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Albalon (Naphazoline Hydrochloride Ophthalmic) - Description and Clinical Pharmacology

 
 



ALBALON®
(naphazoline hydrochloride ophthalmic solution, USP) 0.1%

Sterile

DESCRIPTION

Naphazoline hydrochloride, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as a white, odorless crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is represented by the structural formula:

Chemical Name:

2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride

Contains:

Active: naphazoline HCl 0.1%. Preservative: benzalkonium chloride 0.004%.
Inactives: citric acid, monohydrate; edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium citrate, dihydrate; and sodium hydroxide to adjust the pH. It has a shelf life pH range of 5.5 to 6.5.

CLINICAL PHARMACOLOGY

Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha-adrenergic receptors in the arterioles of the conjunctiva, resulting in decreased conjunctival congestion. Naphazoline belongs to the imidazoline class of sympathomimetics.

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