Onclav

• Approved Indications:
• Respiratory tract infections: acute bacterial sinusitis, acute otitis media, community-acquired pneumonia, acute exacerbations of chronic bronchitis, pharyngitis, and tonsillitis caused by beta-lactamase producing bacteria.
• Skin and soft tissue infections, including cellulitis and abscesses.
• Urinary tract infections, including cystitis and pyelonephritis.
• Bone and joint infections, such as osteomyelitis.
• Dental infections including abscesses and prophylaxis in dental procedures.
• Infections of the biliary tract (cholangitis and cholecystitis).
• Gastrointestinal infections caused by susceptible organisms.
• Clinically accepted off-label uses:
• Prophylaxis in certain surgical procedures.
• Polymicrobial infections involving beta-lactamase producing organisms.
• Helicobacter pylori eradication as part of combination therapy (less common).

• Route: Oral and intravenous.
• Adults:
• Oral: 500 mg/125 mg every 8–12 hours or 875 mg/125 mg every 12 hours depending on infection severity.
• IV: 1.2 g every 8 hours, increasing frequency in severe infections as needed.
• Pediatrics:
• Oral: 20–40 mg/kg/day (amoxicillin component) divided every 8 hours.
• IV: 30 mg/kg every 8 hours (based on total dose).
• Elderly:
• Dose adjustments generally not necessary unless renal impairment is present.
• Renal impairment:
• Moderate impairment (CrCl 10–30 mL/min): reduce dose or extend interval.
• Severe impairment (CrCl <10 mL/min): 500 mg/125 mg every 24 hours. Avoid higher doses.
• Hemodialysis patients require dosing after dialysis.
• Hepatic impairment:
• Use cautiously with liver function monitoring.
• Duration: Usually 5–14 days, tailored to infection severity and clinical response.

Amoxicillin acts by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins, leading to lysis and death. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds beta-lactamase enzymes, protecting amoxicillin from enzymatic degradation, thus extending the antibiotic spectrum against beta-lactamase producing bacteria.

• Absorption: Well absorbed orally (bioavailability ~75%).
• Distribution: Widely distributed in body tissues and fluids including lungs, bile, and bones; crosses placenta and present in breast milk.
• Metabolism: Clavulanic acid metabolized hepatically; amoxicillin partially metabolized.
• Half-life: Approximately 1–1.5 hours (amoxicillin); ~1 hour (clavulanic acid).
• Elimination: Primarily renal via glomerular filtration and tubular secretion.

• Pregnancy: Category B; no evidence of teratogenicity in humans but use only if clearly needed.
• Lactation: Excreted in breast milk in small amounts; generally considered safe. Monitor infant for adverse effects.

• Penicillin-type antibiotic combined with beta-lactamase inhibitor.
• Extended-spectrum beta-lactam antibiotic.

• Known allergy to penicillins or beta-lactam antibiotics.
• Previous severe hypersensitivity reactions to amoxicillin or clavulanic acid.
• History of cholestatic jaundice or hepatic dysfunction associated with this drug.
• Severe renal impairment without appropriate dose adjustment.

• Use with caution in patients with renal or hepatic impairment.
• Monitor liver function during prolonged therapy.
• Risk of Clostridioides difficile associated diarrhea.
• Observe for signs of hypersensitivity including anaphylaxis and severe skin reactions.
• Not recommended for viral infections.

• Common: Diarrhea, nausea, vomiting, rash.
• Less common: Elevated liver enzymes, candidiasis, urticaria, eosinophilia.
• Serious but rare: Anaphylaxis, Stevens-Johnson syndrome, cholestatic hepatitis, seizures (especially in renal impairment).

• Increased rash risk with allopurinol.
• Methotrexate toxicity may increase.
• May reduce effectiveness of oral contraceptives.
• Probenecid decreases renal clearance of amoxicillin, increasing plasma levels.
• Monitor INR if co-administered with warfarin.

• Continued recommendation in guidelines for respiratory tract and skin infections caused by beta-lactamase producing bacteria.
• Antimicrobial stewardship encourages appropriate use to reduce resistance.
• Monitoring for emerging resistance patterns ongoing.

• Store tablets and powder below 25°C in a dry place protected from light.
• Reconstituted suspensions require refrigeration (2–8°C) and use within 7 days.
• Protect from freezing.
• Keep out of reach of children.