Medicinal Products

DEXAFREE 1 mg / mL

Generic drug of the therapeutic class: Ophthalmology
active ingredients: Dexamethasone
laboratory: Thea

Eye drops in solution
Box of 30 single-dose containers of 0.4 mL
All forms

Indication

- Inflammation of the anterior segment of the eye, such as marginal keratitis, stromal edema associated with keratitis, anterior uveitis, episcleritis (if NSAIDs are contraindicated or insufficient), scleritis, acute phase of severe allergic conjunctivitis not responding not to a standard treatment.
- The inflammation must not be due to an infection. The corneal epithelium must be intact.
- This product should only be used under strict ophthalmic monitoring.

Dosage DEXAFREE 1 mg / mL Eye drops in solution Box of 30 Single dose containers of 0.4 mL

- DEXAFREE 1 mg / ml, eye drops in solution, should be administered only by eye.
- The usual dosage is 1 drop, 4 to 6 times a day, in the sick eye.
- In severe cases, treatment may start with 1 drop every hour, but the dose should be reduced to one drop every 4 hours as soon as a favorable response is observed. A gradual reduction in dosage is recommended to avoid a rebound effect.
- The duration of the treatment generally varies from a few days to a maximum of 14 days.
- Use in the elderly:
. The use of eye drops containing dexamethasone is the subject of a long experience in the elderly.
. The recommended dosage above reflects this clinical experience.
- Use in children:
In children, long-term continuous treatment with corticosteroids should be avoided because of a possible risk of adrenal insufficiency (see section on warnings and precautions for use).
- Patients are advised to:
. wash your hands thoroughly before instillation,
. avoid contact of the tip with the eye or the eyelids,
. to discard single dose after use.
- The systemic passage can be reduced by lacrimal occlusion by compressing the lacrimal ducts.
- Only for single use; any unused solution must be discarded.

Against indications

- Hypersensitivity to the active substance or to any of the excipients.
- Eye infections not controlled by an anti-infective treatment, such as:
. acute purulent bacterial infections, including Pseudomonas and mycobacteria infections,
. fungal infections,
. epithelial keratitis due to Herpes simplex virus (dendritic keratitis), vaccinia virus, varicella zoster virus and most other viral infections of the cornea and conjunctiva,
. amoebic keratitis.
- Tuberculosis.
- Perforation, ulceration and lesion of the cornea associated with incomplete reepithelialization (see also indications and warnings and precautions for use).
- Known ocular hypertension caused by glucocorticoids.

Dexafree side effects

- Eye disorders:
. Very common (> 1/10) : Increased intraocular pressure (after 2 weeks of treatment).
. Common (> 1/100, <1/10) : Discomfort, irritation, burning, tingling, itching and blurred vision occur frequently immediately after instillation. These events are usually mild and short-lived and have no consequences.
. Rare (> 1/1000, <1/100) : Allergic and hypersensitivity reactions may occur.
The adverse effects specifically related to corticosteroids are: delayed healing, risk of posterior capsular cataracts, opportunistic infections and glaucoma.
. Very rare (<1/10000, including isolated cases) : Conjunctivitis, mydriasis, facial edema, ptosis, corticosteroid-induced uveitis, corneal calcification, crystalline keratopathy, corneal thickness changes, corneal edema and ulceration of the cornea cornea have been reported. In diseases causing thinning of the cornea, topical use of corticosteroids has in some cases led to perforation.
- General disorders and anomalies at the site of administration:
Rare (> 1/1000, <1/100) : In cases of frequent instillation, systemic absorption associated with depression of adrenocortical function may occur.

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