BRIMONIDINE TARTRATE/TIMOLOL MALEATE- 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:

ARMAS PHARMACEUTICALS INC

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 s

Product summary:

Brimonidine tartrate/timolol maleate ophthalmic solution is supplied sterile, in white LDPE bottles and white controlled dropper tips, with blue caps as follows: 5 mL in 10 mL bottle NDC 72485-634-05 10 mL in 10 mL bottle NDC 72485-634-10 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE/TIMOLOL MALEATE- BRIMONIDINE TARTRATE AND TIMOLOL
MALEATE SOLUTION/ DROPS
ARMAS PHARMACEUTICALS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEBRIMONIDINE
TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTIONSAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FORBRIMONIDINE TARTRATE/TIMOLOL MALEATE
OPHTHALMIC
SOLUTION.
BRIMONIDINE TARTRATE AND TIMOLOLMALEATE 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 Dia