Gentamicin and Prednisolone Acetate

Gentamicin is an antibiotic. It is used to treat bacterial infections.

Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Gentamicin and prednisolone ophthalmic is used to treat bacterial infections of the eyes.

Gentamicin and prednisolone ophthalmic may also be used for purposes other than those listed in this medication guide.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Gentamicin and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

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

Reactions reported with PRED-G®  include eye burning, eye stinging, eye irritation, ocular hyperemia, eye pain, eye discharge, lacrimation increased, eye edema, visual impairment, foreign body sensation in eyes, and dysgeusia. Hypersensitivity including signs and symptoms related to ocular allergy (e.g. conjunctivitis), angioedema (e.g. tongue edema) and allergic skin reactions (e.g. rash and contact allergy) has also been reported. Superficial punctate keratitis has been reported occasionally with onset occurring typically after several days of use.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid 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 ocular infection has occurred after use of combinations containing steroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).

Secondary bacterial ocular infection following suppression of host responses also occurs.

Read the entire FDA prescribing information for Pred-G (Gentamicin and Prednisolone Acetate)