NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Physicians Total Care, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial 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 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 infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (See CLINICAL PHARMACOLOGY: Microbiology ). The particular anti-infective drugs in this produ

Product summary:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC 54868-3250-1 SHAKE WELL BEFORE USING. Store at 20°-25°C (68°-77°F). Rx Only *DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd. 9002784-0707 Mfd. For: FALCON Pharmaceuticals, Ltd. For t Worth, Texas 76134 USA Mfd. By: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE - NEOMYCIN,
POLYMYXIN B
SULFATES AND HYDROCORTISONE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is a sterile
antimicrobial and anti-inflammatory suspension for ophthalmic use.
EACH ML CONTAINS: ACTIVES: neomycin sulfate (equivalent to 3.5 mg
neomycin base), polymyxin B
sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10
mg (1%). PRESERVATIVE:
thimerosal 0.001%. INACTIVES: cetyl alcohol, glyceryl monostearate,
mineral oil, polyoxyl 40 stearate,
propylene glycol, sulfuric acid (to adjust pH) and water for
injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetacae). It has a
potency equivalent to not less than 600
μg of neomycin standard per mg, calculated on an anhydrous basis. Its
structural formula are:
Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, which
are produced by the growth of
_Bacillus polymyxa _(Prazmowski) Migula (Fam. Bacillaceae). It has a
potency of not less than 6,000
polymyxin B units per mg calculated on an anhydrous basis. Its
structural formula are:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an
anti-inflammatory hormone. Its
structural formula is:
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,
concomitant antimicrobial drugs 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 antimicrobials
is made, the administration of
such drugs in combination has the advantage of greater patient
compliance and convenience, with the
added assurance that the intended dosage of all drugs is administered.
When each type of drug is in the
same