Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5), PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
RPK Pharmaceuticals, Inc.
OPHTHALMIC
PRESCRIPTION DRUG
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: 53002-8690 NDC: 53002-8690-1 5 mL in a BOTTLE, DROPPER NDC: 53002-8690-2 10 mL in a BOTTLE, DROPPER
Abbreviated New Drug Application
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 Прочетете целия документ