Filtear Mono

Approved Indications:

• Dry Eye Syndrome (Keratoconjunctivitis Sicca):
  Indicated for the temporary relief of burning, irritation, and discomfort due to ocular dryness or exposure to wind, sun, or environmental conditions.
• Ocular Surface Protection:
  Provides lubrication and protection to the ocular surface in conditions such as post-operative dry eye (e.g., post-cataract or LASIK), contact lens-induced dryness, and exposure keratitis.
• Supportive Use in Ocular Surface Disease:
  Helps maintain tear film stability in patients with meibomian gland dysfunction (MGD) or evaporative dry eye.

Clinically Accepted Off-label Uses:

• Computer Vision Syndrome (CVS):
  Used to relieve eye strain, dryness, and discomfort due to prolonged screen time or reduced blink rate.
• Chronic Conjunctival Irritation:
  May be used adjunctively in managing symptoms of chronic allergic or environmental conjunctivitis with dry eye features.

Adults and Elderly:

• Recommended Dose:
  Instill 1 to 2 drops in the affected eye(s) as needed.
• Maximum Frequency:
  May be used up to 6 times per day for preserved formulations; preservative-free products may be used more frequently.
• Route of Administration:
  Topical ophthalmic use only.

Pediatrics:

• Safe and effective in children aged 2 years and older.
  For children under 2 years, use only under physician supervision.

Special Populations:

• Renal and Hepatic Impairment:
  No dosage adjustment necessary. Systemic absorption is negligible.

Administration Technique:

• Wash hands thoroughly.
• Tilt head back, pull down lower eyelid, and instill drop(s) into the conjunctival sac.
• Do not touch the dropper tip to any surface.
• Wait at least 5 minutes between multiple ophthalmic medications.

Polyethylene Glycol (PEG) and Propylene Glycol (PG) are hydrophilic polymers that function as ocular demulcents and lubricants. Propylene glycol acts by spreading evenly over the ocular surface, improving moisture retention and reducing surface friction. Polyethylene glycol enhances tear film stability by forming a hydrated, protective coating on the corneal and conjunctival epithelium. Together, they mimic natural tears, alleviate dryness, and protect against further irritation by improving hydration and reducing evaporation from the ocular surface.

• Absorption:
  Minimal to negligible systemic absorption after topical ocular administration.
• Distribution:
  Localized to the ocular surface (cornea and conjunctiva).
• Metabolism:
  Systemic metabolism is minimal. If absorbed, propylene glycol is metabolized in the liver; polyethylene glycol undergoes limited metabolic change.
• Excretion:
  If systemically absorbed, excreted via renal route.
• Onset of Action:
  Typically begins within minutes after instillation.
• Duration of Action:
  Temporary relief, typically lasting 1 to 3 hours depending on the formulation and severity of dryness.

• Pregnancy:
  Although the FDA no longer uses letter categories, no known risks have been identified with ocular use of PEG + PG during pregnancy. These agents have minimal systemic absorption and are considered safe when used topically as directed.
• Lactation:
  Due to negligible systemic absorption, it is unlikely that either agent would be excreted in breast milk or affect a breastfeeding infant. Considered safe during lactation.
• Recommendation:
  May be used during pregnancy and breastfeeding with low risk. As with all medications, it is advisable to consult a healthcare provider before use.

• Primary Class: Ophthalmic Lubricant
• Subclass: Artificial Tear / Demulcent Combination

• Known hypersensitivity or allergic reaction to polyethylene glycol, propylene glycol, or any component of the formulation
• Ocular infection or trauma requiring specific therapeutic intervention, where lubricants may obscure diagnostic signs
• Use with contact lenses (in preserved formulations): Some preservatives may not be compatible with contact lenses unless specified as safe

• Preservative Sensitivity:
  Long-term use of benzalkonium chloride (BAK)-containing products may cause ocular surface toxicity or hypersensitivity. Preservative-free formulations are preferred for frequent or chronic use.
• Avoid Tip Contamination:
  Ensure the dropper does not touch any surface, including the eye, to prevent microbial contamination.
• Blurred Vision:
  Temporary blurring may occur after instillation. Advise patients not to drive or operate machinery until vision clears.
• Contact Lens Wearers:
  Remove lenses before instillation and wait at least 15 minutes before reinsertion unless product is labeled as compatible.

Common (usually mild and transient):

• Ocular:
• Mild stinging or burning sensation
• Temporary blurred vision
• Watery eyes
• Eye discomfort or irritation
• Foreign body sensation

Less Common:

• Allergic or Hypersensitivity Reactions:
• Redness
• Swelling
• Itching
• Eyelid edema

Rare but Serious:

• Corneal toxicity (with prolonged use of preserved formulations)
• Contact dermatitis or chronic allergic conjunctivitis (especially in sensitized individuals)

• Other Ophthalmic Medications:
  May alter absorption of concurrently administered drops. Separate multiple products by at least 5 minutes.
• Systemic Drugs:
  No known systemic drug interactions due to negligible absorption.
• Contact Lenses:
  Preservatives like BAK may bind to soft lenses and cause irritation. Preservative-free drops are preferred for lens wearers.
• Enzyme Systems:
  No significant involvement of CYP450 isoenzymes. No known enzyme-mediated interactions.

• 2023–2024 Updates (American Academy of Ophthalmology, TFOS DEWS II):
• Strong emphasis on the use of preservative-free artificial tears in patients with chronic dry eye or frequent usage needs.
• PEG + PG combinations are recommended as first-line treatment for mild to moderate dry eye, especially in evaporative forms.
• Endorsed for post-operative ocular surface protection and computer vision syndrome relief.
• Label Updates (2024):
• Introduction of newer formulations labeled safe for contact lens users and designed for prolonged hydration.

• Temperature:
  Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C–30°C.
• Humidity and Light:
  Store in a dry place, away from excessive humidity and direct sunlight.
• Handling Instructions:
• Do not freeze.
• Keep bottle tightly closed when not in use.
• Discard single-use containers after use.
• Shelf-Life and Discarding:
• Multi-dose bottles: Discard within 30 days after opening unless otherwise stated on the label.
• Preservative-free units: Single-use only; discard immediately after opening.