Tobramycin 3 mg/mL
Tobramycin · SOLUTION · Asclemed USA, Inc.
Tobramycin is an antibiotic eye drop used to treat bacterial infections of the eye. It works by killing bacteria and is typically applied directly to the affected eye as prescribed by your doctor.
Key Facts
- Brand Name
- Tobramycin
- Generic Name
- Tobramycin
- NDC Code (Product)
76420-791- Manufacturer
- Asclemed USA, Inc.
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA064052
- Drug Class
- Aminoglycoside Antibacterial [EPC]
- Marketing Start
- 11/29/1993
Recall History
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Akorn, Inc.
CGMP Deviations:
Nora Apothecary and Alternative Therapies, Inc.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Stat Rx USA
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Akorn, Inc.
CGMP Deviations:
Nora Apothecary and Alternative Therapies, Inc.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Eugia US LLC
Failed Stability Specification: Water determination was found not complying with specification.
Sentara Infusion Services
Lack of sterility assurance
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Tobramycin injection 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 neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, 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 sp, and Enterobacter sp. Skin, bone, and skin structure infections caused by P. aeruginosa , Proteus sp, E. coli , Klebsiella sp, Enterobacter sp and S. aureus Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp, (indole-positive and indole- negative), E. coli , Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus , Providencia sp, and Citrobacte r sp. Aminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are n…
Dosage & Administration
DOSAGE AND ADMINISTRATION Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. This insert is for a Pharmacy Bulk Package and is intended for preparing I.V. admixtures only. Dosage recommendations for intramuscular use are for informational purposes only. 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 (see WARNINGS box and PRECAUTIONS ). Table 3 DOSAGE SCHEDULE GUIDE FOR TOBRAMYCIN INJECTION, USP IN ADULTS WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals) For Patient Weighing Usual Dose for Serious Infections…
Warnings
WARNINGS See WARNINGS box above. This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 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. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tobramycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B …
Contraindications
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.
Adverse Reactions
ADVERSE REACTIONS 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 function. 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, tobramycin caused nephrotoxicity significan…
Frequently Asked Questions
What is Tobramycin used for?
Tobramycin is an antibiotic eye drop used to treat bacterial infections of the eye. It works by killing bacteria and is typically applied directly to the affected eye as prescribed by your doctor.
Is Tobramycin a controlled substance?
Tobramycin is not classified as a controlled substance by the DEA.
What is the generic name for Tobramycin?
The generic name for Tobramycin is Tobramycin. There are 8 other brand versions of Tobramycin.
What is the NDC code for Tobramycin 3 mg/mL?
The NDC (National Drug Code) for Tobramycin 3 mg/mL is 76420-791, listed by Asclemed USA, Inc..
Other Tobramycin Dosages
Other Tobramycin Brands
See all →- BETHKIS300 mg/4mL10122-820
- Tobramycin Inhalation Solution300 mg/5mL43598-605
- Tobramycin and Dexamethasone1 mg/mL50090-1136
- Tobramycin and Dexamethasone1 mg/mL50090-1914
- TOBRAMYCIN AND DEXAMETHASONE1 mg/mL50090-7267
- Tobramycin Ophthalmic Solution3 mg/mL62332-518
- TOBRAMYCIN AND DEXAMETHASONE1 mg/mL63629-9570
- TOBRAMYCIN300 mg/5mL70756-604
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)