Augmentin oral suspension for bacterial infections

Augmentin is a combination antibiotic suspension containing amoxicillin and clavulanate potassium. It is used to treat various bacterial infections in both adults and children by overcoming resistance caused by beta-lactamase producing bacteria.

Augmentin suspension is approved for treating infections caused by susceptible bacteria in adults and pediatric patients, including:

• Lower respiratory tract infections caused by beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis
• Acute bacterial otitis media due to beta-lactamase producing H. influenzae and M. catarrhalis
• Sinusitis caused by beta-lactamase producing H. influenzae and M. catarrhalis
• Skin and skin structure infections caused by beta-lactamase producing Staphylococcus aureus, Escherichia coli, and Klebsiella species
• Urinary tract infections caused by beta-lactamase producing E. coli, Klebsiella species, and Enterobacter species

Important: When bacteria are shown to be susceptible to amoxicillin alone (i.e., no beta-lactamase production), Augmentin should not be used.

Amoxicillin trihydrate, clavulanic acid as potassium salt

Augmentin combines amoxicillin, an antibiotic from the penicillin class that kills bacteria by interfering with cell wall synthesis, with clavulanate potassium, a beta-lactamase inhibitor. Clavulanate protects amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria, extending its antibacterial spectrum.

Adults and pediatric patients ≥40 kg:

• 500 mg or 875 mg every 12 hours, or 250 mg or 500 mg every 8 hours (based on amoxicillin component)

Pediatric patients 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 adult doses

Neonates and infants

• 30 mg/kg/day every 12 hours using 125 mg/5 mL suspension

Renal impairment:

• No adjustment except in severe renal impairment
• Patients with GFR 10–30 mL/min: 250 or 500 mg every 12 hours depending on infection severity
• GFR

Administration:

• May be taken without regard to meals, but taking at the start of a meal enhances clavulanate absorption and reduces gastrointestinal intolerance
• Shake oral suspension well before use; reconstituted suspension must be refrigerated and discarded after 10 days

Important notes:

• The 250 mg/125 mg tablet is not substitutable with the 250 mg/62.5 mg chewable tablet due to different clavulanate content
• Two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg tablet

• History of serious hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to amoxicillin, clavulanate, or other beta-lactam antibiotics such as penicillins or cephalosporins
• History of cholestatic jaundice or hepatic dysfunction associated with Augmentin

Serious hypersensitivity reactions

Anaphylaxis and Stevens-Johnson syndrome (SJS) may occur. Patients with history of penicillin or beta-lactam allergies are at higher risk. Discontinue Augmentin immediately if allergic reaction occurs.

Severe cutaneous adverse reactions (SCAR)

Includes SJS, toxic epidermal necrolysis (TEN), DRESS, and acute generalized exanthematous pustulosis (AGEP). Monitor for rash; stop treatment if rash progresses.

Drug-induced enterocolitis syndrome (DIES)

Seen predominantly in pediatric patients, characterized by protracted vomiting 1–4 hours after ingestion without skin or respiratory symptoms. May include pallor, lethargy, hypotension, shock, diarrhea, and elevated neutrophils. Discontinue and treat appropriately if DIES occurs.

Hepatic dysfunction and cholestatic jaundice

May develop hepatitis or cholestatic jaundice, usually reversible but occasionally fatal. Monitor liver function, especially in patients with pre-existing hepatic impairment, and discontinue if symptoms occur.

Clostridioides difficile-associated diarrhea (CDAD)

May range from mild diarrhea to fatal colitis. Consider CDAD in any patient with diarrhea following antibiotic use; discontinue Augmentin if suspected and manage accordingly.

Use in mononucleosis

High incidence of rash in patients with mononucleosis; avoid use in these patients.

Overgrowth of non-susceptible organisms

Superinfections with fungi or resistant bacteria may occur. Discontinue if such infections develop and initiate appropriate therapy.

Aspartame content

Certain suspension and chewable tablet formulations contain aspartame; contraindicated in patients with phenylketonuria.

Common adverse reactions

• Diarrhea (less frequent with doses every 12 hours)
• Nausea and vomiting (reduced when taken with food)
• Skin rash

Serious adverse reactions

• Anaphylaxis and severe hypersensitivity reactions
• Severe cutaneous adverse reactions (SJS, TEN, DRESS, AGEP)
• Drug-induced enterocolitis syndrome (DIES)
• Hepatic dysfunction including cholestatic jaundice
• Clostridioides difficile-associated diarrhea

No specific drug interactions detailed in the supplied text for this formulation.

Store the reconstituted oral suspension under refrigeration and discard it after 10 days. Some color change during use is normal.