PRED-G- gentamicin, prednisolone acetate suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GENTAMICIN (UNII: T6Z9V48IKG) (GENTAMICIN - UNII:T6Z9V48IKG), PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Available from:

Allergan, Inc.

INN (International Name):

GENTAMICIN

Composition:

GENTAMICIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRED-G ® suspension 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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a 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 against the following common bacterial eye pathogens: Staphylococcus aur

Product summary:

PRED-G ® (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1% is supplied sterile in white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle – NDC 0023-0106-05 Store at 15°-25°C (59°-77°F). Avoid excessive heat, 40°C (104°F) and above. Protect from freezing. Shake well before using. Revised :     0 7 / 201 8 Distributed by: Allergan USA, Inc. Madison, NJ 07940 ©2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.2USPI0106

Authorization status:

New Drug Application

Summary of Product characteristics

PRED-G- GENTAMICIN, PREDNISOLONE ACETATE SUSPENSION/ DROPS
ALLERGAN, INC.
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PRED-G
(GENTAMICIN AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP)
0.3%/1%
STERILE
DESCRIPTION
PRED-G sterile ophthalmic suspension is a topical
anti-inflammatory/anti-infective combination
product for ophthalmic use.
STRUCTURAL FORMULAE:
PREDNISOLONE ACETATE GENTAMICIN SULFATE
CHEMICAL NAMES: Prednisolone acetate:
11ß,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-
acetate.
Gentamicin sulfate is the sulfate salt of gentamicin C , gentamicin C
, and gentamicin C
which are
produced by the growth of _Micromonospora purpurea_.
CONTAINS: Actives: Gentamicin sulfate equivalent to 0.3% gentamicin
base; prednisolone acetate
(microfine suspension) 1%. PRESERVATIVE: Benzalkonium chloride 0.005%.
INACTIVES: edetate disodium;
hypromellose; polyvinyl alcohol 1.4%; polysorbate 80; purified water;
sodium chloride; and sodium
citrate, dihydrate. May contain sodium hydroxide and/or hydrochloric
acid to adjust pH (5.4 to 6.6).
PRED-G suspension is formulated with a pH from 5.4 to 6.6 and its
osmolality ranges from 260 to
340 mOsm/kg.
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.
The anti-infective component in PRED-G is included to provide action
against specific organisms
susceptible to it. Gentamicin sulfate is active _in vitro_ against
susceptible strains of the following
microorganisms: _Staphylococcus aureus, Streptococcus pyogenes,
Streptococcus pneumoniae, Enterobacter_
_aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella
pneumoniae, Neisseria gonorrhoeae,_
_Pseudomonas aeruginosa_, and _Serratia marcescens_.
When a decision to administer both a corticosteroid and an
antimicrobial is made, the administration of
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