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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Brimonidine tartrate and 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 and 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 and 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 and timolol maleate ophthalmic solution is contraindicated in patie

Product summary:

Brimonidine tartrate and timolol maleate ophthalmic solution is supplied sterile, in white opaque plastic LDPE bottles and tips, with blue high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle             NDC 60505-6225-0 10 mL in 10 mL bottle       NDC 60505-6225-1 15 mL in 15 mL bottle       NDC 60505-6225-2 Storage: Store at 15°-25°C (59°-77°F). Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BRIMONIDINE TARTRATE/TIMOLOL MALEATE- BRIMONIDINE TARTRATE, TIMOLOL
MALEATE SOLUTION/ DROPS
APOTEX CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIMONIDINE TARTRATE
AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC
SOLUTION.
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION 0.2%/0.5%
FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Contraindications, Reactive Airway Disease Including Asthma, COPD
(4.1) 10/2015
Warnings and Precautions, Potential for Severe Respiratory or Cardiac
Reactions (5.1) 10/2015
INDICATIONS AND USAGE
Brimonidine tartrate and timolol maleate ophthalmic solution 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
and 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