Label: PATANOL - olopatadine hydrochloride solution/ drops
- NDC Code(s): 54868-4528-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0065-0271
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CV
- Marketing Status: New Drug Application
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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:
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.Close
- 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.Close
- INDICATIONS AND USAGE
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.Close
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL.Close
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.Close
- 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.Close
- 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.Close
- 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
Store at 39°F-77°F (4°C-25°C).
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
- PRINCIPAL DISPLAY PANEL
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1%
- INGREDIENTS AND APPEARANCE
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