API

Amoxycillin (500mg) + Clavulanic Acid (125mg)

Drug classification

Amoxicillin: Antibiotics (beta-lactam); Clavulanic Acid: Beta-lactamase inhibitor.

Dosage form

Tablet (Amoxicillin 500mg + Clavulanic Acid 125mg)

API strength per dosage

Amoxicillin 500 mg, Clavulanic Acid 125 mg per tablet.

Dose

Adults and children ≥40 kg: One tablet (500 mg amoxicillin/125 mg clavulanic acid) every 8 hours. Children <40 kg: Not recommended; use pediatric formulations. Adjust dose in renal impairment. No specific adjustments for liver impairment, but monitor liver function.

Mechanism of action

Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). Clavulanic acid inhibits β-lactamase enzymes, protecting amoxicillin from degradation, thereby enhancing its antibacterial activity. This combination results in extended spectrum of action against β-lactamase producing bacteria.

Indications

Treatment of Bacterial infections

Side effects

Vomiting Nausea Diarrhea Mucocutaneous candidiasis

Pregnancy category

Category B

Precautions

Monitor for allergic reactions, adjust dose in renal impairment, avoid in liver disease or monitor liver function, consider potential for antibiotic-associated colitis, use cautiously in mononucleosis (risk of rash), ensure adequate hydration to prevent crystalluria, monitor for signs of superinfection, especially fungal.

Contraindications

Hypersensitivity to penicillins or beta-lactam antibiotics, history of jaundice/liver dysfunction linked to amoxicillin/clavulanate, severe renal impairment, infectious mononucleosis, phenylketonuria (for formulations containing aspartame).