BRIMONIDINE TARTRATE solution/ drops

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Florida Pharmaceutical Products, LLC

প্রশাসন রুট:

OPHTHALMIC

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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:

পণ্য সারাংশ:

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 71921-185-05 10 mL in 10 mL bottle   NDC 71921-185-10 15 mL in 15 mL bottle   NDC 71921-185-15 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS
FLORIDA PHARMACEUTICAL PRODUCTS, LLC
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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 FLORIDA PHARMACEUTICAL
PRODUCTS, LLC
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: 11/2021
FULL PRESCRIBING INFO