Tobramycin And Dexamethasone Suspension/ Drops
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Questions & Answers
Side Effects & Adverse Reactions
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 does occur, discontinue use.
Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
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.
History
There is currently no drug history available for this drug.
Other Information
Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. Tobramycin is represented by the following structural formula:
C18H37N5O9
Mol. Wt. 467.52
Chemical Name: 0-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-0-[(2,6-diamino-2,3,6-tridexoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine
Dexamethasone is represented by the following structural formula:
C22H29FO5
Mol. Wt. 392.47
Chemical Name: 9-FIuoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Each mL Contains: ACTIVES: Tobramycin 3 mg (0.3%) and Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Sulfate, Sodium Chloride, Hydroxyethyl Cellulose, Tyloxapol, Edetate Disodium and Purified Water. Sulfuric Acid and/or Sodium Hydroxide may be added to adjust pH (5.0 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Sources
Tobramycin And Dexamethasone Suspension/ Drops Manufacturers
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Rebel Distributors Corp
![Tobramycin And Dexamethasone Suspension/ Drops [Rebel Distributors Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tobramycin And Dexamethasone Suspension/ Drops | Rebel Distributors Corp
One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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Physicians Total Care, Inc.
Tobramycin And Dexamethasone Suspension/ Drops | Physicians Total Care, Inc.
One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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Remedyrepack Inc.
Tobramycin And Dexamethasone Suspension/ Drops | Remedyrepack Inc.
One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
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Bausch & Lomb Incorporated
Tobramycin And Dexamethasone Suspension/ Drops | Kmart Corporation
• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
![Tobramycin And Dexamethasone Suspension/ Drops [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0e460787-5413-44d3-bd60-69d3d04f97eb&name=6286.jpg)
![Tobramycin And Dexamethasone Suspension/ Drops [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=75cd548c-c858-4462-9b5d-d12ec2990693&name=MM3.jpg)
![Tobramycin And Dexamethasone Suspension/ Drops [Bausch & Lomb Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6c6fa738-7cc4-4a09-8811-707b0338c7d7&name=1c8e9146-20f0-4265-b994-22e8e267b6b9-01.jpg)
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