Label: statrol- neomycin sulfate and polymyxin B sulfate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0065-0623-05, 0998-0623-05 - Packager: Alcon
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 12, 2006
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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
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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.
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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
- WARNINGS
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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.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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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 USARevised: June 1995
Printed in USA
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INGREDIENTS AND APPEARANCE
STATROL
neomycin sulfate and polymyxin b sulfate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0998-0623 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) 3.5 mg in 1 mL polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K) 16250 in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride () hydroxypropyl methylcellulose 2910 () boric acid (UNII: R57ZHV85D4) sodium chloride (UNII: 451W47IQ8X) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0998-0623-05 5 mL in 1 BOTTLE, PLASTIC STATROL
neomycin sulfate and polymyxin b sulfate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0623 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) 3.5 mg in 1 mL polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K) 16250 in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride () hydroxypropyl methylcellulose 2910 () boric acid (UNII: R57ZHV85D4) sodium chloride (UNII: 451W47IQ8X) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0623-05 5 mL in 1 BOTTLE, PLASTIC Labeler - Alcon