Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Alcon Laboratories (UK) Limited Pentagon Park Boundary Way Hemel Hempstead Hertfordshire HP2 7UD United Kingdom
IOPIDINE 5mg/ml is indicated for short-term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional intraocular pressure (IOP) reduction to delay laser treatment or glaucoma surgery.
The IOP lowering efficacy of IOPIDINE diminishes over time in most patients. Although some patients have received successful treatment with IOPIDINE for longer periods, the benefit for most patients is less than one month.
The addition of IOPIDINE to patients already using two aqueous suppressing drugs (i.e. beta-blockers plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because IOPIDINE is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.
One drop of IOPIDINE should be instilled into the affected eye(s) three times per day (t.i.d.). Since IOPIDINE will be used with other ocular glaucoma therapies, an approximate five minute interval between instillation of each medication should be observed to prevent washout of the previous dose. If, for any reason, the drop of IOPIDINE does not remain in the eye, then the patient should repeat the dose by placing another drop in the eye. The maximum recommended duration of therapy is one month due to loss of effect over time (tachyphylaxis). However, some patients may benefit from treatment with IOPIDINE for longer periods.
There are no special precautions for administration to the elderly.
Clinical studies to establish safety and efficacy in children have not been conducted and, therefore, IOPIDINE is not recommended for use in children under 12 years of age.
Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic side effects.
IOPIDINE may be flushed from the eyes with lukewarm water or sterile saline solution.
Accidental or intentional ingestion of oral clonidine has been reported to cause hypotension, transient hypertension, asthenia, vomiting, irritability, diminished or absent reflexes, lethargy, somnolence, sedation or coma, pallor, hypothermia, bradycardia, conduction defects, arrhythmias, dryness of the mouth, miosis, apnoea, respiratory depression, hypoventilation, and seizure. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Haemodialysis is of limited value, since a maximum of 5% of circulating drug is removed.
3 years.
4 weeks after first opening
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the container in the outer carton.
5 ml and/or 10 ml white LDPE DROP-TAINER dispensers with a natural LDPE dispensing plug and white polypropylene closure.
Not all pack sizes may be marketed.
No special requirements.
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