Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2005 Publisher: Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way Hemel Hempstead, Hertfordshire, HP2 7UD, United Kingdom
VEXOL is indicated for the treatment of postoperative inflammation following ocular surgery, for the treatment of anterior uveitis, and for the treatment of corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. The inflammation should be of a noninfectious nature.In more serious cases, and if the posterior part of the globe is affected, subconjunctival injection or systemic treatment is recommended (see section 4.4).
Apply one drop of VEXOL into the conjunctival sac of the affected eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period. There are no clinical data on the use of VEXOL immediately after surgery.
Apply one drop of VEXOL into the conjunctival sac of the affected eye four times or more daily. The duration of treatment should be determined by the prescribing physician according to the severity of the disease, but should not exceed four weeks.
Apply one drop of VEXOL into the conjunctival sac of the affected eye every hour while awake for the first week, one drop every two hours while awake of the second week, four times per day during the third week; then twice per day during the first 4 days of week four and then once per day during the last 3 days of week four. Alternative dosing may be appropriate in some circumstances.
Clinical studies have indicated that dosage modifications are not required for use in the elderly.
Safety and effectiveness in children have not been established.
No clinical experience in patients with impaired renal or hepatic function is available.
Shake well before use. Do not touch dropper tip to any surface, as this may contaminate the suspension. Keep the bottle tightly closed when not in use.
A topical overdose is not likely to be associated with toxicity. A topical overdosage of VEXOL may be flushed from the eye(s) with luke warm tap water.
Accidental oral ingestion is also unlikely to be associated with toxicity. Treatment of a suspected ingestion is symptomatic and supportive.
1 year for the 3 mL bottle.
2 years for the 5 mL and 10 mL bottles.
In use shelf life – one month after first opening.
Do not store above 30°C. Do not freeze.
Low density polyethylene bottles (droptainer) containing 3 mL, 5 mL, or 10 mL and with polypropylene screw caps.
Not all pack sizes may be marketed.
No special requirements.
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