Moxibac XG5 ml

Moxifloxacin hydrochloride with xanthan gum ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria, in patients 4 months of age and older.

Contains moxifloxacin hydrochloride 0.5% (equivalent to moxifloxacin base) as the active ingredient, formulated with xanthan gum and other inactive ingredients (sodium chloride, boric acid, sorbitol, tyloxapol) in a sterile ophthalmic solution.

This is a fourth-generation fluoroquinolone antibiotic eye drop specifically formulated with xanthan gum, an ingredient that increases the solution's viscosity and prolongs its contact time on the surface of the eye. This formulation design allows effective treatment of bacterial conjunctivitis with a more convenient twice-daily dosing schedule, compared to the three-times-daily schedule required by standard moxifloxacin eye drop formulations without xanthan gum, while maintaining comparable effectiveness against susceptible bacteria.

Therapeutic Class: Ophthalmic Antibiotic (Fluoroquinolone)

The xanthan gum component increases the viscosity of the solution, which prolongs corneal contact time and is designed to maintain effective drug concentrations at the ocular surface for a longer period than a standard aqueous solution, supporting the twice-daily dosing regimen. Moxifloxacin itself has broad-spectrum activity against many gram-positive and gram-negative bacteria commonly responsible for bacterial conjunctivitis, including Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae.

• For topical ophthalmic use only - not for injection into the eye (intracameral or intraocular use), which can cause corneal endothelial damage
• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed drop
• Avoid touching the dropper tip to the eye or any surface, to prevent contaminating the solution
• Complete the full 7-day course, even if symptoms improve before the course is finished

Systemic absorption from topical ophthalmic use is generally limited, so significant systemic drug interactions are uncommon with normal use. If other eye medicines are needed at the same time, space doses apart, and discuss with a doctor or pharmacist.

Common side effects

• Eye discomfort or irritation on instillation
• Eye redness
• Blurred vision (transient)

Serious side effects (seek urgent medical attention)

• Signs of a severe allergic (hypersensitivity) reaction: systemically administered fluoroquinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even after a single dose - rash, swelling, difficulty breathing require immediate medical attention.
• Signs of a secondary infection with prolonged use: new or worsening eye symptoms after initial improvement, which may indicate overgrowth of non-susceptible organisms, including fungi.
• Persistent eye pain, redness, or discharge despite treatment, which should be reassessed by a doctor.

Pregnancy

There are no adequate, well-controlled studies of this ophthalmic formulation in pregnant women; given the generally low systemic absorption from topical ophthalmic use, it is commonly used when clinically indicated, but use during pregnancy should be discussed with a doctor.

Breastfeeding

It is not known whether topical ophthalmic moxifloxacin passes into human milk in clinically significant amounts; use during breastfeeding should be discussed with a healthcare professional.

• Not for injection into the eye - this solution is for topical use only; intraocular administration can cause damage to the corneal endothelium.
• As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi; if a secondary infection occurs, discontinue and institute alternative therapy.
• Systemic fluoroquinolones (a related but different route of administration) have been associated with hypersensitivity reactions, tendon effects, and other serious adverse reactions; while topical ophthalmic use carries much lower systemic exposure, patients with a known systemic fluoroquinolone reaction should discuss this history with their doctor.
• If the condition does not improve, or worsens, after completing the course, seek medical reassessment, since an alternative diagnosis or resistant organism may need to be considered.

Topical ophthalmic overdose is unlikely with normal use. If the product is accidentally swallowed, drink fluids to dilute and contact a doctor or poison control center for advice. Excessive or more frequent use than directed does not improve effectiveness and may increase local irritation.

Store at room temperature, protected from light, as directed on the product label. Keep out of reach of children.

• Infants (4 months and older): Established for use in this population at the same dosing (1 drop twice daily for 7 days) as adults.
• Infants under 4 months: Safety and effectiveness have not been established; use only on specific medical advice.
• Elderly: No specific dose adjustment is generally required.

Treatment is a fixed 7-day course, with the drop instilled twice daily; the full course should be completed even if symptoms resolve earlier, to fully clear the infection. If symptoms do not improve within the expected timeframe, medical reassessment is recommended.

Drug Class: Fourth-generation fluoroquinolone antibacterial, xanthan gum-based extended ocular-retention formulation

Moxifloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, and repair. By blocking these enzymes, moxifloxacin prevents susceptible bacteria from replicating and repairing their DNA, which kills the bacteria and clears the ocular infection. The xanthan gum component does not have antibacterial activity itself but supports the antibiotic's action by keeping it in contact with the eye surface for longer.

This formulation is established for use in infants and children 4 months of age and older, at the same dose (1 drop twice daily for 7 days) as adults, for treatment of bacterial conjunctivitis. Safety and effectiveness in infants under 4 months have not been established.