Cinagen XG

Approved Indications (Ophthalmic Formulation):

• Bacterial Conjunctivitis:
  Indicated for the treatment of acute bacterial conjunctivitis caused by susceptible organisms such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
• Ocular Surface Infections with Tear Film Deficiency:
  Indicated for treating superficial bacterial ocular infections where concurrent lubrication is beneficial—especially in patients with dry eye syndrome or reduced tear production.

Off-label/Clinically Accepted Uses:

• Postoperative Antibacterial Prophylaxis:
  Prevention of infection following ocular procedures, especially in patients at risk of dry eye or compromised corneal surfaces.
• Contact Lens-Related Keratoconjunctivitis:
  Where both antimicrobial activity and ocular surface hydration are needed.

Adults and Adolescents (≥1 year):

• Recommended Dose:
  Instill 1 drop in the affected eye(s) 3 times daily for 5 to 7 days, or as prescribed.
• Maximum Duration:
  Treatment generally should not exceed 7 days without clinical reassessment.

Pediatrics (<1 year):

• Safety Not Established:
  Use not recommended due to insufficient data.

Elderly:

• No dose adjustment required.
  Well tolerated across age groups.

Renal or Hepatic Impairment:

• Not applicable due to topical ophthalmic use with minimal systemic absorption. No dose adjustment needed.

Route of Administration:

• Topical ophthalmic only.
  Not for injection, oral ingestion, or systemic use.

Special Instructions:

• Shake well before use (if suspension).
• Wait at least 5 minutes before using other ophthalmic medications.

Moxifloxacin is a fourth-generation fluoroquinolone that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, key enzymes necessary for bacterial DNA replication, repair, and transcription. Inhibition leads to DNA strand breakage and bactericidal activity against a wide range of Gram-positive, Gram-negative, and atypical ocular pathogens.

Xanthan Gum acts as a mucoadhesive polymer and viscosity-enhancing agent. It forms a stable, bioadhesive matrix on the ocular surface, prolonging the contact time of moxifloxacin with the conjunctival sac. This enhances drug retention and efficacy while simultaneously providing lubrication and protection to the ocular surface, especially in patients with dry eye or compromised tear film.

Together, this combination improves antimicrobial action and symptom relief by combining targeted bacterial killing with enhanced surface hydration and retention.

Moxifloxacin (Topical):

• Absorption:
  Minimal systemic absorption following ophthalmic use. Plasma levels typically ≤2 ng/mL.
• Distribution:
  Rapidly penetrates ocular tissues including the conjunctiva, aqueous humor, and corneal epithelium.
• Metabolism:
  Not significantly metabolized systemically when used topically.
• Elimination:
  Primarily via nasolacrimal drainage; minor renal and fecal routes if absorbed.
• Half-life: ~12 hours (systemic), but topical ocular half-life is much shorter.

Xanthan Gum:

• Not absorbed systemically.
• Acts locally on the eye surface to increase viscosity and residence time of the drug.

• Pregnancy:
  No controlled data in human pregnancy. Moxifloxacin, when used systemically, may pose a risk. However, topical use results in negligible systemic exposure. Should be used during pregnancy only if clearly needed.
• Lactation:
  No data on excretion in human milk after ophthalmic use. Systemic absorption is minimal, but caution is advised. Monitor infant for signs of gastrointestinal disturbance if breastfeeding.
• Summary:
  Safe use cannot be fully confirmed. Use only when benefit outweighs risk, particularly for prolonged treatment.

• Primary Class:
  Ophthalmic Antibacterial and Lubricating Combination
• Components:
• Moxifloxacin Hydrochloride: Fluoroquinolone antibiotic (4th generation)
• Xanthan Gum: Ophthalmic polymer, viscosity enhancer, ocular lubricant

• Known hypersensitivity to moxifloxacin, xanthan gum, other quinolone antibiotics, or any component of the formulation
• Viral or fungal ocular infections
• Patients wearing soft contact lenses during active infection

• Delayed Healing or Superinfection:
  Long-term use may promote the overgrowth of non-susceptible organisms, including fungi.
• Hypersensitivity Reactions:
  Cross-sensitivity with other fluoroquinolones may occur.
• Prolonged Use:
  If signs and symptoms worsen or persist beyond 7 days, reassess diagnosis.
• Contact Lens Use:
  Do not wear contact lenses during active infection or while using this medication.
• Use with Other Ophthalmic Drugs:
  Administer 5–10 minutes apart to prevent dilution or washout.

Common (≥1%):

• Eye irritation or burning upon instillation
• Blurred vision
• Dryness or foreign body sensation
• Tearing

Uncommon:

• Ocular itching, stinging, or discomfort
• Eyelid edema
• Conjunctival hyperemia

Rare but Serious:

• Hypersensitivity reaction (rash, swelling, eyelid edema)
• Superinfection (fungal overgrowth)

Timing & Severity:

• Most side effects are mild and transient, appearing within minutes of instillation.
• Rare systemic reactions may occur but are unlikely due to minimal absorption.

• Systemic Drug Interactions:
  None expected due to minimal systemic absorption.
• Topical/Ophthalmic Interactions:
• Avoid simultaneous use with other ocular antibiotics unless prescribed.
• Separate administration from other ophthalmic agents by at least 5 minutes.
• Enzyme System Involvement:
  Moxifloxacin is not metabolized by CYP450 enzymes when used ophthalmically.

• EMA & FDA Alerts (Class-Wide for Fluoroquinolones):
  Oral fluoroquinolones have raised safety concerns (tendinopathy, neuropathy), but topical ophthalmic moxifloxacin is not affected due to negligible systemic exposure.
• Dry Eye Disease Guidelines (2023):
  Highlighted benefit of combination agents like xanthan gum + antibiotic in patients with mixed bacterial/inflammatory ocular surface disease.
• Clinical Practice Trend:
  Growing use of moxifloxacin + xanthan gum in post-cataract care protocols for improved comfort and infection control.

• Temperature:
  Store between 15°C to 25°C (59°F to 77°F).
• Protection Requirements:
• Keep bottle tightly closed.
• Protect from excessive heat, humidity, and light.
• Do not freeze.
• Handling Instructions:
• Shake well before use (if suspension or emulsion).
• Discard 28 days after opening the bottle.
• Avoid touching the dropper tip to any surface.
• Preservative Warning:
  Some formulations may contain benzalkonium chloride—can be absorbed by soft contact lenses.