Drug Guide
Difluprednate
Classification
Therapeutic: Anti-inflammatory, corticosteroid
Pharmacological: Glucocorticoid receptor agonist
FDA Approved Indications
- Treatment of ocular inflammation and pain following ocular surgery
Mechanism of Action
Difluprednate is a corticosteroid that suppresses inflammation by inhibiting multiple inflammatory cytokines and pathways through glucocorticoid receptor binding, reducing edema, fibrin formation, capillary proliferation, and migration of inflammatory cells.
Dosage and Administration
Adult: Apply one drop to the affected eye(s) 2 times daily until inflammation resolves, then reduce to once daily or as directed.
Pediatric: Safety and effectiveness in pediatric patients less than 18 years have not been established.
Geriatric: No specific dosage adjustment required, but caution in patients with concomitant ocular conditions.
Renal Impairment: No specific data; use caution and monitor closely.
Hepatic Impairment: No specific data; use caution and monitor closely.
Pharmacokinetics
Absorption: Minimally absorbed systemically when used ocularly.
Distribution: Primarily localized in ocular tissues.
Metabolism: Metabolized in the eye tissues.
Excretion: Minimal systemic excretion; primarily local.
Half Life: Not well-defined due to local application.
Contraindications
- Hypersensitivity to difluprednate or other corticosteroids.
Precautions
- Use with caution in patients with herpetic keratitis, fungal, or bacterial ocular infections, or those with a perforated globe. Long-term use may lead to increased intraocular pressure, cataract formation, or secondary ocular infections. Use during pregnancy or lactation only if clearly needed.
Adverse Reactions - Common
- Increased intraocular pressure (Common)
- Cataract formation (Common)
- Delayed wound healing (Uncommon)
- Eye irritation, burning, or stinging (Common)
Adverse Reactions - Serious
- Increased intraocular pressure leading to glaucoma (Uncommon)
- Secondary ocular infection (Uncommon)
- Corneal perforation (Rare)
Drug-Drug Interactions
- Other ocular corticosteroids or medications that increase intraocular pressure.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor intraocular pressure, visual acuity, and ocular health regularly. Watch for signs of increasing intraocular pressure or infection.
Diagnoses:
- Risk for increased intraocular pressure
- Risk for secondary ocular infections
Implementation: Administer eye drops as prescribed, instruct patient on proper technique, and schedule regular follow-up examinations.
Evaluation: Assess for resolution of inflammation, monitor intraocular pressure, and watch for adverse effects.
Patient/Family Teaching
- Use medication as prescribed, do not exceed recommended dosage.
- Report any eye pain, vision changes, or signs of infection.
- Avoid touching the tip of the dropper to any surface.
- Follow up regularly for intraocular pressure monitoring.
Special Considerations
Black Box Warnings:
- Potential for increased intraocular pressure leading to glaucoma, particularly with prolonged use.
Genetic Factors: None specified.
Lab Test Interference: None known or significant.
Overdose Management
Signs/Symptoms: Overdose via systemic absorption is unlikely but may cause excess corticosteroid effects, such as increased intraocular pressure.
Treatment: Discontinue use, monitor intraocular pressure and ocular health, provide supportive care.
Storage and Handling
Storage: Store at room temperature, 15°C to 25°C (59°F to 77°F).
Stability: Stable until expiration date when stored properly.