Tobradex ST
Generic: TOBRAMYCIN / DEXAMETHASONE
Basic Information
Manufacturer
Harrow Eye, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
3b99dbb3-ac84-4d0d-b30f-a5db44fdc316
Indications & Usage
1 INDICATIONS AND USAGE TOBRADEX ST 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.
epidermidi s (coagulase-positive and coagulase-negative), including penicillin-resistant isolates.
Streptococci , including some Group A and other 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 isolates, Haemophilus influenzae, H.
aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus , and some Neisseria species .
TOBRADEX ST is a topical antibiotic and corticosteroid combination 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.
( 1 ).
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.
epidermidi s (coagulase-positive and coagulase-negative), including penicillin-resistant isolates.
Streptococci , including some Group A and other 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 isolates, Haemophilus influenzae, H.
aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus , and some Neisseria species .
TOBRADEX ST is a topical antibiotic and corticosteroid combination 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.
( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia.
The reactions due to the steroid component are increases in IOP with possible development of glaucoma.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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 (TOBREX ® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia.
These reactions occur in less than 4% of patients.
The reactions due to the steroid component are: increased IOP with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing [see Warnings and Precautions (5.1 , 5.3 , 5.4) ] .
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 [see Warnings and Precautions (5.7) ] .
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.
Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.
The following additional adverse reactions have been reported with the individual components below: Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy.
Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function.
Dexamethasone: Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of TOBRADEX ST.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Additional adverse reactions identified from postapproval use include, anaphylactic reaction, and erythema multiforme.
The reactions due to the steroid component are increases in IOP with possible development of glaucoma.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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 (TOBREX ® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia.
These reactions occur in less than 4% of patients.
The reactions due to the steroid component are: increased IOP with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing [see Warnings and Precautions (5.1 , 5.3 , 5.4) ] .
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 [see Warnings and Precautions (5.7) ] .
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.
Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.
The following additional adverse reactions have been reported with the individual components below: Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy.
Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function.
Dexamethasone: Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of TOBRADEX ST.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Additional adverse reactions identified from postapproval use include, anaphylactic reaction, and erythema multiforme.