TRAVOPROSTIN (Preservative Free)

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TRAVOPROSTIN (Preservative Free)



Each ml contains: Travoprost IP 0.004% w/v, Sterile Aqueous Vehicle q.s. In a specially designed container to avoid preservative use.

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Pharmacodynamic properties : Travoprost, a prostaglandin F2alpha analogue, is a selective agonist with affinity for the prostaglandin FP-receptor. The exact mechanism of action by which travoprost reduces IOP has not been fully elucidated. As with other topical prostaglandin analogues, travoprost is believed to increase uveoscleral outflow

TRAVOPROSTIN eye drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.

The recommended dose is one drop of TRAVOPROSTIN in the conjunctival sac of the affected eye(s) once daily in the evening. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with TRAVOPROSTIN, discontinue the other agent and start the following day with TRAVOPROSTIN.

TRAVOPROSTIN has 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. TRAVOPROSTIN may gradually change eye colour, increasing the amount of brown pigmentation in the iris by increasing the number of melanosomes (pigment granules) in melanocytes. The long-term effect on the melanocytes and the consequences of potential injury to the melanocytes and/or deposition of pigment granules to other areas of the eye are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. Patients should be informed of the possibility of iris colour change. Eyelid skin darkening has been reported in association with the use of TRAVOPROSTIN. number of eyelashes. Patients who are expected to receive treatment in only one eye should be informed about the potential for increased brown pigmentation of the iris, periorbital and/or eyelid tissue and eyelashes in the treated eye and thus heterochromia between the eyes. They should also be advised of the potential for a disparity between the eyes in length, thickness, and/or number of eyelashes.

The most frequently reported treatment-related side-effect was ocular hyperaemia, which was reported in 35% to 50% of patients. Approximately 3% of patients discontinued treatment due to conjunctival hyperaemia. The following undesirable effects assessed as definitely, probably or possibly related to treatment were reported during clinical trials with TRAVOPROSTIN. Their incidence was either very common (greater than 10.0%), common (1.0% to 10%), or uncommon (0.2% to less than 1.0%). All other effects were single reports, of which none were serious or related.

5 ml available in 5ml Vial specially designed to avoid contamination of the contents.

Storage :
Store at a temperature not exceeding 30 C and protect from light. Use the solution within 60 days after opening the container.

Medicine :
Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.

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