Product Name: Amikacin Sulfate

CAS Number: 39831-55-5

Molecular Formula:C₂₂H₄₇N₅O₂₁S₂

Molecular Weight: 781.759 g/mol

Appearance: Amikacin Sulfate is typically presented as a white to off-white crystalline powder or solid.

Description:Amikacin Sulfate is an aminoglycoside antibiotic used for the treatment of serious bacterial infections caused by a wide range of Gram-negative bacteria. It is particularly effective against strains that are resistant to other commonly used antibiotics.

Mechanism of Action:The bactericidal action of Amikacin Sulfate is primarily due to its ability to bind to the 30S subunit of the bacterial ribosome, thereby inhibiting protein synthesis. This leads to the arrest of bacterial growth and multiplication.

Pharmacological Properties:

• Broad-Spectrum Activity: It exhibits broad-spectrum antimicrobial activity against both aerobic and facultative anaerobic organisms.

• Potent Against Resistant Strains: Effective against bacteria that have developed resistance to other aminoglycosides.

• Stability: The compound is stable in solution and retains its potency over time when stored properly.

Clinical Uses:

• Infections: It is used to treat a variety of infections, including septicemia, lower respiratory tract infections, urinary tract infections, and skin and skin structure infections.

• Hospital-Acquired Infections: Particularly useful in treating hospital-acquired infections where resistance to other antibiotics is common.

• Complicated Infections: Utilized in the treatment of complicated bacterial infections such as tuberculosis, pneumonia, and bone infections.

Pharmaceutical Applications:

• Formulation: It can be formulated into various dosage forms, including injectable solutions, ointments, and oral solutions.

• Parenteral Administration: Primarily administered parenterally due to its poor oral bioavailability.

Safety and Precautions:

• Ototoxicity and Nephrotoxicity: As with other aminoglycosides, Amikacin Sulfate has the potential to cause ototoxicity (hearing loss) and nephrotoxicity (kidney damage). Therefore, serum levels and renal function should be monitored during treatment.

• Allergic Reactions: Individuals may experience allergic reactions, and a careful patient history should be taken before administration.

Regulatory Status:

• FDA Approved: It is approved by the U.S. Food and Drug Administration for use in the United States.

• Compliance: Manufactured in accordance with Good Manufacturing Practices (GMP) and complies with relevant pharmacopoeial standards.

Storage Conditions:

• Storage: Store in airtight containers, protected from light, and at a controlled room temperature.

Packaging:

• Packaging Options: Available in various packaging sizes, typically in bulk quantities for pharmaceutical manufacturers.

Manufacturing and Quality Control:

• Quality Assurance: Rigorous quality control measures are in place to ensure the product meets the highest standards of purity and potency.

• Batch Testing: Each batch is tested for identity, strength, quality, and purity as per USP or equivalent standards.

Environmental Considerations:

• Disposal: Must be disposed of in accordance with local regulations and guidelines to minimize environmental impact.