TRAVSTAR-T| TRAVOPROST AND TIMOLOL EYE DROPS

Description: Travstar-T Eye drops is a clear & colorless solution that contains two active ingredients – Travoprost and Timolol Maleate. These two drugs decrease raised pressure within the eye. They work in different ways to produce a combined effect greater than either medicines produces on its own.

Pharmacology: Travstar-T Eye drops contains Travoprost and Timolol which reduce intraocular pressure (IOP) by complimentary mechanism of action. Travoprost is a prostaglandin analogue which reduces IOP by increasing trabecular outflow & uveoscleral outflow. Timolol is a non-selective beta adrenergic receptor blocker that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane stabilizing) activity. It lowers IOP by decreasing the formation of aqueous humor in the ciliary epithelium.

Indication and Usage: Travstar-T Eye drops (Travoprost/Timolol) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other IOP lowering agents and when the use of Travstar-T Eye drops (the fixed combination drug) is the use of Travstar-T Eye drops is not recommended for paediatric patients.

Dosage and Administration:

Use in Adults: The dose is one drop of Travstar-T Eye drops in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administrated at the same time each day.

Paediatric Patients: The efficacy and safety of Travstar-T Eye drops in patients below the age of 18 years have not been established.

Use in Special Group:

Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. It should not be used during pregnancy.

Use in Lactation: Caution should be exercised when Travstar-T Eye drops is administered to a nursing mother.

Use in Children: Safety and Effectiveness in padeatric patients have not been established.

Use in Elderly Patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Contraindications: Contraindicated in patients who are hypersensitive to Travoprost, Timolol or any of the components of this preparation.

Warning and Precautions:

Do not drive if you experience blurred vision or eye discomfort, after using Travstar-T Eye drops.

Do not use, while wearing contact lenses. Remove the lens before using Travstar-T Eye drops and you can put them back 15 minutes after using Travstar-T Eye drops.

Drug Interactions: No specific interaction was observed with Travstar-T Eye drops.

Side Effects: No serious ophthalmic or Systemic undesirable effects related to Travstar-T Eye drops were reported. The most frequently reported treatment-related undesirable effect was ocular hyperaemia. Other common side-effects may be keratitis, anterior chamber flare, eye pain, photophobia, eye swelling, conjunctival haemorrhage, corneal staining, ocular discomfort, visual acuity reduced, visual disturbance, blurred vision etc.

Information for Patients:

Travstar-T Eye drops is sterile when packed. Patients should also be instructed to avoid allowing the tip of the dispensingcontainer to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Use the solution within one month of opening the container. If the solution becomes cloudy or dark brown it should be discarded.

• Patients also should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reaction, they should immediately seek their physician’s advice. If more than one topical ophthalmic drug is being used, the drug should be administered at least five (5) minutes apart.
• Since prostaglandins are biologically active and may be absorbed through the skin, women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In case of accidental contact with the contents of the bottle, thoroughly cleanse the exposed area with soap and water immediately.
• Keep the medicine out of reach of children. Travstar-T Eye drops should not be administered while wearing contact lenses.

Packaging Information: Travstar-T Eye drops is supplied in a 3 ml Plastic Bottle.

NOT FOR INJECTION

FOR TOPICAL OPHTHALMIC USE ONLY

Storage: Store at a temperature not exceeding 30°C. Do not freeze. Protect from light and moisture.