Travatan

/ Novartis

Use in adults, including the elderly population: The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily.
Optimal effect is obtained if the dose is administered in the evening. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. When substituting another ophthalmic antiglaucoma agent with TRAVATAN, the other agent should be discontinued and TRAVATAN should be started the following day.
Hepatic and renal impairment: TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min) No dosage adjustment is necessary in these patients.
Method of administration
For ocular use: The patient should remove the protective overwrap immediately prior to initial use. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

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 (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication.

Hypersensitivity to the active substance or to any of the excipients.

Eye colour change: TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the pos sibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia.
Periorbital and eye lid changes: In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues. TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes.
There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma. TRAVATAN should therefore be used with caution in patients with active intraocular inflammation.
Aphakic patients: Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
Iritis/uveitis: In patients with known predisposing risk factors for iritis/uveitis, TRAVATAN should be used with caution.
Contact with the skin: Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Contact lenses: Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait 15 minutes after instillation of the dose before reinsertion.
Excipients: TRAVATAN contains propylene glycol which may cause skin irritation. TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
See prescribing information for full details.

The most common reported adverse reactions were ocular hypearemia and iris hyperpigmentation. Additional common adverse reactions were eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation.
See prescribing information for full details.

N/A.

Women of child-bearing potential/contraception: TRAVATAN must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place.
Pregnancy: Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-bom child. TRAVATAN should not be used during pregnancy unless clearly necessary.
Lactation: It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of TRAVATAN by breast-feeding mothers is not recommended.
See prescribing information for full details.

No cases of overdose have been reported. A topical overdose is not likely to occur or to be associated with toxicity. A topical overdose of TRAVATAN may be flushed from the eye(s) with lukewarm water. Treatment of a suspected oral ingestion is symptomatic and supportive.

Shelf life: 2 years. Discard 4 weeks after first opening.
Storage: Do not store above 30°C.