Dexamethasone 1 MG/ML / Neomycin 3.5 MG/ML / Polymyxin B 10000 UNT/ML Ophthalmic Suspension
WARNINGS
: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning.
Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Steroids should be used with caution in the presence of glaucoma.
Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is not for injection.
It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Products containing neomycin sulfate may cause cutaneous sensitization.
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 22 H 29 FO 5 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 1 and B 2 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: 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% Dexamethasone (structural formula) Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula)
HOW SUPPLIED
: 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 Storage 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)
GERIATRIC USE
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
INDICATIONS AND USAGE
: 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 species, Neisseria species, Pseudomonas aeruginosa .
This product does not provide adequate coverage against Serratia marcescens , and Streptococci, including Streptococcus pneumoniae .
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
PREGNANCY
Pregnancy Teratogenic Effects: Pregnancy Category C.
Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.
In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate.
In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
There are no adequate or well-controlled studies in pregnant women.
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
NUSRING MOTHERS
Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is administered to a nursing woman.
INFORMATION FOR PATIENTS
Information for Patients: If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
This product is sterile when packaged.
To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface.
The use of this bottle by more than one person may spread infection.
Keep bottle tightly closed when not in use.
Keep out of reach of children.
DOSAGE AND ADMINISTRATION
: One or two drops topically in the conjunctival sac(s).
In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides.
In mild disease, drops may be used up to four to six times daily.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
SHAKE WELL BEFORE USING.