TobraDex

TobraDex is an FDA-registered drug product whose active ingredient is TOBRAMYCIN AND DEXAMETHASONE. It is labelled by Novartis Pharmaceuticals Corporation taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 0078-0876, application NDA050616, label effective 20260722. It is one of 8 FDA drug label records sharing the active ingredient TOBRAMYCIN AND DEXAMETHASONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TOBRAMYCIN AND DEXAMETHASONE are most often described in connection with: ocular infection, usage tobradex, dexamethasone ophthalmic, ointment indicated, steroid-responsive inflammatory, superficial bacterial, bulbar conjunctiva, anterior segment. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) 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.

DOSAGE AND ADMINISTRATION: Apply a small amount (approximately ½ 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 ½ inch) of TOBRADEX ® (tobramycin and dexamethasone ophthalmic ointment). 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.

CONTRAINDICATIONS: 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.

WARNINGS: FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. 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 (IOP) 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 acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

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 [TOBREX ® (tobramycin ophthalmic ointment) 0.3%] are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of intraocular pressure 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. Postmarketing Experience: Additional adverse reactions identified from postmarketing use include, anaphylactic reaction, erythema multiforme. The following additional adverse reactions have been reported with the individual components listed below: 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. 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.

FDA lists 8 drug label records with TOBRAMYCIN AND DEXAMETHASONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is TobraDex used for?
INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) 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 …

Who makes TobraDex?
Novartis Pharmaceuticals Corporation is the labeler of record for TobraDex. 8 FDA label records share the active ingredient TOBRAMYCIN AND DEXAMETHASONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TobraDex come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TobraDex prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TOBRAMYCIN AND DEXAMETHASONE?
Yes. 8 FDA drug label records list TOBRAMYCIN AND DEXAMETHASONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TobraDex been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.