Vagi-Sulfa

Sulfacetamide:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Vagi-Sulfa (Sulfacetamide) reviews

DESCRIPTION

Vagi-Sulfa ^® ophthalmic suspension is a sterile, topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Structural Formulas

MW=254.24 C₈H₉N₂NaO₃S·H₂O MW=402.49 C₂₃H₃₀O₆

Structural Formulas

Chemical Names

Vagi-Sulfa (Sulfacetamide) sodium: N-sulfanilylacetamide monosodium salt monohydrate.

Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

Each mL of Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension contains:

Actives: Vagi-Sulfa (Sulfacetamide) sodium 10%, prednisolone acetate (microfine suspension) 0.2%.

Inactives: benzalkonium chloride (0.004%); edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium phosphate, dibasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.6 to 7.2).

CLINICAL PHARMACOLOGY

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 antibacterial 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 antibacterial 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.

Microbiology

Vagi-Sulfa (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 these bacteria may be resistant to Vagi-Sulfa (Sulfacetamide) or resistant strains may emerge in vivo.

The anti-infective component in these products is included to provide action against specific organisms susceptible to it. Vagi-Sulfa (Sulfacetamide) sodium is active in vitro against susceptible strains of the following microorganisms: 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, Pseudomonas species, and Serratia marcescens.

INDICATIONS AND USAGE

Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension is a steroid/anti-infective combination drug 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 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 antibacterial 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, Pseudomonas species, and Serratia marcescens.

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

CONTRAINDICATIONS

Vagi-Sulfa (Sulfacetamide) ^® ophthalmic 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 ocular structures.

Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)

WARNINGS

NOT FOR INJECTION INTO THE EYE.

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

If the 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. Corticosteroids 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.

In those diseases causing thinning of the cornea or sclera, perforation has 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.

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.

Prolonged use of Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension may suppress the host response and thus increase the hazard of secondary ocular infections.

Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

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

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

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. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.

If signs of hypersensitivity, skin rash, or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated.

PRECAUTIONS

General

The initial prescription and renewal of the medication order beyond 20 milliliters of the suspension 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 be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

Use with caution in patients with severe dry eye.

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

Information for Patients

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.

Contact lenses should not be worn during the use of this product.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to eyelids or to any other surface. The use of this bottle 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.

Laboratory Tests

Eyelid cultures and tests to determine the susceptibility of organisms to Vagi-Sulfa (Sulfacetamide) may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension.

Drug Interactions

Vagi-Sulfa ^® ophthalmic suspension is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with Vagi-Sulfa (Sulfacetamide).

One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of Vagi-Sulfa (Sulfacetamide) sodium. The significance of this finding to topical ophthalmic use of Vagi-Sulfa (Sulfacetamide) sodium in the human is unknown.

Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with Vagi-Sulfa (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

Animal reproduction studies have not been conducted with Vagi-Sulfa sodium. 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 being given systemically during the third trimester of pregnancy. It is not known whether Vagi-Sulfa (Sulfacetamide) sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

Vagi-Sulfa (Sulfacetamide) ^® ophthalmic 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 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 Vagi-Sulfa (Sulfacetamide) sodium and prednisolone acetate ophthalmic suspensions, 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 6 years have not been established.

ADVERSE REACTIONS

The following adverse reactions have been identified during use of Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination.

Reactions occurring with Vagi-Sulfa (Sulfacetamide) ^® ophthalmic suspension include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision).

Reactions occurring most often from the presence of the antibacterial 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.

The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.

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 antibacterials. 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.

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Vagi-Sulfa (Sulfacetamide) ^® dosage may be reduced, but 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.

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

HOW SUPPLIED

Vagi-Sulfa (Sulfacetamide) ^® (sulfacetamide sodium–prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:

• 5 mL in 10 mL bottle - NDC 11980-022-05
• 10 mL in 15 mL bottle - NDC 11980-022-10

Note: Shake well before using.

Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Protect from freezing.

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.

Revised: 07/2017

© 2017 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

Irvine, CA 92612

Made in the U.S.A.

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Sulfathiazole:

• Vagi-Sulfa (Sulfathiazole) reviews

Indication: Vagi-Sulfa (Sulfathiazole) is effective against a wide range of gram positive and gram negative pathogenic microorganisms. Although no longer used in humans, it is used in cattle.

Urea:

• Vagi-Sulfa (Urea) reviews

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS MEMBRANES.

DESCRIPTION: Vagi-Sulfa (Urea) Nail Stick 50% is a keratolytic solution, which is gentle yet potent, tissue softener for nails. Each mL of Vagi-Sulfa (Urea) Nail Stick 50% contains 50% Vagi-Sulfa (Urea) along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocophery acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.

Vagi-Sulfa (Urea) is a diamide of carbonic acid with the following chemical structure:

Chemical Structure

CLINICAL

Pharmacology: Vagi-Sulfa (Urea) gently dissolves the intracellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Vagi-Sulfa (Urea) also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS: The mechanism of action of topically applied Vagi-Sulfa (Urea) is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Vagi-Sulfa (Urea) is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized, and ingrown nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips, inside the mouth/nose, and the vaginal/groin area. Consult your physician for directions about any areas of types of skin to apply or not apply the product. Tell your doctor if your condition persists or worsens.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however there are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Vagi-Sulfa (Urea) Nail Stick 50% should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vagi-Sulfa (Urea) Nail Stick 50% is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects.

DOSAGE AND ADMINISTRATION: Use this product as directed, and regularly, to achieve maximum benefit. Follow all directions on the product package and prescription label. If you are uncertain about any of the information, consult your doctor or pharmacist. Apply to the affected areas of the skin/nails, twice a day or as directed by your doctor. Rub in well until absorbed. As the product dries, the level of Vagi-Sulfa (Urea) increases as the level of moisture decreases, allowing some of the Vagi-Sulfa (Urea) to crystallize (white color). The product will work properly whether or not the Vagi-Sulfa (Urea) can be seen on the surface. Wash hands after applying unless you are treating the hands.

HOW SUPPLIED: Vagi-Sulfa (Urea) Nail Stick 50% is supplied in a carton containing 6 nail sticks (2.4 mL each = 2.7 g each) NDC 42808-0205-15.

Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.

How to Dispense Vagi-Sulfa (Urea) Nail Stick 50% from the Container: Shake before use. Remove the cap, applicator side up. Holding the container with one hand, rotate the bottom dispensing dial counterclockwise. As the dial is rotated you will hear a clicking sound, which indicates that the product is being dispensed on the applicator. Rotate until the gel is visibly and apply as needed. After use, place the cap firmly on the container and when not in use keep the product tightly capped.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0205-15-205-00

Iss:6/11