Label: PATANOL - olopatadine hydrochloride solution/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: New Drug Application

Drug Label Information

Updated 05/11

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  • DESCRIPTION

    PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below:

    imae of chemical structure

    Chemical Name:11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride.

    Each mL of PATANOL contains: Active: 1.11 mg olopatadine hydrochloride equivalent to 1 mg olopatadine. Preservative: benzalkonium chloride 0.01%. Inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and purified water. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.

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  • CLINICAL PHARMACOLOGY

    Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1-antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine, and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

    Results from an environmental study demonstrated that PATANOL was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that PATANOL, when subjects were challenged with antigen both initially and up to 8 hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.

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  • INDICATIONS AND USAGE

    PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

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  • CONTRAINDICATIONS

    PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL.

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  • WARNINGS

    PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.

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  • ADVERSE REACTIONS

    Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.

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  • DOSAGE AND ADMINISTRATION

    The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.

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  • HOW SUPPLIED

    PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is supplied as follows: 5 mL in plastic DROP-TAINER® dispenser.

              5 mL: NDC  54868-4528-0


    Storage

    Store at 39°F-77°F (4°C-25°C).

    Rx Only


    U.S. Patent Nos. 4,871,865; 4,923,892; 5,116,863; 5,641,805.

    © 2000, 2003, 2005 Alcon, Inc.

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA

    Printed in USA


    Relabeling of "Additional" label by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146
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  • PRINCIPAL DISPLAY PANEL

    PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1%

    5 mL

    NDC 54868-4528-0

    image of package label

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  • INGREDIENTS AND APPEARANCE
    PATANOL 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4528(NDC:0065-0271)
    Route of Administration OPHTHALMIC DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    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:54868-4528-0 1 in 1 CARTON
    1 5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020688 05/08/2002
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
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