for Injection USP 1.2 gm†
This vial is intended for use by the hospital pharmacist in the extemporaneous
preparation of IV solutions.
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
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.
Patients treated with tobramycin for injection USP and other aminoglycosides
should be under close clinical observation, because these drugs have an inherent
potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested
as both auditory and vestibular ototoxicity, can occur. The auditory changes
are irreversible, are usually bilateral, and may be partial or total. Eighth-nerve
impairment and nephrotoxicity may develop, primarily in patients having preexisting
renal damage and in those with normal renal function to whom aminoglycosides
are administered for longer periods or in higher doses than those recommended.
Other manifestations of neurotoxicity may include numbness, skin tingling, muscle
twitching, and convulsions. The risk of aminoglycoside-induced hearing loss
increases with the degree of exposure to either high peak or high trough serum
concentrations. Patients who develop cochlear damage may not have symptoms during
therapy to warn them of eighth-nerve toxicity, and partial or total irreversible
bilateral deafness may continue to develop after the drug has been discontinued.
Rarely, nephrotoxicity may become apparent until the first few days after cessation
of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible.
Renal and eighth-nerve function should be closely monitored in patients with
known or suspected renal impairment and also in those whose renal function is
initially normal but who develop signs of renal dysfunction during therapy.
Peak and trough serum concentrations of aminoglycosides should be monitored
periodically during therapy to assure adequate levels and to avoid potentially
toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided.
Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such
accumulation, excessive peak concentrations, advanced age, and cumulative dose
may contribute to ototoxicity and nephrotoxicity (see PRECAUTIONS).
Urine should be examined for decreased specific gravity and increased excretion
of protein, cells, and casts. Blood urea nitrogen, serum creatinine, and creatinine
clearance should be measured periodically. When feasible, it is recommended
that serial audiograms be obtained in patients old enough to be tested, particularly
high-risk patients. Evidence of impairment of renal, vestibular, or auditory
function requires discontinuation of the drug or dosage adjustment.
Tobramycin for injection USP should be used with caution in premature and neonatal
infants because of their renal immaturity and the resulting prolongation of
serum half-life of the drug.
Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics,
particularly other aminoglycosides (eg. amikacin, streptomycin, neomycin, kanamycin,
gentamicin, and paromomycin), cephaloridine, viomycin, polymycin B, colistin,
cisplatin, and vancomycin, should be avoided. Other factors that may increase
patient risk are advanced age and dehydration.
Aminoglycosides should not be given concurrently with potent diuretics, such
as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity,
and intravenously administered diuretics enhance aminoglycoside toxicity by
altering antibiotic concentrations in serum and tissue.
Aminoglycosides can cause fetal harm when administered to a pregnant woman
Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group,
is derived from the actinomycete Streptomyces tenebrarius. Sterile tobramycin
sulfate 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 tobramycin sulfate equivalent to 1200 mg of tobramycin. After
reconstitution, the solution will contain 40 mg of tobramycin per mL. The product
contains no preservative or sodium bisulfite.
Tobramycin sulfate is 0-3-amino-3-deoxy-a-D-glucopyranosyl-(1→4)-
L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C18H37N5O9)2•5H2SO4.
The molecular weight is 1425.45. The structural formula for tobramycin is as
The pharmacy bulk package of tobramycin for injection USP is a container of
a sterile preparation for parenteral use that contains multiple single doses.
It is intended for use in a pharmacy admixture program. Package use is restricted
to the preparation of admixures for intravenous infusion or to the filling of
empty sterile syringes for intravenous injections for patients with individualized
† Each vial contains tobramycin sulfate equivalent to
1200 mg of tobramycin.
Last reviewed on RxList: 11/13/2008
This monograph has been modified to include the generic and brand name in many instances.