PROPARACAINE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Proparacaine Hydrochloride (UNII: U96OL57GOY) (Proparacaine - UNII:B4OB0JHI1X)

Available from:

MWI

INN (International Name):

Proparacaine Hydrochloride

Composition:

Proparacaine Hydrochloride 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Proparacaine Hydrochloride Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction. This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

Product summary:

Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied as a sterile solution in 15 mL plastic dropper bottles — NDC 13985-611-15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPARACAINE HYDROCHLORIDE- PROPARACAINE HYDROCHLORIDE SOLUTION/
DROPS
MWI
----------
APEXA™
PROPARACAINE HYDROCHLORIDE
Ophthalmic Solution, USP
0.5% Sterile
Rx Only
DESCRIPTION:
Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is a local
anesthetic for
ophthalmic instillation. Each mL of sterile, aqueous solution
contains: Active:
Proparacaine Hydrochloride 5 mg (0.5%). Inactives: Glycerin as a
stabilizer, Hydrochloric
Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 to 6.0),
and Water for
Injection. Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
Proparacaine hydrochloride is designed chemically as
2-(Diethylamino)ethyl 3-amino-4-
propoxybenzoate monohydrochloride. The active ingredient is
represented by the
structural formula:
CLINICAL PHARMACOLOGY:
Proparacaine Hydrochloride Ophthalmic Solution is a rapid acting local
anesthetic suitable
for ophthalmic use. With a single drop, the onset of anesthesia begins
within 30
seconds and persists for 15 minutes or longer.
The main site of anesthetic action is the nerve cell membrane where
proparacaine
interferes with the large transient increase in the membrane
permeability to sodium ions
that is normally produced by a slight depolarization of the membrane.
As the anesthetic
action progressively develops in a nerve, the threshold for electrical
stimulation gradually
increases and the safety factor for conduction decreases; when this
action is sufficiently
well developed, block of conduction is produced.
The exact mechanism whereby proparacaine and other local anesthetics
influence the
permeability of the cell membrane is unknown; however, several studies
indicate that
local anesthetics may limit sodium ion permeability by closing the
pores through which
the ions migrate in the lipid layer of the nerve cell membrane. This
limitation prevents the
fundamental change necessary for the generation of the action
potential.
INDICATIONS AND USAGE:
Proparacaine Hydrochloride Ophthalmic Solution is indicated for
topical anesthesia in
ophthalmic practice.