Amikin

 500 mg/2 ml IM/IV Injection
Incepta Pharmaceuticals Ltd.

2 ml ampoule: ৳ 48.00 (2 x 5: ৳ 480.00)

Dosage & Administration
  • Route: Intramuscular (IM) or intravenous (IV) administration.
  • Adults:
    • Typical dosage: 15 mg/kg/day divided into 2 or 3 doses (e.g., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours).
    • Severe infections may require up to 20 mg/kg/day.
  • Pediatrics:
    • Dose generally 15 mg/kg/day divided in 2 or 3 doses.
  • Elderly: Use caution; dose adjustment based on renal function recommended.
  • Renal impairment: Dose and interval adjustment essential; based on creatinine clearance and serum drug concentrations.
  • Duration: Typically 7 to 14 days depending on clinical response.
  • Administration notes: For IV, infuse over 30–60 minutes to reduce toxicity risks.
Mechanism of Action (MOA)

Amikacin binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis by causing misreading of mRNA. This results in the production of abnormal or nonfunctional proteins and leads to disruption of bacterial cell membrane integrity, ultimately causing bacterial cell death. It exerts bactericidal activity primarily against aerobic gram-negative bacteria.

Pharmacokinetics
  • Absorption: Poor oral absorption; administered parenterally.
  • Distribution: Distributes into extracellular fluid; limited penetration into cerebrospinal fluid unless meninges are inflamed.
  • Metabolism: Not metabolized; excreted unchanged.
  • Elimination: Primarily renal via glomerular filtration.
  • Half-life: Approximately 2–3 hours in patients with normal renal function; prolonged in renal impairment.
  • Onset: Rapid bactericidal activity after administration.
Pregnancy Category & Lactation
  • Pregnancy: FDA category D; use only if clearly needed due to risk of fetal harm.
  • Lactation: Excreted in small amounts in breast milk; caution advised. Breastfeeding is generally not recommended during treatment.
Therapeutic Class
  • Aminoglycoside antibiotic.
Contraindications
  • Known hypersensitivity to amikacin or other aminoglycosides.
  • Pre-existing hearing loss or vestibular dysfunction unless benefits outweigh risks.
  • Myasthenia gravis or other neuromuscular disorders due to risk of exacerbation.
Warnings & Precautions
  • Monitor renal function closely; nephrotoxicity risk is significant.
  • Ototoxicity risk: monitor auditory and vestibular function; may be irreversible.
  • Use caution with concomitant neurotoxic or nephrotoxic drugs.
  • Neuromuscular blockade and respiratory depression may occur; caution with muscle relaxants or neuromuscular disease.
  • Therapeutic drug monitoring is recommended to optimize dosing and minimize toxicity.
Side Effects
  • Common: Injection site pain, rash, fever, nausea.
  • Renal: Nephrotoxicity with elevated serum creatinine, proteinuria.
  • Auditory: Hearing loss, tinnitus, vertigo; may be irreversible.
  • Neuromuscular: Weakness, respiratory depression (rare).
  • Hypersensitivity: Rare anaphylaxis or rash.
Drug Interactions
  • Increased risk of nephrotoxicity and ototoxicity with loop diuretics, vancomycin, amphotericin B.
  • Enhanced neuromuscular blockade with muscle relaxants (e.g., succinylcholine).
  • Physical incompatibility with penicillins and cephalosporins when mixed in same IV line; administer separately.
  • Avoid concurrent use with other aminoglycosides.
Recent Updates or Guidelines
  • Emphasis on individualized dosing via therapeutic drug monitoring to reduce toxicity.
  • Continued role in multidrug-resistant tuberculosis treatment protocols.
  • Increased caution in elderly and renally impaired patients in recent guidelines.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from light and freezing.
  • Keep vial tightly closed and sterile.
  • Use aseptic technique for preparation and administration.