Label: TRAVOPROST OPHTHALMIC SOLUTION solution/ drops

  • NDC Code(s): 68462-943-03, 68462-943-05
  • Packager: GLENMARK PHARMACEUTICALS INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TRAVOPROST OPHTHALMIC SOLUTION (Ionic Buffered Solution) safely and effectively. See full prescribing information for TRAVOPROST ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular ...
  • 2 DOSAGE AND ADMINISTRATION
    The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travoprost ophthalmic solution (ionic buffered solution) should not be administered more than once daily since ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Ophthalmic solution containing travoprost 0.04 mg/mL.
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Pigmentation - Travoprost 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
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous (SC ...
  • 11 DESCRIPTION
    Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist, which is believed to reduce IOP by increasing uveoscleral outflow. The exact ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did not show any evidence of ...
  • 14 CLINICAL STUDIES
    In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25 to 27 mmHg, who were treated with travoprost ophthalmic solution  (ionic buffered ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost, USP (0.04 mg/mL). Travoprost ophthalmic solution ...
  • 17 PATIENT COUNSELING INFORMATION
    Potential for Pigmentation - Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    2.5 mL Bottle Label - NDC 68462-943-03 - Travoprost Ophthalmic Solution, USP - 0.004% (Ionic Buffered Solution)  Rx only      2.5 mL - Sterile -   2.5 mL Carton Label - Rx Only - NDC ...
  • Package/Label Display Panel
    5 mL Bottle Label - NDC 68462-943-05 - Travoprost Ophthalmic Solution, USP - 0.004% (Ionic Buffered Solution)  Rx only     5 mL - Sterile - 5 mL Carton Label - Rx Only - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information