Generic

Loteprednol Etabonate + Tobramycin

Indications

This is for steroid-responsive inflammatory ocular diseases that require a corticosteroid and if there is a risk of bacterial ocular infection or superficial bacterial ocular infection. Allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis are examples of inflammatory disorders affecting the palpebral and bulbar conjunctiva, cornea, and anterior section of the globe. It’s also used to treat chronic anterior uveitis, corneal injury from chemical, radiation, or thermal burns, and foreign body penetration. This medication is also used to treat post-operative inflammation.

Pharmacology

Loteprednol is a corticosteroid that is considered to work by inducing phospholipase A2 inhibitory proteins, which block the release of arachidonic acid, which controls the manufacture of potent inflammatory mediators such prostaglandins and leukotrienes.

Tobramycin is an aminoglycoside that has bactericidal effect by blocking bacteria’s 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 impact the pharmacokinetics of systemically delivered medicinal drugs because it is not detected in plasma after topical application.

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 it..

Side Effects

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Pregnancy & Lactation

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.

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

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

Ophthalmic steroid – antibiotic combined 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. The contents should not be used for at least four weeks after the bottle is first opened. Protect yourself from the cold.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.