Label: TRAVOPROST solution
- NDC Code(s): 51407-731-05, 51407-731-25
- Packager: Golden State Medical Supply, Inc.
- This is a repackaged label.
- Source NDC Code(s): 60505-0593
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 10, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONTRAVOPROST OPHTHALMIC SOLUTION. These highlights do not include all the information needed to use TRAVOPROST OPHTHALMIC SOLUTION (Ionic Buffered Solution) safely and effectively. See full prescribing ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGETravoprost 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 ...
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2 DOSAGE AND ADMINISTRATIONThe 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 ...
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3 DOSAGE FORMS AND STRENGTHSOphthalmic solution containing travoprost 0.04 mg/mL.
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4 CONTRAINDICATIONSNone
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONS6.1 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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11 DESCRIPTIONTravoprost is a synthetic prostaglandin F analogue. Its chemical name is [1 - R-[1α( Z),2β(1 - E,3 - R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIESIn 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 0.004% or travoprost ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGTravoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution, USP ...
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17 PATIENT COUNSELING INFORMATIONPotential 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 ...
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PRINCIPAL DISPLAY PANELBOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mL - NDC 51407-731-25 - Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution) 0.004% Equivalent to 0.04 mg travoprost - Rx Only
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PRINCIPAL DISPLAY PANELCARTON LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mL - NDC 51407-731-25 - Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution) 0.004% Equivalent to 0.04 mg travoprost - Rx Only
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INGREDIENTS AND APPEARANCEProduct Information