Tobraflex

TOBRAFLEX- tobramycin and fluorometholone acetate suspension
Alcon Pharmaceuticals

DESCRIPTION

Tobraflex™ (tobramycin and fluorometholone acetate ophthalmic suspension, USP) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and fluorometholone acetate are presented below:

Image from Drug Label Content

Tobramycin
Empirical Formula: C18 H37 N5 O9
Chemical Name:
O-3-Amino-3-deoxy-α-D-glucopyranosyl-
(1->4)O-[2,6-diamino-2,3,6-trideoxy-
α-D-ribo-hexopyranosyl-(1->6)]-2-
deoxy-L-streptamine

Image from Drug Label Content
(click image for full-size original)

Fluorometholone Acetate
Empirical Formula: C24 H31 FO5
Chemical Name:
9-Fluoro-11β, 17-dihydroxy-6α-
methylpregna-1,4-diene-3,20-
dione 17-acetate

Each mL contains: Active: Tobramycin 0.3% (3 mg) and Fluorometholone Acetate 0.1% (1 mg).

Preservative: Benzalkonium Chloride 0.01%. Inactive: Tyloxapol, Edetate Disodium, Sodium Chloride, Hydroxyethyl Cellulose, Hydrochloric Acid and Sodium Hydroxide (to adjust pH), Purified Water. The pH range is 6.0 -7.0. DM-00

CLINICAL 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. Clinical studies have demonstrated that Fluorometholone Acetate Suspension is a potent corticosteroid.

In clinical studies of documented steroid-responders, fluorometholone acetate demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: 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, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin. Bacterial resistance to tobramycin may develop upon prolonged use.

No data are available on the extent of systemic absorption from Tobraflex™ Ophthalmic Suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs.

When a decision to administer both a corticoid and an antibiotic is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both is administered, plus assured compatibility of ingredients when both types of drug are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

Tobraflex Indications and Usage

Tobraflex™ 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 anti-infective drug in this product, tobramycin, 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, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.

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 any component of the medication.

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.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye. 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. If used for more than 10 days, intraocular pressure should be routinely monitored even though it may be difficult in children 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.

PRECAUTIONS

General

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.

Information For Patients

Do not touch dropper tip to any surface, as this may contaminate the suspension. Contact lenses should not be worn during the use of this product.

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