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RX ITEM-Tobramycin 40Mg/Ml Vial 50Ml By Hospira Worldwide

NDC 00409-3590-02 UPC/GTIN No.3-04093-59002-9 Mfg.Part No.359002BRAND: TOBRAMYCIN NDC: 00409-3590-02,409359002 UPC: 3-04093-59002-9,304093590029 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Tobramycin 40Mg/Ml Vial 50Ml By Hospira Worldwide

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Item No.: RX165092 NDC No.409359002 UPC No.:304093590029 NDC No. 00409-3590-02 UPC/GTIN No. 3-04093-59002-9 MPN 359002 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx165092 Tobramycin 40mg/ml Vial 50ml by Hospira Worldwide Item No. 3165092 NDC No. 00409359002 UPC No. 304093590029 Other Name To

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TOBRAMYCIN- tobramycin sulfate injection
Mylan Institutional LLC
TOBREX � tobramycin solution/ drops
Alcon Laboratories, Inc.

CartonLabel
DESCRIPTION

TOBREX� (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each mL of TOBREX� solution contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. TOBREX� (tobramycin ophthalmic solution) 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.

In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii , most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata , Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

TOBREX� (tobramycin ophthalmic solution) 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX�. Clinical studies have shown tobramycin to be safe and effective for use in children.


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

WARNINGS



Patients treated with tobramycin injection 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 not 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 injection 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 (e.g, amikacin, streptomycin, neomycin, kanamycin, gentamicin, and paromomycin), cephaloridine, viomycin, polymyxin 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 (See PRECAUTIONS).

DESCRIPTION
Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin injection USP is a clear and colorless sterile aqueous solution for parenteral administration.
Tobramycin sulfate is O -3-amino-3-deoxy-?-D-glucopyranosyl-(1>4)-O -[2,6-diamino-2,3,6-trideoxy-?-D-ribo -hexopyranosyl-(1>6)]-2-deoxy-L-streptamine, sulfate (2:5) (salt)
(C18 H37 N5 O9 )2 5 H2 SO4 M.W.1425.45

Each mL contains Active: Tobramycin sulfate equivalent to 40 mg tobramycin; Preservative: phenol 5 mg; Inactives: 0.1 mg edetate disodium; sodium bisulfite 3.2 mg; sulfuric acid and/or sodium hydroxide may have been added to adjust the pH (3.0 to 6.5) and water for injection, q.s.

Tobramycin 80 mg/2 mL vial contains 1.568 mg (0.0682 mEq) of sodium.

Tobramycin 1.2 g/30 mL vial contains 23.52 mg (1.0226 mEq) of sodium.

CLINICAL PHARMACOLOGY

Tobramycin is rapidly absorbed following intramuscular administration. Peak serum concentrations of tobramycin occur between 30 and 90 minutes after intramuscular administration. Following an intramuscular dose of 1 mg/kg of body weight, maximum serum concentrations reach about 4 mcg/mL, and measurable levels persist for as long as 8 hours. Therapeutic serum levels are generally considered to range from 4 to 6 mcg/mL. When tobramycin is administered by intravenous infusion over a 1-hour period, the serum concentrations are similar to those obtained by intramuscular administration. Tobramycin is poorly absorbed from the gastrointestinal tract.
MICROBIOLOGY

Mechanism Of Action
Tobramycin acts by inhibiting protein synthesis in bacterial cells. In vitro tests demonstrate that tobramycin is bactericidal.

Resistance

Aminoglycosides are generally not active against most gram-positive organisms, including Streptococcus pyogenes, Streptococcus pneumoniae , and enterococci. Cross-resistance between aminoglycosides may occur.
INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Injection USP and other antibacterial drugs, Tobramycin 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.



Tobramycin 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 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 tobramycin 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 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 may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box.
DOSAGE AND ADMINISTRATION
In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. The patient�s pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see WARNINGS box and PRECAUTIONS).



Administration for Patients with Normal Renal Function

Adults with Serious Infections: 3 mg/kg/day in 3 equal doses every 8 hours (See Table 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

NDC 00409-3590-02 UPC/GTIN No.3-04093-59002-9 Mfg.Part No.359002
RX ITEM-Tobramycin 40Mg/Ml Vial 50Ml By
NDC 00409-3590-02 UPC/GTIN No.3-04093-59002-9 Mfg.Part No.359002

BRAND: TOBRAMYCIN NDC: 00409-3590-02,409359002 UPC: 3-04093-59002-9,304093590029
Tobramycin 40Mg/Ml Vial 50Ml By Hospira
BRAND: TOBRAMYCIN NDC: 00409-3590-02,409359002 UPC: 3-04093-59002-9,304093590029

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.