Drops Manufacturer/Distributor: Aristopharma Limited Generic Name: Loteprednol Etabonate 0.5% + Tobramycin 0.3% 5ml Eye Drops
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Indications
Loteprednol etabonate is used to treat steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior region of the globe, including:
Allergic conjunctivitis is a type of allergic conjunctivitis.
Acne rosacea is a type of acne that affects both men and women.
Superficial punctate keratitis is a type of keratitis that occurs on the surface of
Keratitis due to herpes zoster
Iritis
Cyclitis
It can also be used to alleviate post-operative inflammation after ophthalmic surgery.
Pharmacology
Corticosteroids suppress the inflammatory response to various triggers and may delay or slow down healing. They inhibit edema, fibrin deposition, telangiectasia, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation associated with inflammation. There is no universally accepted explanation for the mechanism of action of ophthalmic corticosteroids.
However, it is believed that corticosteroids work by inducing the phospholipase A2 inhibitor protein (collectively called lipocortin). It is hypothesized that these proteins control the biosynthesis of potent inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Dosage & Administration
Shake the bottle vigorously before using
Steroid responsive disease treatment: Apply 1 to 2 drops of Loteprednol 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. Care should be taken not to discontinue therapy prematurely.
Post-Operative Inflammation: Apply 1 to 2 drops of Loteprednol 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.
Interaction
Loteprednol Etabonate is not predicted to impact the pharmacokinetics of systemically delivered medicinal drugs because it is not detected in plasma after topical application.
Contraindications
Loteprednol, like other ophthalmic corticosteroids, is contraindicated in the treatment of most viral diseases of the cornea and conjunctiva, such as epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as mycobacterial infections of the eye and fungal diseases of ocular structures.
Individuals with known or suspected hypersensitivity to any of the components in this medication, as well as other corticosteroids, should avoid taking loteprednol.
Side Effects
Photophobia, headache, rhinitis, and pharyngitis are examples of local reactions (e.g. blurred vision, burning, itching, and dry eye). Long-term use may raise IOP, which has been linked to the development of glaucoma and infrequent optic nerve injury; posterior sub-capsular cataract formation; and globe perforation where the cornea or sclera is thinning.
Pregnancy & Lactation
It's a Pregnancy Category C situation. It's unclear whether corticosteroids given topically in the eyes would cause enough systemic absorption to produce detectable levels in human milk.
Precautions & Warnings
Before using, give the bottle a good shake.
To avoid contamination, patients should be told not to touch their eyes, eyelids, fingers, or any other surface with the dropper tip.
When using this medication, patients should be told not to wear soft contact lenses.
Intraocular pressure should be monitored if this product is used for more than 10 days.
After long-term steroid use, the likelihood of fungal infections of the cornea should be recognized.
Steroids may cause a delay in wound healing.
Storage Conditions
Protect from light. Store in a cool & dry place. Keep out of the reach of children. Do not use it more than 4 weeks after opening. Shake well before using.
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