Pred G

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.

Manufactured by: Allergan, Irvine, CA 92612, U.S.A..

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective component in PRED-G®  is included to provide action against specific organisms susceptible to it. Gentamicin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

• Blephamide

© Pred-G Patient Information is supplied by Cerner Multum, Inc. and Pred-G Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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.

PRED-G® (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1.0% 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

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

Rx Only

Revised December 2005

© 2006 Allergan, Inc.
Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.
Printed in U.S.A.
7484X
71591US12T

NDC 0023-0106-05 Rx Only

PRED-G®

(gentamicin and prednisolone
acetate ophthalmic suspension,
USP) 0.3%/1.0%

5 mL sterile

ALLERGAN

ALLERGAN

NDC 0023-0106-05

Rx Only

PRED-G®

(gentamicin and
prednisolone
acetate ophthalmic
suspension,USP)
0.3%/1.0%

sterile

5 mL

Do not use gentamicin and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

It is not known whether gentamicin and prednisolone ophthalmic will harm an unborn baby. Talk to your doctor before using this medication if you are pregnant.

It is also not known whether gentamicin and prednisolone ophthalmic passes into breast milk. Talk to your doctor before using this medication if you are breast-feeding a baby.

Use gentamicin and prednisolone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops or ointment.

To apply the eyedrops:

• Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

• Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

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.

Do not use any eyedrop that is discolored or has particles in it.

Store gentamicin and prednisolone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with gentamicin and prednisolone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Pred-G, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pred-G. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Pred-G.

Review Date: October 4, 2017

Applies to gentamicin / prednisolone ophthalmic: ophthalmic ointment, ophthalmic suspension

General

The most frequently reported side effects were ocular discomfort, irritation following instillation, and punctate keratitis.[Ref]

Ocular

Frequency not reported: Superficial punctate keratitis, ocular discomfort

Prednisolone:
Frequency not reported: Intraocular pressure increased, glaucoma, optic nerve damage, posterior subcapsular cataract formation[Ref]

Local

Frequency not reported: Burning, stinging, irritation[Ref]

Other

Frequency not reported: Secondary ocular infection developed

Prednisolone:
Frequency not reported: Wound healing delayed[Ref]

Immunologic

Gentamicin:
Frequency not reported: Allergic sensitization[Ref]

Some side effects of Pred-G may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.