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