BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15% solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

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

Product summary:

Brimonidine tartrate ophthalmic solution, 0.15% is supplied sterile, in white opaque LDPE bottles and tips, with purple HDPE caps as follows:   5 mL in 5 mL bottle     NDC 62332-661-05 10 mL in 10 mL bottle   NDC 62332-661-10 15 mL in 15 mL bottle   NDC 62332-661-15 Storage: Store at 15° to 25°C (59° to 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15% - BRIMONIDINE
TARTRATE OPHTHALMIC SOLUTION, 0.15% SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS INC.
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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, 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 1.5 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 ALEMBIC
PHARMACEUTICALS, INC. AT 1-866-
210-9797 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 INFORMA