VASOCIDIN is a sterile topical ophthalmic solution combining an anti-infective and an adrenocortical steroid having the following composition:

Sulfacetamide Sodium 100 mg/mL
  (bacteriostatic antibacterial)

Prednisolone Sodium Phosphate 2.5mg/mL
  (equivalent to Prednisolone Phosphate 2.3 mg/mL)
  (adrenocortical steroid/anti-inflammatory)

In a solution containing edetate disodium, poloxamer 407, boric acid, purified water, preserved with thimerosal 0.1 mg/mL. Hydrochloric acid and/or sodium hydroxide added to adjust pH.

The chemical name for sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl]-, monosodium salt, monohydrate.

The chemical name for prednisolone sodium phosphate is 11β, 17, 21-trihydroxypregna-1,4-diene-3,20-dione, 21-(disodium phosphate).

They have the following chemical structures

Sulfacetamide Sodium

Prednisolone Sodium Phosphate

Last updated on RxList: 4/8/2009

VASOCIDIN is indicated for corticosteroid-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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain 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: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

This product does not provide adequate coverage against: Neisseria species, Serratia marcescens.

A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Instill two drops of VASOCIDIN Ophthalmic Solution topically in the eye(s) every four hours.

Not more than 20 mL should be prescribed initially. If signs and symptoms fail to improve after two days, patients should be reevaluated (see PRECAUTIONS).

Care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

VASOCIDIN Ophthalmic Solution: 5 mL NDC 58768-887-05, and 10 mL NDC 58768-887-10 dropper-tip plastic squeeze bottles.

To be dispensed only in original, unopened container. Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep from freezing. PROTECT FROM LIGHT.

Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

KEEP OUT OF REACH OF CHILDREN.

CAUTION: Federal law prohibits dispensing without prescription.

Mfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683 for: Novartis Ophthalmics, Duluth, GA 30097. Rev February 2001.

Last updated on RxList: 4/8/2009

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid 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. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).

Sulfacetamide sodium may cause local irritation.

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.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.

Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

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 corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

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

VASOCIDIN Ophthalmic Solution is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

Last updated on RxList: 4/8/2009

NOT FOR INJECTION INTO THE EYE. Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.

Prolonged use of VASOCIDIN may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

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

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.

Topical corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids have been demonstrated (see ADVERSE REACTIONS).

Do not administer this product to patients who are sensitive/allergic to thimerosal or any other mercury-containing ingredient.

General

The initial prescription and renewal of the medication order beyond 20 mL of VASOCIDIN Ophthalmic Solution should be made by a physician only after examination of the patient with the aid of magnification, such as slit-lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should return to the office for further evaluation. The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.

Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

Laboratory Tests

Eyelid cultures and tests to determine the susceptibility of organisms to sulfacetamide may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with VASOCIDIN Ophthalmic Solution.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Prednisolone has been reported to be non-carcinogenic. Long-term animal studies for carcinogenic potential have not been performed with prednisolone or sulfacetamide.

One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of sulfacetamide sodium. The significance of this finding to the topical ophthalmic use of sulfacetamide sodium in the human is unknown. Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with sulfacetamide. A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.

Pregnancy

Teratogenic effects

Pregnancy Category C

Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly 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 dosed with corticosteroids.

Kernicterus may be precipitated in infants by sulfonamides given systemically during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

VASOCIDIN Ophthalmic Solution 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 other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from VASOCIDIN, a decision should be made whether to discontinue nursing or to discontinue the medication.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of six years have not been established.

Last updated on RxList: 4/8/2009

No information provided.

VASOCIDIN Ophthalmic Solution 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 ocular structures. VASOCIDIN is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides, or to other corticosteroids. (Hypersensitivity to the antimicrobial components occurs at a higher rate than for other components).

Last updated on RxList: 4/8/2009

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.

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, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

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

Microbiology

Sulfacetamide sodium exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.

Some strains of bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo.

The anti-infective component in VASOCIDIN Ophthalmic Solution is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in-vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella/Enterobacter species. The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens. SEE INDICATIONS AND USAGE SECTION.

Last updated on RxList: 4/8/2009

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 dropper tip to eyelids or to any other surface. The use of this dispenser by more than one person may spread infection. Keep bottle tightly closed when not in use. Protect from light. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. Keep out of the reach of children.

Last updated on RxList: 4/8/2009

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.

SULFACETAMIDE/PREDNISOLONE - OPHTHALMIC SUSPENSION

(sull-fuh-SEET-uh-mide/pred-NIS-oh-loan)

COMMON BRAND NAME(S): Blephamide, Vasocidin

USES: This medication is used to prevent or treat eye infections and to treat swelling in the eye. This product contains an antibiotic (sulfacetamide) that stops the growth of bacteria and a corticosteroid (prednisolone) that reduces inflammation.

This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: To apply eye drops, wash your hands first. Shake this suspension well before each dose. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Before using this product, check it visually. Do not use if it has darkened in color.

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 using them.

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 it. 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 for your other eye if so directed, and if your dose is for more than 1 drop. Apply as often as directed by your doctor.

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.

Use this medication regularly in order to get the most benefit from it. Continue using it for the full time prescribed even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Do not use this medication for longer than prescribed. If you use it regularly for an extended period of time, do not suddenly stop using it without consulting your doctor. Your dosage may need to be gradually decreased.

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

SIDE EFFECTS: This medication may temporarily sting or burn your eyes for a minute or two when applied. Eye discomfort, dry eyes, tearing, itching, or redness may occur. 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 or repeated periods may result in a new type of eye infection (e.g., viral, fungal). Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye pain, staining of the eyes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing, signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising, yellowing of the eyes/skin, dark urine.

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 sulfacetamide/prednisolone, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs (e.g., sulfamethoxazole), corticosteroids (e.g., hydrocortisone, prednisone), 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: eye problems (e.g., glaucoma, severely dry eyes), eye surgeries (e.g., cataract surgery), diabetes.

Use caution engaging in activities requiring clear vision, such as driving or using machinery, because your vision may be temporarily blurred or unstable after applying this drug. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if the medications in this product pass into breast milk. Consult your doctor before breast-feeding.

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

This drug should not be used with the following medications because very serious interactions may occur: gentamicin, certain local anesthetics (e.g., tetracaine), preparations that contain silver.

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

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If 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. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Throw away the unused portion after therapy is completed. Do not use it later for another infection or give it to someone else. A different medication may be necessary in those cases.

With prolonged use (more than 10 days), laboratory and/or medical tests (e.g., eye exams) should be performed periodically 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 between 46-75 degrees F (8-24 degrees C) away from light and heat. Do not freeze or store in the bathroom. Do not use the solution if the color has darkened. 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.