Sulfacetamide sodium And Prednisolone acetate

Sulfacetamide sodium And Prednisolone acetate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Sulfacetamide sodium And Prednisolone acetate is a topical anti-inflammatory/anti-infective that is FDA approved for the treatment of steroid-responsive inflammatory ocular conditions.. Common adverse reactions include allergic sensitizations, elevation of intraocular pressure..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• A steroid/anti-infective combination 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 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.

• Dosing information:

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide sodium And Prednisolone acetate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfacetamide sodium And Prednisolone acetate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide sodium And Prednisolone acetate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfacetamide sodium And Prednisolone acetate in pediatric patients.

Contraindications

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Contraindications in the drug label.

Warnings

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sulfacetamide sodium And Prednisolone acetate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfacetamide sodium And Prednisolone acetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulfacetamide sodium And Prednisolone acetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in geriatric settings.

Gender

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulfacetamide sodium And Prednisolone acetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulfacetamide sodium And Prednisolone acetate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Administration in the drug label.

Monitoring

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sulfacetamide sodium And Prednisolone acetate and IV administrations.

Overdosage

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Pharmacology in the drug label.

Mechanism of Action

• 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

• 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 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. 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

Structure

Chemical Names

• Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt monohydrate.

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

Contains

• Actives: sulfacetamide sodium 10%, prednisolone acetate (microfine suspension) 0.2%.

• Preservative: benzalkonium chloride (0.004%). Inactives: 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).

Pharmacodynamics

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate How Supplied in the drug label.

Storage

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sulfacetamide sodium And Prednisolone acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

BLEPHAMIDE®

Look-Alike Drug Names

There is limited information regarding Sulfacetamide sodium And Prednisolone acetate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.