Schedule H

Intravenous, Oral

• Injection (powder for reconstitution): 250 mg, 500 mg, 1 g vials (as vancomycin hydrochloride)

• Oral capsules: 125 mg, 250 mg (as vancomycin hydrochloride)

• Oral powder for solution: 250 mg sachet (for oral use/compounding)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Serious Gram-Positive Infections (MRSA bacteraemia, infective endocarditis, osteomyelitis, hospital-acquired pneumonia, skin and soft tissue infections)

Route: Intravenous

Parameter Dose Clinical Notes

Loading dose (critically ill) 25–30 mg/kg IV (based on actual body weight) Single dose; infuse over 2 hours; use in sepsis, meningitis, endocarditis

Starting dose 15–20 mg/kg IV every 8–12 hours Based on actual body weight; round to nearest 250 mg

Titration Adjust based on trough concentration Target trough: 15–20 μg/mL for serious infections; 10–15 μg/mL for less severe infections

Usual maintenance dose 15–20 mg/kg IV every 8–12 hours Typically 1–1.5 g every 12 hours in adults with normal renal function

Maximum dose Individualised; up to 4 g/day may be required Only with therapeutic drug monitoring (TDM)

Duration: Bacteraemia: minimum 14 days; Endocarditis: 4–6 weeks; Osteomyelitis: 4–6 weeks; Pneumonia: 7–21 days depending on severity.

1. Clostridioides difficile Infection (CDI) / Clostridioides difficile-Associated Diarrhoea (CDAD)

Route: Oral ONLY (IV vancomycin is NOT effective for CDI)

Severity Dose Duration Clinical Notes

Non-severe (initial episode) 125 mg orally every 6 hours 10 days First-line therapy per ICMR-AMR guidelines

Severe infection 125 mg orally every 6 hours 10–14 days May increase to 250 mg every 6 hours if inadequate response

Fulminant/Severe-complicated (with ileus, megacolon, shock) 500 mg orally every 6 hours + 500 mg in 100 mL NS per rectum every 6 hours 10–14 days Add IV metronidazole 500 mg every 8 hours; surgical consultation

First recurrence 125 mg orally every 6 hours (if standard regimen used initially) OR fidaxomicin if available 10 days Consider pulsed/tapered regimen for recurrence

Dosing Summary (Oral CDI):

• Starting dose: 125 mg orally every 6 hours

• Titration: Increase to 250–500 mg every 6 hours based on severity and response

• Usual maintenance dose: 125 mg every 6 hours

• Maximum dose: 500 mg every 6 hours (2 g/day)

1. Bacterial Meningitis (MRSA or Penicillin-Resistant Pneumococcal Meningitis)

Parameter Dose Clinical Notes

Starting dose 15–20 mg/kg IV every 8–12 hours Use with loading dose in critically ill

Titration Target trough 15–20 μg/mL CNS penetration is limited; higher troughs needed

Usual maintenance dose 15–20 mg/kg IV every 8–12 hours Often combined with ceftriaxone or rifampicin

Maximum dose Up to 60 mg/kg/day in divided doses

Duration 10–14 days minimum Based on organism and clinical response

1. Surgical Prophylaxis (MRSA-colonised patients or beta-lactam allergy)

Parameter Dose Clinical Notes

Starting dose 15 mg/kg IV (maximum 2 g) Single pre-operative dose

Titration Not applicable

Usual maintenance dose Not applicable Single dose prophylaxis

Maximum dose 2 g

Timing Start infusion 60–120 minutes before incision Allows adequate tissue levels at incision time

Note: Not routine first-line for surgical prophylaxis; reserved for documented MRSA colonisation or severe beta-lactam allergy.

Secondary Indications — Adults (Off-label, if any)

1. Enterococcal Endocarditis (Ampicillin-resistant, Vancomycin-susceptible strains) — OFF-LABEL

Parameter Details

Indication Enterococcal endocarditis when ampicillin cannot be used

Dose 15 mg/kg IV every 12 hours (with gentamicin synergy)

Duration 6 weeks

Specialist only Yes — Infectious diseases/Cardiology

Evidence basis ICMR-AMR protocols; Indian tertiary care hospital experience

1. Continuous Ambulatory Peritoneal Dialysis (CAPD)-Related Peritonitis — OFF-LABEL

Parameter Details

Indication Gram-positive CAPD peritonitis

Dose 15–30 mg/kg intraperitoneally in one exchange daily OR 25 mg/L in each exchange (continuous dosing)

Duration 14–21 days based on organism

Specialist only Yes — Nephrology

Evidence basis ISPD guidelines; Indian nephrology practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

1. Serious Gram-Positive Infections (MRSA, Coagulase-negative Staphylococci, Resistant Pneumococci)

Route: Intravenous

Neonates (0–7 days) 15 mg/kg IV Every 12 hours 30 mg/kg/day Monitor trough levels; prolonged half-life in neonates

Neonates (8–28 days) 15 mg/kg IV Every 8–12 hours 45 mg/kg/day Adjust based on gestational and postnatal age

Infants (1–12 months) 15 mg/kg IV Every 6–8 hours 60 mg/kg/day Target trough 10–20 μg/mL

Children (1–12 years) 15 mg/kg IV Every 6 hours 60 mg/kg/day (max 2 g/day)

Adolescents (>12 years) 15 mg/kg IV Every 6–8 hours 60 mg/kg/day (max 4 g/day) Use adult dosing principles

Dosing Summary:

• Starting dose: 15 mg/kg IV (weight-based)

• Titration: Adjust based on trough concentration (target 10–20 μg/mL; 15–20 μg/mL for serious infections)

• Usual maintenance dose: 40–60 mg/kg/day in 3–4 divided doses

• Maximum dose: 60 mg/kg/day; not exceeding 4 g/day

1. Clostridioides difficile Infection (Oral)

Children ≥1 year 10 mg/kg orally Every 6 hours 125 mg per dose (500 mg/day) 10 days

Severe/Refractory cases 10 mg/kg orally Every 6 hours Up to 40 mg/kg/day 10–14 days

1. Bacterial Meningitis (CNS MRSA or Resistant Pneumococci)

Parameter Dose Comments

Starting dose 15 mg/kg IV every 6 hours Combined with third-generation cephalosporin

Titration Target trough 15–20 μg/mL

Usual maintenance dose 60 mg/kg/day in 4 divided doses

Maximum dose 60 mg/kg/day (max 4 g/day)

Duration 10–14 days minimum

Secondary Indications — Paediatrics (Off-label, if any)

Shunt Infections / CNS Device-Related Infections — OFF-LABEL

Parameter Details

Indication VP shunt infections with Gram-positive organisms

Dose 15 mg/kg IV every 6 hours (may require intrathecal/intraventricular vancomycin 5–20 mg/day in select cases)

Duration 10–21 days based on organism and response

Specialist only Yes — Paediatric infectious diseases/Neurosurgery

Evidence basis Indian paediatric neurosurgery protocols

Not recommended below 1 month of age except under neonatology/paediatric infectious disease specialist supervision with mandatory therapeutic drug monitoring.

60 No adjustment 15–20 mg/kg every 8–12 hours Trough before 4th dose

40–60 No adjustment 15–20 mg/kg every 12 hours Trough levels essential

20–39 No adjustment 15–20 mg/kg every 24 hours Monitor trough before each dose initially

10–19 No adjustment 15–20 mg/kg every 24–48 hours Levels-guided dosing mandatory

<10 (non-dialysis) No adjustment 15–20 mg/kg every 48–96 hours Re-dose based on trough <15–20 μg/mL

Haemodialysis (conventional) 25–30 mg/kg loading 500 mg–1 g after each dialysis session Check pre-dialysis trough; re-dose if <15 μg/mL

Haemodialysis (high-flux) 25–30 mg/kg loading May need 1–1.5 g after each session More drug removed; level-guided dosing

CAPD 15–30 mg/kg IP loading 25 mg/L in each exchange OR 15–30 mg/kg IP once daily in long dwell Specialist guidance

CRRT 15–20 mg/kg loading 7.5–10 mg/kg every 12 hours Highly variable clearance; frequent TDM

• Known hypersensitivity to vancomycin or any component of the formulation

• History of severe allergic reaction (anaphylaxis) to vancomycin

• Intrathecal/Intraventricular administration is generally contraindicated due to severe neurotoxicity (except in selected CNS infections under specialist supervision with specific preservative-free preparations)

• Renal impairment — increased risk of nephrotoxicity and drug accumulation; dose adjustment and TDM mandatory

• Concurrent use of other nephrotoxic agents (aminoglycosides, amphotericin B, NSAIDs, contrast media)

• Concurrent use of ototoxic agents (aminoglycosides, loop diuretics)

• Pre-existing hearing impairment — increased ototoxicity risk

• Rapid intravenous infusion — causes Red Man Syndrome (histamine-mediated flushing, hypotension)

• Obesity — dose based on actual body weight; increased volume of distribution may require loading dose and TDM

• Elderly — reduced renal reserve increases toxicity risk

• Prolonged therapy (>7 days) — monitor for neutropenia

• Inflammatory bowel disease — increased systemic absorption of oral vancomycin possible

Aspect Recommendation

Risk category Generally considered safe; crosses placenta; no confirmed teratogenicity in human data

Use in pregnancy Use when clearly indicated for serious Gram-positive infections; preferred over aminoglycosides in pregnancy when glycopeptide indicated

Preferred alternatives Beta-lactams (if susceptible); clindamycin for MRSA skin infections

When to use Serious MRSA infections, penicillin/cephalosporin allergy with severe Gram-positive infection

Monitoring Maternal renal function; therapeutic drug monitoring; fetal auditory assessment in prolonged high-dose therapy (limited data on fetal ototoxicity)

Aspect Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low; poor oral absorption limits infant systemic exposure

Preferred alternatives None specifically required; vancomycin acceptable when indicated

Recommendations Continue breastfeeding; no special timing of feeds required

Infant monitoring Observe for GI disturbances (diarrhoea, oral thrush) — rare

Aspect Recommendation

Starting dose 15 mg/kg IV every 12 hours (lower frequency initially)

Titration Guided by trough levels and renal function

Special considerations Age-related decline in renal function is common; calculate eGFR and adjust accordingly

Extra risks Increased nephrotoxicity and ototoxicity risk; accumulation more likely; Red Man Syndrome may be more pronounced

Monitoring Baseline and serial renal function; trough levels before 4th dose and after any dose adjustment; baseline hearing assessment in prolonged therapy

Drug Interaction Management

Aminoglycosides (gentamicin, amikacin) Additive nephrotoxicity and ototoxicity Avoid concurrent use if possible; if essential, monitor renal function and drug levels closely

Amphotericin B Synergistic nephrotoxicity Avoid combination; if required, monitor renal function daily

IV Loop diuretics (furosemide) Increased ototoxicity risk Use with caution; monitor hearing in prolonged therapy

Colistin Additive nephrotoxicity Avoid or use with extreme caution; frequent renal monitoring

Neuromuscular blocking agents (vecuronium, rocuronium) Enhanced neuromuscular blockade Monitor closely during anaesthesia; may need dose adjustment of NMB

Drug Interaction Management

Piperacillin-tazobactam Increased acute kidney injury risk (controversial but observed in multiple studies) Monitor renal function every 2–3 days when combined; some centres avoid combination

NSAIDs Additive nephrotoxicity with prolonged use Monitor renal function; avoid prolonged concurrent use

Cyclosporine / Tacrolimus Additive nephrotoxicity Monitor renal function and calcineurin inhibitor levels closely

Tenofovir Additive nephrotoxicity Monitor renal function

Contrast media (IV) Additive nephrotoxicity Ensure adequate hydration; space administration if possible

Warfarin Possible enhanced anticoagulant effect (mechanism unclear) Monitor INR; particularly with prolonged vancomycin courses

• Red Man Syndrome (flushing, erythema, pruritus, hypotension) — infusion rate-related; up to 10% incidence

• Phlebitis/Thrombophlebitis at injection site (peripheral IV use)

• Nephrotoxicity (elevated creatinine) — dose and duration dependent

• Nausea and vomiting

• Fever and chills

• Rash (maculopapular, non-allergic)

• Local pain at infusion site

Adverse Effect Clinical Notes

Anaphylaxis Rare but life-threatening; discontinue immediately; manage as anaphylactic emergency

Stevens-Johnson Syndrome / TEN Very rare; discontinue immediately if mucocutaneous lesions develop

Acute interstitial nephritis May present as fever, rash, eosinophilia, rising creatinine; discontinue and evaluate

Ototoxicity (hearing loss, tinnitus, vertigo) May be irreversible; risk increased with high troughs, prolonged therapy, concurrent ototoxic agents

Neutropenia Occurs with prolonged therapy (>7–14 days); reversible on discontinuation; monitor CBC weekly

Thrombocytopenia Rare; immune-mediated; discontinue if confirmed

Linear IgA bullous dermatosis (vancomycin-induced) Rare drug-induced bullous eruption; discontinue immediately

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Rare; fever, rash, hepatitis, eosinophilia; discontinue and hospitalize

Action: Discontinue vancomycin immediately if anaphylaxis, severe cutaneous reactions, or significant worsening of renal/auditory function occurs.

Therapeutic Drug Monitoring Trough concentration (drawn 30 minutes before 4th or 5th dose): Target 10–15 μg/mL for less severe infections; 15–20 μg/mL for serious infections (bacteraemia, endocarditis, osteomyelitis, meningitis, HAP)

After initiation/dose change Repeat trough level 3–5 days after dose change; recheck if renal function changes

During therapy Serum creatinine every 2–3 days (stable patients); daily in critically ill or those on concomitant nephrotoxins

Prolonged therapy (>7 days) CBC weekly (monitor for neutropenia); periodic audiometry if high-dose or prolonged therapy

Infusion monitoring Monitor for Red Man Syndrome during infusion; slow infusion rate if symptoms occur

Target AUC/MIC: Some centres use AUC-guided dosing (target AUC₂₄/MIC ≥400) for improved outcomes; requires specialized software or pharmacist input.

• Vancocin (Lupin)

• Vancomycin (Cipla)

• Vancop (Sun Pharma)

• Vancolon (Alkem)

• Vancopure (Aristo)

• Vanlid (Cipla) — oral formulation

• Vancogen (Glenmark)

• Vancostar (Mankind)

• Vancokem (Alkem)

• Multiple other generic manufacturers

Note: No significant FDCs available or recommended.

• Listed in NLEM 2022 (injection form)

• Subject to NPPA price regulation for scheduled formulations

• Government supply available through public health facilities

1. Oral vancomycin for CDI only — IV vancomycin does not achieve therapeutic gut concentrations and is ineffective for C. difficile infection. Oral formulation or IV preparation given orally is required.

1. Infuse slowly to prevent Red Man Syndrome — infuse over at least 60 minutes (preferably 90–120 minutes for doses >1 g). If reaction occurs, stop infusion, give antihistamines, and restart at slower rate.

1. Weight-based dosing is essential — use actual body weight for initial dosing. In obese patients (>30% above ideal body weight), consider using adjusted body weight and loading doses with TDM.

1. Therapeutic drug monitoring is mandatory — vancomycin has a narrow therapeutic index; target trough 15–20 μg/mL for serious infections. Sub-therapeutic levels contribute to treatment failure and resistance development.

1. Monitor renal function vigilantly — especially when combined with piperacillin-tazobactam, aminoglycosides, or other nephrotoxins. Rising creatinine requires dose adjustment or alternative therapy.

1. Loading doses improve outcomes in critically ill — a 25–30 mg/kg loading dose (maximum 3 g) achieves therapeutic levels faster in sepsis, meningitis, and endocarditis; infuse over 2 hours minimum.

1. Neutropenia with prolonged use — check CBC weekly if therapy extends beyond 7–10 days; neutropenia is usually reversible upon discontinuation.

vancomycin; glycopeptide; MRSA; Gram-positive; C. difficile; CDI; nephrotoxicity; therapeutic drug monitoring; TDM; Red Man Syndrome; NLEM India; ICU antibiotic; Schedule H

RxIndia v1.1 — 17 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• ICMR Treatment Guidelines for Antimicrobial Use

• AIIMS Antibiotic Policy and Treatment Protocols

• Hospital antimicrobial guidelines (PGIMER Chandigarh, CMC Vellore, AIIMS Delhi)

• IAP Guidelines on Antimicrobial Use in Children

• ISPD Peritonitis Guidelines (for CAPD dosing)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)