Description:

Amikacin Sulphate Injection 500mg/2ml IP (MIKA-500 by Oscar) is a potent aminoglycoside antibiotic used to treat serious bacterial infections caused by susceptible Gram-negative organisms (including Pseudomonas aeruginosa, Escherichia coli, Klebsiella, Proteus, Serratia, Enterobacter) and some Gram-positive bacteria (e.g., Staphylococcus). It is indicated for septicemia, bacterial endocarditis, meningitis, bone and joint infections, intra-abdominal infections, skin/soft tissue infections, lower respiratory tract infections, urinary tract infections, and burn infections when other antibiotics are ineffective or contraindicated. It works by binding to the 30S ribosomal subunit, inhibiting bacterial protein synthesis. In Ghana (Accra), it is a prescription injectable commonly used in hospitals for severe or hospital-acquired infections, often in ICU, surgical wards, or when multidrug resistance is suspected.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; administered only by healthcare professionals via IV or IM injection in hospitals/clinics; not for self-administration or OTC dispensing due to serious risks of nephrotoxicity, ototoxicity, and neuromuscular blockade).

Therapeutic Category:

Aminoglycoside Antibiotic (Parenteral antibacterial for serious Gram-negative and selected Gram-positive infections.

Active Ingredients/Composition:

• Active ingredient: Amikacin sulphate – 500 mg per 2 ml ampoule (250 mg/ml). Other ingredients: Water for injection (solvent), sodium citrate or sodium metabisulfite (stabilizer/preservative in some formulations), sulfuric acid (pH adjustment to 3.5–5.5). The solution is clear, colourless to pale yellow, sterile, and ready-to-use or diluted for infusion.

Vitamins: None.

Minerals: None.

Variant:

• MIKA-500 Amikacin Sulphate Injection 500mg/2ml (standard 2 ml ampoule). Related variants: Amikacin 250mg/ml in 4ml ampoules (1000mg total), or other brands (e.g., Amikacin 100mg/ml for pediatric use). The 500mg/2ml is the most common adult dose strength.

Consume Type:

Injectable – Intravenous (IV) infusion (preferred) or Intramuscular (IM) injection (administered only by healthcare professionals; never oral or self-administered).

Directions/Usage: Administered only in clinical settings with monitoring (serum levels, renal function, hearing).

• Adults: Typical dose 15 mg/kg/day IV/IM (usual 500–1000 mg daily) in single daily dose (preferred) or divided every 8–12 hours.
• Maximum daily dose: 1.5 g (rarely higher in life-threatening infections).
• Duration: 7–14 days depending on infection and response.
• IV infusion: Dilute in 100–200 ml compatible fluid (0.9% NaCl or 5% dextrose) and infuse over 30–60 minutes.
• IM: Deep intramuscular injection (alternate sites).
• Renal impairment: Reduce dose/frequency (e.g., every 24–48 hours or based on trough levels 5–10 µg/ml).
• Therapeutic drug monitoring: Trough levels <5–10 µg/ml (to avoid toxicity); peak levels 20–35 µg/ml for serious infections.
• Ensure adequate hydration to reduce nephrotoxicity risk.

Common Side Effects: Common:

• Nephrotoxicity (kidney damage – monitor creatinine).
• Ototoxicity (hearing loss, tinnitus, vestibular disturbance – monitor hearing).
• Injection site pain (IM).
• Nausea, vomiting. Rare/serious (seek immediate help): Neuromuscular blockade (muscle weakness, respiratory paralysis – especially with concurrent neuromuscular blockers), severe allergic reactions, superinfections.

Package Type:

Glass ampoules of 2 ml (each containing 500 mg amikacin sulphate; packs of 5 or 10 ampoules; labelled carton with dilution instructions and warnings).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only under medical supervision with monitoring (high risk of nephrotoxicity and ototoxicity – monitor renal function, hearing, and serum levels).
• Contraindicated in hypersensitivity to aminoglycosides, myasthenia gravis (worsens neuromuscular blockade), or concurrent use with other ototoxic/nephrotoxic drugs (e.g., aminoglycosides, vancomycin, amphotericin B) unless benefits outweigh risks.
• Caution in renal impairment (dose adjustment required), elderly, dehydration, or neuromuscular disorders.
• Ensure adequate hydration and avoid rapid IV bolus (risk of neuromuscular blockade).
• If tinnitus, hearing loss, reduced urine output, muscle weakness, or severe rash occurs, stop use and seek urgent care.
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar amikacin injections in Ghana include:

• Generic amikacin sulphate 250mg/ml or 500mg/2ml injection (various importers).
• Amikacin injection IP (other brands like Amikacin Sulfate by Neon or Samarth).
• Other aminoglycosides: Gentamicin injection (cheaper alternative for some infections). Consult doctor/pharmacist in Accra (e.g., hospital pharmacy) for alternatives.

Manufacturer/Marketer:

Oscar Remedies Pvt. Ltd. (India; primary manufacturer of MIKA-500 Amikacin Sulphate Injection). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported generic).

Country of Origin:

India (manufactured by Oscar Remedies Pvt. Ltd.; imported to Ghana and available in local pharmacies/hospitals).