Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK
Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
The recommended dose is one drop of Alphagan in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.
Alphagan has not been studied in patients with hepatic or renal impairment (see section 4.4).
No clinical studies have been performed in adolescents (12 to 17 years).
Alphagan is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Alphagan have not been established in children aged 2 to 12 years.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. This may result in a decrease of systemic side effects and an increase in locay activity. To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart.
In those cases received, the events reported have generally been those already listed as adverse reactions.
There is very limited information regarding accidental ingestion of brimonidine in adults. The only adverse event reported to date was hypotension. It was reported that the hypotensive episode was followed by rebound hypertension.
Treatment of oral overdose includes supportive and symptomatic therapy; patient’s airways should be maintained.
Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Reports of serious adverse effects following inadvertent ingestion of Alphagan by paediatric subjects have been published or reported to Allergan. The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated. All subjects were reported to have made a full recovery, usually within 6-24 hours.
Before first opening:
2 years for the 2.5 ml container.
3 years for the 5 ml and 10 ml containers.
After first opening:
28 days.
Do not store above 25°C.
White low density polyethylene dropper bottles with a 35 microlitre tip. The cap is either a conventional polystyrene screw cap or a Compliance Cap (C-Cap).
2.5 ml, 5 ml and 10 ml bottles in packs of 1, 3 or 6. Not all pack sizes may be marketed.
No special requirements.
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