Naphcon (Naphazoline Hydrochloride Ophthalmic) - Description and Clinical Pharmacology

DESCRIPTION

NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% is a sterile preparation. Naphazoline HCl, 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:

C₁₄H₁₄N₂HCl

MW=246.74

Chemical name:

2-(1-naphthylmethyl)-2-imidazoline monohydrochloride

Each mL contains: Active: Naphazoline Hydrochloride 0.1%. Preservative: Benzalkonium Chloride 0.01%. Inactives: Boric Acid, Sodium Chloride, Potassium Chloride, Edetate Disodium, Sodium Carbonate and/or Hydrochloric Acid (to adjust pH), Purified Water. DM-00

The solution has a pH of 5.5 to 7.0.

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.