Country: United States
Language: English
Source: NLM (National Library of Medicine)
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
Bausch & Lomb Incorporated
OPHTHALMIC
PRESCRIPTION DRUG
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/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.2%, one drop in one eye, twice 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 (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on brimonidine tartrate ophthalmic solution 0.2% 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.
Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile in a plastic bottle with a purple cap and controlled drop tip in the following sizes: 5 mL - NDC 24208-411-05 10 mL - NDC 24208-411-10 15 mL - NDC 24208-411-15 Storage: Store between 15°C to 25°C (59°F to 77°F). Keep out of reach of children.
Abbreviated New Drug Application
BRIMONIDINE TARTRATE- BRIMONIDINE TARTRATE SOLUTION/ DROPS BAUSCH & LOMB INCORPORATED ---------- 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 BAUSCH & LOMB INCORPORATED AT 1-800- 553-5340 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • USE IN SPECIFIC POPULATIONS Use with caution in children ≥ 2 years of age. (8.4) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 6/2022 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 age of 2 years) 4.2 Hypersensitivity Reactions 5 WARNINGS AND PRECAUTIONS 5.1 Potentiation of Vascular Insufficiency 5.2 Severe Cardiovascular Disease Antihypertensives/cardiac glycosides may lower blood pressure. Read the complete document