SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5), prednisolone sodium phosphate (UNII: IV021NXA9J) (prednisolone - UNII:9PHQ9Y1OLM)

Available from:

Rebel Distributors Corp

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a 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 agains

Product summary:

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution, 10%/0.25%, is available in 5 mL plastic bottle with a controlled drop tip. Dispense only in original, unopened container. 5mL NDC: 21695-186-05 Store at 15°-25°C (59°-77°F) PROTECT 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. Rx Only Bausch & Lomb Incorporated Tampa, FL 33637 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE- SULFACETAMIDE
SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION
REBEL DISTRIBUTORS CORP
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SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE OPHTHALMIC
SOLUTION
DESCRIPTION
Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic
solution is a sterile topical
ophthalmic solution combining an antibacterial and a corticosteroid.
EACH ML CONTAINS: ACTIVES: sulfacetamide sodium (as the monohydrate)
100 mg, prednisolone sodium
phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg).
PRESERVATIVE: thimerosal 0.1 mg.
INACTIVES: edetate disodium, poloxamer 407, boric acid, sodium
hydroxide and/or hydrochloric acid (to
adjust pH) and water for injection. pH range is 6.5 to 7.5.
The chemical name for sulfacetamide sodium, is N-sulfanilylacetamide
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:
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, 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 corticosteroids depends on the molecular
structure, concentration and release
from the vehicle.
MICROBIOLOGY: Sulfacetamide exerts a bacteriostatic effect against
susceptible bacteria by