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TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% for topical ophthalmic use (一)
2018-06-23 12:48:35 来源: 作者: 【 】 浏览:4243次 评论:0
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRAVATAN Z ® safely and effectively. See full prescribing information for TRAVATAN Z ®. 
TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% for topical ophthalmic use 
Initial U.S. Approval: 2001 
INDICATIONS AND USAGE 
TRAVATAN Z® 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 
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 Alcon Laboratories Inc. at 1-800-757-9195 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: 9/2017
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 Bacterial Keratitis 
 5.7 Use with Contact Lenses 
 6 ADVERSE REACTIONS 
 6.1 Clinical Trials Experience 
 6.2 Postmarketing Experience 
 8 USE IN SPECIFIC POPULATIONS 
 8.1 Pregnancy 
 8.3 Nursing Mothers 
 8.4 Pediatric Use 
 8.5 Geriatric Use 
 8.6 Hepatic and Renal Impairment 
 11 DESCRIPTION 
 12 CLINICAL PHARMACOLOGY 
 12.1 Mechanism of Action 
 12.3 Pharmacokinetics 
 13 NONCLINICAL TOXICOLOGY 
 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 
 14 CLINICAL STUDIES 
 16 HOW SUPPLIED/STORAGE AND HANDLING 
 17 PATIENT COUNSELING INFORMATION 
* Sections or subsections omitted from the full prescribing information are not listed. Close 
1 INDICATIONS AND USAGE
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with op
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