Schedule H

Oral, Intravenous

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)

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.

1. 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.

1. 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.

1. 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

1. Dental Infections (Acute odontogenic infections, dental abscess)

Oral Dosing:

Parameter Recommendation

Starting dose 500 mg + 125 mg every 8 hours

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

Clinical Note: Clavulanic acid accumulation poses greater concern than Amoxicillin in renal impairment. Switch to Amoxicillin alone if beta-lactamase coverage not essential.

Monitoring: Check ALT, AST, alkaline phosphatase, and bilirubin at baseline and periodically during treatment. Discontinue immediately if jaundice or hepatitis develops.

Note: Cholestatic jaundice may occur during or up to several weeks after completing therapy.

• 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)

• 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

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

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

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

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

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

• 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

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

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)

Brand Name Manufacturer

Augmentin GlaxoSmithKline

Clavam Alkem

Moxclav Cipla

Clamp Aristo

Curam Sandoz

Advent Cipla

Mega-CV Aristo

Amoxyclav Various (generic)

Regulatory Note: Listed under NLEM 2022; prices regulated by NPPA for scheduled formulations.

1. 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.

1. Refrigeration mandatory: Reconstituted oral suspensions must be stored at 2–8°C and discarded after 7 days.

1. 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.

1. Reserve for resistant organisms: Not first-line for uncomplicated infections where Amoxicillin alone would suffice; reserve for suspected or confirmed beta-lactamase producers.

1. Hepatic vigilance: Risk of cholestatic hepatitis is higher than with Amoxicillin alone; prefer monotherapy in patients with hepatic risk factors.

1. 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.

antibiotic; beta-lactam; co-amoxiclav; penicillin-combination; respiratory-infection; UTI; paediatric-use; hepatic-caution; Schedule-H; NLEM-India

RxIndia v1.0 — 06 Apr 2025

• 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