Visomox D0.5%+0.1%

Visomox D is a fixed-dose combination ophthalmic (eye) preparation containing a fourth-generation fluoroquinolone antibiotic (moxifloxacin) and a corticosteroid (dexamethasone). It is indicated for conditions where both anti-inflammatory action and antibacterial coverage are needed in the same eye condition.

• Guideline/label-supported use: Control of postoperative inflammation and prevention or treatment of bacterial infection in patients undergoing ocular surgery, such as cataract surgery, when a corticosteroid is indicated for inflammation and there is a risk of, or an existing, susceptible bacterial infection.
• Established use: Treatment of steroid-responsive ocular inflammatory conditions (e.g. postoperative uveitis, blepharoconjunctivitis) in which superficial bacterial infection or a risk of bacterial infection exists.
• Adjunct use: Used as an adjunct to systemic therapy in selected external ocular infections accompanied by significant inflammation, under ophthalmologist supervision.

Visomox D is not intended for undiagnosed red eye or for infections not caused by susceptible bacteria, since the corticosteroid component may worsen untreated infections (see Contraindications).

Each mL of Moxifloxacin Hydrochloride + Dexamethasone Phosphate ophthalmic suspension/solution typically contains moxifloxacin hydrochloride equivalent to 5 mg (0.5%) moxifloxacin base and dexamethasone (as dexamethasone sodium phosphate) equivalent to 1 mg (0.1%) dexamethasone base, along with pharmaceutically approved excipients and preservative (e.g. benzalkonium chloride) as an ophthalmic vehicle.

Visomox D is a sterile, multi-dose topical ophthalmic combination product. Moxifloxacin is a fourth-generation fluoroquinolone antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV, providing broad-spectrum coverage against common ocular pathogens. Dexamethasone is a synthetic corticosteroid that suppresses the inflammatory response through multiple mechanisms, reducing edema, fibrin deposition, capillary leakage, and cellular infiltration.

The combination allows simultaneous control of ocular inflammation and reduction of infection risk, and is most commonly used in the peri-operative and post-operative period of ophthalmic surgery.

Visomox D belongs to the therapeutic class of ophthalmic anti-infective and anti-inflammatory combinations — specifically a fluoroquinolone antibiotic combined with a corticosteroid, for topical ocular use.

Moxifloxacin component

Moxifloxacin is a fourth-generation fluoroquinolone that exerts bactericidal activity by inhibiting two essential bacterial enzymes, DNA gyrase (topoisomerase II) and topoisomerase IV, which are required for bacterial DNA replication, transcription, and repair. It has activity against a broad range of Gram-positive and Gram-negative ocular pathogens, including many strains resistant to earlier-generation fluoroquinolones.

Dexamethasone component

Dexamethasone is a potent synthetic corticosteroid that inhibits the inflammatory response to a variety of inciting agents. It suppresses edema, fibrin deposition, capillary dilation, leukocyte migration, and capillary and fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

Moxifloxacin Hydrochloride + Dexamethasone Phosphate combines these two mechanisms so that anti-inflammatory control does not come at the cost of unchecked bacterial proliferation.

Visomox D is administered as a topical eye drop only. It must never be injected, swallowed, or applied to broken skin. Proper aseptic instillation technique (clean hands, avoiding contact between the dropper tip and the eye) should always be followed to prevent contamination of the bottle and secondary ocular infection.

Because Visomox D is applied topically to the eye with minimal systemic absorption, clinically significant drug-drug interactions are uncommon. However:

• Other topical ophthalmic medications: If multiple eye drops are used concurrently, they should be administered at least 5 minutes apart to prevent one drop from washing out another and to allow adequate ocular contact time.
• Other corticosteroid-containing ophthalmic products: Concomitant use may increase the risk of steroid-related ocular adverse effects (e.g. raised intraocular pressure); avoid unnecessary duplication of corticosteroid eye drops.
• Live or attenuated ocular vaccines/products: The corticosteroid component can theoretically impair local immune response; avoid concurrent use of live ocular vaccine preparations.

No clinically significant systemic drug interactions (e.g. with warfarin, theophylline, or other oral medications) are expected at recommended ophthalmic doses, unlike systemic fluoroquinolone or corticosteroid therapy.

Side effects of Visomox D may relate to either the antibiotic or the corticosteroid component:

Common / local effects

• Eye irritation, stinging, or burning on instillation
• Blurred vision (transient)
• Foreign body sensation, itching, or ocular discomfort
• Conjunctival hyperemia (redness)
• Increased tearing

Effects associated with prolonged corticosteroid use

• Elevated intraocular pressure/glaucoma, with possible optic nerve damage, visual field defects, and posterior subcapsular cataract formation with long-term use
• Delayed wound healing
• Secondary ocular infection, including fungal or viral overgrowth, due to suppression of the host inflammatory/immune response during prolonged steroid use
• Rarely, perforation of the globe in diseases that cause thinning of the cornea or sclera

Patients should report any significant eye pain, marked visual change, or persistent redness promptly to their physician.

Pregnancy: There are no adequate and well-controlled studies of Visomox D in pregnant women. Although systemic absorption after ophthalmic administration is low, Visomox D should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, and only under a physician's advice.

Lactation: It is not known whether topically administered Visomox D is excreted in human milk in clinically significant amounts. Caution should be exercised, and Visomox D should be used during breastfeeding only if clearly needed and recommended by a physician, since systemic fluoroquinolones and corticosteroids can pass into milk.

• For topical ophthalmic use only. Not for injection, oral use, or use in the ear.
• Duration of use: Prolonged use of Visomox D increases the risk of elevated intraocular pressure, cataract formation, and secondary infection (see Side Effects). Intraocular pressure should be monitored if treatment continues beyond 10 days.
• Undiagnosed red eye: Do not use for undiagnosed red eye or without prior ophthalmologic evaluation, since the corticosteroid may mask or worsen an unrecognized infection (see Contraindications).
• Fungal/viral infections: Prolonged corticosteroid use may enhance the establishment of secondary fungal or viral ocular infection; if new infection appears during treatment, discontinue and reassess.
• Fluoroquinolone class awareness: Systemic fluoroquinolones have been associated with tendon effects, QT prolongation, and CNS effects; these are not expected to be clinically relevant with topical ophthalmic use at recommended doses, but patients with a known fluoroquinolone hypersensitivity should avoid this product.
• Contact lenses: Avoid wearing contact lenses during active ocular infection or inflammation unless directed by a physician.
• Stewardship: Take exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Topical ocular overdose of Visomox D is unlikely to cause systemic toxicity due to minimal absorption, but excessive or prolonged use may increase the risk of local adverse effects such as raised intraocular pressure, corneal thinning, or secondary infection. If a large amount is accidentally ingested or if it is instilled into the eye in excessive amounts, flush the eye with lukewarm water and seek immediate medical attention or contact a poison control center; do not attempt unsupervised home treatment for suspected overdose.

Store at room temperature (below 30°C), away from light and moisture. Keep the bottle tightly closed when not in use, shake well before each use if it is a suspension, and keep out of reach of children. Discard any unused portion after the period specified on the label (commonly 4 weeks after opening) or as directed by the pharmacist.

Pediatric use

Safety and efficacy of Visomox D in pediatric patients below the age evaluated in clinical studies for the individual components have not been fully established for this fixed combination; use in children should be under close ophthalmologist supervision and only when clearly indicated.

Elderly

No overall differences in safety or efficacy have been observed between elderly and younger adult patients; no dose adjustment is generally required.

Renal/Hepatic impairment

Because systemic absorption after ophthalmic administration is minimal, no dose adjustment is expected to be necessary in patients with renal or hepatic impairment; specific studies have not been conducted.

Duration of treatment with Visomox D is determined by the treating ophthalmologist based on the indication. For post-operative prophylaxis and control of inflammation/infection risk (e.g. after cataract surgery), treatment is commonly continued for about 2 weeks. Treatment should not be continued beyond the prescribed duration, since prolonged corticosteroid exposure increases the risk of raised intraocular pressure, cataract, and secondary infection.

Moxifloxacin Hydrochloride + Dexamethasone Phosphate is classified as a combination of a fourth-generation fluoroquinolone antibiotic (moxifloxacin) and a synthetic corticosteroid (dexamethasone), formulated for ophthalmic (topical eye) use.

Moxifloxacin Hydrochloride + Dexamethasone Phosphate acts through two complementary mechanisms. Moxifloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, resulting in bactericidal activity against susceptible ocular pathogens. Dexamethasone binds to intracellular glucocorticoid receptors, ultimately reducing the synthesis of inflammatory mediators (such as prostaglandins and cytokines), stabilizing cell membranes, and reducing capillary permeability, leukocyte infiltration, and fibroblast proliferation. Together, these actions control ocular inflammation while reducing the risk of bacterial infection during the course of treatment.

The safety and efficacy of Visomox D as a fixed combination have not been formally established in all pediatric age groups; individual components have been used in pediatric ophthalmic practice under specialist supervision. Visomox D should be used in children only when clearly indicated by an ophthalmologist, at doses individualized to the child's age and condition, with attention to the same precautions regarding duration of use and monitoring for intraocular pressure elevation as in adults. Safety and efficacy in neonates and infants below the studied age range have not been established.