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Basic Drug Info
Drug Name:Gentamicin Sulfate
Manufacturer:Hospira, Inc.
Other Info:10 mg Gentamicin/mL FOR INTRAVENOUS INFUSIONONLY AFTER DILUTIONThe Vial Contains Gentamicin Sulfate Injection, USP Equivalent to 60, 80, or 100 mg Gentamicin.ADD-Vantage® VialRx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.



Clinical Trials:


Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacterspecies , and Staphylococcus species (coagulase-positive and coagulase-negative).Clinical studies have shown Gentamicin Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.Gentamicin sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing.

The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the“WARNINGS box”.

If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.In serious infections when the causative organisms are unknown, gentamicin sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing.

If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.Gentamicin sulfate has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.Gentamicin Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use.

It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.In this dosage form, Gentamicin Sulfate Injection, USP is to be used with an ADD-Vantage antibiotic diluent flexible plastic container.

(See INSTRUCTIONS FOR USE).
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Bacterial Infections -- Infections by bacteria, general or unspecified.

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Peritonitis -- INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Endocarditis -- Inflammation of the inner lining of the heart (ENDOCARDIUM), the continuous membrane lining the four chambers and HEART VALVES. It is often caused by microorganisms including bacteria, viruses, fungi, and rickettsiae. Left untreated, endocarditis can damage heart valves and become life-threatening.

Staphylococcal Infections -- Infections with bacteria of the genus STAPHYLOCOCCUS.

Unspecified Staphylococcus infection in conditions classified elsewhere and of unspecified site --

Staphylococcal Pneumonia -- Pneumonia caused by infections with bacteria of the genus STAPHYLOCOCCUS, usually with STAPHYLOCOCCUS AUREUS.

Contraindications

Hypersensitivity to gentamicin is a contraindication to its use.

A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

(See WARNINGS box).Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy.Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate.

It is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Serious side effects to mother, fetus, or newborn have not been reported in treatment of pregnant women with other aminoglycosides.

If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.
Branded Drugs
The following US Branded drugs contain Gentamicin Sulfate


GARAMYCIN -- SCHERING CORP SUB SCHERING PLOUGH CORP

GENTAFAIR -- PHARMAFAIR INC

GENTAMICIN -- PERRIGO NEW YORK INC

APOGEN -- KING PHARMACEUTICALS INC

BRISTAGEN -- BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

GENTAMICIN -- INTERNATIONAL MEDICATION SYSTEMS LTD

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

U-GENCIN -- PHARMACIA AND UPJOHN CO

GENTACIDIN -- NOVARTIS PHARMACEUTICALS CORP

GENOPTIC -- ALLERGAN

GENTAK -- AKORN INC

PRED-G -- ALLERGAN PHARMACEUTICAL


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