TOBRADEX ST- tobramycin / dexamethasone suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

TOBRAMYCIN

Composition:

TOBRAMYCIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TOBRADEX® ST 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: Stap

Product summary:

TOBRADEX® ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle. NDC 0065-0652-25: 2.5 mL NDC 0065-0652-05: 5 mL NDC 0065-0652-10: 10 mL Storage Store at 2° to 25°C (36° to 77°F). Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

TOBRADEX ST - TOBRAMYCIN / DEXAMETHASONE SUSPENSION/ DROPS
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOBRADEX ST OPHTHALMIC SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOBRADEX
ST.
TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE OPHTHALMIC SUSPENSION)
0.3%/0.05%
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
TOBRADEX ST is a topical antibiotic and corticosteroid combination 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. (1)
DOSAGE AND ADMINISTRATION
• Instill one drop into the conjunctival sac(s) every 4 to 6 hours.
(2.1)
• During the initial 24 to 48 hours, dosage may be increased to one
drop every 2 hours. (2.1)
• Frequency should be decreased gradually as warranted by
improvement in clinical signs, but care should be taken not to
discontinue therapy prematurely. (2.1)
DOSAGE FORMS AND STRENGTHS
TOBRADEX ST ophthalmic suspension contains 3 mg/mL tobramycin and 0.5
mg/mL dexamethasone. (3)
CONTRAINDICATIONS
• TOBRADEX ST, as with other ophthalmic corticosteroids, is
contraindicated in most viral diseases of the cornea and
conjunctiva including epithelial herpes simplex keratitis (dendritic
keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures. (4.1)
• Hypersensitivity to any component of the medication (4.2)
WARNINGS AND PRECAUTIONS
• Intraocular pressure (IOP) increase-Prolonged use of
corticosteroids may result in glaucoma with damage to the optic
nerve, defects in visual acuity and fields of vision. If this product
is used for 10 days or longer, IOP should be monitored.
(5.1).
• Sensitivity to topically applied aminoglycosides may occur. (5.2)
• Cataracts- Use of corticosteroids may result in posterior
subcapsular cataract formation. (5.3)
• Delayed healing- The