Amoxicillin + Clavulanic Acid Uses, Dosage, Side Effects | DrugsAtlas
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Therapeutic Class
Antibacterial
Subclass
Penicillin + Beta-lactamase inhibitor combination
Speciality
Infectious Disease
Schedule (India)
Schedule H
Routes
Oral, Intravenous
Formulations
| Form | Strengths (Amoxicillin + Clavulanic Acid) |
|---|---|
| Film-coated Tablets | 500 mg + 125 mg; 875 mg + 125 mg |
| Dispersible Tablets (Paediatric) | 400 mg + 57 mg |
| Oral Suspension | 125 mg + 31.25 mg per 5 mL; 200 mg + 28.5 mg per 5 mL; 400 mg + 57 mg per 5 mL |
| IV Injection (Powder for reconstitution) | 600 mg (500 mg + 100 mg); 1.2 g (1000 mg + 200 mg) |
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Lower Respiratory Tract Infections (Community-acquired pneumonia, Acute exacerbation of COPD)
Oral Dosing:
| Parameter | Recommendation |
|---|---|
| Starting dose | 500 mg + 125 mg every 8 hours OR 875 mg + 125 mg every 12 hours |
| Titration | Not applicable |
| Usual maintenance dose | Same as starting dose |
| Maximum dose | 875 mg + 125 mg every 8 hours (severe cases only) |
| Duration | 5–7 days; extend to 10 days for severe or slow-responding infections |
IV Dosing (Severe/Hospitalised cases):
| Parameter | Recommendation |
|---|---|
| Starting dose | 1.2 g every 8 hours |
| Titration | Increase frequency to every 6 hours if inadequate clinical response |
| Maximum dose | 1.2 g every 6 hours |
| Duration | 5–10 days; step-down to oral when clinically stable |
Clinical Note: Reserve IV for patients unable to tolerate oral intake or with severe pneumonia requiring hospitalization.
2. Acute Bacterial Sinusitis
Oral Dosing:
| Parameter | Recommendation |
|---|---|
| Starting dose | 500 mg + 125 mg every 8 hours OR 875 mg + 125 mg every 12 hours |
| Titration | Not applicable |
| Usual maintenance dose | Same as starting dose |
| Maximum dose | 875 mg + 125 mg every 8 hours |
| Duration | 7–10 days |
Clinical Note: Reserve for patients with symptoms persisting >10 days, severe symptoms, or worsening after initial improvement. Not first-line for viral rhinosinusitis.
3. Urinary Tract Infections (Complicated and Uncomplicated)
Oral Dosing:
| Parameter | Recommendation |
|---|---|
| Starting dose | 500 mg + 125 mg every 8 hours |
| Titration | Not applicable |
| Usual maintenance dose | Same as starting dose |
| Maximum dose | 875 mg + 125 mg every 8 hours (complicated UTI) |
| Duration | 5–7 days (uncomplicated); 10–14 days (complicated/pyelonephritis) |
IV Dosing (Severe UTI/Urosepsis):
| Parameter | Recommendation |
|---|---|
| Starting dose | 1.2 g every 8 hours |
| Maximum dose | 1.2 g every 6 hours |
| Duration | Until clinical improvement, then step-down to oral; total 10–14 days |
Clinical Note: Not first-line for uncomplicated cystitis; use only if susceptibility confirmed or beta-lactamase producing organisms suspected.
4. Skin and Soft Tissue Infections (Including cellulitis, infected wounds, diabetic foot infections)
Oral Dosing (Mild–Moderate):
| Parameter | Recommendation |
|---|---|
| Starting dose | 500 mg + 125 mg every 8 hours |
| Titration | Not applicable |
| Usual maintenance dose | Same as starting dose |
| Maximum dose | 875 mg + 125 mg every 8 hours |
| Duration | 7–10 days |
IV Dosing (Severe/Diabetic foot):
| Parameter | Recommendation |
|---|---|
| Starting dose | 1.2 g every 8 hours |
| Titration | May increase to every 6 hours for severe infections |
| Maximum dose | 1.2 g every 6 hours |
| Duration | 7–14 days; may extend for diabetic foot infections based on response |
5. Dental Infections (Acute odontogenic infections, dental abscess)
Oral Dosing:
| Parameter | Recommendation |
|---|---|
| Starting dose | 500 mg + 125 mg every 8 hours |
| Titration | Not applicable |
| Usual maintenance dose | Same as starting dose |
| Maximum dose | 875 mg + 125 mg every 8 hours (severe) |
| Duration | 5–7 days |
Clinical Note: Should accompany definitive dental treatment (drainage/extraction). Not a substitute for source control.
6. Bone and Joint Infections (Mild–Moderate osteomyelitis, septic arthritis)
IV-to-Oral Step-Down Approach:
| Phase | Dosing |
|---|---|
| IV Phase | 1.2 g every 8 hours until clinical improvement (typically 1–2 weeks) |
| Oral Step-down | 500 mg + 125 mg every 8 hours OR 875 mg + 125 mg every 12 hours |
| Maximum oral dose | 875 mg + 125 mg every 8 hours |
| Total Duration | 2–6 weeks (osteomyelitis may require longer courses under specialist guidance) |
Clinical Note: Requires microbiological guidance; use in combination therapy may be necessary. Specialist supervision recommended.
Secondary Indications — Adults (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Animal/Human bite wounds (mild–moderate) | 500 mg + 125 mg orally every 8 hours | 5–7 days | OFF-LABEL. Supported by IDSA guidelines for polymicrobial and anaerobic coverage including Pasteurella and oral flora |
| Infective endocarditis prophylaxis (dental procedures in high-risk cardiac patients) | 2 g Amoxicillin equivalent as single dose 1 hour before procedure | Single dose | OFF-LABEL. Specialist only. Based on AHA/ESC guidelines adapted in Indian cardiology practice; clavulanic acid component optional |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Acute Otitis Media / Sinusitis / LRTI / UTI
Weight-based Dosing Table (Amoxicillin component):
| Weight | Formulation | Standard Dose | High-Dose (Resistant pathogens/Severe) | Frequency |
|---|---|---|---|---|
| <40 kg | Oral suspension | 20–40 mg/kg/day | 80–90 mg/kg/day | Divided into 3 doses (standard) or 2 doses (high-dose) |
| ≥40 kg | Adult tablets | Use adult dosing | Use adult dosing | As per adult schedule |
Dosing Parameters:
| Parameter | Recommendation |
|---|---|
| Starting dose | 20–25 mg/kg/day (Amoxicillin component) divided TDS |
| Titration | Not applicable |
| Usual maintenance dose | 25–40 mg/kg/day divided TDS |
| Maximum dose | 90 mg/kg/day (Amoxicillin); Clavulanic acid not to exceed 10 mg/kg/day |
| Duration | 5–10 days depending on indication and severity |
Suspension Selection Guide:
| Child Weight | Suggested Formulation | Typical Dose |
|---|---|---|
| 3–6 kg | 125 mg + 31.25 mg/5 mL | 2.5 mL TDS |
| 7–12 kg | 200 mg + 28.5 mg/5 mL | 2.5–5 mL BD (high-dose) |
| 13–20 kg | 400 mg + 57 mg/5 mL | 5 mL BD |
| 21–40 kg | 400 mg + 57 mg/5 mL | 5–10 mL BD or use tablets |
Neonatal Sepsis (Hospital use only — Specialist supervision mandatory)
| Parameter | Recommendation |
|---|---|
| IV dose (Amoxicillin component) | 25–50 mg/kg/dose |
| Frequency | Every 12 hours (may extend to every 8 hours in infants >7 days and >2 kg) |
| Monitoring | Renal function, electrolytes; watch for NEC risk in preterm neonates |
| Duration | As per culture/sensitivity and clinical response; typically 7–14 days |
Secondary Indications — Paediatrics (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Post-splenectomy prophylaxis in sickle cell disease | 20 mg/kg/day (Amoxicillin equivalent) divided BD | Short-term prophylaxis | OFF-LABEL. Specialist only. Based on tertiary centre protocols (AIIMS/CMC Vellore). Amoxicillin monotherapy often preferred |
Age Restrictions and Safety
| Age Group | Recommendation |
|---|---|
| <2 months | Not recommended for oral suspension unless under specialist supervision |
| 2 months to 2 years | Oral suspension appropriate; dose per weight |
| ≥2 years | Oral suspension or dispersible tablets |
| Tablet use | Only for children ≥20 kg who can safely swallow tablets whole |
Safety Monitoring in Paediatrics:
- Monitor stool frequency (risk of AAD/C. difficile)
- Observe for rash or allergic manifestations
- Assess hydration status
- LFTs if treatment >10 days or repeated courses
Renal Adjustments
| eGFR (mL/min) | Dose Recommendation |
|---|---|
| ≥30 | No adjustment required |
| 10–29 | 500 mg + 125 mg every 12 hours (reduce frequency) |
| <10 | 500 mg + 125 mg once daily; consider Amoxicillin monotherapy to avoid clavulanic acid accumulation |
| Haemodialysis | Dose after dialysis session; 500 mg + 125 mg post-dialysis; additional dose if prolonged dialysis |
| Peritoneal dialysis | 500 mg + 125 mg once daily |
Clinical Note: Clavulanic acid accumulation poses greater concern than Amoxicillin in renal impairment. Switch to Amoxicillin alone if beta-lactamase coverage not essential.
Hepatic adjustment
Contraindications
- Known hypersensitivity to Amoxicillin, Clavulanic acid, or any penicillin
- History of severe hypersensitivity (anaphylaxis) to any beta-lactam antibiotic (penicillins, cephalosporins, carbapenems)
- Previous cholestatic jaundice or hepatic dysfunction associated with Amoxicillin-Clavulanic acid use
- Infectious mononucleosis (high risk of maculopapular rash)
Cautions
- History of non-severe penicillin allergy (monitor closely; cross-reactivity risk ~1–2%)
- Pre-existing hepatic disease — increased risk of hepatotoxicity
- Renal impairment — requires dose adjustment; risk of clavulanic acid accumulation
- Concurrent allopurinol use — elevated risk of skin rash
- Prolonged therapy (>14 days) — increased risk of superinfection and hepatotoxicity
- History of antibiotic-associated colitis or GI disease
- Phenylketonuria — some oral suspension formulations contain aspartame
Pregnancy
| Parameter | Recommendation |
|---|---|
| Overall safety | Generally considered safe; no teratogenic effects documented |
| Risk category | Category B (US FDA historical); Not restricted in India unless contraindicated |
| Preferred status | Preferred beta-lactam combination when coverage against beta-lactamase producers required |
| When to use | When benefit outweighs risk; first-line for many infections in pregnancy (UTI, respiratory) |
| Monitoring | Monitor for rash, GI intolerance; foetal monitoring as per routine antenatal care |
| Alternatives | Amoxicillin alone if beta-lactamase coverage not essential |
Lactation
| Parameter | Recommendation |
|---|---|
| Compatibility | Compatible with breastfeeding |
| Milk levels | Low concentrations excreted; clinically insignificant for infant |
| Infant monitoring | Observe for loose stools, oral thrush, nappy rash, or allergic reactions |
| Need to interrupt feeding | No; continue breastfeeding |
| Alternative | Amoxicillin alone if minimal coverage required |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | Standard adult dosing if renal function normal; start at lower end of IV dosing range |
| Titration | Not applicable |
| Dose adjustment | Adjust based on eGFR; avoid high-dose regimens unless necessary |
| Specific risks | Higher susceptibility to hepatotoxicity; GI intolerance more common; monitor hydration status |
| Monitoring | Check renal function before initiating; LFTs if therapy >7 days; watch for signs of C. difficile colitis |
Major drug interactions
| Drug | Interaction | Recommendation |
|---|---|---|
| Methotrexate | Reduced renal clearance of methotrexate → risk of haematological and GI toxicity | Avoid combination; if unavoidable, monitor methotrexate levels and CBC closely |
| Warfarin | Enhanced anticoagulant effect; elevated INR | Monitor INR closely during and for 3–5 days after antibiotic course; adjust warfarin dose as needed |
| Allopurinol | Significantly increased incidence of maculopapular rash | Avoid combination if possible; if essential, warn patient and monitor for rash |
Moderate drug interactions
| Drug | Interaction | Recommendation |
|---|---|---|
| Probenecid | Inhibits renal tubular secretion of Amoxicillin → increased and prolonged plasma levels | May be used intentionally for dose-sparing; otherwise monitor for toxicity |
| Oral contraceptives | Theoretical reduction in efficacy via GI flora alteration (not well substantiated) | Advise additional barrier contraception during antibiotic course and for 7 days after |
| Mycophenolate mofetil | Reduced AUC of active metabolite (mycophenolic acid) | Monitor for transplant rejection; may need temporary MMF dose increase |
| Acenocoumarol | Similar to warfarin; enhanced anticoagulation | Monitor INR |
Common Adverse effects
- Diarrhoea (most frequent; attributed to clavulanic acid)
- Nausea and vomiting
- Abdominal discomfort and bloating
- Skin rash (non-serious, maculopapular)
- Oral candidiasis (thrush)
- Vulvovaginal candidiasis
- Headache
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
| Cholestatic jaundice/hepatitis | May occur during or up to 6 weeks post-treatment; more common in elderly and with prolonged use; discontinue immediately |
| Anaphylaxis | Rare; requires immediate adrenaline and supportive care; contraindication to future use |
| Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis | Very rare; discontinue and hospitalise |
| Clostridioides difficile-associated diarrhoea | May present during or after treatment; stop antibiotic; consider metronidazole or vancomycin |
| Seizures | Risk with very high doses or in severe renal impairment with accumulation |
| Interstitial nephritis | Rare; presents with fever, rash, eosinophilia, rising creatinine |
| Haemolytic anaemia | Very rare; Coombs-positive |
Monitoring requirements
| Phase | Parameters |
|---|---|
| Baseline | Serum creatinine/eGFR; LFTs (ALT, AST, ALP, bilirubin) if prolonged use anticipated; allergy history |
| During treatment | Clinical response; GI tolerance; signs of hypersensitivity; stool pattern (for C. difficile) |
| Prolonged use (>10–14 days) | Repeat LFTs weekly; monitor for superinfection |
| Renal impairment | Monitor eGFR and adjust dose accordingly |
| Post-treatment | Watch for delayed cholestatic jaundice (up to 6 weeks) |
Brands in India
| Brand Name | Manufacturer |
|---|---|
| Augmentin | GlaxoSmithKline |
| Clavam | Alkem |
| Moxclav | Cipla |
| Clamp | Aristo |
| Curam | Sandoz |
| Advent | Cipla |
| Mega-CV | Aristo |
| Amoxyclav | Various (generic) |
| Formulation | Approximate Price |
|---|---|
| Tablet 500 mg + 125 mg (1 tablet) | ₹12–₹28 |
| Tablet 875 mg + 125 mg (1 tablet) | ₹25–₹45 |
| Oral Suspension 30 mL | ₹35–₹60 |
| Oral Suspension 60 mL | ₹50–₹90 |
| IV 1.2 g vial | ₹90–₹180 |
| IV 600 mg vial | ₹55–₹100 |
Regulatory Note: Listed under NLEM 2022; prices regulated by NPPA for scheduled formulations.
Clinical pearls
- Dose by Amoxicillin component: Always prescribe and calculate doses based on the Amoxicillin content; clavulanic acid should not exceed 10 mg/kg/day in children to minimise GI side effects.
- Refrigeration mandatory: Reconstituted oral suspensions must be stored at 2–8°C and discarded after 7 days.
- GI tolerance trick: Administer at the start of meals to reduce nausea and diarrhoea; the 875 mg BD formulation causes fewer GI symptoms than 500 mg TDS despite equal total daily Amoxicillin.
- Reserve for resistant organisms: Not first-line for uncomplicated infections where Amoxicillin alone would suffice; reserve for suspected or confirmed beta-lactamase producers.
- Hepatic vigilance: Risk of cholestatic hepatitis is higher than with Amoxicillin alone; prefer monotherapy in patients with hepatic risk factors.
- Renal impairment caution: In significant renal impairment, consider switching to Amoxicillin monotherapy to avoid clavulanic acid accumulation, which is primarily responsible for GI and hepatic toxicity.
Version
RxIndia v1.0 — 06 Apr 2025
Reference
-
- CDSCO Drug Database and Product Inserts
- Indian Pharmacopoeia 2022
- National List of Essential Medicines (NLEM) 2022
- AIIMS Antimicrobial Prescribing Guidelines
- API Textbook of Medicine (11th Edition)
- IAP Drug Formulary and Treatment Guidelines
- ICMR Treatment Guidelines for Antimicrobial Use
- PGI Chandigarh and CMC Vellore Hospital Protocols
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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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