Indications
This medication is indicated for treating steroid-responsive inflammatory ocular conditions where corticosteroids are warranted and there is a potential for superficial bacterial infections. Ocular steroids are effective for inflammatory issues affecting the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye, including allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also suitable for managing chronic anterior uveitis and corneal injuries caused by chemical, radiation, thermal burns, or foreign body penetration. Additionally, it addresses post-operative inflammation following ocular surgeries.
Pharmacology
Loteprednol, a corticosteroid, is believed to work by inducing phospholipase A2 inhibitory proteins, which regulate the production of inflammatory mediators like prostaglandins and leukotrienes by preventing the release of arachidonic acid, their common precursor.
Tobramycin, an aminoglycoside, exerts its bactericidal effects by inhibiting bacterial protein synthesis.
Dosage & Administration
Before use, shake the bottle well. Instill one drop into the conjunctival sac of the affected eye(s) every four to six hours. In the first 24 to 48 hours, the frequency may be increased to every one to two hours, based on the severity of the condition.
Use as directed by a healthcare professional.
Interaction
Loteprednol Etabonate is not detectable in plasma after topical application, indicating it is unlikely to influence the pharmacokinetics of other systemically administered medications.
Contraindications
This medication is contraindicated for most viral infections of the cornea and conjunctiva. It should also not be used by individuals with known or suspected hypersensitivity to any of its components or to other corticosteroids.
Side Effects
Possible side effects include increased intraocular pressure, burning and stinging upon application, vision disturbances, discharge, itching, tears, photophobia, corneal deposits, ocular discomfort, eyelid disorders, and other unspecified eye issues. Non-ocular side effects, such as headaches, have also been reported.
Pregnancy & Lactation
Pregnancy: There are no adequate well-controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.
Lactation: Caution is advised when administering Loteprednol Etabonate & Tobramycin to nursing mothers.
Precautions & Warnings
- For ophthalmic use only.
- If Lotepro Plus is used for 10 days or more, monitor intraocular pressure.
- Fungal infections of the cornea may develop with long-term steroid use.
- Prolonged usage can lead to overgrowth of non-susceptible organisms, including fungi. Appropriate therapy should be initiated if superinfection occurs.
- Cross-sensitivity to other aminoglycoside antibiotics may arise.
Use in Special Populations
Children: The safety and efficacy of this medication in pediatric patients have not been established.
Therapeutic Class
Ophthalmic corticosteroid-antibiotic combination preparations.
Storage Conditions
Store at room temperature, away from light. Avoid touching the dropper tip to any surface. It is recommended to discard the contents four weeks after first opening the bottle. Protect from freezing.
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