Source: FDA, National Drug Code (US) Revision Year: 2013
ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent).
The structural formula of brimonidine tartrate is:
5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24
In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%).
Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.
Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.
| Dosage Forms and Strengths |
|---|
|
Solution containing 1 mg/mL or 1.5 mg/mL brimonidine tartrate. |
| How Supplied |
|---|
|
ALPHAGAN P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows: 0.1%: 5 mL in 10 mL bottle NDC 0023-9321-05 0.15%: 5 mL in 10 mL bottle NDC 0023-9177-05 Allergan, Inc., Irvine, CA 92612, U.S.A. |
| Drug | Countries | |
|---|---|---|
| ALPHAGAN | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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