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Amikin 100mg Injection — Amikacin 100mg/2mL by Beximco Pharmaceuticals

Amikin 100mg Injection — Amikacin 100mg/2mL by Beximco Pharmaceuticals
Amikin 100mg Injection — Amikacin 100mg/2mL by Beximco Pharmaceuticals
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Amikin 100mg Injection — Amikacin 100mg/2mL | Beximco Pharmaceuticals

Generic NameAmikacin Sulfate 100 mg / 2 mL Injection
Dosage FormSolution for IV / IM Injection
Drug ClassAminoglycoside Antibiotic
ManufacturerBeximco Pharmaceuticals Ltd.
SpectrumBroad-spectrum — aerobic Gram-negative bacteria (including MDR strains)
Prescription StatusPrescription Required — Hospital Use

Overview

Amikin 100mg Injection contains Amikacin Sulfate 100mg per 2mL — the paediatric-dose vial of this broad-spectrum aminoglycoside antibiotic. Amikacin is derived from kanamycin and is the most resistant to aminoglycoside-modifying enzymes among its class, making it active against many strains of Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, and Enterobacteriaceae that are resistant to gentamicin and tobramycin. The 100mg vial is primarily used in neonates, infants, children, and small adults requiring weight-based dosing. Amikacin carries significant nephrotoxicity and ototoxicity risks — mandatory therapeutic drug monitoring (TDM) and renal function assessment are required.

Mechanism of Action

Amikacin binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, causing misreading of mRNA and inhibiting protein synthesis, leading to bactericidal cell death. It requires active oxygen-dependent transport into the bacterial cell — making it ineffective against strict anaerobes. Its narrow spectrum of aminoglycoside-modifying enzyme resistance makes it the aminoglycoside of last resort for many MDR Gram-negative organisms.

Indications

  • MDR Pseudomonas aeruginosa infections — HAP, VAP, bacteraemia, UTI
  • MDR Klebsiella pneumoniae — including ESBL and carbapenem-resistant strains (combination therapy)
  • MDR Acinetobacter baumannii — HAP/VAP in ICU
  • Severe Gram-negative UTI — complicated pyelonephritis, urosepsis
  • Neonatal sepsis (weight-based dosing — 100mg vial)
  • Diabetic foot infections with Gram-negative involvement (combination regimen)
  • MDR-TB — WHO Group C agent in drug-resistant TB regimens

Dosage

Patient GroupDoseFrequencyRoute
Adults (normal renal function)15 mg/kg/day (max 1.5g/day)Once daily (OD) preferred for efficacy & reduced nephrotoxicityIV infusion over 30–60 min or IM
Neonates / ChildrenWeight-based (neonatology protocol)Per protocolIV
Renal impairmentDose reduction + extended intervals per eGFRPer TDM & renal functionIV

Critical Diabetic Patient Warnings

  • Nephrotoxicity — highest risk in diabetic nephropathy: Amikacin causes dose-dependent tubular nephrotoxicity. Pre-existing diabetic nephropathy (any stage of CKD) dramatically increases this risk. Amikacin may be absolutely contraindicated in eGFR <30 mL/min unless no alternative exists. Monitor serum creatinine and eGFR daily during treatment.
  • Ototoxicity — vestibular and cochlear: Amikacin preferentially causes cochlear (hearing) damage. Diabetic patients with pre-existing autonomic neuropathy may have impaired awareness of vestibular symptoms. Audiometry before and during prolonged courses is recommended.
  • Therapeutic Drug Monitoring (TDM) — mandatory: Peak levels (30 min post-dose): target 56–64 mg/L (once-daily dosing). Trough levels (pre-dose): must be <5 mg/L to prevent accumulation and toxicity. Adjust dose if trough elevated.
  • Hydration: Ensure adequate hydration before and during therapy — dehydration dramatically worsens nephrotoxicity. Avoid NSAIDs and other nephrotoxins concurrently.
  • Contrast agents: Withhold amikacin for 48 hours before and after IV contrast administration if possible — additive nephrotoxicity risk.

Drug Interactions

DrugInteractionAction
Loop diuretics (furosemide)Additive ototoxicityAvoid combination if possible; monitor hearing
VancomycinAdditive nephrotoxicityMonitor renal function closely; TDM both agents
NSAIDsReduce renal blood flow → ↑ amikacin nephrotoxicityAvoid concurrent use
CisplatinAdditive nephrotoxicity and ototoxicityAvoid combination
Neuromuscular blocking agentsAmikacin potentiates neuromuscular blockadeUse caution peri-operatively

Side Effects

Nephrotoxicity (tubular damage — rising creatinine, oliguria), ototoxicity (irreversible sensorineural hearing loss, vestibular damage), neuromuscular blockade (rare), skin rash. All side effects are dose and duration-dependent — TDM and dose adjustment are the primary preventive strategies.

Storage

Store at 15–25°C. Do not freeze. Protect from light. Single use — discard unused portion after withdrawal.


Medical Disclaimer: Amikacin requires mandatory renal function monitoring and therapeutic drug monitoring. Diabetic patients with any degree of kidney disease face significantly elevated nephrotoxicity risk. Hospital and prescription use only. Never self-administer.

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