Opthamox Plus

Approved Indications (Ophthalmic Combination):

• Postoperative Ocular Inflammation and Infection Prevention:
  Indicated for the treatment and prevention of inflammation and bacterial infection following ocular surgery, such as cataract extraction.
• Bacterial Conjunctivitis with Inflammatory Component:
  Used when conjunctival inflammation coexists with or predisposes to bacterial conjunctivitis.
• Blepharoconjunctivitis:
  Management of mixed inflammatory and bacterial conditions of the eyelid margins and conjunctiva.

Off-label (Clinically Accepted) Uses:

• Anterior uveitis (mild cases):
  As adjunct therapy to treat infection and reduce inflammation.
• Corneal abrasions or minor trauma with suspected bacterial contamination.

Note: This combination is not approved for systemic use and is intended for topical ophthalmic administration only.

Adults (Ophthalmic Use):

• Standard Regimen (Postoperative inflammation and infection):
  Instill 1 drop in the affected eye 4 times daily, starting 24 hours after surgery and continuing for up to 7 days or as directed.
• Alternative dosing:
  May vary based on clinician preference or severity (e.g., every 2 hours during waking hours for the first 24–48 hours in severe inflammation).

Pediatric Use:

• Children ≥1 year old:
  Safety and efficacy have been established. Dose same as adult: 1 drop in affected eye(s) 4 times daily.
• Children <1 year:
  Not recommended due to lack of sufficient safety data.

Elderly:

• No dose adjustment required.

Renal/Hepatic Impairment:

• Not applicable (topical administration with minimal systemic absorption).

Route of Administration:

• Ophthalmic only (eye drops).
  Do not inject or administer systemically.

This fixed-dose combination contains Moxifloxacin, a fourth-generation fluoroquinolone, and Dexamethasone, a potent corticosteroid.

• Moxifloxacin exerts its antibacterial effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes necessary for DNA replication and repair. This results in rapid bactericidal activity against a broad range of Gram-positive, Gram-negative, and atypical ocular pathogens.
• Dexamethasone acts as an anti-inflammatory agent by binding to glucocorticoid receptors in the cytoplasm, modulating the expression of pro-inflammatory genes and cytokines (e.g., IL-1, TNF-α), and reducing leukocyte infiltration. This suppresses local ocular inflammation, swelling, and discomfort post-surgery or during infection.

Together, the combination provides both antimicrobial coverage and inflammatory suppression in a single formulation.

Moxifloxacin (Ophthalmic Use):

• Absorption:
  Minimal systemic absorption. Peak plasma concentration ~2 ng/mL after topical use.
• Distribution:
  Achieves therapeutic levels in the conjunctiva, aqueous humor, and cornea.
• Metabolism:
  Not significantly metabolized following ophthalmic use.
• Elimination:
  Mainly through tears and nasolacrimal drainage.

Dexamethasone (Ophthalmic Use):

• Absorption:
  Low systemic absorption, but detectable in plasma with frequent or long-term use.
• Distribution:
  Penetrates corneal and conjunctival tissues effectively.
• Metabolism & Elimination:
  Hepatic metabolism if systemically absorbed; excreted via urine.

Onset of Action:

• Moxifloxacin: Within 30 minutes after instillation.
• Dexamethasone: 1–2 hours for anti-inflammatory effect.

Duration of Action:

• Approximately 4–6 hours per dose.

• Pregnancy:
  Dexamethasone and moxifloxacin (systemically) are generally not recommended during pregnancy due to potential fetal risks. However, topical use involves minimal systemic exposure and may be considered if clearly needed.
• Lactation:
  Unknown whether sufficient quantities are excreted in breast milk from ophthalmic use. Use with caution; consider withholding breastfeeding temporarily during treatment.
• Caution:
  Prolonged use during pregnancy or breastfeeding should be avoided. Use only if the benefit outweighs potential risk.

• Primary Class:
  Ophthalmic Anti-infective and Anti-inflammatory Combination
• Components:
• Moxifloxacin Hydrochloride – Fluoroquinolone antibiotic (4th generation)
• Dexamethasone – Glucocorticoid (Corticosteroid)

• Known hypersensitivity to moxifloxacin, dexamethasone, other quinolones, corticosteroids, or any formulation ingredients.
• Viral infections of the eye:
  e.g., epithelial herpes simplex keratitis (dendritic keratitis).
• Fungal or mycobacterial eye infections.
• Untreated parasitic eye infections.
• Advanced glaucoma or optic nerve damage (due to corticosteroid effect on intraocular pressure).

• Increased Intraocular Pressure (IOP):
  Long-term corticosteroid use may increase IOP, leading to glaucoma. Monitor IOP during extended therapy.
• Cataract Formation:
  Posterior subcapsular cataracts may occur with prolonged corticosteroid use.
• Delayed Wound Healing:
  Dexamethasone may delay corneal healing post-surgery or in corneal ulcers.
• Superinfection Risk:
  Prolonged use may lead to overgrowth of non-susceptible organisms including fungi.
• Corneal Perforation:
  May occur in diseases that thin the cornea or sclera.
• Contact Lens Use:
  Avoid during treatment; preservative may be absorbed by lenses and cause irritation.
• Pediatric Use:
  Use with caution due to risk of systemic corticosteroid absorption.

Common (≥1%):

• Ocular:
  Eye irritation, burning, dryness, blurred vision, photophobia, eye pain.
• Systemic (rare):
  Headache, bad taste in mouth after instillation (moxifloxacin-related).

Less Common/Serious:

• Elevated intraocular pressure
• Secondary infection (fungal, viral)
• Corneal thinning or ulceration
• Eye pruritus or allergic conjunctivitis

Rare:

• Anaphylaxis (systemic hypersensitivity)
• Perforation of cornea
• Steroid-induced glaucoma

Timing of Onset:

• Local irritation: Within minutes
• Elevated IOP: May take several days to weeks
• Superinfection: With extended use (>7–10 days)

• Systemic Interactions:
  Minimal with ophthalmic use due to low systemic absorption.
• Topical Interactions:
• Avoid simultaneous use with other topical corticosteroids unless directed.
• Do not combine with aminoglycoside antibiotics or antiviral eye drops without medical advice.
• Absorption Interference:
  If using multiple ophthalmic products, administer drugs at least 5 minutes apart to avoid washout.

• Post-2020 Regulatory Review (FDA/EMA):
  Increased emphasis on short-term use only due to risks associated with prolonged corticosteroid exposure.
• Ophthalmology Practice Guidelines (2022–2024):
  Recommend fixed-dose combinations like moxifloxacin + dexamethasone to improve compliance and reduce postoperative inflammation and infection simultaneously.
• Clinical Practice Shift:
  Preference growing for preservative-free single-use formulations to minimize ocular surface toxicity.

• Temperature:
  Store between 15°C to 25°C (59°F to 77°F).
  Do not freeze.
• Humidity & Light:
  Protect from moisture and direct sunlight. Keep bottle tightly closed when not in use.
• Handling Precautions:
• Shake well before use (if suspension).
• Do not touch dropper tip to any surface.
• Use within 28 days of opening.
• Special Instructions:
  If ocular irritation persists or worsens, discontinue and consult a physician.