Country: United States
Language: English
Source: NLM (National Library of Medicine)
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
Allergan, Inc.
brimonidine tartrate
brimonidine tartrate 1 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
ALPHAGAN ® P (brimonidine tartrate ophthalmic solution) 0.1% or 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. ALPHAGAN ® P is contraindicated in neonates and infants (under the age of 2 years). ALPHAGAN ® P 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 ALPHAGAN ® P 0.1% or 0.15%, 1 drop in both eyes three times daily. There are no adequate and
ALPHAGAN ® P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows: 0.1% 5 mL in 10 mL bottle NDC 0023-9321-05 10 mL in 10 mL bottle NDC 0023-9321-10 15 mL in 15 mL bottle NDC 0023-9321-15 0.15% 5 mL in 10 mL bottle NDC 0023-9177-05 10 mL in 10 mL bottle NDC 0023-9177-10 15 mL in 15 mL bottle NDC 0023-9177-15 Storage: Store at 15o -25o C (59o -77o F).
New Drug Application
ALPHAGAN P- BRIMONIDINE TARTRATE SOLUTION/ DROPS ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALPHAGAN P SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALPHAGAN P. ALPHAGAN P (BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION) 0.1% AND 0.15% INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE ALPHAGAN P 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 ALLERGAN AT 1-800-678-1605 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: 9/2013 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 NEONATES AND INFANTS (UNDER THE Read the complete document