BRIMONIDINE TARTRATE solution/ drops

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Indoco Remedies Limited

관리 경로:

OPHTHALMIC

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% 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, 0.2% is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. Brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in neonates and infants (under the age of 2 years) [see Use in Specific Populations (8.4)]. Brimonidine tartrate ophthalmic solution, 0.2% 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:

제품 요약:

Brimonidine tartrate ophthalmic solution, 0.2% is supplied sterile, in white opaque LDPE plastic bottles and natural nozzle with purple tear-off HDPE caps as follows: 5 mL in 5mL bottle        NDC 14445-400-05 10 mL in 10 mL bottle   NDC 14445-400-10 15 mL in 15 mL bottle   NDC 14445-400-15. STORAGE: Store between 20°-  25°C (68°-  77°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN. TEAR AND DISCARD RING BEFORE USE Do not use if tear-off ring is broken or missing.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS
INDOCO REMEDIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIMONIDINE TARTRATE OPHTHALMIC
SOLUTION, 0.2% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BRIMONIDINE TARTRATE OPHTHALMIC
SOLUTION, 0.2% BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.2%
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 tartrate
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 Indoco Remedies Limited
at [phone] 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: 09/2018
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REV