg. Both distribute well into middle ear, sinuses, respiratory secretions, and urine.
Bioavailability	Oral: Amoxicillin 75-90%, clavulanate ~60-75%. Absorption is not significantly affected by food, though clavulanate may be better tolerated with food.
Onset of Action	Oral: Clinical improvement typically within 24-48 hours for susceptible infections (e.g., acute otitis media, sinusitis). IV: Onset within minutes to hours for systemic infections.
Duration of Action	Dosing interval every 12 hours provides therapeutic levels throughout the interval. Bactericidal effect persists for most of the dosing period. For extended-release formulations, duration may be longer.

Classification & Brands

Dosing & administration

One 200 mg amoxicillin/28.5 mg clavulanate chewable tablet every 8 hours for mild to moderate infections; for severe infections, one 400 mg/57 mg tablet every 12 hours or one 200 mg/28.5 mg tablet every 8 hours.

Dosage form	FOR SUSPENSION
Renal impairment	For GFR 10-30 mL/min: administer every 12 hours. For GFR <10 mL/min: administer every 24 hours. For hemodialysis: 200 mg/28.5 mg every 24 hours, plus a supplemental dose during dialysis.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% or extend interval. Child-Pugh C: contraindicated due to risk of hepatotoxicity.
Pediatric use	For children 9 months to 40 kg: 20-40 mg/kg/day of amoxicillin component in divided doses every 8 hours, based on severity. For children >40 kg: use adult dosing.
Geriatric use	Assess renal function; use lower initial dose (e.g., 200 mg/28.5 mg every 8-12 hours) due to age-related decline in GFR. Adjust interval per renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for AUGMENTIN '200' (AUGMENTIN '200').

Breastfeeding	Amoxicillin and clavulanate are excreted into breast milk in low concentrations. M/P ratio for amoxicillin is approximately 0.04; clavulanate M/P ratio not well defined. Considered compatible with breastfeeding; monitor for infant diarrhea or allergic rash.
Teratogenic Risk	FDA Pregnancy Category B. Animal studies do not indicate fetal harm. No adequate human studies in first trimester; use only if clearly needed. In second and third trimesters, no known teratogenic risk; however, premature infants and high-dose regimens may increase risk of kernicterus due to bilirubin displacement.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of allergic reaction to any penicillin or beta-lactam antibiotic","Previous cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate","Infectious mononucleosis (increased risk of maculopapular rash)"]

Clinical Precautions

Precautions

["Hypersensitivity reactions including anaphylaxis","Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome","Hepatic dysfunction and cholestatic jaundice (more common in elderly and with prolonged use)","Pseudomembranous colitis due to Clostridioides difficile","In patients with renal impairment, adjust dose based on creatinine clearance","Potential for superinfection with prolonged therapy"]

Food/Dietary

Take with food or milk to minimize GI upset and enhance absorption. No specific dietary restrictions; avoid excessive alcohol as it may increase risk of hepatotoxicity.

Clinical Tips & Counseling

Drug interactions

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AUGMENTIN '200'

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AUGMENTIN '200' (AUGMENTIN '200').

How it works

Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), while clavulanate irreversibly inhibits beta-lactamases, preventing degradation of amoxicillin.

What the body does with it

Metabolism	Amoxicillin is partially metabolized by hydrolysis and excreted renally unchanged; clavulanate is extensively metabolized and excreted renally and fecally.
Excretion	Amoxicillin: ~50-70% excreted unchanged in urine via glomerular filtration and tubular secretion, with the remainder hepatically metabolized and excreted in bile and feces. Clavulanate: ~30-50% excreted unchanged in urine, the rest metabolized and eliminated in bile and feces.
Half-life	Amoxicillin: ~1 hour in healthy adults, prolonged to 7-20 hours in renal impairment (CrCl <10 mL/min). Clavulanate: ~1 hour, similarly prolonged in renal impairment. The combination's half-life supports twice-daily dosing for most infections.
Protein binding	Amoxicillin: ~17-20% bound to serum proteins, primarily albumin. Clavulanate: ~25% bound to albumin.
Volume of Distribution	Amoxicillin: ~0.3-0.4 L/kg, indicating distribution into extracellular fluid and tissues. Clavulanate: ~0.3 L/kg. Both distribute well into middle ear, sinuses, respiratory secretions, and urine.
Bioavailability	Oral: Amoxicillin 75-90%, clavulanate ~60-75%. Absorption is not significantly affected by food, though clavulanate may be better tolerated with food.
Onset of Action	Oral: Clinical improvement typically within 24-48 hours for susceptible infections (e.g., acute otitis media, sinusitis). IV: Onset within minutes to hours for systemic infections.
Duration of Action	Dosing interval every 12 hours provides therapeutic levels throughout the interval. Bactericidal effect persists for most of the dosing period. For extended-release formulations, duration may be longer.

Classification & Brands

Dosing & administration

Dosage form	FOR SUSPENSION
Renal impairment	For GFR 10-30 mL/min: administer every 12 hours. For GFR <10 mL/min: administer every 24 hours. For hemodialysis: 200 mg/28.5 mg every 24 hours, plus a supplemental dose during dialysis.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% or extend interval. Child-Pugh C: contraindicated due to risk of hepatotoxicity.
Pediatric use	For children 9 months to 40 kg: 20-40 mg/kg/day of amoxicillin component in divided doses every 8 hours, based on severity. For children >40 kg: use adult dosing.
Geriatric use	Assess renal function; use lower initial dose (e.g., 200 mg/28.5 mg every 8-12 hours) due to age-related decline in GFR. Adjust interval per renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for AUGMENTIN '200' (AUGMENTIN '200').

Breastfeeding	Amoxicillin and clavulanate are excreted into breast milk in low concentrations. M/P ratio for amoxicillin is approximately 0.04; clavulanate M/P ratio not well defined. Considered compatible with breastfeeding; monitor for infant diarrhea or allergic rash.
Teratogenic Risk	FDA Pregnancy Category B. Animal studies do not indicate fetal harm. No adequate human studies in first trimester; use only if clearly needed. In second and third trimesters, no known teratogenic risk; however, premature infants and high-dose regimens may increase risk of kernicterus due to bilirubin displacement.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Clinical Precautions

Precautions

Food/Dietary

Take with food or milk to minimize GI upset and enhance absorption. No specific dietary restrictions; avoid excessive alcohol as it may increase risk of hepatotoxicity.

Clinical Tips & Counseling

Drug interactions

Loading safety data…