FDA

Brimonidine Tartrate

Approved 18 Nov 2014EyeSolution/drops

The FDA lists this product in 22 strengths and forms.

Indications

Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% 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. Brimonidine Tartrate Ophthalmic Solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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Contraindications

Brimonidine Tartrate Ophthalmic Solution, 0.2% 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. 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, 0.2% is contraindicated in neonates and infants (under the age of 2 years) [ see Use in Specific Populations ( 8.4)] .

4.2Hypersensitivity Reactions

Brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past [ see Adverse Reactions ( 6.1 ) and ( 6.2 )].

Warnings and precautions

Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency

Brimonidine tartrate ophthalmic solution, 0.2% may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution, 0.2% 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

At a glance

Brand name: Brimonidine Tartrate
Route: Eye
Dosage form: Solution/drops
Applicant: Regcon Holdings
Status: Prescription
FDA approval: 18 Nov 2014
Application: ANDA091691-001

Indications

( 1 )

Contraindications

4.1Neonates and Infants (under

the age of 2 years) Brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in neonates and infants (under the age of 2 years) [ see Use in Specific Populations ( 8.4)] .

4.2Hypersensitivity Reactions

Warnings and precautions

Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency

5.2Severe Cardiovascular Disease

Adverse reactions

The following serious adverse reactions are described elsewhere in the labeling: 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 )] Neonates and Infants (under the age of 2 years) [ see Contraindications ( 4.1 )] Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine tartrate ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Indoco Remedies Limited at +1-855-642-2594 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 to 30% of the subjects (in descending order): oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

Adverse reactions occurring in approximately 3 to 9% of the subjects (in descending order): corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. Adverse reactions reported < 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

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; conjunctivitis; hypersensitivity; hypotension; iritis; keratoconjunctivitis sicca; lacrimation increased; miosis; nausea; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia.
Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence 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

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

At a glance

Two medicines in one question?

5.3Contamination of Topical Ophthalmic Products After Use

5.4Use with Contact Lenses

Interactions

7.1Antihypertensive/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