Generic

Loteprednol Etabonate + Tobramycin

Indications

This is suitable for steroid-responsive inflammatory eye diseases that require the use of corticosteroids, and there is a superficial bacterial eye infection or risk of bacterial eye infection. Ocular steroids are suitable for inflammation of the palpebral conjunctiva and bulbar conjunctiva, cornea, and anterior part of the eyeball, such as allergic conjunctivitis, rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also suitable for chronic anterior uveitis and corneal damage caused by chemical, radiation or thermal burns or foreign body invasion. This also applies to the treatment of postoperative inflammation after eye surgery.

Pharmacology

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.

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

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.

Contraindications

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Side Effects

Increased intraocular pressure, burning and stinging after instillation, vision problems, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unidentified eye problems are all possible side effects. There was additional information on the occurrence of non-ocular adverse effects (headache).

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 & 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.

Pharmaceutical Name

Aristopharma Ltd.