Travast Plus0.004%+0.5%

Travast Plus ophthalmic solution is a fixed-dose combination indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

• Established/approved use: Patients who are insufficiently responsive to topical beta-blocker or prostaglandin analogue monotherapy — Travast Plus is used as combination therapy when a single agent does not adequately control IOP.
• Not indicated as first-line monotherapy in most treatment guidelines; it is intended for patients already requiring more than one class of IOP-lowering agent.

Travast Plus is not indicated for angle-closure glaucoma or pediatric glaucoma, for which safety and efficacy have not been established.

Each mL of Travoprost + Timolol Maleate sterile ophthalmic solution contains Travoprost 40 micrograms (0.004% w/v) and Timolol Maleate equivalent to Timolol 5 mg (0.5% w/v), formulated as a preserved, isotonic aqueous solution for topical ocular administration.

Travast Plus is a fixed-combination topical ophthalmic solution combining two complementary classes of ocular hypotensive agents: a prostaglandin F2α analogue (travoprost) and a non-selective beta-adrenergic receptor blocking agent (timolol maleate). It is formulated as a once-daily eye drop for patients with open-angle glaucoma or ocular hypertension who need additional IOP lowering beyond what either agent achieves alone.

Ophthalmic anti-glaucoma agent — fixed-dose combination of a prostaglandin F2α analogue and a non-selective beta-adrenergic blocking agent; Travast Plus belongs to the combination ocular hypotensive drug class.

Mechanism of Action

Travoprost + Timolol Maleate lowers intraocular pressure through two complementary mechanisms:

• Travoprost component: a prostaglandin F2α analogue and selective FP receptor agonist that increases aqueous humor outflow, predominantly through the uveoscleral pathway (and to a lesser extent trabecular outflow).
• Timolol maleate component: a non-selective beta-1/beta-2 adrenergic antagonist that reduces aqueous humor production by the ciliary epithelium, with no significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic activity of clinical importance.

The two mechanisms — increased outflow and decreased production — act additively to produce a greater reduction in IOP than either component alone.

For topical ophthalmic (eye) use only — not for injection or oral use.

• Wash hands before use; avoid letting the dropper tip touch the eye, eyelid, or any surface to prevent contamination.
• Tilt the head back, pull down the lower eyelid to form a pocket, and instill one drop of Travast Plus into the affected eye(s).
• Apply gentle pressure over the tear duct (nasolacrimal occlusion) for 1–2 minutes after instillation to reduce systemic absorption.
• If wearing contact lenses, remove them before administration and wait at least 15 minutes before reinserting, as the preservative (benzalkonium chloride) may be absorbed by soft lenses.
• If using other topical eye medications, space administration at least 5 minutes apart.

Clinically significant interactions with Travast Plus arise mainly from the timolol component's systemic beta-blocking effect:

• Oral beta-blockers or other systemic beta-blocking agents: additive effects on IOP and on systemic beta-blockade (bradycardia, hypotension); use with caution.
• Oral calcium channel blockers (especially non-dihydropyridines like verapamil/diltiazem): risk of atrioventricular conduction disturbances, left ventricular failure, and hypotension when combined with the timolol component.
• Digitalis glycosides: both may slow atrioventricular conduction; additive bradycardic effect possible.
• Catecholamine-depleting drugs (e.g., reserpine): additive effect may produce hypotension and/or marked bradycardia.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): may increase systemic exposure to the timolol component.
• Other topical prostaglandin analogues or topical beta-blockers: concurrent use of an additional agent from the same class is not recommended.
• General anesthesia: the timolol component may blunt reflex tachycardia and increase the risk of hypotension; inform the anesthesiologist of use.

The most commonly reported adverse effects of Travast Plus are ocular and generally mild to moderate:

Patients should report any unusual eye changes, breathing difficulty, or cardiovascular symptoms to their physician promptly.

Pregnancy: Travast Plus should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Animal reproduction studies with prostaglandin analogues have shown potential for fetal harm at systemic exposures; adequate, well-controlled human studies are lacking. Use is generally not recommended unless no safer alternative exists.

Lactation: The timolol component is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants (including cardiovascular and respiratory effects), a decision should be made whether to discontinue breastfeeding or discontinue Travast Plus, considering the importance of treatment to the mother. Consult a physician before use while breastfeeding.

• Pigmentation changes: Travast Plus can cause a gradual, often permanent increase in brown iris pigmentation and changes in periorbital/eyelid skin and eyelashes (increased length, thickness, and number). Effects may be more noticeable with unilateral or asymmetric treatment; counsel patients before starting therapy.
• Macular edema: Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or those with known risk factors for macular edema.
• Intraocular inflammation: Use with caution in patients with active or a history of intraocular inflammation (iritis/uveitis), as prostaglandin analogues may exacerbate this condition.
• Bacterial keratitis: Contamination of multidose ophthalmic containers can cause keratitis; avoid touching the dropper tip to any surface.
• Systemic beta-blockade: Although administered topically, timolol is systemically absorbed and can produce the same adverse cardiac and respiratory reactions seen with systemic beta-blockers, including exacerbation of bronchospasm, bradycardia, heart block, hypotension, and precipitation of cardiac failure in susceptible patients.
• Diabetes mellitus: The timolol component may mask signs and symptoms of acute hypoglycemia; use with caution in diabetic patients, especially those with labile glucose control.
• Thyroid disease: May mask certain clinical signs of hyperthyroidism (e.g., tachycardia); abrupt withdrawal may precipitate thyroid storm in predisposed patients.
• Anaphylaxis: Patients on beta-blockers may have more severe anaphylactic reactions that are more refractory to standard epinephrine treatment.
• Contact lenses: Remove before instillation; the preservative benzalkonium chloride can be absorbed by soft lenses. Reinsert at least 15 minutes after dosing.
• Administration technique: Nasolacrimal occlusion after instillation and spacing of at least 5 minutes between different topical ophthalmic products are recommended to reduce systemic absorption and drug dilution.

Ocular overdose: If excess Travast Plus is instilled, flush the eye(s) with lukewarm water.

Systemic overdose (e.g., accidental ingestion): May produce systemic beta-blockade effects such as bradycardia, hypotension, bronchospasm, and acute cardiac failure. There is no specific antidote. Seek immediate medical attention or contact a poison control center/emergency services; treatment is supportive and symptomatic, and should be managed under direct medical supervision.

Store at room temperature (below 30°C), protected from light and moisture. Do not freeze. Once opened, discard any remaining solution after 4 weeks even if some solution remains in the bottle. Keep out of reach of children.

• Elderly: No overall differences in safety or effectiveness have been observed compared with younger adults; no dose adjustment is required.
• Renal impairment: Not specifically studied; systemic exposure from topical ocular Travast Plus is low, but caution is advised in significant renal impairment.
• Hepatic impairment: Not specifically studied; use with caution.
• Pediatric patients: Safety and efficacy have not been established; use is not recommended (see Pediatric Uses).
• Pregnancy and lactation: See Pregnancy and Lactation section.

Travast Plus is typically used long-term/chronically for as long as needed to control intraocular pressure, under regular ophthalmologic monitoring (IOP measurement, optic nerve and visual field assessment). Treatment duration and continued suitability should be reassessed periodically by the prescribing physician.

Fixed-dose combination of a prostaglandin F2α analogue (travoprost) and a non-selective beta-adrenergic receptor blocking agent (timolol maleate); classified as an ophthalmic anti-glaucoma / ocular hypotensive combination agent. Travoprost + Timolol Maleate is not an antibiotic or antimicrobial.

Travoprost + Timolol Maleate combines two distinct ocular hypotensive mechanisms in one formulation:

• Travoprost selectively stimulates FP prostanoid receptors, increasing uveoscleral (and trabecular) outflow of aqueous humor, thereby lowering IOP.
• Timolol maleate non-selectively blocks beta-1 and beta-2 adrenergic receptors in the ciliary epithelium, reducing the rate of aqueous humor production.

Because the two agents act on different aspects of aqueous humor dynamics (outflow versus production), their combined effect on IOP reduction is additive.

C (FDA legacy pregnancy category, based on the individual components travoprost and timolol)

Safety and efficacy of Travast Plus have not been established in pediatric patients. Use in children and adolescents is not recommended outside of specialist supervision, and alternative, better-studied therapies should generally be considered for pediatric glaucoma.