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Basic Drug Info
Drug Name:TobraDex
Manufacturer:Alcon
Other Info:

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.



Clinical Trials:


Indications and Usage

TOBRADEX 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.

aureusand 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 calcoaceticusand some Neisseria species.
Corneal Diseases -- Diseases of the cornea.

Infective conjunctivitis --

Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Superficial Infection --

Eye Infections -- Infection, moderate to severe, caused by bacteria, fungi, or viruses, which occurs either on the external surface of the eye or intraocularly with probable inflammation, visual impairment, or blindness.

Unspecified Staphylococcus infection in conditions classified elsewhere and of unspecified site --

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.
Dendritic keratitis -- A form of herpetic keratitis characterized by the formation of small vesicles which break down and coalesce to form recurring dendritic ulcers, characteristically irregular, linear, branching, and ending in knoblike extremities. (Dictionary of Visual Science, 3d ed)

Vaccinia -- The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Chickenpox -- A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed)

Virus Diseases -- A general term for diseases produced by viruses.

Corneal Diseases -- Diseases of the cornea.

Mycobacterium Infections -- Infections with bacteria of the genus MYCOBACTERIUM.

Mycoses -- disease caused by a fungus.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.

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