Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Amikacin

Amikacin

Aminoglycoside (IV, IM, inhaled)

MDRTBLevelsNephrotoxic

Indication

MDR Acinetobacter/Pseudomonas regimens β€’ NTM β€’ MDR-TB combo β€’ hospital outbreak protocols

At a glance

INDICATIONS (CORE USE)

Reserved for **MDR gram-negatives** + **TB** second-line β€” toxicity same class; **hearing monitoring** long TB course.

ADULT DOSE (STANDARD)

15–20 mg/kg IV daily (MDR GNR) β€” **highly protocol-specific**; TB doses lower and less frequent

MAX DOSE

TB: ~15 mg/kg dosing 2–3Γ—/week IV/IM in DOT β€” not daily high-dose sepsis math

Route

IV, IM, inhaled

PEDIATRIC DOSE

Weight-based per TB or sepsis protocol β€” consult

Do not miss

Must-not-miss safety points

Major warning

- Nephrotoxicity + ototoxicity β€” higher doses in MDR regimens β†’ aggressive monitoring - Do not confuse **TB intermittent dosing** with **sepsis daily dosing** - Synergy nephrotoxicity with vancomycin / colistin / contrast - Pregnancy: fetal ototoxicity systemic use

Indications

USE IF: Organism susceptible only to amikacin in MDR protocol; TB MDR regimen component. AVOID IF: Less toxic alternative active on antibiogram; can use beta-lactam monotherapy.

Primary

  • MDR gram-negative infection as part of specialist combination when susceptibility confirmed
  • MDR-TB regimen component under public health / ID supervision

Secondary

  • Nontuberculous mycobacterial disease (specialist)
  • Inhaled adjuncts in some CF MDR pseudomonas protocols

Other

  • Outbreak response per hospital IPC + stewardship

Dosing

STANDARD (ADULT PO)

15–20 mg/kg IV q24h (MDR GNR) vs 15 mg/kg 2–3Γ—/week (MDR-TB) β€” **never interchange**

ADULT DOSE

MDR GNR: often 15–20 mg/kg IV q24h with levels (institution) MDR-TB: intermittent 15 mg/kg 2–3Γ—/week typical β€” **different**

PEDIATRIC DOSE

TB pediatric mg/kg schedules β€” DOT programs.

MAX DOSE

Therapeutic drug monitoring defines max exposure.

Practical Note

Always state indication when ordering (TB vs sepsis).

Warnings

Clinical warnings

  • Irreversible hearing loss with cumulative exposure

Adverse effects

  • vestibulotoxicity
  • nephrotoxicity
  • rash

Contraindications

  • Myasthenia gravis relative

Drug interactions

  • Vancomycin
  • loop diuretics
  • NSAIDs β†’ AKI

Special populations

Pediatrics

Weight-based per TB or sepsis protocol β€” consult

Pregnancy

Systemic: avoid if alternatives for TB; consult TB program.

Lactation

See lactation references and product labeling.

Renal impairment

TB dosing adjusted or switched to capreomycin/streptomycin pathways per guideline β€” nephrology + TB clinic. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ extended-interval or traditional q8h per **pharmacy nomogram** - **CrCl 10–50** β†’ prolong interval; **trough before 2nd extended dose** mandatory - **CrCl <10** β†’ **dialysis-dependent** redosing; avoid accumulation (**nephro/oto**); consult pharmacy

Hepatic impairment

No standard change.

Elderly

High toxicity; consider alternatives.

Administration

IV extended infusion some MDR protocols; IM TB DOT.

Monitoring

  • Monitor: - Before next extended dose β†’ **trough** (Β± peak per protocol) β†’ rising trough β†’ extend interval / hold - Inpatient β†’ creatinine + urine output **β‰₯2–3Γ—/week**; **daily** if unstable, elderly, or vancomycin co-therapy - Vertigo or acute hearing change β†’ **stop drug** β†’ evaluate **ototoxicity** - Audiometry baseline and serial in prolonged MDR therapy - Drug levels per indication - Creatinine at least 2–3Γ—/week on intensive regimens
  • Recheck: - No clinical improvement at 48–72h β†’ reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **AKI / dialysis-requiring nephrotoxicity**; acute **vestibular failure / deafness** (ototoxicity). **Secondary:** electrolyte derangement from renal injury.

Immediate Actions

Stop aminoglycoside β†’ IV fluids if hypovolemic β†’ BMP; **obtain drug level**; hearing/vestibular symptom review

Antidote

No specific antidote; treat complications (e.g. anaphylaxis β†’ epinephrine per ACLS)

Decontamination

Parenteral β€” hold further doses; extended-interval error β†’ level-guided next dose

Escalation

Dialysis-requiring AKI, acute deafness/vestibular failure, severe electrolyte derangement β†’ **ICU** + nephrology/ENT; **hemodialysis removes aminoglycosides** β€” redose per pharmacy after HD

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**Big gun** aminoglycoside for **MDR GNR** + **MDR-TB**. Dosing **indication-specific** β€” TB β‰  sepsis. Ears + kidneys.

Clinical pearls

Stewardship: microbiology-driven only. Infection control for MDR organisms. DOT for TB regimens. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • TDM always
  • Audiometry TB
  • Indication label on order

Pharmacokinetics

Renal elimination; concentration-dependent.

Mechanism of action

Aminoglycoside β€” resistant to many aminoglycoside-modifying enzymes vs gentamicin/tobra.

Common brand names

Saudi Arabia

Amikin, Amikacin

Global

(placeholder β€” verify local formulary)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Empiric choice β†’ tie to syndrome, severity, and local antibiogram β€” not habit.
  • IV β†’ PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness β€” stewardship.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling

Do not miss

  • Uncomplicated viral URI/bronchitis β†’ antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • Daily MDR-GNR dose mistaken for TB intermittent schedule β†’ toxicity or undertreatment.
  • TDM always
  • Audiometry TB
  • Indication label on order