Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TRAVOPROST (UNII: WJ68R08KX9) (TRAVOPROST - UNII:WJ68R08KX9)
Micro Labs Limited
OPHTHALMIC
PRESCRIPTION DRUG
Travoprost ophthalmic solution 0.004% (ionic buffered solution) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. None. 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) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. Advise pregnant women of a potential risk to a fetus. Because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution 0.004% (ionic buffered solution) should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general pop
Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution) is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost, USP (0.04 mg/mL) supplied in 3 piece open nozzle container. Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution) is supplied as a 2.5 mL solution in a 5 mL and 5 mL solution in a 5 mL natural polypropylene container with a polypropylene open nozzle and an HDPE Turquoise color cap. NDC code: NDC 42571-130-27, 2.5 mL fill in 5 mL NDC 42571-130-21, 5 mL fill in 5 mL Storage: Store at 2° to 25°C (36° to 77°F). After opening, travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) can be used until the expiration date on the bottle.
Abbreviated New Drug Application
TRAVOPROST OPHTHALMIC - TRAVOPROST OPHTHALMIC SOLUTION SOLUTION MICRO LABS LIMITED ---------- 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 OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION). TRAVOPROST OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION), FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Travoprost ophthalmic solution 0.004% (ionic buffered solution) is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1) DOSAGE AND ADMINISTRATION One drop in the affected eye(s) once daily in the evening. ( 2) DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing travoprost 0.04 mg/mL. ( 3) CONTRAINDICATIONS None ( 4) WARNINGS AND PRECAUTIONS Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1) Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2) ADVERSE REACTIONS Most common adverse reaction (30% to 50%) is conjunctival hyperemia. ( 6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MICRO LABS USA, INC. AT 1-855-839-8195 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. ( 8.4) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Pigmentation 5.2 Eyelash Changes 5.3 Intraocular Inflammation 5.4 Macular Edema 5.5 Angle-closure, Inflammatory or Neovascular Glaucoma 5.6 Bacteri Läs hela dokumentet