PRED-G® sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Structural Formulae:

Chemical Names:

Prednisolone acetate: 11β,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate.

Gentamicin sulfate is the sulfate salt of gentamicin C₁, gentamicin C₂, and gentamicin C_1A which are produced by the growth of Micromonospora purpurea.

Contains: Actives: Gentamicin sulfate equivalent to 0.3% gentamicin base; prednisolone acetate (microfine suspension) 1.0%. Preservative: Benzalkonium chloride 0.005%. Inactives: edetate disodium; hypromellose; polyvinyl alcohol 1.4%; polysorbate 80; purified water; sodium chloride; and sodium citrate, dihydrate. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH (5.4 to 6.6).

PRED-G® suspension is formulated with a pH from 5.4 to 6.6 and its osmolality ranges from 260 to 340 mOsm/kg.

Last updated on RxList: 11/11/2008

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.

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.

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.

Revised December 2005. Allergan, Inc. Irvine, CA 92612, U.S.A. FDA rev date: 12/20/2005

Last updated on RxList: 11/11/2008

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 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.

Burning, stinging and other symptoms of irritation have been reported with PRED-G®. Superficial punctate keratitis has been reported occasionally with onset occurring typically after several days of use.

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 steroid. 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.

No information provided.

Last updated on RxList: 11/11/2008

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

PRED-G® sterile ophthalmic suspension is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

General

Ocular irritation and punctate keratitis have been associated with the use of PRED-G® suspension. The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient's intraocular pressure, examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

Carcinogenesis, mutagenesis, impairment of fertility

There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

There are no published mutagenicity or impairment of fertility studies on prednisolone. Prednisolone has been reported to be non-carcinogenic.

Pregnancy

Pregnancy Category C. Gentamicin has been shown to depress body weight, kidney weight, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women. PRED-G® suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects. Because of the potential for serious adverse reactions in nursing infants from PRED-G® suspension, a decision should be made whether to discontinue nursing while the drug is being administered or to discontinue the medication.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last updated on RxList: 11/11/2008

No information provided.

PRED-G® suspension 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 the ocular structures.

PRED-G® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation or to other corticosteroids.

Last updated on RxList: 11/11/2008

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.

Last updated on RxList: 11/11/2008

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Store at 15° - 25°C (59° - 77°F). Protect from freezing and from heat of 40°C (104°F) and above. Keep out of the reach of children. Shake well before using.

Last updated on RxList: 11/11/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GENTAMICIN/PREDNISOLONE - OPHTHALMIC DROPS

(jen-tuh-MY-sin/pred-NIS-oh-loan)

COMMON BRAND NAME(S): Pred-G

USES: This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This product contains gentamicin, an antibiotic that works by stopping the growth of bacteria. It also contains prednisolone, an anti-inflammatory corticosteroid that works by reducing swelling.

This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections and may worsen them (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: This medication is applied to the eye(s) as directed by your doctor. To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. Shake the bottle well before each dose.

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer's directions, and check with your doctor before you begin using them again.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps if your dose is for more than 1 drop and for your other eye if so directed. Repeat as often as directed by your doctor. Your dosage is based on your medical condition and response to therapy.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Do not use this medication more often than prescribed or for longer than 10 days unless directed by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too soon may allow bacteria to continue to grow, which may result in a return of the infection.

Inform your doctor if your condition does not improve in 2 days.

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when this medication is applied. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts, delayed wound healing). Do not use this medication for longer than prescribed. Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening eye symptoms (e.g., discharge, swelling, redness), vision problems, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to gentamicin or prednisolone; or to aminoglycoside antibiotics (e.g., neomycin, tobramycin); or to corticosteroids (e.g., dexamethasone, hydrocortisone); or to preservatives (e.g., benzalkonium chloride); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily unstable. Use caution while driving, using machinery, or doing any other activity that requires clear vision.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Throw away any unused medication after treatment is completed. Do not use it later for another infection. A different medication may be necessary in that case.

If you use this medication for 10 days or longer, laboratory and/or medical tests (e.g., eye exams) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from heat, light, and moisture. Do not freeze. Do not store in the bathroom. Throw away this medication and do not use it if the solution turns brown or cloudy or contains particles. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.