ALPHAGAN P- brimonidine tartrate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

brimonidine tartrate (UNII: 4S9CL2DY2H) (brimonidine - UNII:E6GNX3HHTE)

Available from:

Physicians Total Care, Inc.

INN (International Name):

brimonidine tartrate

Composition:

brimonidine tartrate 1.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ALPHAGAN ® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN ® P is contraindicated in neonates and infants (under the age of 2 years). ALPHAGAN ® P is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. Pregnancy Category B: Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5.0 mg/kg/day) achieved AUC exposure values 360- and 20-fold higher, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with ALPHAGAN ® P 0.1% or 0.15%, 1 drop in both eyes three times daily. There are no adequate and well-

Product summary:

ALPHAGAN ® P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle              NDC 54868-4690-2 10 mL in 10 mL bottle            NDC 54868-4690-0 Storage: Store at 15°-25°C (59°-77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

ALPHAGAN P - BRIMONIDINE TARTRATE SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPHAGAN P SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ALPHAGAN P.
ALPHAGAN P (BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION) 0.1% AND 0.15%
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
ALPHAGAN P is an alpha adrenergic receptor agonist indicated for the
reduction of elevated intraocular pressure (IOP)
in patients with open-angle glaucoma or ocular hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s), three times daily, approximately 8
hours apart. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 1 or 1.5 mg/mL brimonidine tartrate. (3)
CONTRAINDICATIONS
Neonates and infants (under the age of 2 years). (4.1)
WARNINGS AND PRECAUTIONS
Potentiation of vascular insufficiency. (5.1)
ADVERSE REACTIONS
Most common adverse reactions occurring in approximately 5% to 20% of
patients receiving brimonidine ophthalmic
solution (0.1%-0.2%) included allergic conjunctivitis, burning
sensation, conjunctival folliculosis, conjunctival hyperemia,
eye pruritus, hypertension, ocular allergic reaction, oral dryness,
and visual disturbance. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-433-8871 OR THE FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antihypertensives/cardiac glycosides may lower blood pressure. (7.1)
Use with CNS depressants may result in an additive or potentiating
effect. (7.2)
Tricyclic antidepressants may potentially blunt the hypotensive effect
of systemic clonidine. (7.3)
Monoamine oxidase inhibitors may result in increased hypotension.
(7.4)
USE IN SPECIFIC POPULATIONS
Use with caution in children ≥ 2 years of age. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Neonates and Infa