SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE solution/ drops

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:

RPK Pharmaceuticals, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 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

Product summary:

Product: 53002-8690 NDC: 53002-8690-1 5 mL in a BOTTLE, DROPPER NDC: 53002-8690-2 10 mL in a BOTTLE, DROPPER

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE-
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS
RPK PHARMACEUTICALS, INC.
----------
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
OPHTHALMIC SOLUTION 10%/0.23%
(PREDNISOLONE PHOSPHATE) (STERILE)
RX ONLY
DESCRIPTION
Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic
Solution is a
sterile topical ophthalmic solution combining an anti-infective and an
adrenocortical
steroid.
EACH ML CONTAINS: ACTIVES: Sulfacetamide Sodium 100 mg, Prednisolone
Sodium
Phosphate 2.5 mg (equivalent to Prednisolone Phosphate 2.3 mg);
INACTIVES:
Poloxamer 407, Boric Acid, Edetate Disodium, Purified Water.
Hydrochloric Acid and/or
Sodium Hydroxide may be added to adjust pH (6.5-7.5). PRESERVATIVE
ADDED:
Thimerosal 0.01%.
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 structural formulas:
Sulfacetamide Sodium
C H N NaO S•H O Mol. Wt. 254.24
8
9
2
3
2
Prednisolone Sodium Phosphate
C
H
Na O P Mol. Wt. 484.39
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 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
amount of drug is
delivered and retained.
The relative potency of a corticostero