Lotepro DS(Loteprednol Etabonate)
Therapeutic Group: Analgesic, Anti Inflammatory
Presentation
Loteproâ„¢ DS Sterile Ophthalmic Suspension: Each ml contains LoteprednolEtabonate INN 10 mg.
Description
LoteprednolEtabonate is a topical anti-inflammatory corticosteroid for ophthalmic use.
LoteprednolEtabonate is structurally similar to other corticosteroids. It is highly lipid soluble which enhances its penetration into cells.
Indications
Loteproâ„¢DS is indicated for the treatment of post-operative inflammation and Pain following ocular surgery.
Dosage & Administration
Shake the bottle vigorously before using
Apply 1 to 2 drops of LoteprednolEtabonate 1% into the conjunctival sac of the operated eye(s) twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
Side Effects
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Precautions
• Shake the bottle well before use.
• Patients should be advised not to allow the dropper tip to touch the eye, eyelid, fingers, or any other surface to prevent contamination.
• Patients should be advised not to wear soft contact lenses when using this drug.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve as well as visual acuity and visual field defects. Steroids should be used with caution in the presence of glaucoma.
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. The use of steroids may delay wound healing.
Use in Pregnancy & Lactation
Pregnancy: LoteprednolEtabonate 1% is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug.
Lactation: LoteprednolEtabonate 1% is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in exposure of the child to LoteprednolEtabonate 1%.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Storage
• Do not store above 30oC. Protect from light.
• Keep out of the reach of children.
• Do not use more than 4 weeks after opening.
• Shake well before use.
Commercial Pack
Loteproâ„¢DS Sterile Ophthalmic Suspension: Each plastic dropper bottle containing 5ml sterile ophthalmic suspension.