Pred G (Gentamicin Sulfate / Prednisolone Acetate Ophthalmic) - Indications and Dosage

INDICATIONS AND USAGE

PRED-G ^® 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: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased, if necessary, up to 1 drop every hour. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

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

PRED-G ^® (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1% is supplied sterile in white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle – NDC 0023-0106-05

10 mL in 15 mL bottle – NDC 0023-0106-10

Storage: Store at 15°-25°C (59°-77°F). Avoid excessive heat, 40°C (104°F) and above. Protect from freezing. Shake well before using.

Revised: 04/2014

© 2014 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Made in the U.S.A.

71591US14