TRAVOSUN - Travoprost Ophthalmic Solution USP

Composition   Each ml contains   Travoprost USP 40 mg Benzalkonium Chloride Solution IP 0.02% v/v (as preservative)   Water for injection IP q.s. Dosage Form Ophthalmic Solution (Eye Drops) Category Anti Glaucoma Description Travosun is a synthetic prostaglandin F2a analogue. Clinical Pharmacology – 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. Indications Travosun Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive pressure lowering medication. Dosage The recommended dosage is one drop in the affected eye(s) once-daily in the evening. The dosage of Travosun 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. Travosun 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. Contraindications Known hypersensitivity to travoprost, benzalkonium chloride or any other ingredients in this product. Precautions Pregnanacy Category: C No adequate and well-controlled studies have been performed in pregnant women. Travosun may interfere with the maintenance of pregnancy and should not be used by women during pregnancy or by women attempting to become pregnant. Nursing Mothers A study in lactating rats demonstrated that radio labeled 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 Travosun is administered to nursing women. 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 Effects The most common ocular adverse event observed in controlled clinical studies with Travoprost 0.004% was ocular hyperemia which was reported in 35 to 50% of patients. Approximately 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse events reported at an incidence of 5 to 10% included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. Ocular adverse events reported at an incidence of 1 to 4% included , abnormal vision, blepraritis, blurred vision, cataract, cells, conjunctivitis, dry eye, eye disorder, flare, iris discoloration, keratitis. Lid margin crusting, photophobia, subconjunctival hemorrhage, and tearing. Storage Store in a cool dry place. Protect from light. Presentation Travosun is available in 3ml plastic bottle.