524.1982—Proparacaine hydrochloride ophthalmic solution.
(a) Specifications.
The drug is an aqueous solution containing 0.5 percent proparacaine hydrochloride, 2.45 percent glycerin as a stabilizer, and 0.2 percent chlorobutanol (choral derivative) and 1:10,000 benzalkonium chloride as preservatives.
(c) Special considerations.
The longterm toxicity of proparacaine is unknown. Prolonged use may possibly delay wound healing.
(d) Conditions of use.
(1)
The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local applications may also be used as an aid in the removal of foreign bodies from the nose and ear canal, as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.
(ii)
For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to 10 drops in the ear; for nasal use, instill five to 10 drops in each nostril every 3 minutes for three doses.
(iv)
As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses.
(vi)
For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter.