SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE solution/ drops

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Commercializzato da:

REMEDYREPACK INC.

INN (Nome Internazionale):

SULFACETAMIDE SODIUM

Composizione:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE- SULFACETAMIDE
SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS
REMEDYREPACK INC.
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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 corticosteroid depen