Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Mayo, Ireland
Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers.
The recommended dose is one drop of Combigan in the affected eye(s) twice daily, approximately 12 hours apart.
Combigan is contraindicated in neonates and infants aged less than 2 years (see section 4.3 Contraindications, section 4.4 Special warnings and precautions for use, section 4.8 Undesirable effects and section 4.9 Overdose).
The safety and efficacy of Combigan in children and adolescents aged 2 to 17 years have not been established and therefore, its use is not recommended in children or adolescents (see also section 4.4, section 4.8 and section 4.9).
Combigan has not been studied in patients with hepatic or renal impairment. Therefore, caution should be used in treating such patients.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctual occlusion) or eyelids are closed for two minutes. 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 local 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 product is to be used, the different products should be instilled at least 5 minutes apart.
Rare reports of overdosage with COMBIGAN in humans resulted in no adverse outcome. Treatment of an overdose includes supportive and symptomatic therapy; a patient’s airway should be maintained.
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. 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 brimonidine ophthalmic solution 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.
Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness and cardiac arrest. A study of patients showed that timolol did not dialyse readily.
21 months.
After first opening: Use within 28 days.
Keep the bottle in the outer carton in order to protect from light.
White low density polyethylene bottles with polystyrene screw caps. Each bottle has a fill volume of 5 ml.
The following pack sizes are available: cartons containing 1 or 3 bottles of 5 ml. Not all pack sizes may be marketed.
No special requirements.
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