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
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.
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.
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.
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.
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 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.
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 |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| STATROL
neomycin sulfate and polymyxin b sulfate solution |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - Alcon |