Augmentin oral suspension for bacterial infections in adults and children

Augmentin is an oral antibiotic suspension combining amoxicillin, a penicillin-type antibacterial, with clavulanate potassium, a beta-lactamase inhibitor. It is used to treat various bacterial infections in both adults and pediatric patients, especially those caused by bacteria that produce beta-lactamase enzymes that can inactivate amoxicillin.

Augmentin oral suspension is prescribed for the treatment of infections caused by beta-lactamase-producing bacteria, including:

• Lower respiratory tract infections (e.g., bronchitis, pneumonia) due to Haemophilus influenzae and Moraxella catarrhalis.
• Acute bacterial otitis media in children.
• Sinusitis.
• Skin and skin structure infections caused by Staphylococcus aureus, Escherichia coli, and Klebsiella species.
• Urinary tract infections caused by Escherichia coli, Klebsiella species, and Enterobacter species.

Use is limited to infections proven or strongly suspected to be caused by susceptible bacteria producing beta-lactamase. It should not be used when bacteria are susceptible to amoxicillin alone (i.e., non-beta-lactamase producers).

Amoxicillin and clavulanate potassium

Augmentin combines amoxicillin, which kills bacteria by interfering with their cell wall synthesis, with clavulanate potassium, which inhibits beta-lactamase enzymes produced by some bacteria. This inhibition protects amoxicillin from being destroyed, allowing it to effectively eliminate beta-lactamase-producing bacteria that would otherwise be resistant.

Adults and pediatric patients 40 kg or more:

• Severe respiratory infections: 875 mg amoxicillin component every 12 hours (via one 875 mg/125 mg tablet or equivalent suspension) or 500 mg every 8 hours.
• Less severe infections: 500 mg every 12 hours or 250 mg every 8 hours.

Pediatric patients 12 weeks (3 months) and older and weighing less than 40 kg:

• 25 to 45 mg/kg/day amoxicillin component every 12 hours or 20 to 40 mg/kg/day every 8 hours, not to exceed adult doses.
• The every 12 hour regimen is preferred due to lower diarrhea risk.

Neonates and infants less than 12 weeks:

• 30 mg/kg/day divided every 12 hours using the 125 mg/5 mL oral suspension formulation.

Patients with severe renal impairment:

• For GFR 10-30 mL/min: 250 or 500 mg every 12 hours depending on infection severity.
• For GFR less than 10 mL/min or on hemodialysis: 250 or 500 mg every 24 hours with an additional dose during and after dialysis.

Administration Instructions:

• Augmentin may be taken without regard to food, but taking it at the start of a meal enhances absorption of clavulanate potassium and reduces gastrointestinal side effects.
• Oral suspension should be reconstituted with the specified amount of water and stored refrigerated; discard after 10 days.
• Do not substitute certain tablet formulations (e.g., 250 mg/125 mg tablets are not interchangeable with 250 mg/62.5 mg chewable tablets or equivalent doses of other tablets).

• History of serious hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to Augmentin, amoxicillin, clavulanate, or other beta-lactam antibiotics (penicillins, cephalosporins).
• History of cholestatic jaundice or hepatic dysfunction linked to prior Augmentin use.

Serious hypersensitivity reactions:

Anaphylaxis and Stevens-Johnson syndrome can occur, especially in patients with a history of penicillin or multiple allergen sensitivities. Discontinue Augmentin immediately if signs of allergy develop.

Severe cutaneous adverse reactions (SCAR):

Include Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, and AGEP. Monitor patients with rash closely and stop treatment if rash worsens.

Drug-induced enterocolitis syndrome (DIES):

Reported primarily in pediatric patients; characterized by prolonged vomiting 1-4 hours post-dose without skin or respiratory symptoms, plus pallor, lethargy, hypotension, shock, or diarrhea. Discontinue if DIES occurs.

Hepatic dysfunction:

Cases of hepatitis and cholestatic jaundice have been reported. Liver damage usually reverses but can be fatal. Monitor liver function in patients with pre-existing liver disease and discontinue if hepatitis symptoms develop.

Clostridioides difficile-associated diarrhea (CDAD):

Can develop during or after therapy, ranging from mild diarrhea to fatal colitis. Consider CDAD in any patient with diarrhea following antibiotic use and manage accordingly.

Mononucleosis:

Use is contraindicated in patients with mononucleosis due to high incidence of rash.

Superinfections:

Fungal or bacterial overgrowth can occur during treatment; discontinue if superinfection develops and provide appropriate therapy.

Aspartame content:

Certain formulations contain aspartame and should not be used by individuals with phenylketonuria.

Antibacterial stewardship:

Use only for proven or strongly suspected bacterial infections to reduce antibiotic resistance development.

Common side effects:

• Gastrointestinal upset including diarrhea, nausea, and vomiting.

Serious reactions:

• Anaphylaxis and other severe allergic reactions.
• Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Drug-induced enterocolitis syndrome with vomiting and shock.
• Hepatic dysfunction, including hepatitis and jaundice.
• Clostridioides difficile-associated diarrhea ranging from mild to fatal.

No specific drug interactions detailed in the supplied label text.

Reconstituted oral suspension must be stored refrigerated and used within 10 days. Shake well before use. Some color change is normal during use.