Brimonidine Tartrate
Generic: BRIMONIDINE TARTRATE
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd
Indications & Usage
1 INDICATIONS AND USAGE Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic agonist indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension ( 1 ).
Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic agonist indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [see Contraindications ( 4.1 )] • Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.1 )] • Severe Cardiovascular Disease [see Warnings and Precautions ( 5.2 )] • Contamination of Topical Ophthalmic Products After Use [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are allergic conjunctivitis, conjunctival hyperemia, and eye pruritis ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring in approximately 10 to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis.
Adverse reactions occurring in approximately 5 to 9% of the subjects included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
Adverse reactions occurring in approximately 1 to 4% of subjects included: allergic reaction, arthralgia, arthritis, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, chest pain, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, diabetes mellitus, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection, insomnia, joint disorder, keratitis, lid disorder, osteoporosis, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.
The following adverse reactions were reported in less than 1% of subjects: corneal erosion, nasal dryness, and taste perversion.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solution.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Bradycardia, iritis, miosis, skin reactions (including erythema, eyelid pruritis, rash, and vasodilation), and tachycardia.
• Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring in approximately 10 to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis.
Adverse reactions occurring in approximately 5 to 9% of the subjects included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
Adverse reactions occurring in approximately 1 to 4% of subjects included: allergic reaction, arthralgia, arthritis, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, chest pain, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, diabetes mellitus, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection, insomnia, joint disorder, keratitis, lid disorder, osteoporosis, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.
The following adverse reactions were reported in less than 1% of subjects: corneal erosion, nasal dryness, and taste perversion.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solution.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Bradycardia, iritis, miosis, skin reactions (including erythema, eyelid pruritis, rash, and vasodilation), and tachycardia.
• Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.