Schedule H

Intramuscular, Intravenous, Inhalational (off-label, specialist only)

Injection: 500 mg/2 mL vial

Injection: 1000 mg/4 mL vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Multidrug-Resistant Tuberculosis (MDR-TB) — Injectable Agent

Parameter Details

Starting dose 15 mg/kg once daily IM or slow IV infusion

Titration Not applicable

Usual maintenance dose 15 mg/kg once daily

Maximum dose 1000 mg/day

Duration 6–8 months in conventional regimens; up to 4 months in shorter regimens as per NTEP individualized treatment plan

Clinical Notes:

• Mandatory monthly audiometry and renal function monitoring

• WHO and NTEP guidelines recommend phasing out injectable agents in favour of all-oral regimens

• Reserve use only when all-oral alternatives are not feasible

• Administer under DOTS-Plus or equivalent programmatic supervision

1. Serious Gram-Negative Infections (Limited Use)

Parameter Details

Starting dose 15 mg/kg/day IM or slow IV infusion

Titration Not applicable

Usual maintenance dose 15 mg/kg/day once daily or divided into two doses

Maximum dose 1000 mg/day

Duration Based on clinical response and culture sensitivity; typically 7–14 days

Clinical Notes:

• Use only when culture sensitivity confirms susceptibility

• Reserve for situations where other aminoglycosides or beta-lactams are unsuitable

• Requires specialist infectious disease consultation

• Resistance rates are high; empirical use is discouraged

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

Indication Dose Duration Notes Evidence Basis

Pulmonary Mycobacterium avium complex (MAC) disease 10–15 mg/kg IM/IV daily or 3 times weekly Months, as part of combination therapy OFF-LABEL; Specialist only Supportive evidence from ATS/IDSA guidelines; used in Indian tertiary care specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. MDR-TB in Children (As per NTEP/RNTCP Paediatric DR-TB Guidelines)

Age/Weight Starting Dose Usual Maintenance Maximum Dose Duration

Children >6 months 15–20 mg/kg/day IM 15–20 mg/kg/day once daily 1000 mg/day 6 months (or shorter in approved short-course regimens)

Clinical Notes:

• Monthly audiometric monitoring is mandatory

• Baseline and periodic serum creatinine, urinalysis, and electrolytes required

• Not preferred in infants <6 months due to elevated ototoxicity risk

• Administer only under paediatric TB specialist supervision

Secondary Indications — Paediatric Doses (Off-label, if any)

Indication Dose Duration Notes Evidence Basis

Neonatal sepsis Historically 15 mg/kg/day IV in 2 divided doses Variable OFF-LABEL; No longer recommended due to toxicity; use only under tertiary NICU specialist protocols when no alternative exists Historical practice; superseded by safer agents

⚠️ Not recommended in neonates or infants <6 months unless no alternative exists and under direct specialist supervision in a tertiary care setting.

Required. Dose must be adjusted based on creatinine clearance:

Creatinine Clearance (CrCl) Dose Adjustment

60 mL/min Usual dose (15 mg/kg once daily)

30–60 mL/min 10 mg/kg every 24–48 hours

<30 mL/min 7.5 mg/kg every 48–72 hours; specialist supervision essential

Haemodialysis Administer dose post-dialysis; therapeutic drug monitoring if available

• Known hypersensitivity to kanamycin or other aminoglycosides

• Myasthenia gravis (risk of neuromuscular blockade)

• Pregnancy (Category D) — documented fetal ototoxicity risk

• Concurrent use of other nephrotoxic or ototoxic agents without proper monitoring

• Elderly patients — increased susceptibility to renal and auditory toxicity

• Concurrent loop diuretic therapy — additive ototoxicity

• Dehydration or hypovolaemia — heightened nephrotoxicity risk

• Pre-existing vestibular or auditory impairment

• Poorly controlled diabetes mellitus — renal compromise risk

• Neuromuscular disorders other than myasthenia gravis

• Prolonged therapy beyond 2 weeks — cumulative toxicity

Parameter Details

Risk category Category D — Contraindicated unless life-threatening infection with no alternative

Fetal risks Irreversible congenital ototoxicity; potential nephrotoxicity

Preferred alternatives All-oral MDR-TB regimens as per NTEP; if injectable essential, consult national programme guidance

When it may be used Only under NTEP track for MDR-TB when no oral regimen is feasible; requires documented benefit-risk assessment

Monitoring Fetal growth surveillance; maternal renal function; audiometry post-delivery for neonate

Parameter Details

Compatible with breastfeeding Likely compatible; use with caution

Drug levels in milk Low; poor oral absorption by infant

Preferred alternatives Amikacin or bedaquiline-based oral regimens (as per NTEP) if available

Infant monitoring Observe for adequate feeding, loose stools; hearing screening if maternal therapy prolonged

• Starting dose: Initiate at lower end of range (10–12 mg/kg/day)

• Titration: Not applicable; maintain reduced dose throughout

• Extra risks: Increased susceptibility to ototoxicity (often irreversible), nephrotoxicity, and electrolyte disturbances

• Monitoring: Serum creatinine at least twice weekly initially; monthly audiometry

• Recommendation: Consider alternative antibiotics if renal function is impaired or borderline; ensure adequate hydration

Interacting Drug Effect Recommendation

Loop diuretics (furosemide, ethacrynic acid) Synergistic ototoxicity; increased risk of irreversible hearing loss Avoid combination; if essential, monitor audiometry frequently

Other aminoglycosides (streptomycin, amikacin) Additive nephrotoxicity and ototoxicity Do not combine; sequential use requires washout period

Vancomycin Additive nephrotoxicity Avoid if possible; if used, monitor renal function daily

Amphotericin B Synergistic nephrotoxicity Avoid concurrent use; consider alternatives

Cisplatin Additive ototoxicity and nephrotoxicity Contraindicated together

Neuromuscular blocking agents (pancuronium, vecuronium) Potentiation of neuromuscular blockade; respiratory paralysis risk Avoid or use with extreme caution; ensure ventilation support

Interacting Drug Effect Recommendation

Penicillins (ampicillin, piperacillin) In vitro inactivation of aminoglycoside Do not mix in same IV solution; administer separately

Cephalosporins (cefotaxime, ceftriaxone) Additive nephrotoxicity potential Monitor renal function; adequate hydration

Methotrexate Increased nephrotoxicity risk Monitor renal function closely

Carboplatin Additive ototoxic potential Monthly audiometry if concurrent use unavoidable

Cyclosporine Increased nephrotoxicity Monitor serum creatinine and cyclosporine levels

• Injection site pain and induration

• Transient elevation of serum creatinine

• Mild fever or chills

• Nausea

• Transient leukocytosis

Adverse Effect Clinical Significance

Ototoxicity Vestibular and/or auditory damage; may be irreversible; requires immediate discontinuation

Nephrotoxicity Non-oliguric acute kidney injury; usually reversible if detected early

Neuromuscular blockade Risk with rapid IV administration or high doses; may cause respiratory paralysis

Anaphylaxis Rare; requires immediate cessation and supportive care

Electrolyte disturbances Hypokalaemia, hypomagnesaemia — monitor and correct

⚠️ Immediate discontinuation required if ototoxicity symptoms (tinnitus, vertigo, hearing loss) or neuromuscular weakness develop.

Phase Parameters

Baseline Serum creatinine, urinalysis (proteinuria), audiometry, complete blood count, serum potassium and magnesium

During therapy Serum creatinine: twice weekly initially, then weekly; Monthly audiometry mandatory (especially beyond 2 weeks); Weight monitoring in paediatric patients

Long-term/Post-therapy Repeat audiometry up to 6 months after therapy cessation; Monitor for delayed vestibular symptoms (balance disturbance, vertigo)

• Kanamycin Injection (generic — various manufacturers)

• Kanasure™

• Kenacin™

• Ksmicin™

Formulation Private Market Government/NTEP Supply

• Phasing out: NTEP and WHO recommend transitioning to all-oral bedaquiline/linezolid-containing regimens; kanamycin should be reserved only when no oral alternatives exist.

• Hydration is critical: Ensure adequate fluid intake before and during therapy to minimise nephrotoxicity.

• Audiometry is non-negotiable: Monthly hearing assessment is mandatory for all patients receiving kanamycin beyond 2 weeks.

• Pregnancy exclusion: Strongly contraindicated in pregnancy unless documented under national programme track with no oral options.

• Avoid loop diuretics: Concurrent use markedly increases irreversible hearing loss risk; seek alternatives.

• Therapeutic drug monitoring: Rarely available in routine Indian practice; rely on clinical monitoring and serum creatinine trends.

Kanamycin; Aminoglycoside; MDR-TB; nephrotoxicity; ototoxicity; injectable antibiotic; renal-adjustment; pregnancy-contraindicated; NTEP; Schedule H India

RxIndia v1.0 — 12 May 2025

• CDSCO Approved Package Inserts

• Indian Pharmacopoeia

• National Tuberculosis Elimination Programme (NTEP) India — Guidelines for Programmatic Management of Drug-Resistant TB (PMDT)

• AIIMS Paediatric TB Management Protocol

• WHO Global TB Treatment Guidelines (supportive reference for off-label use)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• API Textbook of Medicine