CLINICAL PHARMACOLOGY

Pharmacodynamics

Mechanism of Action

Travoprost free acid is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Pharmacokinetics

Absorption: Travoprost is absorbed through the cornea and is hydrolyzed to the active free acid.

Metabolism: Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to its biologically active free acid.

Elimination: The elimination of Travoprost free acid from plasma was rapid and levels were generally below the limit of quantification within one hour after dosing.

INDICATIONS AND USAGE

Travstar Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

WARNINGS

NOT FOR INJECTION. FOR EXTERNAL USE ONLY.

Travstar Eye Drops have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris and periorbital tissue (eyelid and increased pigmentation and growth of eyelashes. These changes may be permanent.

PRECAUTIONS

Travstar Eye Drops should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2 alpha analogues. These reports have mainly occurred in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Travstar Eye Drops should be used with caution in these patients.

Travstar Eye Drops has not been evaluated for the treatment of angle closure, inflammatory or neovascular glaucoma.

Travstar Eye Drops should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travstar Eye Drops.

USE IN SPECIFIC POPULATIONS

Pregnancy: Teratogenic Effects

Pregnancy Category: C

There are no adequate and well-controlled studies in pregnant women. Travstar Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

A study in lactating rats demonstrated that radiolabeled Travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Travstar Eye Drops is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS

The most common ocular adverse event observed in controlled clinical studies with Travoprost 0.004% w/v was ocular hyperemia which was reported in 35 to 50% of patients.

APPLICATION AND ADMINISTRATION

The recommended application is one drop in the affected eye(s) once daily in the evening or as directed by the Physician. The dosage of Travstar Eye Drops should not exceed once daily since it has been shown that more frequent administration may decrease the intraocular pressure lowering effect.

Reduction of intraocular pressure starts approximately 2 hours after administration, and the maximum effect is reached after 12 hours.

Travstar Eye Drops may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

STORAGE

Store below 25°C. Protect from light & moisture. Do not freeze.

Keep out of reach of children.

PRESENTATION

Travstar Eye Drops is available in 3ml pack.