Amgofil 300 mg Ingredients and Usage

The active ingredient is Amikacin Sulphate, an aminoglycoside antibiotic. The 300 mg strength is supplied as a sterile solution for intramuscular (IM) or slow intravenous (IV) infusion after dilution.

Amgofil is clinically used to treat serious infections when first-line antibiotics are ineffective or when the infection is confirmed to be resistant to them. Indications include:

• Septicemia and Bacteremia (bloodstream infections).
• Severe Respiratory Tract Infections (e.g., hospital-acquired pneumonia).
• Complicated Urinary Tract Infections (UTIs).
• Serious Skin, Soft-Tissue, Bone, and Joint Infections.
• Intra-abdominal Infections (including peritonitis).

How Does Amgofil Work?

Amikacin is a bactericidal antibiotic, meaning it directly kills the bacteria. Its mechanism of action is dependent on its ability to irreversibly interfere with bacterial protein synthesis:

1. Bacterial Penetration: Amikacin crosses the bacterial cell membrane and is actively transported into the cell.
2. Ribosomal Binding: Inside the cell, it irreversibly binds to the 30S subunit of the bacterial ribosome.
3. Protein Synthesis Disruption: This binding action leads to misreading of the mRNA genetic code, causing the synthesis of non-functional or toxic proteins. This disruption rapidly kills the susceptible bacteria.

Amgofil 300 mg Side Effects and Warnings

Amikacin is associated with serious, dose-related toxicities, necessitating careful dosing based on weight, renal function, and therapeutic drug monitoring (TDM). Common side effects may include pain at the injection site, nausea, and vomiting.

Black Box Warnings and Critical Precautions:

1. Nephrotoxicity (Kidney Damage): Amikacin can cause damage to the renal tubules, leading to acute kidney failure. The risk increases with higher doses, longer duration of treatment, dehydration, and concurrent use of other nephrotoxic drugs. Monitoring of serum creatinine and urine output is mandatory.
2. Ototoxicity (Hearing/Balance Damage): Amikacin can cause irreversible damage to the vestibular (balance) and cochlear (hearing) portions of the inner ear. Symptoms include tinnitus (ringing in the ears), vertigo, and permanent hearing loss. Risk increases with high trough concentrations and prolonged therapy.
3. Neuromuscular Blockade: Aminoglycosides can cause reversible neuromuscular blockade, potentially leading to respiratory paralysis, especially when administered rapidly or in patients with pre-existing neuromuscular disorders (e.g., Myasthenia Gravis).
4. Contraindication: Amgofil is contraindicated in patients with known hypersensitivity to Amikacin or other aminoglycosides.

Amgofil 300 mg Storage Conditions

Amgofil 300 mg Injection is supplied as a sterile solution that requires controlled storage:

• Store the unopened ampoules/vials at controlled room temperature, typically between 15°C and 30°C (59°F and 86°F). Do not freeze.
• Protect from Light: Keep the product in the original box/carton to protect it from light.
• Inspect Before Use: The solution should be clear and colorless to pale yellow. Do not use if the solution is discolored or contains particulate matter.
• Dilution: For IV infusion, the dose must be diluted in a suitable intravenous fluid (5% Dextrose or 0.9% Sodium Chloride) and administered over 30 to 60 minutes.