TRAVOPROSTIN-T (Preservative Free)

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TRAVOPROSTIN-T (Preservative Free)



Each ml contains : Travoprost IP 0.004% w/v, Timolol Maleate IP equivalent to Timolol 0.5% 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.Timolol is reported to suppress the formation of aqueous humor and thereby reduce the intra ocular pressure. Topical application of Timolol does not affect indothelial permeability.

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

Patients may slowly develop increased brown pigmentation of the iris. This change may not be noticeable for months to years (see Warnings). Iris pigmentation changes may be more noticeable in patients with mixed coloured irides, i.e., blue-brown, grey-brown, yellow brown and green-brown; however, it has also been observed in patients with brown eyes. The colour change is believed to be due to increased melanin content in the stromal melanocytes of the iris. The exact mechanism of action is unknown at this time. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. Until more information about increased brown pigmentation is available, patients should be examined regularly and depending on the situation, treatment may be stopped if increased pigmentation ensues. Owing to systemic absorption, the side-effects associated with beta blockers are likely to occur. Caution should be exercised in patients with bronchial asthma, COPD or CHF. TRAVOPROSTIN-T should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Macular oedema, including cystoid macular oedema, has been reported during treatment with prostaglandin F2alpha 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 oedema. TRAVOPROSTIN-T should be used with caution in these patients. TRAVOPROSTIN-T has not been evaluated for the treatment of angle closure, inflammatory or neovascular glaucoma. TRAVOPROSTIN-T has not been studied in patients with renal or hepatic impairment and should be used with caution in such patients. TRAVOPROSTIN-T 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 TRAVOPROSTIN-T.

TRAVOPROSTIN-T 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-T 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-T.
TRAVOPROSTIN-T may gradually change eyelashes in the treated eye; these changes include increased length, thickness, pigmentation and/or 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-T. 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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