Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
Alembic Pharmaceuticals Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Brimonidine tartrate ophthalmic solution, 0.1% 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 0.1% or 0.15%, 1 drop in both ey
Brimonidine tartrate ophthalmic solution, 0.1% is supplied sterile, in white opaque LDPE bottles and tips with purple high density polyethylene (HDPE) caps as follows: 5 mL in 5 mL bottle NDC 62332-749-05 10 mL in 10 mL bottle NDC 62332-749-10 15 mL in 15 mL bottle NDC 62332-749-15 Storage: Store at 15° to 25°C (59° to 77°F).
Abbreviated New Drug Application
BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS ALEMBIC PHARMACEUTICALS INC. ---------- 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 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 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 INFORMATION. REVISED: 8/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS & USAGE 2 DOSAGE & ADMI Прочитајте комплетан документ