NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops

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), Dexamethasone (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

Phoenix Pharmaceutical, Inc.

INN (International Name):

Neomycin Sulfate

Composition:

Neomycin Sulfate 3.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 conjunctivitis 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. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter sp

Product summary:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP is supplied in a controlled drop tip bottle in the following size: 5 mL - Prod. No. 04107 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. FOR OPHTHALMIC USE ONLY Store between 15°-30° C (59°-86° F). Store upright. KEEP OUT OF REACH OF CHILDREN. Revised September 2008 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9114201 (Folded) 9114301 (Flat)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPS
PHOENIX PHARMACEUTICAL, INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
SUSPENSION USP (STERILE)
RX ONLY
DESCRIPTION:
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Suspension USP is a multiple dose
anti-infective steroid combination in a sterile suspension for topical
application. The active ingredient,
Dexamethasone, is represented by the following structural formula:
C
H FO
Mol. Wt. 392.47
Chemical Name: Pregna-1,4-diene-3,20-dione,
9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-.
Neomycin Sulfate is the sulfate salt of neomycin B and C which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetaceae). It has a
potency equivalent to not less than 600
micrograms of neomycin base per milligram, calculated on an anhydrous
basis. The structural formula
is:
Polymyxin B Sulfate is the sulfate salt of polymyxin B and B 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 milligram, calculated on an anhydrous basis. The
structural formula is:
22
29
5
1
2
EACH ML CONTAINS: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg
Neomycin), Polymyxin B
Sulfate equal to 10,000 polymyxin B units, Dexamethasone 1 mg (0.1%);
INACTIVES: Sodium
Chloride, Hypromellose, Polysorbate 20, Purified Water. Hydrochloric
Acid and/or Sodium
Hydroxide may be added to adjust pH (3.5 – 6.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%
CLINICAL PHARMACOLOGY:
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
the healing. Since corticoids 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 corticoid and an antimicrobi