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 1 mg (0.1%). Preservative: benzalkonium chloride 0.1mg (0.01%).
Inactives: Boric acid; edetate disodium; purified water; sodium chloride; sodium carbonate; and hydrochloric acid may be added to adjust the pH (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 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.

INDICATIONS AND USAGE

Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as a topical ocular vasoconstrictor.

CONTRAINDICATIONS

Contraindicated in the presence of an anatomically narrow angle or in narrow-angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.

WARNINGS

Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

PRECAUTIONS

General:

For topical ophthalmic use only. Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or injury.

Patient Information:

Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.

To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.

Drug Interactions:

Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. (See WARNINGS.)

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been
conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established. See “WARNINGS.” and “CONTRAINDICATIONS.”

ADVERSE REACTIONS

Ocular: Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.

Systemic: Dizziness, headache, nausea, sweating , nervousness, drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.

DOSAGE AND ADMINISTRATION

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.

HOW SUPPLIED

Naphazoline Hydrochloride Ophthalmic Solution, USP) is supplied as a sterile 0.1% solution in

15 mL plastic dropper bottles. NDC 17478-216-12

Storage: Store at 20° to 25°C (68° to 77°F). Keep container tightly closed.

Rx Only

Manufactured by:

Akorn Inc.
Lake Forest, IL 60045

Repackaged by:

Preferred Pharmaceuticals, Inc

Anaheim, CA

Principal Display Panel

AK-Con Label

AK-CON
naphazoline hydrochloride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68788-0446 (17478-216)
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
naphazoline hydrochloride (naphazoline)	naphazoline hydrochloride	1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
edetate disodium
water
sodium chloride
SODIUM CARBONATE
BENZALKONIUM CHLORIDE
HYDROCHLORIC ACID
BORIC ACID

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68788-0446-1	15 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA083590	08/22/1974

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Operations
Preferred Pharmaceuticals, Inc		791119022	RELABEL, REPACK

Revised: 05/2011Preferred Pharmaceuticals, Inc