AUGMENTIN® (Amoxicillin / Clavulanic Acid): The Complete Guide

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 Misuse of antibiotics promotes resistance.

AUGMENTIN® (Amoxicillin / Clavulanic Acid): The Complete Guide

Manufacturer & Marketer

• Global Brand Owner / MAH: GlaxoSmithKline (GSK).
• Local Manufacturer (Egypt): Medical Union Pharmaceuticals (MUP), under license from GSK (historically SmithKline Beecham/Beecham Group).

Category & Active Ingredients

• Category: Penicillin antibiotic combined with a β-lactamase inhibitor.
• Active Ingredients: Amoxicillin (as trihydrate) + Clavulanic Acid (as potassium clavulanate).

Summary

AUGMENTIN® combines the bactericidal penicillin amoxicillin with the β-lactamase inhibitor clavulanic acid. Clavulanate protects amoxicillin from enzymatic degradation, broadening coverage against β-lactamase–producing organisms. The product line includes tablets, pediatric suspensions (standard and high-dose/“ES”), infant drops, oral sachets, and IV vials for hospital use.

Available Forms & Strengths

Common Egyptian market presentations include:

Formulation	Strength (Amoxicillin / Clavulanic Acid)	Notes / Typical Use
Film-Coated Tablets	375 mg (250/125), 625 mg (500/125), 1 g (875/125)	Adults & ≥12 years
Pediatric Suspensions	156 mg/5 mL; 312 mg/5 mL; 457 mg/5 mL (400/57); 228 mg/5 mL (200/28.5)	Infants & children (DUO strengths 228 & 457 are 7:1 amox:clav ratios)
ES-600 Suspension	600/42.9 mg per 5 mL	High-dose pediatric regimens
Infant Drops	62.5 mg/mL	Infants
Oral Sachets (Adults)	1 g / 125 mg	Convenient single doses
IV Vials	600 mg (500/100), 1.2 g (1000/200)	Hospital use for severe infections

Mechanism of Action

• Amoxicillin: Inhibits bacterial cell-wall synthesis by binding PBPs → cell lysis (bactericidal).
• Clavulanic Acid: Irreversible (“suicide”) inhibitor of many β-lactamases → restores amoxicillin activity vs β-lactamase–producing strains.

Indications

• Upper respiratory: Acute bacterial sinusitis, tonsillitis, otitis media.
• Lower respiratory: Acute exacerbation of chronic bronchitis, community-acquired pneumonia.
• Genito-urinary: Cystitis, pyelonephritis.
• Skin & soft tissue: Cellulitis, abscesses, bite wounds.
• Bone & joint: e.g., osteomyelitis (as directed).
• Dental infections.

Dosage & Administration

• Administration with food: Take at the start of a meal to improve clavulanate tolerance and absorption.
• Adults (typical): 625 mg every 8–12 h, or 1 g every 12 h for more severe infections (per physician judgment).
• Pediatrics: Dosed by amoxicillin component (e.g., 25–45 mg/kg/day in divided doses; high-dose regimens up to 90 mg/kg/day with appropriate clavulanate ratios for otitis media/sinusitis). Use labeled pediatric strengths.
• Renal impairment: Avoid 875/125 mg (1 g) if CrCl <30 mL/min; extend dosing intervals; dose after hemodialysis on dialysis days.
• Hepatic impairment: Use with caution; monitor liver function.
• Suspensions: Reconstitute exactly as directed; shake well before each dose.

Contraindications

• History of severe hypersensitivity to penicillins and/or previous immediate reaction to any β-lactam (e.g., cephalosporins, carbapenems).
• History of cholestatic jaundice/hepatic dysfunction associated with co-amoxiclav.
• Not recommended in infectious mononucleosis (high incidence of rash).

Warnings & Precautions

• Hypersensitivity: Discontinue immediately if signs of allergy/anaphylaxis occur.
• Hepatobiliary: Rare cholestatic jaundice/hepatitis (risk ↑ with age, male sex, prolonged therapy); usually reversible.
• Antibiotic-associated colitis: Consider C. difficile if severe, persistent diarrhea occurs.
• Superinfection: Prolonged use may cause overgrowth of non-susceptible organisms (e.g., Candida).
• Pregnancy/Lactation: Generally considered acceptable when clinically indicated; small amounts appear in breast milk (monitor infant for GI effects/rash).

Drug Interactions

• Anticoagulants (e.g., warfarin): May increase INR; monitor and adjust dose as needed.
• Methotrexate: Reduced renal clearance → ↑ toxicity risk; monitor closely.
• Probenecid: Decreases renal tubular secretion of amoxicillin → ↑ levels (not recommended concomitantly).
• Allopurinol: Concomitant use ↑ risk of rash.
• Oral contraceptives: Theoretical reduction of efficacy; consider additional contraception if GI upset/diarrhea occurs.
• Mycophenolate mofetil: May ↓ MPA exposure; monitor clinical response/transplant parameters.
• Live oral typhoid vaccine: Antibiotics may reduce vaccine efficacy; separate appropriately.

Side Effects

• Very common/common: Diarrhea, nausea, vomiting, abdominal discomfort, headache, rash.
• Uncommon/rare: Cholestatic jaundice, hepatitis, hypersensitivity reactions (including urticaria/angioedema), C. difficile–associated diarrhea.
• Lab/diagnostic: May cause false-positive urine glucose with non-enzymatic tests (e.g., Clinitest®); use glucose oxidase–based methods.

Pharmacokinetics

• Absorption: Rapid; T_max ~1–2 h. Taking at the start of a meal improves clavulanate GI tolerability with minimal impact on amoxicillin exposure.
• Bioavailability (oral): Amoxicillin ~70–90%; Clavulanate ~55–70% (formulation-dependent).
• Distribution: Widely distributed; low to moderate protein binding (amoxicillin ~17–20%, clavulanate ~25%).
• Metabolism: Amoxicillin minimal; clavulanate partially metabolized hepatically.
• Elimination: Primarily renal (glomerular filtration/tubular secretion). t_1/2 ~1–1.5 h for both components (prolonged in renal impairment).
• Special populations: Dose adjustment required in significant renal dysfunction; use caution and monitor LFTs in hepatic impairment.

Storage

• Tablets/Sachets: Store below 30°C in a dry place.
• After reconstitution (suspensions/drops): Refrigerate (2–8°C), shake well, and discard after the labeled period (commonly up to 7–10 days; follow the pack insert).
• Keep out of reach of children.

Frequently Asked Questions (FAQ)

How is AUGMENTIN® different from amoxicillin alone?
Clavulanate inhibits many β-lactamases, restoring amoxicillin activity against otherwise resistant organisms.

Why take it with food?
Dosing at the start of a meal improves gastrointestinal tolerance and supports clavulanate absorption.

What if I miss a dose?
Take it when remembered. If it’s near the next dose, skip the missed dose—do not double up.

Does it affect birth control?
A direct clinically significant reduction is unlikely, but severe vomiting/diarrhea can impair absorption—use backup contraception in that case.

When should I call my doctor?
Severe diarrhea, signs of allergy (rash, swelling, breathing difficulty), jaundice, dark urine, or persistent abdominal pain.

References

1. GSK Prescribing Information / Co-amoxiclav Product Literature.
2. British National Formulary (BNF): Co-amoxiclav monograph & dosing guidance.
3. Standard infectious disease guidelines for adult and pediatric dosing ranges and renal adjustments.