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Amikacin injection product usage.


Amikacin sulfate is a potent aminoglycoside antibiotic primarily used for serious, multidrug-resistant Gram-negative infections. As a pharmacist, you likely know it for its narrow therapeutic index, necessitating strict adherence to dosing and monitoring protocols.

Indications & Usage

Amikacin is reserved for short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria (e.g., Pseudomonas aeruginosa, Escherichia coli, Klebsiella, and Serratia).

  • Primary Clinical Uses:

    • Septicemia: Including neonatal sepsis.

    • Respiratory Tract: Serious nosocomial pneumonia.

    • Bones and Joints: Osteomyelitis.

    • CNS: Meningitis (often used in combination).

    • Skin and Soft Tissue: Including severe burns and postoperative infections.

    • Urinary Tract: Complicated or recurrent UTIs.

    • Mycobacterial Infections: Used as a second-line agent for multi-drug resistant Tuberculosis (MDR-TB) and Non-tuberculous mycobacteria (NTM).

       

Dosage & Administration

Amikacin can be administered Intramuscularly (IM) or Intravenously (IV). Dosages are calculated based on ideal body weight (IBW).

 

1. Adult and Pediatric Dosing (Normal Renal Function)

  • Standard Regimen: 15 mg/kg/day divided into 2 or 3 equal doses (e.g., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours).

     

  • Once-Daily Dosing (ODD): 15 mg/kg once every 24 hours. (Note: ODD is generally avoided in patients with ascites, extensive burns, or pregnancy).

     

  • Max Dose: Generally should not exceed 1.5 g/day.

     

2. Neonatal Dosing

  • Loading Dose: 10 mg/kg.

     

  • Maintenance: 7.5 mg/kg every 12 hours.

     

3. Renal Impairment (Critical for Pharmacists)

Dosage must be adjusted by either increasing the interval or decreasing the dose based on Creatinine Clearance ($CrCl$).

  • Dosing Interval Formula: $Serum\ Creatinine\ (mg/dL) \times 9 = Interval\ in\ hours$.

    Dialysis: Amikacin is hemodialyzable; supplemental doses (usually 50% of the maintenance dose) are typically given after a dialysis session.

Monitoring Parameters

Due to the risk of toxicity, clinical monitoring is mandatory:

  • Therapeutic Drug Monitoring (TDM):

    • Peak levels (30–60 min post-infusion): Target 20–35 mcg/mL.

    • Trough levels (just before next dose): Target <5 mcg/mL (for multi-dose) or <1 mcg/mL (for once-daily).

  • Renal Function: Monitor serum creatinine and BUN every 2–3 days.

  • Auditory/Vestibular: Audiograms should be performed if treatment exceeds 7–10 days.

Critical Warnings & Precautions

  • Black Box Warnings: 1. Nephrotoxicity: Usually reversible if caught early.

    2. Ototoxicity: Can be irreversible (auditory and vestibular).

    3. Neuromuscular Blockage: Can cause respiratory paralysis; use caution with anesthetics or neuromuscular blocking agents (e.g., succinylcholine).

    Contraindications: History of hypersensitivity to amikacin or other aminoglycosides.

  • Physical Compatibility: Do not physically mix with beta-lactam antibiotics (penicillins/cephalosporins) in the same IV bag, as they can inactivate the aminoglycoside.

Would you like me to look into the specific formulation requirements for your manufacturing firm, or perhaps the export regulations for amikacin in specific target markets?

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