1. Clinical & Scientific Overview
Amoxicillin + Clavulanic Acid (Co-amoxiclav) (TIP-MED-000130, Reference Code [8.2]) is classified under
Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08) as a Aminopenicillin + Irreversible Beta-Lactamase Inhibitor Combination (Bactericidal Broad-Spectrum Beta-Lactam; WHO 'Access' Group).
Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).
Augmentin (GSK), Clavam (Alkem), Moxikind-CV (Mankind)
Oral Film-Coated Tablets: 625 mg (Amoxicillin 500 mg + Clavulanic Acid 125 mg), 375 mg (250/125 mg), 1000 mg Duo (875/125 mg); Paediatric Oral Suspension: 228.5 mg/5 mL, 457 mg/5 mL (Duo); IV Injection: 1.2 g (1000/200 mg), 600 mg
3. Mechanism of Action & Pharmacodynamics
Aminopenicillin + Irreversible Beta-Lactamase Inhibitor Combination (Bactericidal Broad-Spectrum Beta-Lactam; WHO 'Access' Group) acting on target receptor/enzyme pathways in Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08): clinical efficacy is mediated via Aminopenicillin + Irreversible Beta-Lactamase Inhibitor Combination (Bactericidal Broad-Spectrum Beta-Lactam; WHO 'Access' Group) for Beta-lactamase-producing infections: Acute bacterial rhinosinusitis, acute exacerbation of COPD, community-acquired pneumonia, complicated urinary tract infections, diabetic foot infections, skin and soft-tissue infections, animal/human bites, and severe dental abscesses..
4. Therapeutic Indications & Evidence-Supported Uses
- Beta-lactamase-producing infections: Acute bacterial rhinosinusitis, acute exacerbation of COPD, community-acquired pneumonia, complicated urinary tract infections, diabetic foot infections, skin and soft-tissue infections, animal/human bites, and severe dental abscesses
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: General Adult Reference: 625 mg (500/125 mg) three times daily (every 8 hours) or twice daily (for mild-to-moderate infections), OR 1000 mg (875/125 mg) twice daily (every 12 hours) for 5 to 7 days. Never substitute two 375 mg tablets for one 625 mg tablet (doing so doubles the clavulanic acid to 250 mg and causes severe diarrhoea!). Follow physician prescription.
Administration & Meal Timing: MUST be taken AT THE START OF A MEAL! (Taking at the very beginning of breakfast, lunch, and dinner optimises clavulanate absorption and markedly reduces clavulanic-acid-induced gastrointestinal cramping and diarrhoea). | Every 8 hours (with breakfast, lunch, dinner for 625 mg TDS) or every 12 hours (with breakfast and dinner for 625 mg BD / 1000 mg BD).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Strictly renal-function dependent! • Do NOT use the 1000 mg (875/125 mg) tablet if CrCl <30 mL/min! • CrCl 10–30 mL/min: 625 mg (500/125 mg) twice daily. • CrCl <10 mL/min: 625 mg once every 24 hours. Hepatic: Contraindicated in prior co-amoxiclav jaundice; monitor LFTs if used >10–14 days in liver disease.
Renal: Strictly renal-function dependent! • Do NOT use the 1000 mg (875/125 mg) tablet if CrCl <30 mL/min! • CrCl 10–30 mL/min: 625 mg (500/125 mg) twice daily. • CrCl <10 mL/min: 625 mg once every 24 hours. Hepatic: Contraindicated in prior co-amoxiclav jaundice; monitor LFTs if used >10–14 days in liver disease.
Renal: Strictly renal-function dependent! • Do NOT use the 1000 mg (875/125 mg) tablet if CrCl <30 mL/min! • CrCl 10–30 mL/min: 625 mg (500/125 mg) twice daily. • CrCl <10 mL/min: 625 mg once every 24 hours. Hepatic: Contraindicated in prior co-amoxiclav jaundice; monitor LFTs if used >10–14 days in liver disease.
7. Contraindications, Precautions & High-Risk Warnings
- Strictly contraindicated in penicillin/beta-lactam allergy AND in patients with a history of Co-amoxiclav-associated cholestatic jaundice or hepatic dysfunction! Avoid in infectious mononucleosis.
Key Clinical Precautions: Renal: Strictly renal-function dependent! • Do NOT use the 1000 mg (875/125 mg) tablet if CrCl <30 mL/min! • CrCl 10–30 mL/min: 625 mg (500/125 mg) twice daily. • CrCl <10 mL/min: 625 mg once every 24 hours. Hepatic: Contraindicated in prior co-amoxiclav jaundice; monitor LFTs if used >10–14 days in liver disease.
8. Adverse Effects Profile
- Antibiotic-associated diarrhoea (10–25%, driven by clavulanic acid stimulating small-bowel motility and altering flora), nausea, abdominal cramping, mucocutaneous candidiasis (thrush/vaginitis), skin rash.
- Drug-Induced Cholestatic Jaundice / Hepatitis (clavulanic acid idiosyncratic reaction—more common in men and elderly patients >65 years, and can appear during therapy or up to 2 to 6 weeks AFTER completing the course!), anaphylaxis, C. difficile colitis, SJS/TEN.
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Warfarin / Acitrom: Potentiates anticoagulation and causes major INR spikes—check INR within 3–5 days of starting Augmentin! Allopurinol (increased rash)
- Methotrexate (reduced renal clearance)
- Mycophenolate mofetil levels reduced
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: 1. Take right at the start of your meal to prevent loose motions. 2. Blister Moisture Alert: Clavulanic acid is extremely hygroscopic (absorbs humidity from Indian monsoon/summer air and turns soft, sticky, and dark brown, losing all potency)—keep strips sealed inside their outer aluminium desiccant pouch and never pop tablets out into weekly pill boxes in advance! 3. Reconstituted paediatric Augmentin Duo syrups MUST be stored in the refrigerator (2°C–8°C) and discarded after 7 days!
- Meal & Clock Timing Instruction: MUST be taken AT THE START OF A MEAL! (Taking at the very beginning of breakfast, lunch, and dinner optimises clavulanate absorption and markedly reduces clavulanic-acid-induced gastrointestinal cramping and diarrhoea). (Every 8 hours (with breakfast, lunch, dinner for 625 mg TDS) or every 12 hours (with breakfast and dinner for 625 mg BD / 1000 mg BD).)
- Missed Dose Protocol: Take with food as soon as remembered; maintain regular spacing for remaining tablets.
- Geriatric Dispensing Pearl: Elderly men (>65 years) have the highest risk of clavulanate-induced cholestatic jaundice (which may present weeks after finishing the strip) and C. difficile diarrhoea. Avoid the 1000 mg strength if CrCl <30 mL/min.
Storage, Stability & Dispensing Safeguards: COLD CHAIN MANDATORY (2°C–8°C): Store in a pharmaceutical refrigerator between 2°C and 8°C; DO NOT FREEZE. Protect from light and heat during dispensing.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 08 [8.2] (p. 93)
Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.