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Basic Drug Info
Drug Name:Tobramycin
Manufacturer:X-Gen Pharmaceuticals, Inc.
Other Info:To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection USP and other antibacterial drugs, tobramycin 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

Tobramycin for injection USP is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:Septicemia in the pediatric patient and adult caused by P.

aeruginosa, E.

coli, and Klebsiella sppLower respiratory tract infections caused by P.

aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E.

coli, and S.

aureus (penicillinase- and non-penicillinase-producing strains)Serious central-nervous-system infections (meningitis) caused by susceptible organismsIntra-abdominal infections, including peritonitis, caused by E.

coli, Klebsiella spp, and Enterobacter sppSkin, bone, and skin structure infections caused by P.

aeruginosa, Proteus spp, E.

coli, Klebsiella spp, Enterobacter spp, and S.

aureusComplicated and recurrent urinary tract infections caused by P.

aeruginosa, Proteus spp (indole-positive and indole-negative), E.

coli, Klebsiella spp, Enterobacter spp, Serratia spp, S.

aureus, Providencia spp, and Citrobacter sppAminoglycosides, including tobramycin for injection USP, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.  Tobramycin for injection USP may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin.

If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted.

In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin for injection USP may be initiated before the results of susceptibility studies are obtained.

The decision to continue therapy with tobramycin for injection USP should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the Warnings box above.To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, Tobramycin for Injection USP 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.
Bacterial Infections -- Infections by bacteria, general or unspecified.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Infections of the central nervous system -- Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

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)

Abdominal Infection --

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.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

URINARY TRACT INFECTIONS RECURRENT --

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.

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

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

Contraindications

A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin.

A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside 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

SeeWarnings box above.Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson Syndrome have been reported rarely in patients on tobramycin therapy.

Although rare, fatalities have been reported.

(SeeCONTRAINDICATIONS).If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
Branded Drugs
The following US Branded drugs contain Tobramycin


TOBRADEX -- ALCON LABORATORIES INC

TOBRADEX ST -- ALCON INC

TOBRAMYCIN AND DEXAMETHASONE -- BAUSCH AND LOMB PHARMACEUTICALS INC

TOBRASONE -- ALCON LABORATORIES INC

ZYLET -- BAUSCH AND LOMB INC

TOBREX -- ALCON LABORATORIES INC

AKTOB -- AKORN INC

TOBREX -- FALCON PHARMACEUTICALS LTD

TOBI -- NOVARTIS PHARMACEUTICALS CORP


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