Drugplain

ALPHAGAN P 1.5 mg/mL

brimonidine tartrate · SOLUTION/ DROPS · Allergan, Inc.

No Recall History
Plain English

ALPHAGAN P is a solution/ drops containing brimonidine tartrate at 1.5 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..

Key Facts

Brand Name
ALPHAGAN P
Generic Name
brimonidine tartrate
NDC Code (Product)
0023-9177
Manufacturer
Allergan, Inc.
Strength
1.5 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
NDA021262
Marketing Start
07/10/2001

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective573 reports
eye irritation548 reports
eye pain546 reports
ocular hyperaemia542 reports
fatigue444 reports
vision blurred429 reports
intraocular pressure increased385 reports
off label use369 reports
headache353 reports
dizziness333 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN P is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop of ALPHAGAN P in the affected eye(s) three times daily, approximately 8 hours apart. ALPHAGAN P may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s) three times daily, approximately 8 hours apart. ( 2 )

Contraindications

4 CONTRAINDICATIONS Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 ) Hypersensitivity Reactions. ( 4.2 ) 4.1 Neonates and Infants (Pediatric Patients Younger than 2 Years Old) ALPHAGAN P is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )]. 4.2 Hypersensitivity Reactions ALPHAGAN P is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

Drug Interactions

7 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 ) 7.1 Antihypertensives/Cardiac Glycosides Because ALPHAGAN P may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with ALPHAGAN P is advised. 7.2 CNS Depressants Although specific drug interaction studies have not been conducted with ALPHAGAN P, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. 7.3 Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with ALPHAGAN P in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulati…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Potentiation of Vascular Insufficiency [ see Warnings and Precautions ( 5.1 ) ] Severe Cardiovascular Disease [ see Warnings and Precautions ( 5.2 ) ] Contamination of Topical Ophthalmic Products after Use [ see Warnings and Precautions ( 5.3 ) ] Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [ see Contraindications ( 4.1 ) ] Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1% to 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 AbbVie at 1-800-678-1605 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in …

Frequently Asked Questions

What is ALPHAGAN P used for?

ALPHAGAN P contains brimonidine tartrate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is ALPHAGAN P a controlled substance?

ALPHAGAN P is not classified as a controlled substance by the DEA.

What is the generic name for ALPHAGAN P?

The generic name for ALPHAGAN P is brimonidine tartrate. There are 10 other brand versions of brimonidine tartrate.

What is the NDC code for ALPHAGAN P 1.5 mg/mL?

The NDC (National Drug Code) for ALPHAGAN P 1.5 mg/mL is 0023-9177, listed by Allergan, Inc..

Product NDC

0023-9177

Package NDC

0023-9177-05

Other ALPHAGAN P Dosages

Other Brimonidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)