Westren Medicine Gentamicin (gentamicin sulfate) Injection 2ml: 80mg Westren Pharma for Human 2ml

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Customization: Available
Application: Internal Medicine
Usage Mode: For external use
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  • Westren Medicine Gentamicin (gentamicin sulfate) Injection 2ml: 80mg Westren Pharma for Human 2ml
  • Westren Medicine Gentamicin (gentamicin sulfate) Injection 2ml: 80mg Westren Pharma for Human 2ml
  • Westren Medicine Gentamicin (gentamicin sulfate) Injection 2ml: 80mg Westren Pharma for Human 2ml
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Basic Info.

Model NO.
injection
State
Liquid
Shape
Injection
Type
Organic Chemicals
Pharmaceutical Technology
Chemical Synthesis
Dosage
80mg/2ml
Dosage1
40mg/Ml
Dosage2
20mg/2ml
Use
Injection
Transport Package
B
Origin
China
Production Capacity
500000box/Month

Product Description

Westren Medicine Gentamicin (gentamicin sulfate) Injection 2ml: 80mg Westren Pharma for Human 2ml
ABOUT US

DMS is a leading pharmaceutical Contract Development and Manufacturing Organizations (CDMO).
 
DMS's Manufacturing Services supply several hundred different products in a variety of dosage forms including solid dose, semi solids, sterile (liquids, freeze dried,powder), beta-lactams, hormones, dry powder metered dose inhalers, oral liquids and granulates, from our facilities across the world.
 
Product name Gentamycin Sulfate Injection
Contains Gentamycin Sulfate 80mg/2ml; 40mg/ml;20mg/2ml
Package 5amps/box
application Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete.
CLINICAL PHARMACOLOGY

After intramuscular (IM) administration of gentamicin sulfate, peak serum concentrations usually occur between 30 and 60 minutes and serum levels are measurable for six to eight hours.  When gentamicin is administered by intravenous (IV) infusion over a two-hour period, the serum concentrations are similar to those obtained by IM administration.

In patients with normal renal function, peak serum concentrations of gentamicin (mcg/mL) are usually up to four times the single IM dose (mg/kg); for example, a 1 mg/kg injection in adults may be expected to result in a peak serum concentration up to 4 mcg/mL; a 1.5 mg/kg dose may produce levels up to 6 mcg/mL.  While some variation is to be expected due to a number of variables such as age, body temperature, surface area and physiologic differences, the individual patient given the same dose tends to have similar levels in repeated determinations.  Gentamicin administered at 1 mg/kg every eight hours for the usual 7 to 10 day treatment period to patients with normal renal function does not accumulate in the serum.

Gentamicin, like all aminoglycosides, may accumulate in the serum and tissues of patients treated with higher doses and/or for prolonged periods, particularly in the presence of impaired renal function.  In adult patients, treatment with gentamicin dosages of 4 mg/kg/day or higher for 7 to 10 days may result in a slight, progressive rise in both peak and trough concentrations.  In patients with impaired renal function, gentamicin is cleared from the body more slowly than in patients with normal renal function.  The more severe the impairment, the slower the clearance.  (Dosage must be adjusted.)

Since gentamicin is distributed in extra-cellular fluid, peak serum concentrations may be lower than usual in adult patients who have a large volume of this fluid.  Serum concentrations of gentamicin in febrile patients may be lower than those in afebrile patients given the same dose.  When body temperature returns to normal, serum concentrations of the drug may rise.  Febrile and anemic states may be associated with a shorter than usual serum half-life.  (Dosage adjustment is usually not necessary.)  In severely burned patients, the half-life may be significantly decreased and resulting serum concentrations may be lower than anticipated from the mg/kg dose.

Protein binding studies have indicated that the degree of gentamicin binding is low; depending upon the methods used for testing, this may be between 0 and 30%.

After initial administration to patients with normal renal function, generally 70% or more of the gentamicin dose is recoverable in the urine in 24 hours; concentrations in urine above 100 mcg/mL may be achieved.  Little, if any, metabolic transformation occurs; the drug is excreted principally by glomerular filtration.  After several days of treatment, the amount of gentamicin excreted in the urine approaches the daily dose administered.  As with other aminoglycosides, a small amount of the gentamicin dose may be retained in the tissues, especially in the kidneys.  Minute quantities of aminoglycosides have been detected in the urine weeks after drug administration was discontinued.  Renal clearance of gentamicin is similar to that of endogenous creatinine.

In patients with marked impairment of renal function, there is a decrease in the concentration of aminoglycosides in urine and in their penetration into defective renal parenchyma.  This decreased drug excretion, together with the potential nephrotoxicity of aminoglycosides, should be considered when treating such patients who have urinary tract infections.

Probenecid does not affect renal tubular transport of gentamicin.

The endogenous creatinine clearance rate and the serum creatinine level have a high correlation with the half-life of gentamicin in serum.  Results of these tests may serve as guides for adjusting dosage in patients with renal impairment (see DOSAGE AND ADMINISTRATION).

Following parenteral administration, gentamicin can be detected in serum, lymph, tissues, sputum and in pleural, synovial and peritoneal fluids.  Concentrations in renal cortex sometimes may be eight times higher than the usual serum levels.  Concentrations in bile, in general, have been low and have suggested minimal biliary excretion.  Gentamicin crosses the peritoneal as well as the placental membranes.  Since aminoglycosides diffuse poorly into the subarachnoid space after parenteral administration, concentrations of gentamicin in cerebrospinal fluid are often low and dependent upon dose, rate of penetration and degree of meningeal inflammation.  There is minimal penetration of gentamicin into ocular tissues following IM or IV administration.

 

Microbiology

In vitro tests have demonstrated that gentamicin is a bactericidal antibiotic which acts by inhibiting normal protein synthesis in susceptible microorganisms.  It is active against a wide variety of pathogenic bacteria including Escherichia coli, Proteus species, (indole-positive and indole-negative), Pseudomonas aeruginosa, species of the Klebsiella-Enterobacter-Serratia group, Citrobacter species and Staphylococcus species (including penicillin- and methicillin-resistant strains).  Gentamicin is also active in vitro against species of Salmonella and Shigella. The following bacteria are usually resistant to aminoglycosides: Streptococcus pneumoniae, most species of streptococci, particularly group D and anaerobic organisms, such as Bacteroides species or Clostridium species.

In vitro studies have shown that an aminoglycoside combined with an antibiotic that interferes with cell wall synthesis may act synergistically against some group D streptococcal strains.  The combination of gentamicin and penicillin G has a synergistic bactericidal effect against virtually all strains of Streptococcus faecalis and its varieties (S. faecalis var. liquifaciens, S. faecalis var. zymogenes), S. faecium and S. durans.  An enhanced killing effect against many of these strains has also been shown in vitro with combinations of gentamicin and ampicillin, carbenicillin, nafcillin or oxacillin.

The combined effect of gentamicin and carbenicillin is synergistic for many strains of Pseudomonas aeruginosa.  In vitro synergism against other gram-negative organisms has been shown with combinations of gentamicin and cephalosporins.

Gentamicin may be active against clinical isolates of bacteria resistant to other aminoglycosides.  Bacteria resistant to one aminoglycoside may be resistant to one or more other aminoglycosides.  Bacterial resistance to gentamicin is generally developed slowly.

 

Susceptibility Testing

If the disc method of susceptibility testing used is that described by Bauer et al. (Am J Clin Path 45:493, 1966; Federal Register 37:20525-20529, 1972), a disc containing 10 mcg of gentamicin should give a zone of inhibition of 15 mm or more to indicate susceptibility of the infecting organism.  A zone of 12 mm or less indicates that the infecting organism is likely to be resistant.

Zones of greater than 12 mm and less than 15 mm indicate intermediate susceptibility.  In certain conditions it may be desirable to do additional susceptibility testing by the tube or agar dilution method; gentamicin substance is available for this purpose.


 
           
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Chlorhexidine Acetate Suppositories 20mg CP/BP  Chlorhexidine Gluconate Solution 250ml:50g/250ml:12.5g CP/BP 
Erythromycin Suppositories 0.1g CP/BP  Indometacin Cream 10g:100mg CP/BP 
Metronidazole and Furazolidone Suppositories Compound CP/BP   Ferrous Sulfate  Syrup 100ml:5gram CP/BP 
Metronidazole Clotrimazole and Chlorhexidine Acetate Suppositories Compound CP/BP  Inosine Oral Solution 2% CP/BP 
Paracetamol Suppositories 0.15g CP/BP  Betahistine Hydrochloride Oral Solution 10ml:20mg CP/BP 
      Saponated Cresol Solution 50% CP/BP 
 
INFUSION
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Fluconazole Injection 100ml:0.2g (PP) CP/BP  Paracetamol Injection 100ml:1g CP/BP 
Metronidazole Injection 100ml:0.5g (PP) CP/BP  Metronidazole and Glucose Injection 250ml:0.5g,12.5g CP/BP 
Ofloxacin Injection 100ml:0.2g CP/BP  Metronidazole and Sodium Chloride Injection 100ml:0.5g CP/BP 
Bromhexine Hydrochloride and Glucose Injection 100ml:4mg CP/BP  10% Glucose Injection 500ml CP/BP 
Compound Amino Acid Injection(3AA) 250ml:10.65g CP/BP  5% Glucose Injection 500ml CP/BP 
Compound Amino Acid Injection (9AA) 250ml:13.98g CP/BP  0.9% Sodium Chloride Injection 500ml CP/BP 
Compound Amino Acid Injection (15AA) 250ml:20g CP/BP  Cimetidine and Sodium Chloride Injection 100ml:0.2g,0.9g CP/BP 
Compound Amino Acid Injection (17AA) 250ml:19.133g CP/BP  Levofloxacin Lactate Injection 100ml:300mg CP/BP 
Compound Amino Acid Injection(18AA) 250ml:12.5g CP/BP  Sodium Lactate Ringer's Injection 500ml CP/BP 
Dextran20 and Glucose Injection 500ml:30g CP/BP  Multiple Electrolytes Injection 500ml (plastic bag) CP/BP 
Dextran40 and Glucose Injection 500ml:30g CP/BP  Multiple  Electrolytes  and  Glucose 500ml CP/BP 
Dextran40 and Sodium Chloride 500ml:30g CP/BP  MG3 Injection 500ml CP/BP 
Tinidazole Injection 100ml:0.4g(plastic bag) CP/BP  Ciprofloxacin Lactate Injection 100ml:0.2g (PP) CP/BP 
Norfloxacin and Glucose Injection 100ml:0.2g (PP) CP/BP       
Product name SP ST Product name SP ST
Omeprazole Sodium for Injection 40mg CP/BP Vitamin B1 Injection 2ml:100mg BP
Ethyl Enediamine Diaceturate for Injection 400mg;200mg CP/BP Vitamin B6 injection 1ml:50mg 2ml:100mg,300mg CP/BP
Marine for Injection 200mg CP/BP Vitamin B12 Injection 1ml:1mg 2ml:1mg CP/BP
Pantoprazole Sodium for Injection 40mg;80mg CP/BP Vitamin C Injection 5ml: 500mg ,250mg CP/BP
Enoxacin Gluconate for Injection 100mg;200mg;300mg CP/BP Quinine Dihydrochloride Injection 10ml:0.25g CP/BP
Levocarnitine for Injection 500mg; CP/BP Lincomycin Hydrochloride Injection 1ml:300mg 2ml:600mg CP/BP
Benzylpenicillin Sodium for Injection 0.8mega BP Paracetamol Injection 1ml:150mg,2ml:300mg CP/BP
Cefazolin Sodium for injection 0.25g BP Analgin Injection(Dipyrone injection) 2ml:500mg, 5ml:2.5g CP/BP
Cefotaxime Sodium for injection 0.25g BP Gentamycin Injection 2ml:80mg,2ml40mg CP/BP
Ceftriaxone Sodium for injection 0.25g BP Iron Dextran Injection 2ml:100mg CP/BP

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