Your browser does not support JavaScript! NAPHAZOLINE (NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]
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NAPHAZOLINE (naphazoline hydrochloride) solution/ drops
[Akorn, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Rx only

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:

Figure

Chemical Name:

2-(1-naphthylmethyl)-2-imidazole monohydrochloride

Each mL contains:

Active: Naphazoline Hydrochloride 1 mg (0.1%).

Inactives: Boric Acid, Edetate Disodium, Sodium Carbonate, Sodium Chloride and Hydrochloric Acid may be added to adjust pH (5.5 to 7.0), and Purified Water USP.

Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Naphazoline Hydrochloride Ophthalmic Solution, USP, 0.1% is a sterile solution with a pH between 5.5 and 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 presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or injury.

Patient Information: Patients should be advised to discontinue the drug and consult the 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 any surface, 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 also 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 harm when administered to a pregnant women or can affect reproduction capacity. Naphazoline should be given to a pregnant women 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 women.

Pediatric Use: Safety and effectiveness in the pediatric population 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) [see USP Controlled Room Temperature].

Keep container tightly closed.

Akorn

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

GNH00N Rev. 12/11

Principal Display Panel Text for Container Label:

NDC 17478-216-12

Naphazoline

Hydrochloride

Ophthalmic

Solution, USP

0.1%

15 mL

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-216-12

Naphazoline

Hydrochloride

Ophthalmic

Solution, USP

0.1%

15 mL

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Carton Label
NAPHAZOLINE 
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:17478-216
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Edetate Disodium 
Sodium Carbonate 
Sodium Chloride 
Hydrochloric Acid 
Water 
Benzalkonium Chloride 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-216-121 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08359012/19/1995
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.063434679LABEL(17478-216), PACK(17478-216)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE(17478-216), ANALYSIS(17478-216), STERILIZE(17478-216)

Revised: 3/2012
 
Akorn, Inc.

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