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Common name
Nebcin (Tobramycin)
Description
Nebcin is an aminoglycoside antibiotic. It works by killing sensitive bacteria. Treating serious infections caused by certain bacteria
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Active Ingredients:
Tobramycin
Therapeutic actions:
Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Nebcin, Sterile, is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of Sterile Water for Injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains 1,200 mg of tobramycin activity. After dilution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite.
What is it used for?:
(Indications:)
Nebcin 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 spp Lower 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 organisms Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp Skin, bone, and skin structure infections caused by P.aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S.aureus
Complicated 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 spp Aminoglycosides, including Nebcin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.
Nebcin 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 wshow 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 Nebcin may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Nebcin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts.
Contraindications and cautions:
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.(See CONTRAINDICATIONS.) If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
PRECAUTIONS
Serum and urine specimens for examination should be collected during therapy, as recommended in the Warnings box. Serum calcium, magnesium, and sodium should be monitored. Peak and trough serum levels should be measured periodically during therapy. Prolonged concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, advanced age, and cumulative dosage may contribute to ototoxicity and nephrotoxicity. It is particularly important to monitor serum levels closely in patients with known renal impairment.
A useful guideline would be to perform serum level assays after 2 or 3 doses, so that the dosage could be adjusted if necessary, and at 3-to 4-day intervals during therapy. In the event of changing renal function, more frequent serum levels should be obtained and the dosage or dosage interval adjusted according to the guidelines provided in the
Dosage and Administration section.
In order to measure the peak level, a serum sample should be drawn about 30 minutes following intravenous infusion or 1 hour after an intramuscular injection. Trough levels are measured by obtaining serum samples at 8 hours or just prior to the next dose of Nebcin. These suggested time intervals are intended only as guidelines and may vary according to institutional practices.
It is important, however, that there be consistency within the individual patient program unless computerized pharmacokinetic dosing programs are available in the institution. These serum level assays may be especially useful for monitoring the treatment of severely ill patients with changing renal function or of those infected with less susceptible organisms or those receiving maximum dosage. Neuromuscular blockade and respiratory paralysis have been reported in cats receiving very high doses of tobramycin (40mg/kg).
The possibility of prolonged or secondary apnea should be considered if tobramycin is administered to anesthetized patients who are also receiving neuromuscular blocking agents, such as succinylcholine, tubocurarine, or decamethonium, or to patients receiving massive transfusions of citrated blood. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts. Cross-allergenicity among aminoglycosides has been demonstrated. In patients with extensive burns or cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with Nebcin, measurement of serum concentration is especially important as a basis for determination of appropriate dosage. Elderly patients may have reduced renal function that may not be evident in the results of routine screening tests, such as BUN or serum creatinine. A creatinine clearance determination may be more useful. Monitoring of renal function during treatment with aminoglycosides is particularly important in such patients. An increased incidence of nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins. Aminoglycosides should be used with caution in patients with muscular disorders, such as myasthenia gravis or parkinsonism, since these drugs may aggravate muscle weakness because of their potential curare-like effect on neuromuscular function. Aminoglycosides may be absorbed in significant quantities from body surfaces after local irrigation or application and may cause neurotoxicity and nephrotoxicity. Aminoglycosides have not been approved for intraocular and/or subconjunctival use. Physicians are advised that macular necrosis has been reported following administration of aminoglycosides, including tobramycin, by these routes.
Side effects:
Neurotoxicity Adverse effects on both the vestibular and auditory branches of the eighth nerve have been noted, especially in patients receiving high doses or prolonged therapy, in those given previous courses of therapy with an ototoxin, and in cases of dehydration. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss. Hearing loss is usually irreversible and is manifested initially by diminution of high-tone acuity. Tobramycin and gentamicin sulfates closely parallel each other in regard to ototoxic potential. Nephrotoxicity Renal function changes, as shown by rising BUN, NPN, and serum creatinine and by oliguria, cylindruria, and increased proteinuria, have been reported, especially in patients with a history of renal impairment who are treated for longer periods or with higher doses than those recommended. Adverse renal effects can occur in patients with initially normal renal funotion.
Clinical studies and studies in experimental animals have been conducted to compare the nephrotoxic potential of tobramycin and gentamicin.
In some of the clinical studies and in the animal studies, tobrarnycin caused nephrotoxicity significantly less frequently than gentamicin. In some other clinical studies, no significant difference in the incidence of nephrotoxicity between tobramycin and gentamicin was found. Other reported adverse reactions possibly related to Nebcin include anemia, granulocytopenia, and thrombocytopenia; and fever, rash, exfoliative dermatitis, itching, urticaria, nausea, vomiting, diarrhea, headache, lethargy, pain at the injection site, mental confusion, and disorientation.
Laboratory abnormalities possibly related to Nebcin include increased serum transaminases (AST, ALT); increased serum LDH and bilirubin; decreased serum calcium, magnesium, sodium, and potassium; and leukopenia, leukocytosis, and eosinophilia.
Interactions:
No information provided
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Nebcin brands
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Product |
Manufacturer |
Price |
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Tobrased
eye drops 0.3% (5 ml)
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Bilim Pharmaceutic, Turkey |
$10.00 |
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Tobrimed
eye drops 0.3% (5 ml)
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World Medicine, Egypt |
$12.00 |
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Tobrimed
eye drops 0.3% (5 gr)
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World Medicine, Egypt |
$15.00 |
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Tobrom
eye drops 0.3% (5 ml)
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Rompharm Company, Romania |
$8.00 |
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