Therapeutic Class: Corticosteroid

Indications: 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, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when inherent hazard of steroid use in accepted to obtain an advisable diminution in edema and inflammation. Treatment of post-operative inflammation following ocular surgery.

Dosage: Adults: Steroid-Responsive Disease: 1-2 drops into the conjunctival sac of the affected eye(s) qid. May increase up to 1 drop qh, if necessary, during the initial treatment within the 1^st week. Re-evaluate if signs/symptoms fail to improve after 2 days. Postoperative Inflammation: 1-2 drops into the conjunctival sac of the operated eye(s) qid beginning 24 hrs after surgery and continuing throughout the first 2 weeks of the post-operative period.

Contraindications: Most viral diseases of the cornea and conjunctiva (eg, epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings & Precautions: For ophthalmic use only. Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation; caution with glaucoma. Prolonged use may suppress host response and increase hazard of secondary ocular infections. Perforations reported with diseases causing thinning of cornea/sclera. May mask or enhance existing infection in acute purulent conditions of the eye. Caution with history of herpes simplex; may prolong course and exacerbate severity of many viral infections of the eye. May delay healing and increase incidence of bleb formation after cataract surgery. Initial prescription and renewal of medication order beyond 14 days should only be made after examination of the patient with aid of magnification (eg, slit lamp biomicroscopy) and where appropriate, fluorescein staining. Monitor intraocular pressure (IOP) if used for ≥ 10 days. Fungal infections of the cornea may develop coincidentally woth long-term use; consider fungal invasion in any persistent corneal ulceration and take fungal cultures when appropriate. For steroid-responsive diseases, caution not to d/c therapy prematurely. Should not be used for acute anterior uveitis in patients who require a more potent corticosteroid.

Adverse Reactions: Abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, photophobia, headache, rhinitis, pharyngitis.

Pregnancy: Category C, caution in nursing.

Mechanism of Action: Corticosteroid has not been established. Thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Assessment: Assess for previous drug hypersensitivity, viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye, fungal diseases of ocular structures, glaucoma, thinning of the cornea/sclera, history of herpes simplex and pregnancy/nursing status. Perform examination of patient with the aid of magnification (eg, slip lamp biomicroscopy, fluorescein staining). Assess use in patient who have undergone recent cataract surgery.

Monitoring: Monitor for glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, perforation of the cornea/sclera, secondary ocular infections, fungal infections, masking of existing infections and other adverse reactions. Reevaluate if signs/symptoms fail to improve after 2 days. Monitor IOP during prolonged use (≥ 10 days). Perform examination of patient with the aid of magnification (eg, slit lamp biomicroscopy, fluorescein staining) before renewal of medication order beyond 14 days.

Patient Counseling: Advice bot to allow dropper tip to touch any surface to avoid contamination pf suspension. Instruct to consult physician if pain develops or if redness, itching or inflammation becomes aggravated. Inform not to wear soft contact lenses during treatment.

Use the suspension within one month after opening the container. Keep the medicine out of reach of children.

For external use only. Not for injection. Shake well before use.

Administration: Ocular route.

Storage: Store below 30°C. Protect from light & moisture. Do not freeze.

Application: As directed by the physician.

Packaging Information: Lotevail LS Eye drops is available in a 5 ml container.