E/DROP, Generic Name: Loteprednol Etabonate 0.5% & Tobramycin 0.3%, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
This is suggested for steroid-responsive inflammatory ocular diseases that need a corticosteroid and if there is superficial bacterial ocular infection or a risk of bacterial ocular infection. Inflammatory diseases of the palpebral and bulbar conjunctiva, cornea, and anterior portion of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis, are treated with ocular steroids. It is also used to treat chronic anterior uveitis and corneal damage caused by chemical, radiation, or thermal burns, as well as foreign body penetration. This medication is also approved for the treatment of post-operative inflammation after ocular surgery.
Pharmacology
Loteprednol is a corticosteroid that is hypothesized to work by inducing phospholipase A2 inhibitory proteins, which regulate the production of powerful inflammatory mediators including prostaglandins and leukotrienes by preventing the release of their common precursor arachidonic acid.
Tobramycin is an aminoglycoside that has bactericidal action by blocking bacterial protein synthesis.
Dosage & Administration
Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.
Interaction
Loteprednol Etabonate is not predicted to alter the pharmacokinetics of systemically given medicinal drugs because it is not found in plasma after topical treatment.
Contraindications
Most viral infections of the cornea and conjunctiva are contraindicated. Individuals with known or suspected hypersensitivity to any of the components in this product, as well as other corticosteroids, should avoid using it.
Side Effects
Increased intraocular pressure, burning and stinging after instillation, vision abnormalities, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other nonspecific eye disorders are possible. Non-ocular adverse effects (headache) were also recorded.
Pregnancy & Lactation
Pregnancy use: There have been no sufficient and well-controlled trials in pregnant women. Loteprednol Etabonate & Tobramycin should only be taken during pregnancy if the possible benefit outweighs the danger to the fetus.
When provided to a nursing mother, Loteprednol Etabonate & Tobramycin should be used with caution.
Precautions & Warnings
For ophthalmic use only.
If this product is used for 10 days or longer, intraocular pressure should be monitored.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.
Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate therapy should be initiated.
Cross-sensitivity to other aminoglycoside antibiotics may occur.
Therapeutic Class
Combination ophthalmic steroid-antibiotic preparations
Storage Conditions
Store at room temperature and keep away from direct sunlight. Do not let the dropper tip come into contact with any surface. It is preferable not to utilize the contents four weeks after the bottle is first opened. Keep away from the cold.
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