BRIMONIDINE TARTRATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)

Available from:

A-S Medication Solutions

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution 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 is contraindicated in neonates and infants (under the age of 2 years) [see  Use  in  Specific  Populations  (8.4) ].   Brimonidine tartrate ophthalmic solution 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) ]. Pregnancy Category B: Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/

Product summary:

Product: 50090-6368 NDC: 50090-6368-0 5 mL in a BOTTLE / 1 in a CARTON

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIMONIDINE TARTRATE
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s), three times daily, approximately 8
hours apart. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 2 mg/mL brimonidine tartrate. (3)
CONTRAINDICATIONS
Neonates and infants (under the age of 2 years). (4.1)
WARNINGS AND PRECAUTIONS
Potentiation of vascular insufficiency. (5.1)
ADVERSE REACTIONS
Most common adverse reactions occurring in approximately 10 to 30% of
patients receiving brimonidine
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 SOMERSET THERAPEUTICS,
LLC AT 1-800-
417-9175 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antihypertensives/cardiac glycosides may lower blood pressure. (7.1)
Use with CNS depressants may result in an additive or potentiating
effect. (7.2)
Tricyclic antidepressants may potentially blunt the hypotensive effect
of systemic clonidine. (7.3)
Monoamine oxidase inhibitors may result in increased hypotension.
(7.4)
USE IN SPECIFIC POPULATIONS
Use with caution in children ≥ 2 years of age. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINI