(loe te PRED nol)
Seasonal allergic conjunctivitis (0.2% suspension): Temporary relief of signs and symptoms of seasonal allergic conjunctivitis
Postoperative inflammation/pain (0.5% suspension/ointment/gel):Treatment of postoperative inflammation and pain following ocular surgery
Ophthalmic inflammatory conditions (0.5% suspension): Treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation)
Hypersensitivity to loteprednol, other corticosteroids, and any component of the formulation; viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, and varicella); mycobacterial infection of the eye; fungal diseases of ocular structures
Seasonal allergic conjunctivitis: Ophthalmic: 0.2% suspension: Instill 1 drop into affected eye(s) 4 times daily.
Steroid-responsive inflammatory conditions: Ophthalmic: 0.5% suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily. During the initial treatment within the first week, the dosing may be increased up to 1 drop every hour. Advise patients not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, re-evaluate the patient.
Postoperative inflammation/pain: Ophthalmic:
0.5% ointment: Apply ~1/2 inch ribbon into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
0.5% gel, 0.5% suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Gel: While bottle is closed, invert and shake once to fill tip prior to instilling drops.
Suspension: Shake well before using.
Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F); do not freeze.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, Ophthalmic, as etabonate:
Lotemax: 0.5% (5 g) [contains benzalkonium chloride, edetate disodium dihydrate, propylene glycol]
Ointment, Ophthalmic, as etabonate:
Lotemax: 0.5% (3.5 g)
Suspension, Ophthalmic, as etabonate:
Alrex: 0.2% (5 mL, 10 mL)
Lotemax: 0.5% (5 mL, 10 mL, 15 mL)
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Intraocular pressure (if >10 days); signs and symptoms of infection
>10%:
Central nervous system: Foreign body sensation (2% to 15%), headache (2% to <15%)
Dermatologic: Pruritus (5% to 15%)
Endocrine & Metabolic: Chemosis (5% to 15%)
Local: Application site burning (5% to 15%)
Ophthalmic: Anterior chamber inflammation (5% to 25%), blurred vision (5% to 15%), epiphora (5% to 15%), eye discharge (5% to 15%), photophobia (5% to 15%), visual disturbance (5% to 15%), xerophthalmia (5% to 15%)
Respiratory: Pharyngitis (<15%), rhinitis (<15%)
1% to 10%:
Ophthalmic: Conjunctival hyperemia (4% to 5%), corneal edema (4% to 5%), eye pain (2% to 5%), blepharitis (<5%), conjunctivitis (<5%), corneal changes (<5%), eye irritation (<5%), keratoconjunctivitis (<5%), uveitis (<5%), increased intraocular pressure (2%)
Miscellaneous: Papilla (<5%)
Concerns related to adverse effects:
- Immunosuppression: Prolonged use of corticosteroids (including ophthalmic preparations) may increase the incidence of secondary ocular infections (including fungal infections). Acute purulent ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
- Ocular effects: Prolonged use may result in glaucoma, injury to the optic nerve, visual defects in acuity and field of vision, and formation of posterior subcapsular cataracts. Use with caution in presence of glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation. Intraocular pressure should be monitored if this product is used >10 days.
Special populations:
- Contact lens wearers: Some preparations contain benzalkonium chloride which may be absorbed by contact lenses. When used for the treatment of seasonal allergic conjunctivitis, wait ≥10 minutes after instilling eye drops before inserting contact lenses; do not wear contacts if eyes are red. Contact lenses should not be worn during treatment following ophthalmic surgery.
- Pediatric: Do not use ointment in children following ocular surgery; may interfere with amblyopia treatment.
Other warnings/precautions:
- Acute anterior uveitis: More potent steroids may be required for this indication.
- Appropriate use: For ophthalmic use only; patients should be re-evaluated if symptoms fail to improve after 2 days. Initial prescription and renewal of medication after 14 days should be made by healthcare provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Avoid contamination; do not touch tip of applicator or let tip of applicator touch eye. Corticosteroids should not be used to treat ocular herpes simplex; use extreme caution in patients with a history of ocular herpes simplex.
C
Adverse events have been observed in animal reproduction studies following oral administration. The amount of loteprednol absorbed systemically following ophthalmic administration is not known but expected to be <1 ng/mL.
Corticosteroids inhibit the inflammatory response including edema, capillary dilation, leukocyte migration, and scar formation. Loteprednol is highly lipid soluble and penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes.
Minimal
Metabolized to inactive carboxylic acid metabolites
Seasonal allergic conjunctivitis: Reduction of symptoms seen within 2 hours of instillation
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience headache, burning, itching, dry eyes, blurred vision, foreign body sensation of eye, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.