Label: LATANOPROST solution/ drops

  • NDC Code(s): 68462-944-03
  • Packager: GLENMARK PHARMACEUTICALS INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 16, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LATANOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LATANOPROST OPHTHALMIC SOLUTION ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • 2 DOSAGE AND ADMINISTRATION
    The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of latanoprost ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).
  • 4 CONTRAINDICATIONS
    Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Pigmentation - Latanoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: • Iris pigmentation changes [see Warnings and ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women to inform drug-associated ...
  • 10 OVERDOSAGE
    IV infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with latanoprost ophthalmic solution ...
  • 11 DESCRIPTION
    Latanoprost is a prostaglandin F2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Latanoprost is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. Studies in animals and man suggest that the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 ...
  • 14 CLINICAL STUDIES
    14.1 Elevated Baseline IOP - Patients with mean baseline IOP of 24 – 25 mmHg who were treated for 6 months in multi-center, randomized, controlled trials demonstrated 6 – 8 mmHg reductions in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Latanoprost ophthalmic  solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 50 mcg/mL (0.005%) ...
  • 17 PATIENT COUNSELING INFORMATION
    Potential for Pigmentation - Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Bottle Label: NDC 68462-944-03  Rx Only - Latanoprost - Ophthalmic Solution - 0.005% 125 mcg/2.5 mL - STERILE             For eye use only -    Carton Label: NDC 68462-944-03   Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information