Presentation and Status in Health Basket
| Presentation | Basket | Yarpa | Pharmasoft |
|---|---|---|---|
|
Suspension 5 ml |
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12494 | 1940 |
Dosage
The recommended dose is one drop in the affected eye(s) three times daily approximately 8 hours apart. Thisophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
Indications
For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Contra-Indications
Neonates and infants (under the age of 2 years). Patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
Special Precautions
Potentiation of Vascular Insufficiency: This medicinal product may potentiate syndromes associated with vascular insufficiency. This medicinal product should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Do not touch the tip of the dispensing container to the eye or surrounding structures. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Effects on ability to drive and use machines:As with other similar medications, this medicinal product may cause fatigue and/or drowsiness in some patients. Patients who engage in activities such as driving and operating machinery should be cautioned of the potential for a decrease in mental alertness. This medicinal product may also cause blurred vision or visual disturbance in some patients. The patient should wait until these symptoms have cleared before driving or using machinery.
Side Effects
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10-20% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis. Adverse reactions occurring in approximately 5-9% of the subjects included: burning sensation, conjunctival foliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
See prescribing information for full details.
Drug interactions
Antihypertensives/Cardiac Glycosides: Because this medicinal product may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides is advised.
CNS Depressants: Although specific drug interaction studies have not been conducted, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.
Tricyclic Antidepressants: Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with this medicinal product in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
Monoamine Oxidase Inhibitors: Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Pregnancy and Lactation
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding. This medicinal product should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation: It is not known whether brimonidine tartrate is excreted in human milk. Because of the potential for serious adverse reactions, including central nervous system depression and apnea, this medicinal product is not recommended for use during lactation.
See prescribing information for full details.
Overdose
Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving this productas part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Important notes
Shelf life after first openning: 28 days, or expiry date which ever comes first. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
See prescribing information for full details.