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brand travatan z 0.004% eye drop

In stock Manufacturer ALCON/NOVARTIS 00065026005
$391.04 / 5 Milliliters Drop Btl

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Uses

Ocular Hypertension and Glaucoma

Travoprost ophthalmic solution is used topically to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering drugs or who have not responded adequately (i.e., failed to achieve target IOP as determined after multiple measurements over time) to another IOP-lowering drug. Travoprost has not been evaluated for the treatment of angle-closure, inflammatory, or neovascular glaucoma.

Safety and efficacy of travoprost have been evaluated in several multicenter, randomized, double-blind studies in patients with open-angle glaucoma or ocular hypertension. In these studies, which included patients with a mean baseline diurnal IOP value of 25-27 mm Hg, topical application of travoprost 0.004% once daily reduced IOP by 7-8 mm Hg. Subgroup analyses of clinical studies indicate that mean reductions in IOP may be up to 1.8 mm Hg greater in black patients than in other races. It currently is not known whether this difference is related to race or to heavily pigmented irides.

Once-daily administration of travoprost 0.004% appears to be more effective than twice-daily administration of timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension. In several multicenter, double-blind, comparative studies, mean IOP was reduced by 7-9 or 5-8 mm Hg after 6-9 months of therapy following topical administration of travoprost 0.004% once daily or timolol 0.5% twice daily, respectively. In another study, mean IOPs appeared to be lower among patients treated with travoprost than in those treated with timolol (18-19 versus 19-20 mm Hg). Limited data indicate that travoprost 0.004% may be equally or more effective than latanoprost 0.005% in reducing IOP in patients with open-angle glaucoma or ocular hypertension. Travoprost 0.004% also appears to be superior to timolol 0.5% or latanoprost 0.005% in reducing IOP in black patients.

In one multicenter, randomized study in patients with mean baseline IOP of 24-26 mm Hg while receiving timolol 0.5%, the addition of travoprost 0.004% once daily reportedly reduced IOP by an additional 6-7 mm Hg.

Dosage and Administration

General

Travoprost is applied topically to the eye as an ophthalmic solution. Care should be taken to avoid contamination of the solution container.(See Advice to Patients.)

If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered at least 5 minutes apart.

The recommended dosage of travoprost for the treatment of open-angle glaucoma or ocular hypertension is 1 drop of a 0.004% solution in the affected eye(s) once daily in the evening. Travoprost solution 0.004% should not be administered more frequently than once daily since more frequent dosing may paradoxically diminish the IOP-lowering effect of the drug.

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to travoprost, benzalkonium chloride, or any ingredient in the formulation. Known or suspected pregnancy.

Warnings/Precautions

Warnings

Ocular Effects

Increases in brown pigmentation of the iris and periorbital tissue (eyelid) or increased pigmentation and growth of eyelashes have occurred in 2 or 59% of patients, respectively, receiving the drug in clinical studies; these changes may be permanent. The increased pigmentation of the iris develops slowly and may not be evident until after months to years of travoprost therapy. Long-term effects of these changes are unknown. Pending further accumulation of data, patients receiving travoprost should be examined regularly and, depending on the clinical situation, therapy may be discontinued if increased pigmentation of the iris persists.

Eyelashes may become longer, thicker, more numerous, and darker. Patients expected to receive travoprost therapy in only one eye should be informed of the potential for a disparity between eyes in length, thickness, and/or number of eyelashes and that heterochromia between the eyes may occur.

General Precautions

Ocular Effects

Macular edema, including cystoid macular edema, has been reported during therapy with other prostaglandin F analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Use with caution in patients with a history of intraocular inflammation (e.g., iritis, uveitis); use generally not recommended in patients with active intraocular inflammation.

Specific Populations

Pregnancy

Category C. (See Users' Guide.) Prostaglandins are biologically active and may be absorbed through the skin; caution should be exercised to avoid direct exposure to the drug in women who are pregnant or attempting to become pregnant. If accidental contact occurs, the exposed area should be immediately and thoroughly cleansed with soap and water.

Nursing Women

Travoprost is distributed in milk in animals. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children younger than 11 years of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Renal and Hepatic Impairment

Efficacy not established; use with caution.

Common Adverse Effects

Ocular hyperemia occurred in approximately 35-50% of patients who received travoprost ophthalmic solution in clinical trials. Approximately 3% of patients discontinued therapy because of conjunctival hyperemia. Decreased visual acuity, ocular discomfort, foreign body sensation, pain, and pruritus have been reported in approximately 5-10% of patients who received travoprost ophthalmic solution in clinical trials. Adverse ocular effects reported in approximately 1-4% of patients include abnormal vision, blepharitis, blurred vision, cataract, cells, conjunctivitis, dry eye, eye disorder, flare, iris discoloration, keratitis, lid margin crusting, photophobia, subconjunctival hemorrhage, and tearing.

Adverse nonocular events reported in approximately 1-5% of patients include accidental injury, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold syndrome, depression, dyspepsia, GI disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infection.

Drug Interactions

None currently known.

Pharmacokinetics

Absorption

Bioavailability

Prodrug; absorbed through the cornea following ocular instillation and hydrolyzed to active form (travoprost free acid).

Peak plasma concentrations of travoprost free acid occur within 30 minutes.

Onset

Reduction in IOP generally occurs within 2 hours after topical application and peaks within 12 hours.

Distribution

Extent

Distributed into milk in animals; not known whether the drug or its metabolites distribute into milk in humans.

Elimination

Metabolism

Hydrolyzed by esterases in the cornea to biologically active form (travoprost free acid). Systemically, travoprost free acid is metabolized to inactive metabolites.

Travoprost free acid is rapidly eliminated from plasma; plasma levels are below the limit of quantitation within one hour following ocular instillation.

Elimination Route

Less than 2% of the topical ocular dose is excreted in urine within 4 hours as travoprost free acid.

Half-life

Mean terminal elimination half-life of travoprost free acid is 45 minutes.

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