FDA

Brimonidine Tartrate

Approved 29 Mar 2023EyeSolution/drops

The FDA lists this product in 22 strengths and forms.

Indications

Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Contraindications

Neonates and infants (under the age of 2 years). ( 4.1 )

4.1Neonates and Infants (under

the age of 2 years) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years).

4.2Hypersensitivity Reactions

Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

Warnings and precautions

Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency

Brimonidine tartrate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

5.2Severe 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.

5.3Contamination 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 (see PATIENT COUNSELING INFORMATION , 17).

At a glance

Brand name: Brimonidine Tartrate
Route: Eye
Dosage form: Solution/drops
Applicant: Alembic
Status: Prescription
FDA approval: 29 Mar 2023
Application: ANDA215225-001

Indications

Contraindications

Neonates and infants (under the age of 2 years). ( 4.1 )

4.1Neonates and Infants (under

the age of 2 years) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years).

4.2Hypersensitivity Reactions

Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

Warnings and precautions

Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency

5.2Severe Cardiovascular Disease

5.3Contamination of Topical Ophthalmic Products After Use

Adverse reactions

Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1%-0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

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 pruritus.

Adverse reactions occurring in approximately 5-9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. Adverse reactions occurring in approximately 1-4% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, 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 (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, 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 reactions were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.

6.2Postmarketing Experience

The following reactions have been identified during postmarketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia.

Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

Brimonidine Tartrate

Indications

Contraindications

4.1Neonates and Infants (under

4.2Hypersensitivity Reactions

Warnings and precautions

5.1Potentiation of Vascular Insufficiency

5.2Severe Cardiovascular Disease

5.3Contamination of Topical Ophthalmic Products After Use

At a glance

Two medicines in one question?

Brimonidine Tartrate

Indications

Contraindications

4.1Neonates and Infants (under

4.2Hypersensitivity Reactions

Warnings and precautions

5.1Potentiation of Vascular Insufficiency

5.2Severe Cardiovascular Disease

5.3Contamination of Topical Ophthalmic Products After Use

At a glance

Two medicines in one question?

Interactions

7.1Antihypertensives/Cardiac Glycosides

7.2CNS Depressants

7.3Tricyclic Antidepressants

7.4Monoamine Oxidase Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category B:

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information