Grasil 50 mg / 1 ml Injection – Box of 5 Ampoules (Amikacin Antibiotic)

Description

Grasil injection is a brand name for amikacin, an aminoglycoside antibiotic used for the treatment of serious bacterial infections caused by susceptible Gram-negative organisms. The injectable form delivers 50 mg per 1 ml ampoule, allowing high systemic levels for severe infections. 

Ingredients

• Active ingredient: Amikacin sulfate equivalent to 50 mg per 1 ml ampoule 

• Inactive ingredients / excipients: Typically includes water for injection, stabilizers, buffers. (As per manufacturer’s formulation) 

Drug Class

Aminoglycoside antibiotic (bactericidal) 

Dosage Form

Sterile injectable solution in ampoule form — 1 ml per ampoule containing 50 mg amikacin

Uses (Indications)

Grasil (amikacin) is indicated in the short-term treatment of serious bacterial infections due to susceptible Gram-negative bacteria, including:

• Bacteremia / septicemia

• Respiratory tract infections (e.g. pneumonia)

• Intra-abdominal infections

• Urinary tract infections

• Skin and soft tissue infections

• Postoperative infections

• Other severe infections where resistant Gram-negative organisms are suspected 

Dosage

• Dosing should be based on patient body weight, renal function, and severity of infection. (Usually expressed in mg per kg per day) 

• Common reference: 15 mg/kg per day, divided into 2–3 doses via IV/IM routes, or using extended-interval dosing regimens. 

• Because each ampoule is 50 mg, multiple ampoules may be needed to reach therapeutic dose depending on weight and infection severity.

• In patients with renal impairment, adjustments and longer dosing intervals are required. 

In Case of Overdose

• Possible symptoms: hearing loss (ototoxicity), kidney damage (nephrotoxicity), neuromuscular blockade, muscle weakness, vestibular disturbances. Management: Stop drug, supportive care, monitoring of kidney function, hydration, monitoring of auditory and renal parameters.

Missed Dose

• As an injectable managed in clinical settings, missed dose should be handled by the treating clinician.

• Do not self-administer double dose to compensate.

How To Use / Administration

• Administer via intravenous (IV) (infusion or carefully injected) or intramuscular (IM) routes using aseptic technique. 

• IV injections are typically given over 30–60 minutes to reduce toxicity risk.

• Monitor patients during and after administration for vital signs, renal function, auditory function, and signs of adverse effects.

When Not to Use (Contraindications)

• Known hypersensitivity to amikacin or other aminoglycosides 

• Pre-existing impaired renal function unless carefully monitored and dose adjusted 

• Pre-existing hearing impairment or vestibular dysfunction 

• Neuromuscular disorders (e.g. myasthenia gravis) because of risk of neuromuscular blockade

• Use in pregnancy / lactation only if benefits outweigh risks (aminoglycosides cross placenta)

• Caution in elderly patients, dehydration, or co-administration with other nephrotoxic or ototoxic drugs

Side Effects

Common / less serious:

• Nausea, vomiting

• Dizziness, vertigo

• Injection site reactions (pain, redness)

• Elevated creatinine or renal indices

• Mild changes in kidney function 

Serious / toxic:

• Irreversible ototoxicity (hearing loss, tinnitus, balance disturbances) 

• Nephrotoxicity (renal damage) 

• Neuromuscular blockade especially in predisposed individuals

• Allergic reactions (rash, anaphylaxis)

Precautions & Warnings

• Hydration is recommended to reduce nephrotoxicity risk 

• Monitor renal function (serum creatinine, BUN, urine output) periodically 

• Monitor auditory / vestibular function, especially in patients receiving prolonged therapy or high doses 

• Avoid co-administration with other nephrotoxic or ototoxic drugs (e.g. cisplatin, vancomycin, loop diuretics) 

• In patients with renal impairment, dose adjustments and extended intervals are necessary 

• Use the lowest effective dose and shortest duration to reduce toxicity risk 

Drug Interactions

• Other nephrotoxic or ototoxic agents increase risks (e.g. cisplatin, vancomycin, loop diuretics, amphotericin B) 

• Neuromuscular blocking agents (e.g. curare derivatives) may have additive neuromuscular blockade risk

• Co-use with other aminoglycosides or overlapping antibiotics should be cautious

Storage / Disposal

• Store at controlled room temperature, protected from light and moisture as per manufacturer directions 

• Do not freeze

• Use before expiry date

• Dispose unused or expired ampoules safely as medical/biomedical waste

Control Drug Status

• Amikacin is not a controlled narcotic, but is a prescription-only antibiotic requiring medical supervision

Quick Tips

• Always adjust dose based on renal function and body weight

• Use slow IV infusion to reduce nephrotoxicity and ototoxicity risk

• Monitor hearing, balance, and kidney parameters regularly

• Avoid combining with other toxic drugs

• Use shortest effective duration to reduce adverse events