Tobramycin and Dexamethasone
Generic: TOBRAMYCIN AND DEXAMETHASONE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
61693e79-81d1-3162-e053-2a91aa0ae925
Indications & Usage
INDICATIONS AND USAGE 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.
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.
Warnings
WARNINGS 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.
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.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.
Exact incidence figures are not available.
The most frequent adverse reactions to topical ocular tobramycin (Tobramycin Ophthalmic Solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.
These reactions occur in less than 4% of patients.
Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection : The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses also occurs.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Exact incidence figures are not available.
The most frequent adverse reactions to topical ocular tobramycin (Tobramycin Ophthalmic Solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.
These reactions occur in less than 4% of patients.
Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection : The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses also occurs.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.