Description
Tobramycin Ophthalmic .3% Solution is a broad spectrum aminoglycoside antibiotic solution for the topical treatment of ocular bacterial infections. Made by Sandoz.
Tobramycin 0.3% Ophthalmic Solution, 5 ml
Prescription Required
$10.87
Tobramycin Ophthalmic .3% Solution is a broad spectrum aminoglycoside antibiotic solution for the topical treatment of bacterial infections in eyes.
- Description
- Additional information
- More Details
- Formulations
- Administration
- Precautions
- Manufacturer Product Information
Additional information
| Weight | .03 lbs |
|---|---|
| Dimensions | 1.0 x 1.25 x 2.63 in |
More Details
This medication requires a prescription from your veterinarian.
Tobramycin Ophthalmic is labeled for human use but is used extra-label to treat ocular infections in animals.
Tobramycin, like the other aminoglycoside antibiotics, acts on susceptible bacteria presumably by irreversibly binding to the 30S ribosomal subunit thereby inhibiting protein synthesis. It is considered a bactericidal antibiotic.
Tobramycin’s spectrum of activity includes coverage against many aerobic gram-negative and some aerobic gram-positive bacteria, including most species of E. coli, Klebsiella, Proteus, Pseudomonas, Salmonella, Enterobacter, Serratia, Shigella, Mycoplasma, and Staphylococcus. Like amikacin, tobramycin may have more activity against Pseudomonas isolates than gentamicin.
Formulations
Tobramycin Ophthalmic Solution, USP 0.3% is supplied as 5 ml volume in a plastic bottle with a controlled drop tip.
Administration
USE AS DIRECTED BY YOUR VETERINARIAN.
Common dosing recommendations:
1 drop of the solution in the affected eye(s) 2-3 times daily. Frequency may be increased to every 30-60 minutes for treating equine corneal ulcers.
Subconjunctival Injection (extra-label): 10 mg of tobramycin injection once.
Precautions
Tobramycin sulfate is contraindicated in patients with a history of hypersensitivity to it or any component of the formulation. Cross sensitivity with other aminoglycosides has been known to occur.
Adverse effects reported in humans or animals include are ocular burning and irritation upon drug instillation, nonspecific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
Manufacturer Product Information
TOBRAMYCIN- tobramycin solution
Sandoz Inc.
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Tobramycin Ophthalmic Solution USP, 0.3%
Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution USP, 0.3% 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.
Tobramycin Ophthalmic Solution USP, 0.3% has a pH range between 7.0 and 8.0.
Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.
The chemical structure of tobramycin is:
MW=467.2
Molecular Formula
C18H37N5O9
Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)} -0- {2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→6) }-2-deoxystreptamine.
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.
Tobramycin Ophthalmic Solution USP, 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 Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin Ophthalmic Solution USP, 0.3% occurs, discontinue use.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Do not touch dropper tip to any surface, as this may contaminate the solution.
Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Because of the potential for adverse reactions in nursing infants from Tobramycin Ophthalmic Solution USP, 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients below the age of 2 months has not been established.
The most frequent adverse reactions to Tobramycin Ophthalmic Solution USP, 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with Tobramycin Ophthalmic Solution USP, 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic Solution USP, 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
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.
5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 61314-643-05) containing tobramycin 0.3% (3 mg/mL).
Storage: Store at 2° - 25°C (36° - 77°F).
Rx Only
*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
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