Schedule H

Intravenous, Intramuscular

• Injection (powder for reconstitution): 200 mg, 400 mg vials (as teicoplanin)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

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

Route: Intravenous (preferred) or Intramuscular (for mild-moderate infections)

Standard Dosing (Adults ≥60 kg):

Parameter Dose Clinical Notes

Loading dose 400 mg IV every 12 hours × 3 doses (Day 1–2) Total 3 loading doses over first 24–48 hours

Starting maintenance dose 400 mg IV/IM once daily Begin after loading doses completed

Titration Based on trough levels and clinical response Target trough: 15–30 μg/mL for serious infections

Usual maintenance dose 400 mg once daily For most infections

Maximum dose 12 mg/kg/day (up to 800 mg/day in severe infections) For endocarditis, osteomyelitis, severe sepsis

Weight-Based Dosing (Adults <60 kg):

Parameter Dose Clinical Notes

Loading dose 6 mg/kg IV every 12 hours × 3 doses

Starting maintenance dose 6 mg/kg IV/IM once daily

Titration Based on trough levels Target trough: 15–30 μg/mL

Usual maintenance dose 6 mg/kg once daily

Maximum dose 12 mg/kg/day For severe/complicated infections

Duration by Infection Type:

• Skin and soft tissue infections: 7–14 days

• Bacteraemia: 14–21 days minimum

• Osteomyelitis: 4–6 weeks

• Infective endocarditis: 4–6 weeks

Note: Administer IV infusion over 30 minutes minimum. IM route acceptable for mild-moderate infections when IV access limited.

1. Febrile Neutropenia with Suspected Gram-Positive Infection

Parameter Dose Clinical Notes

Loading dose 6 mg/kg IV every 12 hours × 3 doses

Starting maintenance dose 6 mg/kg IV once daily

Titration Not applicable Fixed dosing regimen

Usual maintenance dose 6 mg/kg once daily

Maximum dose 12 mg/kg/day

Duration Until neutropenia resolves or infection controlled Minimum 7–10 days

1. Surgical Prophylaxis (MRSA-colonised patients or high MRSA prevalence settings)

Parameter Dose Clinical Notes

Starting dose 400 mg IV single dose Alternative: 6 mg/kg if <60 kg

Titration Not applicable Single dose prophylaxis

Usual maintenance dose Not applicable

Maximum dose 400 mg

Timing 60–120 minutes before surgical incision Allows adequate tissue penetration

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

1. Clostridioides difficile Infection (CDI) — Severe/Refractory Cases — OFF-LABEL

Parameter Details

Indication Severe or refractory CDI when oral vancomycin unavailable or failed

Route Oral only (IV teicoplanin NOT effective for CDI)

Starting dose 100 mg orally every 6 hours

Titration May increase to 200 mg every 6 hours based on response

Usual dose 100–200 mg orally every 6 hours

Maximum dose 200 mg every 6 hours (800 mg/day)

Duration 10–14 days

Specialist only Yes — Infectious diseases/Gastroenterology

Evidence basis Indian tertiary care experience; limited international data; used when oral vancomycin unavailable

1. CAPD-Related Peritonitis (Gram-positive organisms) — OFF-LABEL

Parameter Details

Indication Peritoneal dialysis-related peritonitis

Dose 400 mg IP loading, then 20 mg/L in each exchange

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, Enterococci)

Route: Intravenous

Neonates (0–28 days) 16 mg/kg IV once on Day 1 8 mg/kg IV once daily 8 mg/kg/day Infuse over 30–60 min; monitor levels

Infants (1–12 months) 10 mg/kg IV every 12 hours × 3 doses 6–10 mg/kg IV once daily 10 mg/kg/day

Children (1–12 years) 10 mg/kg IV every 12 hours × 3 doses 6–10 mg/kg IV once daily 10 mg/kg/day

Adolescents (>12 years) 10 mg/kg IV every 12 hours × 3 doses (max 400 mg/dose) 6–10 mg/kg IV once daily (max 400 mg) 12 mg/kg/day Use adult dosing if >60 kg

Dosing Summary:

• Starting dose: 10 mg/kg IV every 12 hours × 3 loading doses (neonates: 16 mg/kg single loading dose)

• Titration: Based on trough levels (target 10–30 μg/mL; 15–30 μg/mL for serious infections)

• Usual maintenance dose: 6–10 mg/kg IV once daily

• Maximum dose: 10–12 mg/kg/day

Duration: As per adult guidance based on infection type.

1. Febrile Neutropenia (Gram-positive coverage)

Parameter Dose Comments

Loading dose 10 mg/kg IV every 12 hours × 3 doses

Maintenance dose 10 mg/kg IV once daily

Duration Until neutropenia resolves or source controlled

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

Clostridioides difficile Infection (Severe/Refractory) — OFF-LABEL

Parameter Details

Indication Severe or refractory paediatric CDI

Dose 10–20 mg/kg/day orally in 3–4 divided doses

Maximum dose 400 mg/day

Duration 10–14 days

Specialist only Yes — Paediatric infectious diseases/Gastroenterology

Evidence basis Limited data; extrapolated from adult practice; used in Indian tertiary centres when oral vancomycin unavailable

Not recommended below 7 days of age except under neonatology/paediatric infectious disease specialist supervision due to immature renal function and drug accumulation risk.

60 No adjustment No adjustment Standard monitoring

40–60 No adjustment Standard dose every 48 hours Check trough levels

<40 No adjustment Standard dose every 72 hours TDM mandatory; target trough 15–30 μg/mL

Haemodialysis No adjustment Dose after dialysis only if trough <15 μg/mL Not significantly removed by HD; check pre-dialysis trough

CAPD Loading as standard 20 mg/L in each exchange OR systemic dose every 72 hours Specialist guidance; monitor levels

CRRT No adjustment to loading Maintenance based on trough levels Highly variable clearance; frequent TDM

Teicoplanin is not primarily hepatically metabolised; excreted largely unchanged by kidneys.

• Known hypersensitivity to teicoplanin

• History of severe allergic reaction to other glycopeptide antibiotics (vancomycin) — consider cross-reactivity risk

• Previous teicoplanin-induced severe thrombocytopenia

• Previous teicoplanin-induced ototoxicity

• Pre-existing renal impairment — increased accumulation risk; dose adjustment and TDM required

• Concurrent nephrotoxic or ototoxic agents (aminoglycosides, loop diuretics, amphotericin B, cisplatin)

• Pre-existing hearing impairment — increased ototoxicity risk

• Prolonged therapy (>10 days) — monitor for haematological toxicity (thrombocytopenia, neutropenia)

• Rapid IV infusion — can cause histamine-release reactions (flushing, hypotension); infuse over ≥30 minutes

• Elderly patients — reduced renal reserve; higher toxicity risk

• History of allergic reactions to vancomycin (potential cross-reactivity, though less common)

Aspect Recommendation

Risk category Limited human data; animal studies have not shown teratogenicity

Use in pregnancy Use only if clearly indicated and benefit outweighs risk; avoid in first trimester unless essential

Preferred alternatives Vancomycin (more human safety data); beta-lactams if organism susceptible

When to use Serious MRSA infections unresponsive to or intolerant of vancomycin

Monitoring Maternal renal function, therapeutic drug monitoring; fetal growth monitoring in prolonged therapy

Aspect Recommendation

Compatibility Likely compatible; expected low transfer to breast milk

Drug levels in milk Low (based on molecular weight and protein binding)

Preferred alternatives Vancomycin if glycopeptide required; beta-lactams if susceptible

Recommendations May breastfeed with monitoring; consider timing feeds after trough drug levels

Infant monitoring GI disturbances (diarrhoea, oral thrush), rash, feeding difficulties

Aspect Recommendation

Starting dose Same loading regimen as adults

Titration Adjust maintenance frequency based on calculated creatinine clearance (not serum creatinine alone)

Special considerations Age-related decline in renal function is common; eGFR often overestimates renal function in elderly

Extra risks Increased nephrotoxicity, ototoxicity, and haematological toxicity risk; prolonged half-life increases accumulation

Monitoring Baseline and serial renal function; TDM recommended for therapy >7 days; periodic audiometry in prolonged high-dose therapy

Drug Interaction Management

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

Amphotericin B Synergistic nephrotoxicity Avoid combination; use liposomal formulation if antifungal required; monitor renal function

Loop diuretics (furosemide, torsemide) Increased ototoxicity risk Use with caution; monitor hearing in prolonged therapy; avoid high-dose diuretics

Cisplatin Additive nephrotoxicity and ototoxicity Avoid if possible; if essential, close renal and audiometric monitoring

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

Drug Interaction Management

NSAIDs Potential additive nephrotoxicity with prolonged use Monitor renal function; avoid prolonged concurrent use

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

Vancomycin Sequential use generally safe; concurrent use has additive toxicity risk Avoid concurrent use; if switching, no washout period needed

Warfarin Possible enhanced anticoagulant effect (limited data) Monitor INR if prolonged teicoplanin course

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

Note: Teicoplanin does not have significant CYP450 interactions.

• Injection site reactions (pain, erythema, induration) — especially with IM use

• Rash and pruritus

• Fever

• Nausea and vomiting

• Diarrhoea

• Transient elevation of liver transaminases (ALT, AST)

• Eosinophilia

• Headache

Adverse Effect Clinical Notes

Ototoxicity (hearing loss, tinnitus, vestibular dysfunction) May be irreversible; risk increased with prolonged therapy, high doses, concurrent ototoxic agents; discontinue if symptoms occur

Nephrotoxicity Less common than with vancomycin; risk increased with high doses, prolonged therapy, concurrent nephrotoxins

Thrombocytopenia Can be severe; immune-mediated; monitor platelet count weekly; discontinue if significant drop

Neutropenia / Leukopenia Rare; occurs with prolonged therapy; reversible on discontinuation

Anaphylaxis / Severe hypersensitivity Rare; discontinue immediately; manage as anaphylactic emergency

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

Red Man Syndrome-like reaction Less common than with vancomycin; due to histamine release with rapid infusion; slow infusion rate

Action: Discontinue teicoplanin immediately if severe hypersensitivity, significant thrombocytopenia, or ototoxicity symptoms occur.

Therapeutic Drug Monitoring Trough concentration (drawn before next dose): Target 10–15 μg/mL for mild-moderate infections; 15–30 μg/mL for serious infections (endocarditis, osteomyelitis, bacteraemia)

After initiation/dose change Trough level after 3–5 doses (steady state); renal function every 2–3 days initially

During therapy (>7 days) CBC with platelet count weekly; renal function twice weekly; LFTs weekly

Prolonged therapy Audiometry if high-dose or therapy >3 weeks; periodic assessment for signs of ototoxicity (ask about tinnitus, hearing changes)

TDM Indication: Recommended for serious infections, prolonged therapy (>7 days), renal impairment, extremes of weight, paediatric patients, and elderly.

• Targocid (Sanofi) — originator brand

• Ticocin (Cipla)

• Teicoplan (Sun Pharma)

• Teico (Glenmark)

• Teicogem (Hetero)

• Teicobact (Alkem)

• Teisafe (Intas)

• Ticozen (Ranbaxy/Sun Pharma)

• Multiple other generic manufacturers

Note: No significant FDCs available.

• Not listed under current NLEM (as of 2022)

• Not under NPPA price control

• Limited government supply; primarily available through private channels

1. Once-daily maintenance dosing advantage — teicoplanin's long half-life (40–70 hours) allows once-daily dosing after loading, making it suitable for outpatient parenteral antibiotic therapy (OPAT) and reducing nursing burden compared to vancomycin.

1. IM route is viable — unlike vancomycin, teicoplanin can be given intramuscularly for mild-moderate infections, useful when IV access is difficult or in outpatient settings.

1. Lower infusion-related reactions — teicoplanin causes significantly less Red Man Syndrome than vancomycin, making it preferable in patients who experienced this reaction with vancomycin.

1. Loading doses are critical — due to long half-life, loading doses are essential to achieve therapeutic levels quickly; skipping or inadequate loading leads to subtherapeutic levels for first 3–4 days.

1. TDM optimises outcomes — therapeutic drug monitoring improves clinical outcomes and reduces toxicity in serious infections; target trough 15–30 μg/mL for endocarditis, osteomyelitis, and bacteraemia.

1. Thrombocytopenia requires vigilance — platelet count should be monitored weekly; teicoplanin-induced thrombocytopenia can be severe and is an indication for drug discontinuation.

1. Oral use for CDI is off-label — oral teicoplanin for C. difficile infection is not first-line; use only when oral vancomycin is unavailable; IV teicoplanin has NO activity against CDI.

teicoplanin; glycopeptide; MRSA; Gram-positive; vancomycin alternative; TDM; nephrotoxicity; ototoxicity; once-daily dosing; OPAT; Schedule H

RxIndia v1.0 — 17 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Antibiotic Policy 2022

• NCDC Guidelines — Hospital-Acquired Infections

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

• IAP Guidelines on Antimicrobial Use in Children

• ISPD Peritonitis Guidelines (for CAPD dosing)

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