Label: statrol- neomycin sulfate and polymyxin B sulfate ointment

  • 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 Ointment, USP) is a sterile ophthalmic drug combining two antibacterials in ointment form.

    Each gram of ointment contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units.

    Preservatives: Methylparaben 0.05%, Propylparaben 0.01%. Inactive: White Petrolatum, Anhydrous Liquid Lanolin. DM-01

  • CLINICAL PHARMACOLOGY

    The anti-infective components in STATROL Ophthalmic Ointment 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 Ointment 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. Ophthalmic ointments may retard corneal wound healing. 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 tube tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection. Keep tube 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 Enects

    Pregnancy Category C.

    Animal reproduction studies have not been conducted with STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, 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 Ointment 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 Ointment 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 about a half-inch ribbon into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with the solution at bedtime.

  • HOW SUPPLIED

    STATROL (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP) in 3.5 g ophthalmic tube: NDC 0065-0624-36.

    STORAGE: Store at 46° - 80°F (8° - 27°C).

    Federal (USA) law prohibits dispensing without prescription.

    Alcon®

    OPHTHALMIC

    ALCON LABORATORIES, INC.

    Fort Worth, Texas; 76134; USA

    Revised: June 1995

    Printed in USA

    298392

  • INGREDIENTS AND APPEARANCE
    STATROL 
    neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0624
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) 3.5 mg  in 1 g
    polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K) 10000   in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    white petrolatum (UNII: 4T6H12BN9U)  
    anhydrous liquid lanolin ()  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0624-363.5 g in 1 TUBE
    Labeler - ALCON LABORATORIES, INC.
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