Product image of Osaera (Amikacin Sulfate) supplied by GNH India

Osaera

Active Ingredient:
Amikacin Sulfate
Origin:
EU

Osaera (Amikacin Sulfate)

Amikacin, the active ingredient in Osaera, is an aminoglycoside antibiotic presented as an injectable solution for intravenous use. It treats severe Gram‑negative bacterial infections in hospitalized patients, including sepsis, pneumonia, and intra‑abdominal infections.

GNH India supplies Osaera as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. The product meets EU quality standards and is suitable for use in intensive care and surgical settings.

Manufacturer / TM Owner

Cross Pharmaceuticals P.C.

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Indications & Clinical Uses

Amikacin is used to treat serious infections caused by susceptible Gram‑negative bacteria.

  • Severe sepsis: eradicates causative Gram‑negative pathogens and supports hemodynamic recovery.
  • Hospital‑acquired pneumonia: provides bactericidal activity against resistant organisms.
  • Complicated urinary tract infections: eliminates pathogens resistant to other antibiotics.
  • Intra‑abdominal infections: targets mixed aerobic and anaerobic Gram‑negative flora.

How It Works

  • Amikacin binds to the bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibition of protein synthesis. This results in rapid bactericidal activity against aerobic Gram‑negative organisms, including Pseudomonas aeruginosa and Enterobacteriaceae. Its high affinity for ribosomal RNA reduces the likelihood of resistance compared with other aminoglycosides.

Side Effects

Amikacin may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nephrotoxicity: dose‑related decline in renal function.
  • Ototoxicity: reversible vestibular disturbances.
  • Rash: mild skin eruptions.
  • Fever: transient temperature elevation.

Serious or Rare Side Effects

  • Permanent hearing loss: irreversible auditory damage.
  • Severe renal failure: acute kidney injury requiring dialysis.
  • Anaphylaxis: life‑threatening allergic reaction.
  • Neuromuscular blockade: respiratory muscle weakness.

Precautions & Warnings

When using amikacin, clinicians should observe several safety precautions.

  • Renal monitoring: assess serum creatinine and urine output regularly.
  • Auditory monitoring: perform baseline and periodic hearing tests.
  • Dose adjustment: reduce dosage in patients with impaired renal function.
  • Avoid in myasthenia gravis: risk of exacerbating muscle weakness.
  • Concurrent nephrotoxic drugs: limit use with vancomycin, cisplatin, or loop diuretics.
  • Pregnancy and lactation: use only if benefits outweigh potential risks.
  • Store below 25°C: keep in original packaging, protect from moisture and light.

Avoid Interactions

Amikacin interacts with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Other nephrotoxic agents (e.g., vancomycin, cisplatin): increase risk of kidney damage.
  • Other ototoxic agents (e.g., loop diuretics, gentamicin): amplify hearing loss.
  • Neuromuscular blocking drugs (e.g., succinylcholine, pancuronium): potentiate respiratory paralysis.
  • Concurrent use with high-dose penicillins: may reduce antibacterial efficacy.

Moderate Interactions (Monitor Closely)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): may modestly affect renal clearance.
  • ACE inhibitors or ARBs: monitor renal function and potassium levels.
  • Diuretics (e.g., furosemide): watch for additive nephrotoxicity.
  • Proton pump inhibitors: observe for potential changes in drug absorption.

Frequently Asked Questions

Osaera contains amikacin, an aminoglycoside antibiotic indicated for the treatment of serious Gram‑negative bacterial infections such as sepsis, hospital‑acquired pneumonia, complicated urinary tract infections and intra‑abdominal infections in hospitalized patients.

Amikacin binds to the 30S ribosomal subunit of susceptible bacteria, causing misreading of messenger RNA and inhibition of protein synthesis. This leads to rapid bactericidal activity against aerobic Gram‑negative organisms.

The dosage of amikacin is individualized by the prescribing clinician based on infection severity, patient weight, renal function and susceptibility data; dosing regimens are not standardized in public information.

Amikacin is classified as pregnancy category D and can cross the placenta and be excreted in breast milk. It should be used during pregnancy or lactation only when the potential benefits justify the potential risks and under close medical supervision.

To order Osaera, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and necessary import documentation.

Compared with gentamicin and tobramycin, amikacin (Osaera) offers a broader spectrum against resistant Gram‑negative organisms and a lower incidence of enzymatic inactivation, although the risks of nephro‑ and ototoxicity remain comparable across the class.

Osaera should be stored below 25 °C, protected from moisture and light, and kept in its original packaging until use. Do not freeze the product.

Osaera is supplied as an injectable solution for intravenous infusion. It is administered by a qualified healthcare professional, typically via a peripheral or central IV line, with infusion rates adjusted according to dosing guidelines and patient tolerance.

The most serious adverse effects of amikacin include nephrotoxicity leading to acute kidney injury, irreversible ototoxicity causing permanent hearing loss, and severe hypersensitivity reactions such as anaphylaxis. Regular monitoring of renal function and auditory status is essential.

Amikacin is contraindicated in patients with known hypersensitivity to aminoglycosides, those with pre‑existing severe renal impairment, and individuals with myasthenia gravis due to the risk of exacerbating muscle weakness. Caution is also advised in pregnant or lactating women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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