Loteranol 0.5% Sterile ophthalmic gel 5 g

Loteranol 0.5% Sterile ophthalmic gel 5 g

Composition:

Loteprednol Etabonate 0.5% w/w (5 mg per gram of gel).
Preservative: Benzalkonium Chloride 0.003% w/w.
Other excipients: sterile ophthalmic gel base.

Product Description: 

Loteranol is a topical ophthalmic corticosteroid formulated as a sterile gel.
It is designed to reduce inflammation and pain following ocular surgery.
The gel formulation provides sustained contact with ocular tissues compared to drops.

Indications for Use:

Treatment of postoperative inflammation and pain following ocular surgery.
Relief of ocular surface inflammation where corticosteroid therapy is appropriate.

Method of Administration and Dosage:

Adults: 1–2 drops into the conjunctival sac of the affected eye four times daily, starting 24 hours after surgery.
Duration: typically, up to 2 weeks.
Shake bottle before use; avoid touching dropper tip to any surface.
Not recommended for paediatric patients due to insufficient data.

Contraindications:

Viral diseases of the cornea and conjunctiva (e.g., herpes simplex keratitis, vaccinia, varicella).
Mycobacterial or fungal infections of ocular structures.
Untreated purulent ocular infections.
Hypersensitivity to loteprednol or excipients.

Precautions:

Intraocular pressure (IOP): prolonged use may cause glaucoma; monitor if used >10 days.
Cataracts: risk of posterior subcapsular cataract formation.
Delayed healing: caution after cataract surgery; risk of corneal/scleral thinning and perforation.
Secondary infections: corticosteroids may mask or worsen bacterial, viral, or fungal eye infections.

Adverse Effects:

Common: eye irritation, burning, blurred vision.
Possible: increased IOP, cataract formation, delayed wound healing.
Rare: hypersensitivity reactions, secondary ocular infections

Pregnancy and Lactation:

Use only if potential benefit outweighs risk; safety data limited
Unknown if excreted in breast milk after ophthalmic use.

Storage Conditions:

Store at room temperature (15–25 °C).
Keep bottle tightly closed; protect from contamination.
Keep out of reach of children.

Packaging: 

Sterile ophthalmic gel, 5 g tube or bottle, packed in carton box.