Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary.
No dosage adjustment in elderly patients is necessary.
Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of Opatanol in children aged under 3 years has not been established. No data are available.
Olopatadine in the form of eye drops (Opatanol) has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2).
For ocular use only.
After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.
In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications. Eye ointments should be administered last.
No data are available in humans regarding overdose by accidental or deliberate ingestion. Olopatadine has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a bottle of Opatanol would deliver a maximum systemic exposure of 5 mg olopatadine. This exposure would result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption.
Prolongation of the QTc interval in dogs was observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. A 5 mg oral dose was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy volunteers with no significant prolongation of QTc interval compared to placebo. The range of peak steady-state olopatadine plasma concentrations (35 to 127 ng/ml) seen in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation.
In the case of overdose, appropriate monitoring and management of the patient should be implemented.
Shelf-life: 3 years.
Shelf-life after first opening: Discard four weeks after first opening.
This medicinal product does not require any special storage conditions.
5 ml opaque low density polyethylene bottles with polypropylene screw caps.
Cartons containing 1 or 3 bottles. Not all pack sizes may be marketed.
No special requirements.
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