BRIMONIDINE TARTRATE/TIMOLOL MALEATE- brimonidine tartrate and timolol maleate solution/ drops

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

可用日期:

Actavis Pharma, Inc.

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1, 5.3)] . Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardi

產品總結:

Brimonidine tartrate/timolol maleate 0.2%/0.5% ophthalmic solution is supplied sterile, in white opaque plastic LDPE bottles and tips, with blue high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle           NDC 0591-2422-26 10 mL in 10 mL bottle         NDC 0591-2422-79 15 mL in 15 mL bottle         NDC 0591-2422-12 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

授权状态:

Abbreviated New Drug Application

产品特点

BRIMONIDINE TARTRATE/TIMOLOL MALEATE- BRIMONIDINE TARTRATE AND TIMOLOL
MALEATE SOLUTION/ DROPS
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIMONIDINE
TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR BRIMONIDINE TARTRATE/TIMOLOL MALEATE
OPHTHALMIC
SOLUTION.
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION, FOR
TOPICAL
ADMINISTRATION
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
Brimonidine tartrate/timolol maleate is an alpha-adrenergic receptor
agonist with a beta-adrenergic
receptor inhibitor indicated for the reduction of elevated intraocular
pressure (IOP) in patients with
glaucoma or ocular hypertension who require adjunctive or replacement
therapy due to inadequately
controlled IOP; the IOP-lowering of brimonidine tartrate/timolol
maleate ophthalmic solution dosed twice a
day was slightly less than that seen with the concomitant
administration of timolol maleate ophthalmic
solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic
solution, 0.2% dosed three times
per day. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s), twice daily approximately 12 hours
apart. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol.
(3)
CONTRAINDICATIONS
Bronchial asthma, a history of bronchial asthma, severe chronic
obstructive pulmonary disease. (4.1,
5.1, 5.3)
Sinus bradycardia, atrioventricular block, overt cardiac failure,
cardiogenic shock. (4.2, 5.2)
Neonates and infants (under the age of 2 years). (4.3)
Hypersensitivity to any component of this product. (4.4)
WARNINGS AND PRECAUTIONS
Potential for Severe Respiratory or Cardiac Reactions (5.1)
Cardiac Failure (5.2)
Obstructive Pulmonary Disease (5.3)
Potentiation of Vascular Insufficiency (5.4)
Increased Reactivity to Allergens (5.5)
Potentiation of Muscle Weakness (5.6)
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus