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:

Apotex Corp.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 contraindicated in neonates and infants (under the age of 2 years). Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. 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/day) and rabbits (5.0 mg/kg/day) achieved AUC exposure values 360- and 20-fold higher, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution, 0.15%, 1 drop in both eyes three times daily. There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from brimonidine tartrate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years (see CONTRAINDICATIONS , 4.1). During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years. In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age (>20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. No overall differences in safety or effectiveness have been observed between elderly and other adult patients. Brimonidine tartrate ophthalmic solution has not been studied in patients with hepatic impairment. Brimonidine tartrate ophthalmic solution has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.

Product summary:

Brimonidine Tartrate Ophthalmic Solution is supplied sterile, in white opaque LDPE ophthalmic bottles with white translucent LDPE ophthalmic droppers and purple opaque ophthalmic HDPE plastic caps as follows: 0.15% 5 mL in 5 mL bottle            NDC 60505-0564-1 10 mL in 11 mL bottle         NDC 60505-0564-2 15 mL in 15 mL bottle         NDC 60505-0564-3 Storage: Store at 20° - 25°C (68° - 77°F)[See USP Controlled Room temperature]. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE- BRIMONIDINE TARTRATE SOLUTION/ DROPS
APOTEX CORP.
----------
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, 0.15%
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
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. (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 1 or 1.5 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 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 APOTEX CORP. AT
1-800-706-5575 OR THE
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: 12/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 D