Gentamicin Sulfate Injection 40mg/2ml Ampoules

• Customization: Available
• Application: Internal Medicine
• Usage Mode: For external use
• 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: Box
• Specification: 2ml
• Trademark: dmscare
• Origin: China
• Production Capacity: 500000box/Month

Product Description

Company Profile

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 Description

 

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.

Certifications

 

 

Suppositories			SOLUTION(LOTION)
Product name	SP	ST	Product name	SP	ST
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
Product name	SP	ST	Product name	SP	ST
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