ETAPRED - Loteprednol Etabonate 0.5% Ophthalmic Suspension

Composition   Each ml contains   Loteprednol Etabonate 5 mg Benzalkonium Chloride Solution I.P. 0.02 % V/V Sterile Aqueous Buffered Solution q.s. Dosage form Ophthalmic Suspension Description Etapred  (loteprednol etabonate ophthalmic suspension) is a sterile, topical anti-inflammatory corticosteroid for  ophthalmic use. Clinical pharmacology Corticosteroids inhibit the release of inflammatory mediators like prostaglandins Indications and Usage Etapred is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, iritis, cyclitis, when the inherent hazard of steroid use is accepted to obtain  an advisable diminution in edema and inflammation. Etapred is also indicated for the treatment of post-operative inflammation following ocular surgery. Dosage Steroid Responsive Disease Treatment: Apply one to two drops of Etapred (loteprednol etabonate ophthalmic suspension) into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Post-Operative Inflammation: Apply one to two drops of Etapred (loteprednol etabonate ophthalmic suspension) into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period. Contraindications Etapred (loteprednol etabonate ophthalmic suspension) , as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Etapred (loteprednol etabonate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. Warnings Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Precautions Pregnancy Etapred should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Etapred (loteprednol etabonate ophthalmic suspension) is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Storage Store in a cool dry place. Protect from light. Presentation Etapred  is available in a pack of 5 ml plastic bottle.