Gotadex

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial 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 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:

Staphylococcus aureus

Escherichia coli

Haemophilus influenzae

Klebsiella/Enterobacter species

Neisseria species

The product does not provide adequate coverage against:

Pseudomonas aeruginosa

Serratia marcescens

Streptococci, including Streptococcus pneumoniae

Neomycin (Gotadex) is an antibiotic. It is used to treat bacterial infections.

Dexamethasone (Gotadex) is a steroid. It is used to treat the inflammation associated with bacterial infections of the eye.

Neomycin (Gotadex) and Dexamethasone (Gotadex) ophthalmic is used to treat bacterial infections of the eyes.

Neomycin (Gotadex) and Dexamethasone (Gotadex) ophthalmic may also be used for purposes other than those listed in this medication guide.

The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response.

Instill one or two drops of Ophthalmic Solution Gotadex (Neomycin (Gotadex) and Dexamethasone (Gotadex)) into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

How supplied

Sterile Ophthalmic Solution Gotadex (Neomycin (Gotadex) and Dexamethasone (Gotadex)) is a clear, colorless to pale yellow solution.

No. 7639 — Ophthalmic Solution Gotadex (Neomycin (Gotadex) and Dexamethasone (Gotadex)) is supplied as follows:

NDC 0006-7639-03 in 5 mL white opaque, plastic OCUMETER ophthalmic dispenser with a controlled drop tip.

(6505-01-039-4352 0.1% 5 mL).

Storage

Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from light.

Distributed by: MERCK & CO., INC., West Point, PA 19486, USA. Issued December 1995.

Gotadex (Neomycin (Gotadex) and Dexamethasone (Gotadex)) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Gotadex (Neomycin (Gotadex) and Dexamethasone (Gotadex)) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, including sulfites, and to other corticosteroids. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

See also:
What other drugs will affect Gotadex?

Increased risk of hypokalaemia when used concurrently with potassium-depleting drugs such as amphotericin B and loop diuretics. Reduces efficacy of isoniazid, salicylates, vaccines and toxoids. Increased activity of Dexamethasone (Gotadex) and cyclosporin when used together. Concurrent use with aspirin or ethanol may lead to increased GI side effects.

Potentially Fatal: Reduced efficacy in combination with ephedrine, cholestyramine, phenytoin, phenobarbital and rifampicin.

Food Interaction:

Dexamethasone (Gotadex) interferes with calcium absorption. Limit caffeine.

See also:
What are the possible side effects of Gotadex?

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, the combination, or any other component of the product. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) 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 corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.