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Eye products (Brimodin)
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Brimodin
Eye Drops Brimonidine tartrate Eye drops
Composition
Brimodin Eye drops
Each ml contains:
Brimonidine tartrate .......... 2 mg
(equivalent to 1.32 mg as Brimonidine base)
Benzalkonium chloride NF
(as preservative) ..... 0.005% w/v
Sterile aqueous vehicle ....... q.s.
Description
Brimonidine is an alpha adrenergic receptor agonist. It has a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.
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Indications
Brimonidine is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
Dosage and Administration
The recommended dose is one drop of Brimonidine in the affected eye(s) two times daily. For those patients whose IOP peaks in the afternoon or need additional IOP control , an additional drop of brimonidine in the afternoon can be added.
Contraindications
Brimonidine is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
Warnings and Precautions
Drug Interactions
Although specific drug interaction studies have not been conducted with brimonidine, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. Brimonidine did not have significant effects on pulse and blood pressure in clinical studies. However, since alpha-agonists, as a class, may reduce pulse and blood pressure, caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised. 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 brimonidine can lead to an interference in IOP lowering effect. No data on the level of circulating catecholamines after brimonidine is instilled are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
Brimonidine ophthalmic solution cannot be used as an ophthalmic injection. Use the solution within one month after opening the container. Do not touch the nozzle tip to any surface since this may contaminate the solution. Should irritation or hypersensitivity to any component of the formulation develop, discontinue use of the preparation and initiate appropriate therapy.
Although brimonidine had minimal effect on blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Brimonidine has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients. Brimonidine should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. The IOP-lowering efficacy observed with brimonidine ophthalmic solution during the first month of therapy may not always reflect the long-term level of IOP reduction. Patients prescribed IOP-lowering medication should be routinely monitored for IOP.
The preservative in brimonidine, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling brimonidine to insert soft contact lenses. As with other drugs in this class, brimonidine may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.
Pregnancy
Teratogenic Effects: Pregnancy Category B.
Brimonidine 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 is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Side Effects
Side effects occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions and ocular pruritus.
Overdosage
No information is available on overdosage in humans. Treatment of an oral overdose includes supportive and symptomatic therapy.
Storage
Store in a cool dry place, protect from light.
Presentation
Brimodin Eye Drops-----vial of 5 ml with a metered dose dropper
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