TobraDex Ophthalmic Ointment

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 S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillinresistant 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.

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.

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

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.

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.

Suspension: 1 or 2 drops into the conjunctival sac(s) every 4 to 6 hours
Ointment: Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to 3 or 4 times per day

Comments:
SUSPENSION:
-During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours.
-Frequency should be decreased gradually as indicated by improvement in clinical signs.
-No more than 20 mL should be prescribed initially and the prescription should not be refilled without additional evaluation.
OINTMENT:
-No more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation.

Use: 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

2 years or older:
Suspension: 1 or 2 drops into the conjunctival sac(s) every 4 to 6 hours
Ointment: Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to 3 or 4 times per day

Comments:
SUSPENSION:
-During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours.
-Frequency should be decreased gradually as indicated by improvement in clinical signs.
-No more than 20 mL should be prescribed initially and the prescription should not be refilled without additional evaluation.
OINTMENT:
-No more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation.

Use: 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

2 years or older:
Suspension: 1 or 2 drops into the conjunctival sac(s) every 4 to 6 hours
Ointment: Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to 3 or 4 times per day

Comments:
SUSPENSION:
-During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours.
-Frequency should be decreased gradually as indicated by improvement in clinical signs.
-No more than 20 mL should be prescribed initially and the prescription should not be refilled without additional evaluation.
OINTMENT:
-No more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation.

Use: 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

Data not available

Data not available