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Amoxicillin + Clavulanic Acid Uses, Dosage, Side Effects | DrugsAtlas

Authoritative Clinical Reference

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)

Price range (INR)

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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