Trevox D0.1%+0.5%

Trevox D is an ophthalmic (eye) combination of a corticosteroid (dexamethasone) and a fluoroquinolone antibiotic (levofloxacin). It is indicated for steroid-responsive inflammatory ocular conditions in which a bacterial ocular infection exists or there is a risk of bacterial ocular infection.

Established / guideline-supported uses

• Post-operative ocular inflammation with infection prophylaxis: control of inflammation following ophthalmic surgery (e.g., cataract surgery) in patients at risk of, or with, superficial bacterial infection.
• Blepharoconjunctivitis and blepharokeratoconjunctivitis: steroid-responsive inflammation of the lids and conjunctiva with an accompanying or suspected bacterial component.
• Other steroid-responsive inflammatory conditions of the eye (e.g., allergic conjunctivitis, iritis, cyclitis) where a bacterial infection or the risk of one is also present, such that corticosteroid use alone would be inappropriate.

Important limitation

Trevox D is intended only for conditions that require BOTH anti-inflammatory and antibacterial cover. It should not be used for purely bacterial infections without inflammation, or for purely inflammatory conditions without any infective risk, since unnecessary corticosteroid or antibiotic exposure carries its own risks (see Precautions and Warnings).

Each mL/dose of Dexamethasone + Levofloxacin ophthalmic suspension/solution typically contains Dexamethasone 0.1% (1 mg/mL) and Levofloxacin 0.5% (5 mg/mL) as active ingredients, together with ophthalmic-grade preservative, tonicity agent, buffer, and vehicle base. Exact strengths and excipients vary by manufacturer/brand; refer to the specific product label.

Trevox D is a fixed-dose ophthalmic combination product. Dexamethasone is a synthetic corticosteroid that suppresses ocular inflammation, edema, and fibrin deposition, while levofloxacin is a broad-spectrum fluoroquinolone antibiotic active against many common Gram-positive and Gram-negative ocular pathogens.

It is formulated as a sterile ophthalmic suspension or solution for topical instillation into the eye and is not intended for injection, oral use, or use in the ear or elsewhere on the body unless specifically labeled for that route.

Ophthalmic corticosteroid–antibiotic combination (Trevox D); Anti-inflammatory (corticosteroid) + Fluoroquinolone antibacterial, for topical ocular use.

Dexamethasone + Levofloxacin combines two agents with complementary mechanisms:

• Dexamethasone is a potent synthetic glucocorticoid. It diffuses into ocular cells, binds glucocorticoid receptors, and inhibits phospholipase A2, reducing arachidonic acid release and downstream prostaglandin/leukotriene synthesis. This suppresses leukocyte infiltration, capillary dilation, fibroblast proliferation, and fibrin/collagen deposition, thereby reducing inflammation, edema, and scarring in ocular tissue.
• Levofloxacin is the levo-isomer fluoroquinolone antibacterial. It inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes required for bacterial DNA replication, transcription, and repair, leading to bactericidal activity against a broad range of Gram-positive and Gram-negative organisms commonly implicated in ocular surface infections (e.g., Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa).

Following topical ocular administration of Dexamethasone + Levofloxacin, systemic absorption is generally minimal, but measurable systemic levels of both components can occur, particularly with prolonged use, punctal occlusion avoidance, or damaged corneal epithelium.

• Wash hands before use.
• If using a suspension formulation of Trevox D, shake the bottle well before each use.
• Tilt the head back, gently pull down the lower eyelid to form a small pocket, and instill the prescribed number of drops without letting the dropper tip touch the eye, eyelid, or any surface (to avoid contamination).
• Close the eye gently for 1–2 minutes after instillation; applying light pressure at the inner corner of the eye (punctal occlusion) can reduce systemic absorption.
• If more than one topical ophthalmic product is being used, wait at least 5–10 minutes between different products.
• Remove contact lenses before instillation and do not reinsert them during active treatment of an ocular infection unless the physician advises otherwise (see Precautions and Warnings).
• Discard the bottle after the course of treatment or after the manufacturer-specified in-use period, whichever is sooner.

Formal drug-drug interaction studies with topical ophthalmic Trevox D are limited because systemic absorption after ocular instillation is minimal. Clinically relevant considerations include:

• Other topical ophthalmic corticosteroids or NSAIDs: concurrent use may increase the risk of corticosteroid-related ocular adverse effects (raised intraocular pressure, delayed healing); avoid unnecessary duplication.
• Other topical ophthalmic antibiotics: concurrent use of another topical fluoroquinolone or antibacterial is generally unnecessary and does not add benefit; may increase risk of local irritation.
• Multiple topical eye products: when other eye drops are required, separate administration by at least 5–10 minutes to prevent one product washing out another and to reduce additive local irritation.

Report all other medicines, including other eye drops, to your physician or pharmacist before starting Trevox D.

Side effects reported with Trevox D and similar corticosteroid-fluoroquinolone ophthalmic combinations include:

Common

• Transient burning, stinging, or discomfort on instillation
• Blurred vision immediately after application
• Eye irritation, itching, or foreign-body sensation
• Increased tearing

Less common but clinically important

• Raised intraocular pressure/steroid-induced glaucoma with prolonged use
• Posterior subcapsular cataract formation with prolonged use
• Delayed wound/corneal healing
• Secondary ocular infection, including fungal or bacterial superinfection (see Precautions and Warnings)
• Hypersensitivity reactions (eyelid swelling, redness, rash)

Patients should seek prompt medical advice if vision changes, worsening pain or redness, or symptoms failing to improve occur (see Precautions and Warnings).

Pregnancy: Adequate, well-controlled studies of Trevox D in pregnant women are lacking. Although systemic absorption after ocular use is low, both corticosteroids and fluoroquinolones can have systemic effects when absorbed. Trevox D should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation: It is not known whether topically applied dexamethasone or levofloxacin from Trevox D are excreted in human milk in clinically significant amounts. Caution is advised, and a physician should be consulted before use while breastfeeding; the smallest effective dose for the shortest necessary duration is recommended if use is considered necessary.

The following precautions apply to the use of Trevox D:

• Prolonged use risk: Extended use of Trevox D can raise intraocular pressure (with possible optic nerve damage, visual field defects, and steroid-induced glaucoma), cause posterior subcapsular cataract formation, and delay corneal/wound healing. Intraocular pressure should be monitored, especially if Trevox D is used for longer than 10 days.
• Masking or worsening of infection: Corticosteroid components can mask signs of infection or suppress the host response, permitting undetected worsening of infection, particularly herpetic keratitis, where corticosteroid use can cause serious worsening or spread of the disease. Trevox D should not be used in undiagnosed red eye without professional ophthalmic evaluation.
• Secondary infection: Use of steroid-antibiotic combinations, especially long term, may result in secondary ocular infections, including fungal infections of the cornea, and overgrowth of non-susceptible organisms.
• Fluoroquinolone class effects: As with other fluoroquinolones, hypersensitivity reactions may occur even after a single dose; discontinue immediately if signs of an allergic reaction appear.
• Contact lens use: Contact lenses should generally not be worn during treatment of an active ocular infection with Trevox D.
• When to stop and seek advice: Discontinue Trevox D and seek medical advice if irritation worsens, vision changes occur, pupils appear dilated, or symptoms fail to improve or worsen after a few days of therapy.
• Complete the antibiotic course: Even if symptoms improve early, complete the full antibiotic course of Trevox D as prescribed; do not stop, extend, skip doses, or share this medicine with others without medical advice (see Dosage and Administration).
• Not for injection: Trevox D is for topical ophthalmic use only and must not be injected into the eye or used systemically.

Topical ocular overdose of Trevox D (e.g., excessive drops or accidental ingestion of the bottle contents) may cause increased local irritation, or, if swallowed, gastrointestinal upset and systemic effects related to the individual components. Flush the eye with lukewarm water if excessive product is instilled. In case of suspected overdose or accidental ingestion, seek immediate medical attention or contact a poison control center/emergency services; do not attempt unsupervised specific home treatment.

Store at room temperature (below 30°C), protected from light and moisture. Do not freeze. Keep the bottle tightly closed when not in use, discard any unused portion after the manufacturer-specified in-use period (commonly around 4 weeks after opening), and keep out of reach of children.

Pediatric use

Safety and efficacy of Trevox D in infants and very young children have not been as well established as in adults; use in children should be under close physician supervision, with attention to the same monitoring recommendations (intraocular pressure, signs of infection) as in adults (see Pediatric Uses).

Elderly

No specific dose adjustment is generally required in elderly patients based on age alone; monitor as for other adults, since elderly patients may be more susceptible to steroid-related intraocular pressure elevation and cataract formation.

Renal/hepatic impairment

Because systemic absorption of Trevox D after ocular administration is minimal, specific renal or hepatic dose adjustment is not established or generally required for the ophthalmic route; no well-established dosage adjustment data exist.

Contact lens wearers

Contact lenses should generally not be worn during active infection treatment with Trevox D (see Precautions and Warnings).

The duration of Trevox D therapy depends on indication and clinical response but is generally limited to the shortest effective period. Treatment commonly ranges from a few days up to about 2 weeks. Use beyond 10 days requires ophthalmologist reassessment, including intraocular pressure monitoring, due to the risks of prolonged corticosteroid exposure (see Precautions and Warnings). The antibiotic component should always be used for the full prescribed course, even if symptoms resolve earlier.

Dexamethasone + Levofloxacin belongs to the ophthalmic corticosteroid–fluoroquinolone antibacterial combination class: dexamethasone (a glucocorticoid/corticosteroid) combined with levofloxacin (a fluoroquinolone antibiotic).

Dexamethasone + Levofloxacin acts through two complementary mechanisms: dexamethasone suppresses the inflammatory cascade by inhibiting phospholipase A2 and reducing prostaglandin/leukotriene-mediated inflammation, edema, and fibrosis in ocular tissue; levofloxacin kills susceptible bacteria by inhibiting bacterial DNA gyrase and topoisomerase IV, blocking DNA replication and repair. Together they reduce ocular inflammation while covering or preventing bacterial infection in the same treatment site.

C

Trevox D may be used in children under physician supervision for the same steroid-responsive inflammatory ocular conditions with an infective component/risk as in adults, using the instillation technique and frequency directed by the prescriber. However, safety and efficacy in infants and very young children have not been as extensively established as in adults, and formal pediatric dosing data are limited for many brands. Close monitoring for intraocular pressure elevation, signs of secondary infection, and local irritation is recommended. Trevox D should not be used in children for undiagnosed red eye without an ophthalmic evaluation.