ALPHAGAN P (brimonidine tartrate)

There are 0 contraindications.

Drug contraindication overview.

Brimonidine is contraindicated in neonates and infants younger than 2 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) Brimonidine also is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.

Adverse reaction overview.

Adverse effects reported in approximately 10-30% of patients receiving brimonidine tartrate 0.1-0.2% ophthalmic solution include oral dryness, ocular or conjunctival hyperemia, burning and stinging, allergic conjunctivitis, 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, hypertension, asthenia, conjunctival blanching, abnormal vision, visual disturbances, and muscular pain have been reported in approximately 3-9% of patients receiving brimonidine tartrate 0.1-0.2% ophthalmic solution.

Adverse effects reported in approximately 1-4% of patients receiving brimonidine tartrate 0.025% ophthalmic solution include decreased visual acuity, conjunctival or ocular hyperemia, dry eye, instillation site pain, and headache.

Safety and efficacy of topical brimonidine tartrate for the treatment of open-angle glaucoma or ocular hypertension in pediatric patients younger than 2 years of age have not been established. Because potentially serious adverse effects, including apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence, have been reported in infants treated with topical brimonidine tartrate, use of the drug is contraindicated in infants 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% of those 7 years of age who weighed more than 20 kg. The individual components of brinzolamide and brimonidine tartrate fixed-combination ophthalmic suspension have been studied in pediatric patients 4 weeks to 5 years of age (brinzolamide) and 2-7 years of age (brimonidine).

Safety and efficacy of brimonidine tartrate and timolol fixed-combination ophthalmic solution in pediatric patients 2-16 years of age have been established based on evidence from adequate and well-controlled studies of the fixed combination in adults and additional data from a study evaluating the individually administered drugs (brimonidine tartrate 0.2% administered 3 times daily as an adjunct to timolol therapy) in children 2-7 years of age with glaucoma. Safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution for self-medication for relief of ocular redness due to minor irritation have not been established in children younger than 5 years of age. Safety and efficacy in pediatric patients 5 years of age or older are supported by evidence from controlled clinical trials in adults and additional data from a safety study that included both adults and pediatric patients 5 years of age or older.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None