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brimonidine 0.2% eye drop

Out of Stock Manufacturer VALEANT/BAUSCH 24208041110
Out of Stock

Uses

Ocular Hypertension and Glaucoma

Brimonidine tartrate 0.15 and 0.2% ophthalmic solutions are used topically to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Reduction in IOP may reduce or prevent glaucomatous visual field loss or optic nerve damage.

Controlled studies in patients with primary open-angle glaucoma or ocular hypertension have demonstrated that brimonidine tartrate 0.15% ophthalmic solution is therapeutically equivalent (i.e., in terms of the magnitude and duration of the hypotensive effect) to the 0.2% solution. In one 12-month clinical study, there were no substantial differences in IOP among patients treated with brimonidine tartrate 0.15 or 0.2% three times daily; the difference in mean IOP between the groups was less than 1 mm Hg at all evaluations during the 12-month period.

No clinical studies have been performed to date to compare the efficacy of brimonidine tartrate 0.15% with that of other ophthalmic drugs commonly used to reduce IOP in patients with open-angle glaucoma or ocular hypertension. However, in comparative clinical studies, efficacy of brimonidine tartrate 0.2% ophthalmic solution administered twice daily appeared to be similar to that of timolol 0.5% or betaxolol 0.25% administered twice daily.

During prolonged therapy with topical brimonidine tartrate 0.2%, the effect in reducing IOP generally was well maintained, but tolerance has been reported in some patients. (See Intraocular Pressure Monitoring under Warnings/Precautions: General Precautions, in Cautions.) The reduction in mean IOP has been maintained for up to 4 years after initial stabilization with the drug in some patients.

When used in conjunction with a topical β-adrenergic blocking agent (e.g., timolol), brimonidine may have an additive IOP-lowering effect. In clinical studies in patients receiving topical β-adrenergic blocking agents, the additive IOP-lowering effect of topical brimonidine tartrate 0.2% administered twice daily appeared to be comparable to that of topical pilocarpine hydrochloride 2% administered 3 times daily or topical apraclonidine 0.5% administered twice daily and more effective than topical dorzolamide 2% administered 3 times daily.

Dosage and Administration

General

Brimonidine tartrate is applied topically to the eye as an ophthalmic solution. Although topical brimonidine generally has been administered twice daily in clinical studies, reductions in intraocular pressure (IOP) induced by the drug appear to diminish 8 hours following administration. Therefore, the manufacturers recommend administering brimonidine tartrate 0.15 or 0.2% ophthalmic solution 3 times daily, approximately 8 hours apart. Care should be taken to avoid contamination of the solution container. (See Advice to Patients.)

If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered at least 5 minutes apart.

The recommended dosage of topical brimonidine tartrate for the treatment of open-angle glaucoma or ocular hypertension in adults is one drop of the 0.15 or 0.2% solution in the affected eye(s) 3 times daily, approximately 8 hours apart. The manufacturers make no specific dosage recommendations for children 2 years of age or older. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) Since IOP may not stabilize for a few weeks after initiating topical brimonidine therapy in some patients, IOP should be determined after about 4 weeks of therapy with the drug; thereafter, IOP should be determined as necessary.

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Concomitant use with a monoamine oxidase (MAO) inhibitor.

Known hypersensitivity to brimonidine or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Topical hypersensitivity reactions (e.g., allergic conjunctivitis, conjunctival hyperemia, ocular pruritus) have occurred in about 10-20% of patients in clinical studies. If a sensitivity reaction occurs during topical brimonidine therapy, the drug should be discontinued.

Evidence of partial cross-sensitivity between brimonidine and apraclonidine has been reported in clinical studies; use with caution in patients with a history of hypersensitivity to apraclonidine.

General Precautions

Systemic Effects

Although brimonidine has had minimal effects on blood pressure of patients in clinical studies, the manufacturer recommends that the drug be used with caution in patients with severe cardiovascular conditions. Caution also is recommended in patients with mental depression, orthostatic hypotension, cerebral or coronary insufficiency, Raynaud's phenomenon, or thromboangiitis obliterans.

Intraocular Pressure Monitoring

The reduction in intraocular pressure (IOP) caused by brimonidine tartrate 0.2% ophthalmic solution may diminish over time. In clinical studies, 8% of patients receiving brimonidine tartrate 0.2% ophthalmic solution discontinued therapy because of inadequately controlled IOP, which in 30% of patients occurred during the first month of therapy. Because the onset of such diminished effect is variable, the manufacturer recommends that IOP be monitored routinely. (See Dosage and Administration: General.)

Specific Populations

Pregnancy

Category B. ()

Lactation

Brimonidine is distributed into milk in rats. It is not known whether brimonidine is distributed into human milk. Discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy of topical brimonidine tartrate in children younger than 2 years of age have not been established. Because potentially serious adverse CNS effects, including apnea and lethargy, have been reported in infants treated with topical brimonidine tartrate, use of the drug is not recommended in children younger than 2 years of age. In a well-controlled clinical study in children 2-7 years of age with glaucoma who received brimonidine tartrate 0.2% ophthalmic solution 3 times daily, the most commonly observed adverse effects were somnolence and decreased mental alertness; approximately 16% of these children discontinued therapy because of somnolence. The incidence of somnolence generally appeared to be age- and weight-related, occurring in 50-83% of children 2-6 years of age and 25% less frequently in children 7 years of age and older who weighed more than 20 kg.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Renal Impariment

Brimonidine tartrate has not been studied in patients with renal impairment; use with caution.

Hepatic Impairment

Brimonidine tartrate has not been studied in patients with hepatic impairment; use with caution.

Common Adverse Effects

Adverse effects reported in 10-30% of patients receiving topical brimonidine tartrate 0.2% include oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. In addition, corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, GI symptoms, asthenia, conjunctival blanching, abnormal vision, and muscular pain have been reported in 3-9% of patients receiving topical brimonidine tartrate 0.2%. In clinical studies, approximately 20% of patients discontinued therapy because of adverse effects.

Adverse effects reported in 10-20% of patients receiving topical brimonidine tartrate 0.15% include allergic conjunctivitis, conjunctival hyperemia, and ocular pruritus. In addition, burning sensation, conjunctival folliculosis, hypertension, xerostomia, and visual disturbances have been reported in 5-9% of patients receiving the drug.

Drug Interactions

No formal drug interaction studies have been performed.

CNS Depressants (e.g., alcohol, general anesthetics, barbituates, opiates, sedatives)

Potential pharmacologic interaction (additive CNS depressant effects).

β-Adrenergic Blocking Agents (topical or systemic)

Potential pharmacologic interaction (additive IOP-lowering and cardiovascular effects); use with caution.

Hypotensive Agents

Potential pharmacologic interaction (additive IOP-lowering and cardiovascular effects); use with caution.

Cardiac Glycosides

Potential pharmacologic interaction (additive cardiovascular effects); use with caution.

Tricyclic Antidepressants

Potential pharmacologic interaction (may interfere with IOP-lowering effect of brimonidine tartrate) when used concurrently with tricyclic antidepressants that affect the metabolism and uptake of circulating amines; use with caution.

Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations occurred within 0.5-4 hours after ocular administration of brimonidine tartrate 0.1 or 0.2% ophthalmic solution.

Onset

Peak ocular hypotensive effects occur 2-3 hours following topical administration of brimonidine.

Distribution

Extent

Distributed into milk in animals; not known whether the drug distributes into milk in humans.

Elimination

Metabolism

Extensively metabolized in the liver.

Elimination Route

Brimonidine and its metabolites are excreted principally in urine.

Half-life

2-3 hours.

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