BRIMONIDINE TARTRATE AND TIMOLOL MALEATE- brimonidine tartrate and timolol maleate solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Florida Pharmaceutical Products, LLC

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 71921-188-05 10 mL in 10 mL bottle         NDC 71921-188-10 15 mL in 15 mL bottle         NDC 71921-188-15 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE - BRIMONIDINE TARTRATE AND
TIMOLOL MALEATE SOLUTION
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/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 Pati