Augmentin
Combination product
What it isAminopenicillin plus beta-lactamase inhibitor; bacterial sinusitis, COPD exacerbations, community-acquired pneumonia, bites.
Why this oneRegimen of choice for bacterial sinusitis; clavulanate restores coverage of beta-lactamase-producing H. influenzae and Moraxella.
What limits itClavulanate-related diarrhea is common; as with other beta-lactams, weaker than fluoroquinolones for empiric pyelonephritis.
Pearls
- High-dose ER (2 g bid) for severe sinusitis or resistant pneumococcus.
- Most sinusitis and bronchitis are viral; antibiotics usually unneeded.
- Pneumonia: pair with a macrolide.
- Take with meals to reduce GI upset.
Augmented Moxie = A Moxie ceiling + Clavicle Annie
Components (2)
FDA-approved for
- bacterial infections (1984)
- sinusitis (1984)
- otitis media (1984)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Usual susceptible infections | adults & peds >=40 kg | 500/125 mg q12h or 250/125 mg q8h | same | 875/125 mg q12h |
| More severe infections and respiratory tract infections | adults & peds >=40 kg | 875/125 mg q12h or 500/125 mg q8h | same | 875/125 mg q12h |
| Otitis media (10 days), sinusitis, lower respiratory tract, more severe infections | peds >=12 weeks | 45 mg/kg/day div q12h OR 40 mg/kg/day div q8h (amoxicillin component) | same | up to adult dose |
| Less severe infections | peds >=12 weeks | 25 mg/kg/day div q12h OR 20 mg/kg/day div q8h | same | up to adult dose |
| Susceptible infections | neonates & infants <12 weeks | 30 mg/kg/day div q12h (use 125 mg/5 mL suspension) | same | 30 mg/kg/day |
Renal GFR >=30: no adjustment. GFR <30: do NOT use 875/125. GFR 10-30: 500/125 or 250/125 q12h. GFR <10: 500/125 or 250/125 q24h. Hemodialysis: 500/125 or 250/125 q24h + extra dose during AND at end of dialysis
Hepatic No dose adjustment given; contraindicated if prior amox/clav-associated cholestatic jaundice/hepatic dysfunction; monitor LFTs at regular intervals in hepatic impairment
All weight-based dosing is calculated on the amoxicillin component
Instructions
- Take at the start of a meal (enhances clavulanate absorption, minimizes GI intolerance); may be taken without regard to meals
- Two 250/125 tablets are NOT equivalent to one 500/125 tablet (both contain 125 mg clavulanate)
- 250/125 tablet and 250/62.5 chewable are NOT interchangeable (different clavulanate content)
- Do not use 250/125 tablets in children <40 kg
- q12h regimen preferred in children — significantly less diarrhea
Available strengths
- tab 250/125, 500/125, 875/125 mg
- ER tab 1/62.5 g
- chew tab 200/28.5, 400/57 mg
- susp 125/31.25, 200/28.5, 250/62.5, 400/57, 600/42.9 mg/5 mL
Contraindications
- History of serious hypersensitivity reaction (anaphylaxis, SJS) to amoxicillin/clavulanate or any other beta-lactam (penicillins, cephalosporins)
- History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate
Cautions
- Serious, occasionally fatal anaphylaxis — more likely with penicillin hypersensitivity or multiple-allergen history; discontinue if reaction occurs
- Hepatic dysfunction/cholestatic jaundice (usually reversible; deaths reported) — monitor LFTs in hepatic impairment
- C. difficile-associated diarrhea (mild to fatal colitis; may occur >2 months after therapy)
- Mononucleosis: high rate of erythematous rash — avoid use
- Superinfection (fungal/bacterial) possible — discontinue and treat if it occurs
Adverse reactions
- Diarrhea/loose stools (9%), nausea (3%), skin rash/urticaria (3%), vomiting (1%), vaginitis (1%); diarrhea increases with higher doses
- Postmarketing: pseudomembranous colitis, SJS/TEN/AGEP/erythema multiforme, hepatitis/cholestatic jaundice, interstitial nephritis, cytopenias, increased PT with anticoagulants, tooth discoloration (peds)
Pregnancy Pregnancy Category B — no animal harm; no adequate human studies; use only if clearly needed
Lactation Amoxicillin excreted in human milk; may sensitize infants — use with caution while nursing
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 250/125 mg | tab | 60 BID | $91.87 | offered |
| 500/125 mg | tab | 60 BID | $15.20 | offered |
| 875/125 mg | tab | 60 BID | $17.03 | offered |
Other forms: Clavulanate (in AUGMENTIN)
Clinical profile
Defining liabilityDiarrhea and cholestatic liver injury
Part D rank #81.
Self-check
- What does clavulanate contribute to amoxicillin?
Beta-lactamase inhibition. - Name one listed ENT indication for amoxicillin–clavulanate.
Sinusitis or otitis media.