GENTAMICIN SULFATE IN SODIUM CHLORIDE- gentamicin sulfate injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Sẵn có từ:

Baxter Healthcare Corporation

INN (Tên quốc tế):

GENTAMICIN SULFATE

Thành phần:

GENTAMICIN 60 mg in 50 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection 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 in 0.9% Sodium Chloride Injection 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, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin sulfate 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 in 0.9% Sodium Chloride Injection 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 boxed WARNINGS. 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 in 0.9% Sodium Chloride Injection 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 injection 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 injection 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 judgement 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 (see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION sections). 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 known cross-sensitivity of patients to drugs in this class.

Tóm tắt sản phẩm:

Gentamicin Sulfate in 0.9% Sodium Chloride Injection in VIAFLEX PLUS plastic container is available in the following sizes and concentrations. Gentamicin 60 mg 50 mL unit: 2B0851, NDC 0338-0507-41 Gentamicin 80 mg 50 mL unit: 100 mL unit: 2B0852, NDC 0338-0509-41 2B0862, NDC 0338-0503-48 Gentamicin 100 mg 50 mL unit: 100 mL unit: 2B0853, NDC 0338-0511-41 2B0863, NDC 0338-0505-48 Gentamicin 120 mg 100 mL unit: 2B0864, NDC 0338-0507-48 Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

GENTAMICIN SULFATE IN SODIUM CHLORIDE- GENTAMICIN SULFATE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
GENTAMICIN SULFATE IN 0.9% SODIUM CHLORIDE INJECTION
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
FOR INTRAVENOUS ADMINISTRATION
FURTHER DILUTION NOT REQUIRED
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other
antibacterial drugs,
Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
WARNINGS
Patients treated with aminoglycosides should be under close clinical
observation
because of the potential toxicity associated with their use.
As with other aminoglycosides, gentamicin sulfate is potentially
nephrotoxic. The
risk of nephrotoxicity is greater in patients with impaired renal
function and in those
who receive high dosage or prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory,
can occur in
patients treated with gentamicin sulfate, primarily those with
pre-existing renal
damage and in patients with normal renal function treated with higher
doses and/or
for longer periods than recommended. Aminoglycoside-induced
ototoxicity is
usually irreversible. Other manifestations of neurotoxicity may
include numbness,
skin tingling, muscle twitching and convulsions.
Renal and eighth cranial nerve function should be closely monitored,
especially in
patients with known or suspected reduced renal function at onset of
therapy and
also in those whose renal function is initially normal but who develop
signs of renal
dysfunction during therapy. Urine should be examined for decreased
specific
gravity, increased excretion of protein, and the presence of cells or
casts. Blood
urea nitrogen (BUN), serum creatinine, or creatinine clearance should
be
determined periodically. When feasible, it is recommended that serial
audiograms
be obtained in patients old enough to be