Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TRAVOPROST (UNII: WJ68R08KX9) (TRAVOPROST - UNII:WJ68R08KX9)
Mylan Pharmaceuticals Inc.
OPHTHALMIC
PRESCRIPTION DRUG
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 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 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 population, the estimated background risk of major birth
Travoprost ophthalmic solution USP, (ionic buffered solution) 0.004% is a clear colorless, sterile, aqueous solution of travoprost, USP (0.04 mg/mL). Travoprost ophthalmic solution, USP (ionic buffered solution) is supplied as a 2.5 mL or 5 mL solution in a 5 mL natural colored low density polyethylene bottle with a turquoise, high density polyethylene, tamper evident screw cap and a low density polyethylene nozzle. 2.5 mL fill NDC 0378-9651-32 carton of one bottle 5 mL fill NDC 0378-9651-50 carton of one bottle Storage: Store at 2° to 25°C (36° to 77°F). After opening, travoprost ophthalmic solution, USP (ionic buffered solution) can be used until the expiration date on the bottle.
Abbreviated New Drug Application
TRAVOPROST OPHTHALMIC SOLUTION, 0.004%- TRAVOPROST OPHTHALMIC SOLUTION, 0.004% SOLUTION/ DROPS MYLAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRAVOPROST OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAVOPROST OPHTHALMIC SOLUTION. TRAVOPROST OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION) 0.004%, FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Travoprost ophthalmic solution (ionic buffered solution) is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) 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 • • ADVERSE REACTIONS Most common adverse reaction (30% to 50%) is conjunctival hyperemia. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679 (1-877-4-INFO- RX) OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 5/2020 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 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) 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) 5.4 Macular Edema 5.5 Angle-closure, Inflammatory or Neovascular Glaucoma 5.6 Bacterial K Lugege kogu dokumenti