Lotenol T

Approved Indications:

• Postoperative Ocular Inflammation with Risk of Infection:
  Indicated for the treatment of postoperative inflammation and prevention of bacterial infection following ocular surgery.
• Steroid-Responsive Ocular Inflammatory Conditions with Suspected Bacterial Infection:
  For the treatment of inflammatory ocular conditions such as conjunctivitis, blepharitis, and keratitis, where bacterial infection is also suspected or present.

Clinically Accepted Off-label Uses:

• Management of acute or chronic blepharoconjunctivitis with bacterial superinfection
• Prophylaxis in patients undergoing high-risk ophthalmic procedures (e.g., LASIK, intravitreal injections)

Route of Administration: Ophthalmic (eye drops)

Adults and Children ≥2 Years:

• Instill 1 drop into the affected eye(s) every 4 to 6 hours.
• In more severe cases, dosing may be increased to 1 drop every 1 to 2 hours initially, then tapered based on clinical response.

Elderly:

• No dose adjustment is required.

Children <2 Years:

• Safety and efficacy not established.

Renal/Hepatic Impairment:

• No dosage adjustment necessary due to negligible systemic absorption.

Duration of Therapy:

• Generally limited to 7 to 14 days. Treatment should be tapered to prevent rebound inflammation.

This combination provides both anti-inflammatory and antibacterial effects.
Loteprednol Etabonate is a corticosteroid that acts by inhibiting the release of inflammatory mediators such as prostaglandins and leukotrienes. It binds to glucocorticoid receptors in ocular tissues, reducing inflammation, edema, and immune cell infiltration. It is a "soft" steroid, retrometabolically designed to be rapidly deactivated after therapeutic action, minimizing systemic side effects.
Tobramycin is an aminoglycoside antibiotic that binds to the 30S subunit of bacterial ribosomes, interfering with protein synthesis and resulting in bacterial cell death. It provides broad-spectrum antibacterial coverage, particularly against Gram-negative pathogens commonly associated with ocular infections.

Loteprednol Etabonate:

• Absorption: Minimal systemic absorption
• Distribution: Localized ocular tissue penetration
• Metabolism: Rapid inactivation via hydrolysis to inactive metabolites
• Excretion: Renal excretion of metabolites
• Half-life: Short ocular half-life; systemic half-life not clinically significant

Tobramycin:

• Absorption: Low systemic absorption after ophthalmic use
• Distribution: Concentrates in conjunctival and corneal tissues
• Metabolism: Not significantly metabolized
• Excretion: Primarily unchanged in urine (if systemically absorbed)
• Half-life: ~2 hours (systemic; not relevant for topical use)

Pregnancy:

• No specific FDA category assigned.
• Use during pregnancy only if clearly needed and under physician supervision.

Lactation:

• Systemic absorption is minimal; therefore, excretion in breast milk is unlikely.
• The risk to a breastfeeding infant is expected to be low; however, caution is advised.

• Primary Class: Ophthalmic corticosteroid and antibiotic combination
• Subclasses:
• Loteprednol Etabonate: Corticosteroid (retrometabolic or "soft" steroid)
• Tobramycin: Aminoglycoside antibiotic

• Known hypersensitivity to Loteprednol Etabonate, Tobramycin, or any excipients
• Active viral infections of the cornea and conjunctiva (e.g., herpes simplex keratitis)
• Fungal or mycobacterial ocular infections
• Untreated purulent ocular infections
• Children under 2 years of age (safety not established)

• Increased Intraocular Pressure (IOP): Prolonged use may cause elevation of IOP. Monitor regularly, especially in steroid responders.
• Cataract Formation: Long-term corticosteroid use may increase risk of posterior subcapsular cataracts.
• Delayed Wound Healing: Use cautiously in patients with corneal thinning or recent ocular surgery.
• Secondary Infections: Prolonged use may mask or exacerbate underlying bacterial, viral, or fungal infections.
• Use with Contact Lenses: Contact lenses should not be worn during treatment unless approved by a physician.

Common Side Effects:

• Transient eye irritation or stinging
• Conjunctival hyperemia
• Blurred vision
• Tearing or dryness

Serious or Rare Side Effects:

• Elevated intraocular pressure
• Posterior subcapsular cataract (with prolonged use)
• Secondary infections (e.g., fungal, viral)
• Corneal thinning or perforation
• Hypersensitivity reactions (e.g., lid swelling, itching)

Timing & Severity:

• Mild side effects usually occur early in treatment.
• Serious effects are typically associated with long-term use or inappropriate application.

• Other topical corticosteroids or NSAIDs: May increase risk of corneal thinning or delayed healing.
• Contact lens disinfectants: Preservatives like benzalkonium chloride may be absorbed by soft contact lenses and cause irritation.
• Systemic drug interactions: None significant due to minimal systemic absorption.
• CYP450 interactions: Not applicable; components do not significantly affect CYP enzymes.

• AAO and ESCRS (2023): Recommend combination corticosteroid-antibiotic therapy for short-term management of inflammation with suspected bacterial involvement post-ocular surgery.
• FDA Safety Advisory (2022): Reinforced caution about elevated intraocular pressure with prolonged steroid use.
• Preferred over dexamethasone combinations: Due to Loteprednol's lower risk of increasing IOP and better tolerability in long-term use.

• Storage Temperature: Store at 15°C to 25°C (59°F to 77°F)
• Humidity: Protect from excessive moisture
• Light: Store in the original container away from direct light
• Handling Instructions:
• Shake well before each use (if a suspension)
• Do not freeze
• Do not touch the dropper tip to any surface to avoid contamination
• Discard 30 days after opening or as per manufacturer instructions