Label: OLOPATADINE- olopatadine hydrochloride solution/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 1, 2021

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% safely and effectively. See full prescribing information for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.
    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%
    Initial U.S. Approval: 1996

    INDICATIONS AND USAGE

    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis. (1)

    DOSAGE AND ADMINISTRATION

    The recommended dose is one drop in each affected eye once a day. (2)

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine hydrochloride. (3)

    WARNINGS AND PRECAUTIONS

    For topical ocular use only. Not for injection or oral use. (5.1)

    ADVERSE REACTIONS

    Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 3/2021

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

  • 2 DOSAGE AND ADMINISTRATION

    The recommended dose is one drop in each affected eye once a day.

  • 3 DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine hydrochloride.

  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 For topical ocular use only

    Not for injection or oral use.

    5.2 Contamination of Tip and Solution

    As with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

    5.3 Contact Lens Use

    Patients should be advised not to wear a contact lens if their eye is red.

    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% should not be used to treat contact lens related irritation.

    The preservative in Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% before they insert their contact lenses.

  • 6 ADVERSE REACTIONS

    Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.

    The following adverse experiences have been reported in 5% or less of patients:

    Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.

    Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.

    Some of these events were similar to the underlying disease being studied.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic effects: Pregnancy Category C

    Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

    8.3 Nursing Mothers

    Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is administered to a nursing mother.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

    8.5 Geriatric Use

    No overall differences in safety and effectiveness have been observed between elderly and younger patients.

  • 11 DESCRIPTION

    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3 • HCl. The chemical structure is presented below:

    Chemical Structure

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

    Each mL of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% contains: Active: 2.22 mg Olopatadine Hydrochloride equivalent to 2 mg Olopatadine. Inactives: Povidone; Dibasic Sodium Phosphate; Sodium Chloride; Edetate Disodium; Benzalkonium Chloride 0.01% (Preservative); Hydrochloric Acid/Sodium Hydroxide (adjust pH); and Water for Injection.

    It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

    12.3 Pharmacokinetics

    Systemic bioavailability data upon topical ocular administration of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% solution are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a 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 elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 to 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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 μL drop size and a 50 kg person, these doses were approximately 150,000 and 50,000 times higher than the maximum recommended ocular human dose (MROHD). No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Olopatadine administered to male and female rats at oral doses of approximately 100,000 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of approximately 15,000 times the MROHD level.

  • 14 CLINICAL STUDIES

    Results from clinical studies of up to 12 weeks duration demonstrate that Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Product: 50090-3489

    NDC: 50090-3489-0 2.5 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • 17 PATIENT COUNSELING INFORMATION

    17.1 Topical Ophthalmic Use Only

    For topical ophthalmic administration only.

    17.2 Sterility of Dropper Tip

    Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.

    17.3 Concomitant Use of Contact Lenses

    Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. The preservative in Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.

    Rx only

    AKORN

    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045

    OLP00N Rev. 12/17

  • Olopatadine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    OLOPATADINE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50090-3489(NDC:17478-305)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3489-01 in 1 CARTON06/18/2018
    12.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20472312/05/2017
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3489)