BRIMONIDINE TARTRATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Brimonidine Tartrate Ophthalmic Solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Brimonidine Tartrate Ophthalmic Solution, 0.15% is contraindicated in patients with hypersensitivity to any component of this product. Pregnancy Category: B Reproductive studies performed in rats and rabbits with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine Tartrate Ophthalmic Solution, 0.15%. Dosing at this level produced an exposure in rats and rabbits that is 80 and 40 times higher than the exposure seen in humans, respectively. There are no adequate and well-controlled studies in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine Tartrate Ophthalmic Solution, 0.15% 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 this drug is excreted in human milk. In animal studies, brimonidine tartrate was excreted in breast milk. 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. In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years), the most commonly observed adverse events 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 or older (>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. The safety and effectiveness of brimonidine tartrate ophthalmic solution have not been studied in pediatric patients below the age of 2 years. Brimonidine tartrate ophthalmic solution is not recommended for use in pediatric patients under the age of 2 years. No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Product summary:

Brimonidine Tartrate Ophthalmic Solution, 0.15% is supplied sterile in opaque white LDPE plastic bottles and natural tips with purple polypropylene caps as follows: 5 mL in 8 mL bottle NDC: 63629-8792-1 Storage: Store at 15°-25° C (59° - 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE- BRIMONIDINE TARTRATE SOLUTION
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIMONIDINE TARTRATE
OPHTHALMIC SOLUTION, 0.15% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15%.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15%, STERILE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Brimonidine Tartrate Ophthalmic Solution, 0.15% is an alpha-2
adrenergic receptor agonist indicated for
the lowering of intraocular pressure in patients with open-angle
glaucoma or ocular hypertension (1).
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Solution containing 1.5 mg/mL brimonidine tartrate (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
Most common adverse reactions are allergic conjunctivitis,
conjunctival hyperemia, and eye pruritis (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
Instill one drop in the affected eye(s) three-times daily (2).
If more than one topical ophthalmic product is being used, the
products should be administered at
least 5 minutes apart (2).
Hypersensitivity to any component of this product (4.1).
Potentiation of vascular insufficiency (5.1)
Concomitant use with systemic beta-blockers may potentiate systemic
beta-blockade (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).
Not for use in children below the age of 2 years (8.4).
4.1 Hypersensiti