AFM-Plus

Approved Indications:

• Bacterial Eye Infections with Inflammatory Components:
• Acute and chronic conjunctivitis
• Blepharitis
• Blepharoconjunctivitis
• Keratitis and keratoconjunctivitis (without epithelial ulceration)
• Post-operative Ocular Inflammation:
• Prevention and treatment of inflammation and secondary bacterial infection following ocular surgery (e.g., cataract extraction)
• Allergic Eye Disorders with Secondary Infection:
• Allergic conjunctivitis or seasonal allergic conjunctivitis with suspected or confirmed bacterial superinfection
• Inflammatory Conditions of the Anterior Segment with Bacterial Involvement:
• Scleritis
• Episcleritis
• Iritis (non-infectious origin where secondary infection is suspected)

Route:
Ophthalmic (eye drops or ointment)

Adults & Elderly:

• Mild to moderate infection/inflammation:
  1–2 drops instilled into the affected eye(s) every 4–6 hours.
• Severe cases:
  1–2 drops every 1–2 hours initially, then reduce frequency as symptoms improve.
• Ointment form (if applicable):
  Apply a small amount (approx. 1 cm ribbon) 2–4 times daily in the conjunctival sac.

Pediatric Use:

• Safety and efficacy are established for children aged 2 years and older with the same dosing as adults.
• Not recommended for infants under 2 years without specialist consultation.

Special Populations:

• Hepatic/Renal Impairment:
  No dose adjustment necessary due to minimal systemic absorption from ophthalmic route.

Duration:

• Use for the shortest possible duration, typically up to 7–10 days.
• Reassessment required if symptoms persist beyond this period.

This fixed-dose combination works via two complementary mechanisms:

• Fluorometholone is a corticosteroid that penetrates ocular tissues and binds to glucocorticoid receptors. It inhibits inflammatory mediators such as prostaglandins, leukotrienes, and cytokines, reducing capillary dilation, leukocyte migration, and edema in ocular tissues.
• Gentamicin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit of bacteria, causing misreading of mRNA and interruption of protein synthesis. It is bactericidal, active against a broad range of Gram-negative and some Gram-positive organisms.

Combined, these agents control both inflammation and bacterial infection, particularly where both are present concurrently in ocular conditions.

Fluorometholone:

• Absorption: Minimal systemic absorption via the conjunctiva and cornea.
• Distribution: Primarily retained within ocular tissues; plasma concentrations are negligible.
• Metabolism: Undergoes local metabolism in ocular tissues.
• Excretion: Primarily eliminated via biliary or renal routes as inactive metabolites.

Gentamicin:

• Absorption: Poor systemic absorption when used topically in the eye.
• Distribution: Localized action within conjunctival sac and corneal tissue.
• Metabolism: Not metabolized; remains active locally.
• Excretion: Excreted unchanged if systemically absorbed (rare).

Pregnancy:

• FDA Category C (based on individual components)
• Animal studies show adverse fetal effects from corticosteroids at high systemic levels. Gentamicin may cross the placenta and potentially cause fetal ototoxicity.
• Use only if potential benefits justify risks to the fetus.

Lactation:

• No data on excretion of fluorometholone or gentamicin into human breast milk following ophthalmic use.
• Systemic absorption is minimal; unlikely to affect nursing infant.
• Consider risk-benefit; avoid direct contact of the infant with treated areas.

• Primary Class:
  Ophthalmic Anti-infective with Anti-inflammatory Agent
• Subclasses:
• Corticosteroid (Fluorometholone – low to medium potency)
• Aminoglycoside Antibiotic (Gentamicin – bactericidal)

• Known hypersensitivity to fluorometholone, gentamicin, or any formulation excipients
• Viral eye infections, including herpes simplex keratitis, vaccinia, and varicella
• Fungal infections of the eye
• Tuberculosis of the eye
• Corneal epithelial ulceration or injuries with epithelial thinning
• Use in infants under 2 years unless prescribed by an ophthalmologist

• Prolonged corticosteroid use may lead to:
• Increased intraocular pressure (IOP) → possible glaucoma
• Optic nerve damage
• Posterior subcapsular cataract formation
• Bacterial resistance may develop with gentamicin overuse.
• Fungal infections may be masked or promoted with corticosteroid use.
• Re-evaluation required if no improvement within 7 days.
• Monitor IOP regularly in long-term use or in patients with glaucoma risk.
• Avoid contact lenses during active infection or when using this medication.
• Use with caution in ocular trauma or surgery, particularly with thin corneas or sclera.

Common (≥1%):

• Ocular burning or stinging
• Blurred vision after application
• Eye redness or discomfort
• Increased tearing

Less Common:

• Foreign body sensation
• Eyelid itching or swelling
• Dry eyes

Serious (rare):

• Raised intraocular pressure (glaucoma)
• Optic nerve damage (with long-term use)
• Secondary ocular infections (bacterial, viral, or fungal)
• Corneal thinning or perforation
• Allergic reactions (local or systemic hypersensitivity)

• No major systemic interactions expected due to minimal absorption.
• Avoid concurrent use with other topical ophthalmic corticosteroids unless advised.
• Live viral ophthalmic vaccines (e.g., varicella) may have reduced efficacy or higher risk if corticosteroids suppress immune response.
• Do not mix with other eye drops without consulting a healthcare provider.
• If multiple ophthalmic medications are required, separate applications by at least 5 minutes.

• Recent ophthalmology guidelines emphasize limiting topical corticosteroid-antibiotic combinations to short-term, targeted use only to prevent resistance and minimize steroid-related adverse effects.
• Newer formulations with lower preservative content are recommended for chronic users to reduce ocular surface toxicity.
• Updated caution regarding ocular surface disease in long-term corticosteroid users.

• Temperature: Store below 25°C (77°F)
• Do not freeze
• Protect from light and moisture
• Ophthalmic drops:
• Discard 28 days after opening the bottle.
• Shake well before each use (suspension form).
• Ointment (if applicable):
• Keep tube tightly closed after use.
• Use within recommended period after opening.