BRIMONIDINE TARTRATE AND 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:

Upsher-Smith Laboratories, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Brimonidine tartrate/timolol maleate ophthalmic solution is supplied sterile, in white opaque plastic LDPE bottles and white LDPE dropper, with dark blue HDPE cap. They are supplied as follows: Storage:  Store at 15°C to 25°C (59°F to 77°F). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE- BRIMONIDINE TARTRATE AND
TIMOLOL MALEATE SOLUTION/ DROPS
UPSHER-SMITH LABORATORIES, LLC
----------
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,
FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
Brimonidine tartrate/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/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 S