It is a topical anti-infective and steroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.
Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.
Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.
Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.
Apply one or two drops of It into the conjunctival sac of the affected eye every four to six hours.
Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.
It,as with other steroid anti-infective ophthalmic combination drugs,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 structur ? Intraocular pressure (IOP) ? Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve,defects in visual acuity and fields of vision. If this product is used for 10 days or longer,IOP should be monitored. ? Cataracts ? Use of corticosteroids may result in posterior subcapsular cataract formation. ? Delayed healing ? The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera,perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of a magnification such as slit lamp biomicroscopy and,where appropriate,fluorescein staining. ? Bacterial infections ? Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions,steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days,the patient should be re-evaluated. ? Viral infections ? Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ? Fungal infections ? Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use
punctate keratitis,increased intraocular pressure,burning and stinging upon instillation.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 that appear in human milk could suppress growth,interfere with endogenous corticosteroid production,or cause other untoward effects. Caution should be exercised when It is administered to a nursing woman.
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.
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