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:

Sandoz Inc

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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) achi

Product summary:

Brimonidine tartrate ophthalmic solution, 0.2% is supplied sterile in white opaque LDPE plastic dropper bottles with tips with purple polypropylene caps as follows: 5 mL in 8 mL bottle       NDC 61314-143-05 10 mL in 10 mL bottle   NDC 61314-143-10 15 mL in 15 mL bottle   NDC 61314-143-15 NOTE: Store between 15° to 25°C (59° to 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE- BRIMONIDINE TARTRATE SOLUTION
SANDOZ 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
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 SANDOZ INC. AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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•
•
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USE IN SPECIFIC POPULATIONS
Use with caution in children ≥ 2 years of age. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2021
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. (7.1)
Use with CNS depressants may r