Amiza-500 Injection
Amikacin 500 mg / 2 ml Injection — High-Dose Aminoglycoside Therapy (Once-Daily Regimen)
| Composition | Amikacin 500 mg / 2 ml |
|---|---|
| Dosage Form | Injection (IV/IM) |
| Pack Type | Vial |
| Pack Size | 1 Vial of 2 ml (500 mg) |
| MRP | ₹ 113.7 |
| Therapy | Injectable + Antibiotic — Aminoglycoside Antibiotic (High Strength) |
| Storage | Store below 25 °C, protected from light. Do not freeze. |
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About Amiza-500 Injection
Amiza-500 Injection contains Amikacin Sulphate 500 mg in 2 ml, the high-strength vial designed for once-daily aminoglycoside regimens in adults. Modern aminoglycoside protocols favour once-daily extended-interval dosing, which exploits Amikacin’s concentration-dependent killing and post-antibiotic effect while minimising trough-dependent toxicity (nephrotoxicity and ototoxicity).
The single-vial 500 mg presentation eliminates the need for multiple-vial reconstitution in standard 15 mg/kg adult doses, reducing dosing errors and nursing time in critical care. It is particularly used in severe sepsis, nosocomial pneumonia, complicated intra-abdominal infections and febrile neutropenia.
Amiza-500 is manufactured by Trumac Healthcare under WHO-GMP injectable conditions. Available for monopoly-based PCD pharma franchise, government tenders and third-party manufacturing — a high-margin hospital SKU.
Indications
- Severe gram-negative septicaemia and sepsis
- Hospital-acquired and ventilator-associated pneumonia
- Complicated intra-abdominal infections
- Febrile neutropenia (with anti-pseudomonal beta-lactam)
- Multi-drug-resistant tuberculosis (adjunct)
- Once-daily extended-interval aminoglycoside protocols
Mechanism of Action
Amikacin binds the 30S bacterial ribosomal subunit, causing mRNA misreading and inhibiting protein synthesis. Concentration-dependent bactericidal action and a prolonged post-antibiotic effect (PAE) underpin the rationale for once-daily extended-interval dosing — which achieves higher peak levels for efficacy while allowing trough levels to fall and minimising toxicity.
Dosage & Administration
Adults: 15 mg/kg/day as a single IV infusion over 30–60 minutes (extended-interval regimen). Adjust dose by serum trough monitoring in renal impairment. Treatment duration typically 7–10 days. Hospital use only.
Side Effects
Nephrotoxicity, ototoxicity (cochlear and vestibular), neuromuscular blockade. Local injection site pain. Higher peak levels of extended-interval regimens may slightly increase ototoxicity risk in prolonged courses.
Contraindications & Precautions
Hypersensitivity to aminoglycosides. Concomitant nephrotoxic/ototoxic drugs. Pre-existing 8th cranial nerve damage. Myasthenia gravis. Pregnancy (Category D). Severe renal impairment without serum-level monitoring. Therapeutic drug monitoring strongly advised.
Storage
Store below 25 °C, protected from light. Do not freeze.
Amiza-500 Injection is available for monopoly-based PCD pharma franchise across India and for third-party manufacturing under your brand. WHO-GMP certified, with full visual-aid and promotional support. Become a Trumac franchise partner →
Frequently Asked Questions
What is Amiza-500 Injection used for?
Amiza-500 Injection contains Amikacin 500 mg/2 ml and is used for severe gram-negative bacterial infections, sepsis, hospital-acquired pneumonia and once-daily extended-interval aminoglycoside regimens.
Why is the 500 mg strength used?
The 500 mg vial allows single-vial dosing for standard adult once-daily regimens (15 mg/kg), reducing dosing errors and nursing time compared with multiple lower-strength vials.
Is Amiza-500 available for PCD pharma franchise?
Yes, Trumac Healthcare offers Amiza-500 Injection on monopoly-based PCD pharma franchise, government tenders and third-party manufacturing.
How should Amiza-500 Injection be stored?
Store below 25 °C, protected from light. Do not freeze. Use immediately after opening.
Is Amiza-500 WHO-GMP certified?
Yes, Amiza-500 Injection is manufactured in WHO-GMP and DCGI-compliant injectable facilities.
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