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TobraDex
Overview
What is TobraDex?
TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below:
Each gram of TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) contains: Actives :
Preservative :
Inactives :
What does TobraDex look like?
What are the available doses of TobraDex?
Sorry No records found.
What should I talk to my health care provider before I take TobraDex?
Sorry No records found
How should I use TobraDex?
TOBRADEX(tobramycin and dexamethasone ophthalmic ointment) is indicated for steroidresponsive 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 and (coagulase-positive and coagulase-negative), including penicillinresistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some .
Pseudomonas aeruginosa
Escherichia coli
Klebsiella pneumoniae
Enterobacter aerogenes
Proteus mirabilis
Morganella morganii
Proteus vulgaris
Haemophilus influenzae
H. aegyptius
Moraxella lacunata
Acinetobacter calcoaceticus
Neisseria
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to three or four times daily.
How to apply TOBRADEX(tobramycin and dexamethasone ophthalmic ointment) :
1. Tilt your head back.
2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.
3. Place a small amount (about 1/2 inch) of TOBRADEX(tobramycin and dexamethasone ophthalmic ointment) in the "V" pocket. Do not let the tip of the tube touch your eye.
4. Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
What interacts with TobraDex?
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What are the warnings of TobraDex?
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What are the precautions of TobraDex?
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What are the side effects of TobraDex?
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What should I look out for while using TobraDex?
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
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, ste roids may mask infection or enhance existing infection.
What might happen if I take too much TobraDex?
Clinically apparent signs and symptoms of an overdose of TOBRADEX(tobramycin and dexamethasone ophthalmic ointment) (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
How should I store and handle TobraDex?
StorageStore at room temperature between 15°C and 30°C (59° to 86° F) [see USP]. Protect from light. StorageStore at room temperature between 15°C and 30°C (59° to 86° F) [see USP]. Protect from light. 3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35). STORAGE: Rx Only © 2002, 2010 Alcon, Inc.Revised: April 201004-201044281-2 Alcon Manufactured for:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Manufactured by:S.A. ALCON-COUVREUR N.V.Puurs, Belgium
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.
The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:
Staphylococci, including and (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some .
Pseudomonas aeruginosa
Escherichia coli
Klebsiella pneumoniae
Enterobacter aerogenes
Proteus mirabilis
Morganella morganii
Proteus vulgaris
Haemophilus influenzae
H. aegyptius
Moraxella lacunata
Acinetobacter calcoaceticus
Neisseria
Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain sus ceptible to tobramycin.
No data are available on the extent of systemic absorption from TOBRADEX(tobramycin and dexamethasone ophthalmic ointment); however, it is known that some systemic absorption can occur with ocularly applied drugs. The usual physiologic replacement dose is 0.75 mg daily. The administered dose for TOBRADEX(tobramycin and dexamethasone ophthalmic ointment) in both eyes four times daily would be 0.4 mg of dexamethasone daily.
Non-Clinical Toxicology
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.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, ste roids may mask infection or enhance existing infection.
Aminoglutethimide:
Amphotericin B injection and potassium-depleting agents:
Antibiotics:
Anticholinesterases:
Anticoagulants, oral:
Antidiabetics:
Antitubercular drugs:
Cholestyramine:
Cyclosporine:
Digitalis glycosides:
Estrogens, including oral contraceptives:
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin):
Ketoconazole:
Nonsteroidal anti-inflammatory drugs (NSAIDs):
Skin tests:
The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.
Ophthalmic ointment may retard corneal wound healing.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.
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 tobramycin ophthalmic ointment) 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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