TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect.
TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
Pigmentation - Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Eyelash Changes - TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation - TRAVATAN Z® Solution should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Macular Edema - Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z® Solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Angle-closure, Inflammatory or Neovascular Glaucoma - TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory, or neovascular glaucoma.
Bacterial Keratitis - There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Use with Contact Lenses - Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes following its administration.
The most common adverse reaction observed in controlled clinical studies with TRAVATAN® (travoprost ophthalmic solution) 0.004% and TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus.
Additional adverse reactions have been identified during post approval use of TRAVATAN® or TRAVATAN Z® in clinical practice. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possiblecausal connection to TRAVATAN® or TRAVATAN Z®, or a combination of these factors,include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
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.
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