Active Pharmaceutical Ingredients

Gentamicin sulphate is an aminoglycoside antibiotic, which can inhibit the growth of Gram-positive bacteria and Gram-negative bacteria, and inhibit a variety of mycoplasma strains in tissue culture. It is used to treat sepsis, urinary tract infection, staphylococcal infection, endocarditis and other diseases.

CAS No.:1405-41-0

Description

Gentamicin sulfate is a white or almost white, hygroscopic powder. It is freely soluble in water, practically insoluble in ethanol (96 per cent).

Application

Gentamycin sulfate is a broad-spectrum aminoglycoside antibiotic. It has bacteriostatic and bactericidal effects on many Gram-negative and positive bacteria. It has strong effects on Gram-negative bacteria such as Pseudomonas aeruginosa, Aerobacter, Pneumonia, Salmonella, Escherichia coli and Proteus, Staphylococcus aureus, etc.

Packing and Storage

Preserve in an airtight container. If the substance is sterile, store in a sterile, airtight, tamper- proof container.

Minimum Order

One package

Gentamycin Sulphate Introduction

Item	Details
Basic Information	Gentamycin sulphate is an aminoglycoside antibiotic. Its chemical formula is C₂₁H₄₃N₅O₇·nH₂SO₄ (where n is usually around 1.5 – 2.5). It is a complex mixture of related gentamicin components. It appears as a white or almost white powder. It has good solubility in water, which is beneficial for its use in various pharmaceutical preparations, including injectable solutions, topical creams, and ophthalmic solutions. It is produced by the fermentation of Micromonospora purpurea.
Pharmacological Action	Gentamycin sulphate acts by binding to the 30S subunit of the bacterial ribosome. This binding interferes with the initiation of protein synthesis and causes misreading of the genetic code on the messenger RNA. As a result, incorrect amino acids are incorporated into the growing polypeptide chain, leading to the production of non – functional or toxic proteins. It has a broad – spectrum antibacterial activity, with a particular affinity for Gram – negative bacteria. Against Gram – negative bacteria, it is highly effective against Escherichia coli, Klebsiella pneumoniae, Proteus species, Pseudomonas aeruginosa, and Serratia marcescens. It also shows activity against some Gram – positive bacteria, such as Staphylococcus aureus (including some methicillin – resistant strains), although it is generally less effective against Gram – positive bacteria compared to Gram – negative ones.
Clinical Applications	1. Systemic Infections: – In cases of severe sepsis, especially when caused by Gram – negative bacteria, gentamycin sulphate can be used. It may be administered intravenously or intramuscularly, often in combination with other antibiotics to provide broader coverage. – For hospital – acquired pneumonia, especially when Pseudomonas aeruginosa or other Gram – negative pathogens are suspected, gentamycin sulphate can be part of the treatment regimen. 2. Urinary Tract Infections: – It is effective in treating both uncomplicated and complicated urinary tract infections. It can target common urinary pathogens like Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa. 3. Intra – abdominal Infections: – For intra – abdominal abscesses and peritonitis, gentamycin sulphate can be used in combination with other antibiotics to target the diverse mix of aerobic and anaerobic bacteria present in the abdominal cavity. 4. Topical Applications: – In topical creams and ointments, gentamycin sulphate is used to treat skin infections such as impetigo, cellulitis, and infected wounds. – In ophthalmic solutions, it is used to treat eye infections like conjunctivitis, keratitis, and blepharitis caused by susceptible bacteria.
Adverse Reactions	1. Ototoxicity: One of the most serious side effects is ototoxicity. It can cause damage to the inner ear, leading to sensorineural hearing loss and balance problems. The risk of ototoxicity increases with higher doses, longer treatment duration, and in patients with pre – existing hearing impairment or renal impairment. 2. Nephrotoxicity: Gentamycin sulphate can cause damage to the kidneys, leading to acute tubular necrosis and impaired renal function. Symptoms may include increased serum creatinine levels, decreased urine output, and electrolyte imbalances. 3. Neuromuscular Blockade: In some cases, it can cause neuromuscular blockade, leading to muscle weakness, respiratory depression, and in severe cases, respiratory arrest. This is more likely to occur in patients with pre – existing neuromuscular disorders or those receiving other drugs that can affect neuromuscular function. 4. Allergic Reactions: Allergic reactions can occur, ranging from mild rashes, itching, and hives to severe anaphylactic shock. Patients with a history of allergic reactions to aminoglycoside antibiotics are at a higher risk. 5. Gastrointestinal Effects: Although less common compared to some other antibiotics, nausea, vomiting, and diarrhea may occur, especially with oral administration (which is less common for gentamycin sulphate).
Drug Interactions	1. With Other Nephrotoxic Drugs: Concurrent use with other nephrotoxic drugs, such as amphotericin B, vancomycin, or certain non – steroidal anti – inflammatory drugs (NSAIDs), can increase the risk of nephrotoxicity. 2. With Neuromuscular – Blocking Agents: Gentamycin sulphate can enhance the neuromuscular – blocking effect of drugs like succinylcholine and tubocurarine, leading to increased muscle weakness and respiratory depression. 3. With Diuretics: Diuretics, especially loop diuretics like furosemide, can increase the risk of ototoxicity when used in combination with gentamycin sulphate. 4. With Probenecid: Probenecid can inhibit the renal tubular secretion of gentamycin, increasing its plasma concentration and half – life, which may enhance the antibacterial effect but also increase the risk of side effects.
Special Population Considerations	1. Pregnant Women: The use of gentamycin sulphate during pregnancy is generally not recommended due to the potential risk of ototoxicity and nephrotoxicity to the fetus. However, in life – threatening situations where no other suitable alternatives are available, it may be used with careful monitoring. 2. Breastfeeding Women: Gentamycin is excreted in breast milk in small amounts. Although the risk to the breastfeeding infant is relatively low, alternative medications may be preferred if possible. 3. Patients with Renal Impairment: In patients with renal impairment, the clearance of gentamycin sulphate is significantly reduced. Dosage adjustment is crucial, and close monitoring of serum drug levels and renal function is required to avoid toxicity. 4. Elderly Patients: Elderly patients are more sensitive to the ototoxic and nephrotoxic effects of gentamycin sulphate. Close monitoring and appropriate dosing adjustments are necessary.

 

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