Alerdex eye drops 0.1% 10.0 #1

Alerdex Eye Drops 0.1% – 10 ml

Composition:

Each 1 ml of the product contains:

• Active ingredient: Dexamethasone 1 mg.

• Excipients: Sodium chloride, disodium edetate dihydrate, benzalkonium chloride, citric acid monohydrate, hydroxypropyl methylcellulose, disodium phosphate dodecahydrate, polysorbate 80, purified water.

Indications:

Indicated for the treatment of non-infectious inflammatory conditions of the conjunctiva, cornea, and anterior segment of the eye that are responsive to steroid therapy, such as:

• Anterior uveitis

• Iritis (inflammation of the colored part of the eye)

• Cyclitis (inflammation of the ciliary body)

• Allergic conjunctivitis

• Vernal conjunctivitis

• Herpes zoster ophthalmicus

• Superficial punctate keratitis

• Non-specific superficial keratitis

Also indicated for the treatment of corneal injuries caused by chemical, radiation, or thermal burns, or from foreign bodies in the eye.
May be used postoperatively to reduce inflammatory reactions and to suppress graft rejection.

Dosage and Administration:

Adults, adolescents, and children:
The frequency and duration of administration depend on the severity of the condition and the therapeutic response.

• In cases of acute inflammation: instill 1 or 2 drops every 30 to 60 minutes until improvement.

• If no improvement is observed, consider sub-conjunctival or systemic corticosteroid therapy.

• Once symptoms begin to improve, reduce the dosage to 1 drop every 4 hours.

Contraindications:

• Vaccination against chickenpox or active varicella infection

• Herpes simplex keratitis

• Fungal infections of ocular structures

• Ocular mycobacterial infections

• Untreated acute bacterial eye infections

• Hypersensitivity to dexamethasone or any of the excipients

Pregnancy and Lactation:

Alerdex 0.1% eye drops should be used during pregnancy and breastfeeding only if the potential benefit to the mother justifies the potential risk to the fetus or infant.

Effects on Driving and Use of Machinery:

Due to possible temporary tearing after instillation, avoid driving or operating machinery immediately after using the drops.

Storage Conditions and Shelf Life:

• Shelf life: 3 years in unopened original packaging.

• After opening the bottle, use within 4 weeks.

• Store at a temperature not exceeding 25°C, in the original packaging, protected from light.

• Keep out of reach of children.