S
Dosage Form: ophthalmic solution
DESCRIPTION
STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) is a sterile ophthalmic drug combining two antibacterials in solution form.
Each mL of solution contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 16,250 polymyxin B units.
Preservative: Benzalkonium Chloride .004%. Vehicle: 0.5% Hydroxypropyl Methylcellulose 2910. Inactive: Boric Acid, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02
CLINICAL PHARMACOLOGY
The anti-infective components in Statrol Ophthalmic Solution provide action against specific organisms susceptible to them. Polymyxin B Sulfate and Neomycin Sulfate are active in vitro against Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens, Streptococci, including Streptococcus pneumoniae.
INDICATIONS AND USAGE
STRATOL Ophthalmic Solution is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.
CONTRAINDICATIONS
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
WARNINGS
NOT FOR INJECTION INTO THE EYE. Should a sensitivity reaction occur, discontinue use. Neomycin Sulfate may cause cutaneous sensitization. Remove contact lenses before using.
PRECAUTIONS
General
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate measures should be initiated. Whenever clinical judgment dictates; the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, corneal staining.
Information for patients
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 the reach of children.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with Polymyxin B Sulfate. Treatment of cultured human lymphocytes in-vitro with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Polymyxin B Sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.
Pregnancy
Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP). It is also not known whether Neomycin Sulfate and/or Polymyxin B Sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Statrol Ophthalmic Solution should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Statrol Ophthalmic Solution is administered to a nursing mother.
ADVERSE REACTIONS
Adverse reactions have occurred with the anti-infective components. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. (SEE WARNINGS.)
DOSAGE AND ADMINISTRATION
Instill one or two drops in the lower conjunctival sac(s) three or more times daily as required.
HOW SUPPLIED
STATROL (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) in 5 mL plastic DROP-TAINER® dispenser: NDC 0998-0623-05.
STORAGE: Store at 46° - 80°F (8° - 27°C).
Federal (USA) law prohibits dispensing without prescription.
Alcon®
OPHTHALMIC
ALCON (Puerto Rico) INC.
Humacao, Puerto Rico 00791 USA
Revised: June 1995
Printed in USA
238382
STATROL
neomycin sulfate and polymyxin b sulfate solution
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
0998-0623
Route of Administration
OPHTHALMIC
DEA Schedule
INGREDIENTS
Name (Active Moiety)
Type
Strength
neomycin sulfate (neomycin)
Active
3.5 MILLIGRAM In 1 MILLILITER
polymyxin B sulfate (polymyxin B)
Active
16250 UNITS In 1 MILLILITER
benzalkonium chloride
Inactive
hydroxypropyl methylcellulose 2910
Inactive
boric acid
Inactive
sodium chloride
Inactive
hydrochloric acid
Inactive
sodium hydroxide
Inactive
water
Inactive
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
0998-0623-05
5 mL (MILLILITER) In 1 BOTTLE, PLASTIC
None
STATROL
neomycin sulfate and polymyxin b sulfate solution
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
0065-0623
Route of Administration
OPHTHALMIC
DEA Schedule
INGREDIENTS
Name (Active Moiety)
Type
Strength
neomycin sulfate (neomycin)
Active
3.5 MILLIGRAM In 1 MILLILITER
polymyxin B sulfate (polymyxin B)
Active
16250 UNITS In 1 MILLILITER
benzalkonium chloride
Inactive
hydroxypropyl methylcellulose 2910
Inactive
boric acid
Inactive
sodium chloride
Inactive
hydrochloric acid
Inactive
sodium hydroxide
Inactive
water
Inactive
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
0065-0623-05
5 mL (MILLILITER) In 1 BOTTLE, PLASTIC
None
Revised: 05/2006Alcon
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